Top 10 Pitfalls of a 510(k) Submission and How to Avoid Them | MDDI Medical Device and Diagnostic Industry News Products and Suppliers. While the U.S. regulatory system can be credited with ensuring high standards of patient safety and device effectiveness, the process of submitting a 510(k) can pose many challenges for medical device manufacturers both inside and outside of the United States. Each 510(k) submission is nuanced and dynamic, with any number of variations, depending on the type of device, the risk level, its history, etc. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device. To help medical device manufacturers—especially smaller start-ups and medical device companies outside of the United States (OUS)—to increase the likelihood that their 510(k) submissions will be reviewed and cleared with minimal delays, the following Top 10 Pitfalls should be understood and successfully navigated. 1. 2. 3. 4.
To adequately test the two devices side-by-side, samples of the predicate device must be acquired. 5. 6. 7. 8. 9. 10. Putting Guidewires to the Test. Author: Amy Peterson, DDL Addressing sterile single-use intravascular catheter introducers, ISO 11070:1998(E) tests help medical device manufacturers to ensure that products such as guidewires are safe for use. For guidewires in development, ISO 11070 provides a set of relatively quick and uncomplicated methods with which to evaluate different materials, manufacturing means, and engineering configurations in order to optimize the final product. Below is a crash course in ISO 11070 and tests that manufacturers must know to introduce a safe, effective guidewire to market. Outlined in Section 4 of the standard, the general requirements for the four devices covered under ISO 11070 include sterilization, biocompatibility, surface, corrosion resistance, and radiodetectability, as well as information to be supplied by the manufacturer.
And in Section 4.4, which directs the reader to Annex B, manufacturers can find the test requirements related to corrosion resistance. The Indium Corporation offers materials for hermetic and cryogenic sealing. Hobby Flyer. Part Drawings - Luer Fittings and Luer Connectors. 30505 92ISO%20594 2%20LUER%20TAPER%20STANDARDS. New Generation of Microlaparoscopic Instruments: Improved Strength, Invisible Scars - SAGES Abstract Archives. Andrew S Kastenmeier, MD, Konstantinos I Makris, MD, Christy M Dunst, MD, Lee L Swanstrom, MD. The Oregon Clinic Objective: The quest to minimize pain and scarring from surgical access has led to the development of novel techniques and surgical platforms. Natural orifice transluminal endoscopic surgery (NOTES) emerged as a revolutionary method of eliminating external surgical incisions, but it has not achieved widespread acceptance due to inherent technical challenges. Single incision laparoscopic surgery (SILS) has gained popularity by maintaining the laparoscopic approach, while limiting the incisions.
Despite good results, such “scarless” surgery has yet to become widely integrated due to its steep learning curve. It is commonly stated that the cosmetic benefits are outweighed by a significantly more difficult dissection. Session: Emerging Technology PosterProgram Number: ETP081View Poster « Return to SAGES 2011 abstract archive. Microlap Technologies Rolla, ND|Ferrules | Sleeves | Orifice/Nozzles | Jewel Bearings | Windows/Lenses | Pins/Blades. Needlescopy: Ultra-Minimally Invasive Surgery | Torrance Memorial Medical Center. Minimally invasive techniques like laparoscopy and surgical robotics have dramatically decreased the size of surgical incisions and scars.
But there’s a new type of surgery that goes one step further. Ultra-minimally invasive surgery, also known as needlescopy, uses surgical instruments so small, scars are virtually unnoticeable and pain is minimal. Traditional laparoscopy uses small incisions to access internal anatomy. Compared with traditional or open surgery, there is less scarring, less pain and faster recovery. Needlescopic surgery shares these benefits, but because it uses “needle-size” incisions, it is even less invasive. “Ordinary laparoscopic instruments vary in girth from 5 to 15 millimeters and will leave various size skin scars accordingly,” says Houman Solomon, MD, a physician with the Association of South Bay Surgeons who specializes in minimally invasive surgery.
Cosmetically, the scar is so small that it is usually not visible after the skin heals, says Dr. Bronchoscopic Forceps. The SpineView™ MIS Decompression System - SpineView, Inc. The SpineView™ MIS Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical instruments for interventional spinal procedures such as discectomy, nucleotomy, and foraminotomy. The system includes the enVue™ Cannula, and the enCise™ Bone Cutter which create a visualizable working space in the epidural region through a small port of approximately 8mm in diameter. 100% of decompression procedure is under Direct Visualization! Small incision for minimal musculature and soft tissue interruption. The enVue™ clear jaws retracts tissue allowing for greater visualization and bleeding control. The enCise™ osteotome tip can be rotated and precisely positioned against the bone. Rapid patient recovery.
Shorter procedure times. Logic™ | Surgical Innovations Ltd. Z-XYS. Enjoy!.... And remember, please submit a ER (Enhancement Request). 8^) ER link - - - Other SW Links - - Oh, and remember, don't be a coward, thief or shill. And, that means you SW Corp as well as SW Var's. Thanks to those who have contributed their models.
If you would like to contribute models, the site swxupload, is not working. Please send me the "defragged and zipped" files directly and less than 2 megs please. Copyright notice - all data shown here is shareware only, to be used for learning and reference only, not for profit redistribution, advertising, sale or resale. Paul Salvador - paul@zxys.com. 80/20 Inc. - T-slotted aluminum framing system. ENT Product Catalog 2015. XYZ Compact Translation Stage – CTS50 | E - Holmarc. Search.newport. XYZ Compact Translation Stage – CTS50 | E - Holmarc. Ftacourse. Circular Connectors, Cable Assembly | Fischer Connectors.
Isolator Series 120V 250W UL60601 1 Medical Grade Isolation Transformer 2 Hospital Grade Outlets (IS250HG) | Tripp Lite. Isolator Series UL60601-1 Listed Medical Grade Isolation Transformers offer line isolation, continuous noise filtering and enhanced common mode surge suppression. An internal low-impedance isolation transformer component offers 100% isolation from the input AC line. Full UL60601-1 medical-grade listing with hospital-grade plug and outlet receptacles makes Isolator medical-grade transformers ideal for protection of sensitive electronic equipment in patient-care areas. Faraday shield reduces the cumulative leakage current of the Isolator and connected equipment to levels less than 100 microamps. Secondary neutral-to-ground bonding virtually eliminates common mode noise, providing an isolated neutral-ground reference for sensitive equipment, and an inexpensive alternative to dedicated circuits and site electrical upgrades.
Removes EMI/RFI noise, utility switching transients and harmonics generated by other on-site loads and utility or lightning related surge conditions. Toroid Corporation > Transformer Products > IsoBox Transformers > Domestic C-Series. For Safer Use of Medical Electronics in Patient Care Areas The Medical Grade Enclosed Transformers have both low mechanical noise and low EMR (Electro-Magnetic Radiation). We have two standard formats, available in attractive white aluminum cases for floor, wall, chassis and cart installation. Typical applications include installation of computers, video monitors, surveillance cameras, test and measurement instruments, printers, clinics, doctor’s offices, or whenever safe operation of electronics equipment requires low leakage current levels.
This line of enclosed medical transformers offers all the advantages of the toroidal constructions such as low weight, low magnetic strayfield, low mechanical noise, low losses, high efficiency and cool operating temperature. The low height of the toroidal transformer allows the enclosure to have a low profile for easy installation in a modern office environment. The enclosures are made of sturdy aluminum with a white finish. Application Note: Passive Benchtop Isolation Systems. Thorlabs' passive benchtop isolation solutions are designed for temporary setups or less demanding applications. They provide vibrational isolation using either pneumatic isolators or sorbothane.
Options are available for use with breadboards, optical tables, or other heavy equipment. For more demanding applications, see our line of active isolation breadboard support frames. IsoPlateThorlabs' IsoPlate Isolation Systems use pneumatic isolators to provide vibrational isolation for breadboards. They consist of four inflated cushions that are built into the corners of a heavy-duty support plate. Passive Isolation MountsOur Passive Isolation Mounts are pneumatic isolator feet that are used to stabilize a small optical table or breadboard. Sorbothane FeetThorlabs' Vibration Isolating Feet are fabricated from sorbothane and provide vibrational isolation for workbench-mounted breadboards.
Example Based on the values given above, the calculated load per isolator is 13.5 lbs. Mobile Video Cart, Mobile Presentation Cart, Mobile Computer Cart & Live Event System. UEI T206IR 20 inch Flip Down TFT LCD Monitor with Wide Screen - Black. Photonics Buyers' Guide. Stainless Steel Tubing - Medical Needle Fabrication | Vita Needle Company. Racks | Products | SANUS. Glass capillaries - Hilgenberg GmbH. Since the 1950s we have been producing glass capillaries in utmost perfection for a wide range of applications. In the past decades our expertise as well as the variety of our products have been growing continuously. Apart from standard dimensions we also produce numerous special sizes – even in small quantities. Our modern production technology enables us to realize customer requirements at short notice.
The high-precision measuring equipment ensures compliance with tight tolerances. We use a wide range of glass types for the production of our capillaries. The materials we use include the following glass types: Soda-lime glass (AR, I860, PH360 etc.)Borosilicate glass (DURAN©, PYREX©, SIMAX© etc.)Neutral glass (FIOLAX© and DUROBAX©)Aluminium silicate glass (Schott 8252/8253)Quartz glass (naturally melted quartz glass and synthetically produced quartz glass, incl. The largest part of our capillaries is produced with the redrawing method. Subsequent In-house Processing Cutting: Drawing Tips: The Fiber Optic Association - Fiber Optic Standards. The Fiber Optic Association Tech Topics FOA Standards FOA Standard FOA-1: Testing Loss of Installed Fiber Optic Cable Plant, (Insertion Loss, TIA OFSTP-14, OFSTP-7, ISO/IEC 61280, ISO/IEC 14763, etc.) More FOA Standard FOA-2: Testing Loss of Fiber Optic Cables, Single Ended, (Insertion Loss, TIA FOTP-171, OFSTP-7, , ISO/IEC 14763) More FOA Standard FOA-3: Measuring Optical Power (Transmitter and Receiver Power, FOTP-95, Numerous ISO/IEC standards) More FOA Standard FOA-4: OTDR Testing of Fiber Optic Cable Plant (TIA FOTP-8/59/60/61/78, ISO/IEC 14763, etc.)
More US and International Fiber Optic Standards EIA-TIA Fiber Optic Standards These standards are under continual updating so it's unlikely this list is ever fully up to date. A full catalog of TIA specs is at TIA Fiber Optic Test Procedures (FOTPs) (These are commonly known as "FOTPs" but are officially called "EIA-455-x, e.g. EIA-458-B Standard Optical Fiber Material Classes and Preferred Sizes. JUNFLON® Peelable Heat-shrink Tube.
What is JUNFLON®Peelable Heat-shrink Tube? JUNFLON®Peelable Heat-shrink Tube is the industry’s first peelable heat-shrink tubing, offering time saving and process improvements in Catheter Manufacturing. Problems with traditional method Removing traditional FEP-HST tubing smoothly is a serious problem in Catheter Manufacturing. FEP-HST tubing is used to weld, laminate, tip and other processes. It is necessary to remove by “skiving”, this takes a long time and there is a possibility that the catheter can get damaged. Key Benefits PHST provide you with the following benefits. Characteristic PHST’s shrink force and temperature is suitable for polyamide-welding. Applications PHST has been used successfully in the Polyamide-Welding process of Catheters and Guidewires. Line up Our free samples have a large choice of different sizes . Contact us. Large Diameter Fiber Fusion Splicing System LDS II- 3SAE Technologies.
The rapid development of photonic technologies has created the need for sophisticated optical products well outside the “telecom standards”. User requirements and specifications for these photonic components are both increasingly diverse and technically challenging; often they cannot be realized due to the limitations in the glass processing and/or fiber splicing technology. Utilizing precision engineering, over 20 years of fiber splicing and glass processing experience, and actual listening to the wants and needs of our customers, 3SAE Technologies has developed the Large Diameter Splicing System II.
Precision mechanical design, coupled with powerful, high contrast optics, absolute control of positional and angular fiber alignment, sets the Large Diameter Splicing System II apart from competing technologies. An extremely sophisticated image processing software package allows the user to view, in real time, the progress of a fiber splice or optical component fabrication step. Custom Manufacturing. Although our reputation for standard components is well known, S4J is equally proud of our Custom Manufacturing Service. We are pleased that our customers often include us in the early stages of design to confirm the cost-effective manufacturability of the product.
From prototypes to production runs, S4J stands ready to serve your needs. All of our products are manufactured and, typically, finished in house which allows us to control quality and lead time. All designs for custom products are treated as confidential. Custom products are routinely manufactured from the following materials: Acetal/Delrin®* (natural and black) Aluminum Brass (C36000, electroless nickel plated) PEEK (polyetheretherketone), natural and black Polypropylene Radel®* R (Polyphenylsulfone- PPSU) Stainless Steel (303, 304, 316) Titanium Ultem®* (Polyetherimide) "Special is standard at S4J!
" We enjoy working closely with our customers to ensure that the final product meets their needs and expectations. Learn How To Easily Fabricate Your Own Gears. In 2010, we asked Dustyn Roberts, then teaching a course at NYU’s Interactive Telecommunications Program (ITP) called Mechanisms and Things That Move, to contribute something on fabricating your own gears for our Physical Science and Mechanics theme. Dustyn had just written a book, called Making Things Move, and we wanted to feature some of the kinds of content that could be found in it. — Gareth Gears are easy to understand, make, and use, if you know the vocabulary and can space the gears at the correct distance apart.
One nice thing about gears is that if you know any two things about them – let’s say outer diameter and number of teeth — you can use some simple equations to find everything else you need to know, including the correct center distance between them. First, look over the anatomy of the spur gear pair in figure 1 and the vocab below. Number of Teeth (N)Pitch Diameter (D): The circle on which two gears effectively mesh, about halfway through the tooth. Figure 1 Figure 2 More: Namiki Precision Jewel Co., Ltd. : dc motors, micro motors, sapphire wafers, diaphragm pumps, vibration motors : Namiki supplies high precision components.
Plastic. Tools. Optics. Mechanical Design.