(196 days)
a) Carpal tunnel release / carpal tunnel syndrome
b) plantar fasciotomy/ Plantar fascitis
c) lateral release of the knee / extensor mechanism malignment
d) forearm fasciotomy / compartment syndrome
e) Mortons Neuroma/ Interdigital Neuroma
Mountable Endoscopic Knife
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Mountable Endoscopic Knife" (K982142), indicating that the device has been found substantially equivalent to a predicate device.
The letter mentions:
- Trade Name: Mountable Endoscopic Knife
- Regulatory Class: II
- Product Code: EMF
- Indications For Use: Carpal tunnel release/syndrome, plantar fasciotomy/fascitis, lateral release of the knee/extensor mechanism malignment, forearm fasciotomy/compartment syndrome, Mortons Neuroma/Interdigital Neuroma.
However, it does not specify any performance-based acceptance criteria, details of a study (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, training set details, or ground truth establishment) used to demonstrate compliance with such criteria. The substantial equivalence determination is based on the device being comparable to a legally marketed predicate device, not necessarily on a performance study against predefined acceptance criteria outlined in this document.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 30 1998
Mr. Eugene T. King President/Chief Executive Officer A.M. Surgical 290 East Main Street Smithtown, New York 11787
Re: K982142
Trade Name: Mountable Endoscopic Knife Regulatory Class: II Product Code: EMF Dated: October 5, 1998 Received: October 14, 1998
Dear Mr. King:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Eugene T. King
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark M. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (If known): | K982142 | Page 1 of 1 |
|---|---|---|
| Device Name: | Mountable Endoscopic Knife | |
| - Indications For Use: | ||
| a) Carpal tunnel release / carpal tunnel syndrome | ||
| b) plantar fasciotomy/ Plantar fascitis | ||
| c) lateral release of the knee / extensor mechanism malignment | ||
| d) forearm fasciotomy / compartment syndrome | ||
| e) Mortons Neuroma/ Interdigital Neuroma |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
Mark n Milkerson
K982142
| Prescription Use X (Per 21 CFR 801.109) | OR | Over-The-Counter Use: ______ (Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------------ | ---- | ------------------------------------------------------- |
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.