Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair.

Device Description

Stylet with 16 gauge Cannula, for insertion through a separate incision into the abdominal cavity, in Laparoscopic Hernia Repair, to capture and temporarily hold. with spring retraction, the surgical mesh against the abdominal wall for permanent attachment by stapling. On completion of stapling, the stylet and cannula are advanced to release the mesh, enclose the hook within the cannula and safely remove the Hernia Mesh Stabilizer from the surgical site.

AI/ML Overview

This document is an FDA 510(k) summary for a medical device called the "Hernia Mesh Stabilizer." It describes the device, its intended use, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as per your request.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. It does not typically involve the submission of detailed performance studies against specific acceptance criteria in the same way a Premarket Approval (PMA) application would for a higher-risk device.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to a predicate device, not on specific performance metrics.
Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth is discussed.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (this device is not an AI/ML algorithm that requires a training set).
How the ground truth for the training set was established: Not applicable.

The document states that the Hernia Mesh Stabilizer is substantially equivalent to the GraNee Needle System for Hernia Repair due to similar intended use, entry method, function (capturing and holding surgical mesh), and material (stainless steel for internal body contact surfaces), and being sterile and single-use. This comparison serves as the basis for its market clearance, not a performance study against specific acceptance criteria.

Summary

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JUL 1 1998

SECTION 6

510(k) SUMMARY (21 CFR 807.92)

K 9815 98

Hernia Mesh Stabilizer Device Name: 1. Classification Name: Laparoscopic Accessory Predicate Device: GraNee Needle System for Hernia Repair. During 2. Laparoscopic Hernia Repair, the GraNee Needle enters the abdominal wall through a separate incision and captures the sutures attached to the surgical mesh, withdraws the sutures and either permanently attaches the mesh in place with the sutures or holds the mesh against the abdominal wall for permanent attachment with staples. Stylet with 16 gauge Cannula, for insertion through a 3. Device Description: separate incision into the abdominal cavity, in Laparoscopic Hernia Repair, to capture and temporarily hold. with spring retraction, the surgical mesh against the abdominal wall for permanent attachment by stapling. On completion of stapling, the stylet and cannula are advanced to release the mesh, enclose the hook within the cannula and safely remove the Hernia Mesh Stabilizer from the surgical site. 4. Intended Use: Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair. 5. Comparative Summary: Both the Hernia Mesh Stabilizer and the predicate device enter the surgical site through separate incisions to capture and hold surgical mesh against the abdominal wall prior to permanent stapling of the mesh over the herniated area. Both devices have internal body contact surfaces made of stainless steel and are provided to the user packaged sterile, for single use.

Page 11

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Section 6 (continued)

Summary Submitted by:

John K. Belknap President Medivices, Inc. 1740 Amherst Street Buffalo, NY 14214 Telephone: 716-835-5888 716-862-0483 Fax: April 27, 1998

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three curved lines representing its body and wings, symbolizing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 川

Medivices, Inc. ·c/o Thomas L. Parker 29 Lancaster Lane Orchard Park, New York 14127

Re: K981598 Trade Name: Hernia Mesh Stabilizer Regulatory Class: II Product Code: GCJ Dated: April 30, 1998 Received: May 4, 1998

Dear Mr. Parker:

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 (OS) 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.

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.

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Page 2 - Mr. Thomas Parker

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,

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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Page 10

SECTION 5

INDICATIONS FOR USE

HERNIA MESH STABILIZER

K 981598 :

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Over-The-Counter Use

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K981590
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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.