(105 days)
The Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.
Surgipro* Mesh Plug** device is a nonabsorbable, inert sterile, porous, surgical mesh knitted from yarns o polypropylene polymer from which Surgipro* surgical sutures are manufactured.
The provided text is a 510(k) summary for a medical device (Surgipro™ Mesh Plug) and a letter from the FDA. It does not contain any information about a study proving the device meets acceptance criteria, nor does it mention any performance metrics, sample sizes, expert involvement, or any of the other specific details requested in the prompt for AI/algorithm performance.
This document is a regulatory submission for a physical medical device (surgical mesh), not an AI/algorithm-based device. Therefore, a study proving the device meets acceptance criteria in the context of AI (e.g., accuracy, sensitivity, specificity, F1 score) is not applicable here.
The document primarily focuses on establishing substantial equivalence to predicate devices for its intended use (repair of groin hernia defects) and regulatory classification.
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510(k)_Summary of Safety and Effectiveness IX.
| SUBMITTER: | United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856 |
|---|---|
| CONTACT PERSON: | Jamie Yieh |
| DATE PREPARED: | July 23, 1998 |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| COMMON NAME: | Nonabsorbable Surgical Mesh |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | Bard® Marlex® Mesh PerFix™ Plug (K922916)Surgipro* Mesh (K905655) |
| DEVICE DESCRIPTION: | Surgipro* Mesh Plug** device is a nonabsorbable, inertsterile, porous, surgical mesh knitted from yarns opolypropylene polymer from which Surgipro* surgicalsutures are manufactured. |
| INTENDED USE: | Surgipro* Mesh Plug** device is indicated for the repairof groin hernia defects. |
| MATERIALS: | All component materials of the Surgipro* Mesh Plug**device are comprised of materials which are in accordancewith ISO Standard # 10993-1 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the heads, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 1998
Mr. Jamie Yieh Regulatory Affairs, Associate United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K982575 Re: Surgipro™ Mesh Plug Trade Name: Requlatory Class: II Product Code: FTL Dated: October 05, 1998 Received: October 13, 1998
Dear Mr. Yieh:
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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation (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 In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Jamie Yieh
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K9825.75
IV. Indications For Use:
510(k) Number (if known):
Name: Surgipro* Mesh Plug** device
Indications For Use:
The Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.
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Concurrence of CDRH, Office of Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)
to colle
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982575
RA05
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.