Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Device Description

INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission). INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

AI/ML Overview

This document describes the INSORB™ Absorbable Staple, a medical device, and the study supporting its 510(k) clearance.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Attribute	Acceptance Criteria (from document)	Reported Device Performance (from document)
Functional Characteristics	Appropriate functional characteristics for a subcuticular skin closure stapling device.	"This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications."
Safety	Safe for use as an implantable absorbable staple for subcuticular skin closure.	"This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications."
Equivalence	Substantially equivalent to legally marketed predicate devices.	The device was found substantially equivalent to the indicated predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly mentions an "animal study" as part of the functional and safety testing. However, it does not specify the sample size for this animal study, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of human experts to establish ground truth for any test set. The validation appears to be based on an animal study and mechanical performance testing.

4. Adjudication Method for the Test Set

Not applicable, as human expert involvement and a test set requiring adjudication are not described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to human readers improving with or without AI assistance. The device is a surgical stapler, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device described. The INSORB™ Absorbable Staple is a physical medical device, not an algorithm or software. Its performance is evaluated through functional, safety, and animal testing, not through algorithmic standalone performance.

7. The Type of Ground Truth Used

Based on the information provided, the ground truth for the device's performance appears to be established through:

Mechanical performance testing: Assessing physical properties and function against predefined specifications.
Animal study: Evaluating in-vivo performance, degradation, and tissue reaction in a living model.

8. The Sample Size for the Training Set

Not applicable. The INSORB™ Absorbable Staple is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary of Study that Proves Acceptance Criteria:

The study proving the device meets the acceptance criteria is summarized as "FUNCTIONAL & SAFETY TESTING". This testing included:

An animal study: Designed to verify appropriate functional characteristics and safety in a biological environment.
Mechanical performance testing: To ensure the staples perform according to engineering specifications.
Package testing: (Likely to ensure sterility and integrity during storage and transport).

The document states, "This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications," and concludes that the device is "substantially equivalent" to predicate devices, which is the primary regulatory acceptance criterion for K024117.

Summary

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KO24117
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APR 2 2 2003

A. 510(k) Summary

SUBMITTER:	Incisive Surgical Inc.1409 Fairfield RoadMinnetonka, MN 55305Phone: 952-591-2543Fax: 952-591-5989
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CONTACT PERSON: Jim Peterson Vice President, Regulatory and Quality Affairs
December 12, 2002 DATE PREPARED:

TRADE NAME: INSORB™ Absorbable Staple

Implantable Staple COMMON NAME:

CLASSIFICATION: 21 CFR 878.4750, Staple, Implantable Class II

PRODUCT CODE: GDW

PREDICATE DEVICE(S): The INSORB™ Absorbable Staple is substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).

DEVICE DESCRIPTION: INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

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K024117
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INTENDED USE: Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. FUNCTIONAL & SAFETY TESTING: Prior to commercialization INSORB™ Absorbable Staples underwent testing to verify appropriate functional characteristics. This testing included an animal study, mechanical performance testing, and package testing. This testing demonstrates that the INSORBTM Absorbable Staples meet all required specifications. CONCLUSION: The INSORB™ Absorbable Staples from Incisive are substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).

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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH" is arranged vertically, curving along the left side of the logo.

APR 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Peterson Vice President, Regulatory and Quality Affairs Incisive Surgical, Inc. 1409 Fairfield Road Minnetonka, Minnesota 55305

Re: K024117

Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 2, 2003 Received: April 8, 2003

Dear Mr. Peterson :

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Page

Device Name: INSORB™ Absorbable Staple

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K624117

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.