SUTURTEK FASTCLOSE SUTURING DEVICE by SUTURTEK INCORPORATED

The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE™ Suturing Device. The submission focuses on demonstrating substantial equivalence to a previously marketed device (K011105) and highlights an added "Sharps Injury Prevention Feature Claims."

However, the document does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML device. The provided text describes a medical device (suturing device) and its premarket notification, which is a different type of submission than what would typically include AI/ML performance data.

Here's a breakdown of why the requested information cannot be extracted from the given text:

AI/ML Device: The SuturTek FASTCLOSE™ Suturing Device is a manual instrument, not an AI/ML powered device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," "MRMC comparative effectiveness study," or "standalone algorithm performance" as they relate to AI/ML devices are not applicable or discussed in this document.
Acceptance Criteria and Device Performance: The document states that "Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features' (March 1995) were: Simulated Use Testing." However, it does not provide:
- Specific quantitative acceptance criteria (e.g., "sharps injury reduction rate of X%").
- The reported device performance against those criteria (e.g., "achieved Y% reduction").
- Any details about the methodology, sample size, or results of the "Simulated Use Testing."
Ground Truth, Experts, Adjudication: These terms are relevant for evaluating diagnostic or predictive AI/ML models where there's a need to establish a definitive correct answer (ground truth) often through expert consensus. For a mechanical surgical device with a sharps injury prevention feature, the "ground truth" would likely be the actual occurrence or non-occurrence of a sharps injury during simulated use, and typically wouldn't involve expert adjudication in the same way an image interpretation task would. No such details are present.

In summary, the provided document is a 510(k) summary for a mechanical surgical device and does not contain the specific information you've requested regarding acceptance criteria and performance studies in the context of an AI/ML device.

To illustrate, if this were an AI/ML device, the detailed information about acceptance criteria and study results would typically be found in a "Performance Testing" section that provides quantitative metrics (e.g., sensitivity, specificity, AUC) and a thorough description of the study design. This document does not include such a section.

Summary

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K030227 page 1/2

MAR 1 7 2003

SuturTek 51 Middlesex Street North Chelmsford Massachusetts 01863 (978)-251-8088

510K Summary of Safety and Effectiveness January 14, 2003 SuturTek FASTCLOSE™ Suturing Device

Sponsor Name SuturTek 51 Middlesex Street North Chelmsford Massachusetts 01863 (978)-251-8088 Contact Individual: Debbie Iampietro

1. Device Name

Proprietary Name: FASTCLOSE™ Common/Usual Name: Suture Panel: General and Plastic Surgery Class II 878.4830, 878.4800 GAL, GAB, HCF

Identification of Legally Marketed Device 3. The modified SuturTek FASTCLOSE™ Suturing Device is substantially equivalent to the SuturTek FASTCLOSE™ Suturing Device K011105.

Device Description 4.

The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

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K030227 Page 2/2

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న. Intended Use

The SuturTek Incorporated FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.

The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.

It is designed to aid in the prevention of accidental suture needle stick injuries.

Comparison of Technological Characteristics 6. The proposed SuturTek FASTCLOSE™ Suturing Device and the currently marketed device:
Have the same intended use Both are intended for soft tissue approximation and/or ligation in general surgical procedures.

Use the same fundamental scientific technology

Manual instrument passes a needle through tissue to place . sutures
. Have the same components reusable instrument single-use, disposable cartridge single-use, disposable needle sutures

The differences between the proposed SuturTek FASTCLOSE™ Suturing Device, and the current SuturTek FASTCLOSE™ Suturing Device, K011105 are:

에 Added Sharps Injury Prevention Feature Claims

7. Performance Testing

Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features" (March 1995) were: Simulated Use Testing

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2003

SuturTek Incorporated c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K030227

Trade/Device Name: SuturTek FASTCLOSE™ Suturing Device Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: January 14, 2003 Received: January 22, 2003

Dear Ms. Iampietro:

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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Page 2 - Ms. Debbie Iampietro

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

W 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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KO30 Jul 510(k) Number (if known):

SuturTek FASTCLOSE™ Suturing Device Device Name:

Indications For Use:

The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.

The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.

It is designed to aid in the prevention of suture needle stick injuries.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use _____________

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K030227

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Regulation Number and Section

§ 878.4830 Absorbable surgical gut suture.

(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.