The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.

AI/ML Overview

The provided text is a 510(k) summary for the Saph-Loop™ Ligating Loop, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. 510(k) summaries for devices like sutures often rely on comparison to a predicate and adherence to recognized standards, rather than defining specific performance metrics and acceptance thresholds for a new clinical study. The device is a variation of an existing suture with a new deployment mechanism.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As this is a 510(k) for a modified device, the submission primarily focuses on technical comparison to the predicate device and conformance to standards, not a new clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. No "ground truth" or expert consensus for a test set is mentioned, as there isn't a new clinical study described in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. There is no description of a test set or adjudication process in the summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Saph-Loop™ Ligating Loop is a surgical device, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. No new ground truth data is established or discussed in this 510(k) summary. The "ground truth" for this submission is substantial equivalence to the predicate device, demonstrated through descriptive comparison and adherence to standards.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device and submission type.

9. How the ground truth for the training set was established

This information is not applicable/provided. See point 8.

Summary of what is known from the document regarding meeting acceptance criteria (substantive equivalence):

The device gained 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Tevdek® II suture (K001440).

The basis for this substantial equivalence included:

A detailed device description of the Saph-Loop™ Ligating Loop.
The Saph-Loop™ uses the same suture material (Tevdek™) as the predicate.
The difference lies in the addition of a deployment mechanism (carrier tubing, handle, pull ring) for the pre-tied knot.
Conformance to consensus standards and voluntary standards (though specific standards are not listed in this summary).

The FDA's letter states: "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... to legally marketed predicate devices..." This indicates that the submitted evidence was sufficient for the FDA to determine that the Saph-Loop™ Ligating Loop met the acceptance criteria for a 510(k) clearance based on substantial equivalence.

Summary

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K02410

510(k) Summary of Substantial Equivalence

1. MANUFACTURER:

Genzyme Biosurgery A division of GENZYME CORPORATION 600 Airport Road Fall River, MA 02720

Contract: Karen K. Sylvia, Sr. Regulatory Specialist Date Prepared: 22 July, 2002

2. DEVICE:

Tradename:	Saph-Loop™ Ligating Loop
Classification:	Nonabsorbable poly(ethylene terephthalate) surgical sutureper 21 CFR § 878.5000.
Common Name:	Suture with integral Deployment Device

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence is the Tevdek® II suture currently marketed by Genzyme Biosurgery, Fall River, MA 02720 (K001440). This 510(k)for Tevdek® II NextStitch™ and "silkv" II POLYDK® NextStitch™ Cardiovascular Valve Suture is a special configuration of Tevdek® II.

4. DEVICE DESCRIPTION:

5. INTENDED USE:

The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

6. COMPARISON

The Saph-Loop™ Ligating Loop is a means to deploy a cut length of Tevdek® II with a pre-tied knot. The suture is the same suture as currently marketed by Genzyme Biosurgery with the addition of the carrier tubing and handle for deployment.

The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards.

Genzyme Biosurgery, A division of GENZYME CORPORATION Fall River, MA 02720

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 depiction of a human figure, represented by three curved lines that suggest a profile. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2002

Genzyme Biosurgery Karen K. Sylvia Senior Regulatory Specialist 600 Airport Road Fall River, Massachusetts 02720

Re: K022410

Trade/Device Name: Saph-Loop™ Ligating Loop Regulation Number: 878.5000 Regulation Name: Non-absorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: July 18, 2002 Received: July 24, 2002

Dear Ms. Sylvia:

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. Drue, 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. Karen K. Sylvia

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 and additionally 21 CFR Part 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 Part 807.97). 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,

for Mark A. Milkerma

Celia M. Witten, Ph.D., M.D.

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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510(k) Number (if known) Device Name

K022410

Saph-Loop™ Ligating Loop

Indications for Use

The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

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

510(k) Number K022410

Prescription Use
(Per 21 CFR § 801.109)

Over-the-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(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.