Indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. Surgilon (polyamide), Dermalon, Ophthalon are both braided and monofilament sutures available in white or dyed (black or blue) with a Logwood extract. These sutures are available in various lengths, diameters and quantities with or without surgical needles. These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of its tensile strength.

Device Description

Surgilon (polyamide) Ophthalon and Dermalon Non-Absorbable Surgical Suture are braided and monofilament sutures with a silicone coated dyed white or black with Logwood extract. These surgical sutures are composed of a long-chain aliphatic polymer Nylon 6 or Nylon 6,6. Surgilon, Dermalon and Ophthalan sutures are a class II device per 21 CFR Section 878.5020. Classification Code: 80GAR.

AI/ML Overview

The provided text describes the 510(k) summary for Surgilon®, Ophthalon®, and Dermalon® Non-Absorbable Surgical Sutures, focusing on their substantial equivalence to previously marketed sutures. The core of the submission is to justify that the change from a manual to an automated end stiffening process does not alter the safety or effectiveness of the device.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets requirements of ANSI/AAMI ISO 10993: Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. (Implicitly, the new manufacturing process does not negatively impact biocompatibility.)
Pharmacopeia Standards	Meets all requirements established by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures. (Implicitly, the new manufacturing process does not negatively impact compliance with these standards.)
Equivalence in Design, Composition, and Intended Use	Considered substantially equivalent in design, composition, and intended use to currently marketed Surgilon, Dermalon, and Ophthalon non-absorbable sutures covered under K930586. This implies that the tensile strength, sterility, packaging, and other critical physical properties are maintained.
Tensile Strength (Implicit)	The product description states "These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of tensile strength over time." The substantiation of substantial equivalence implies that this rate of strength loss and initial tensile strength are comparable to the predicate device.

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

The document does not explicitly state sample sizes for specific tests. It refers to testing in accordance with ANSI/AAMI ISO 10993 and compliance with USP and EP standards. These standards themselves define sample size requirements for various tests (e.g., cytotoxicity, sensitization, irritation, material characterization, mechanical properties).

Sample Size: Not explicitly stated. The tests would have used an appropriate number of suture samples as dictated by the referenced biocompatibility and pharmacopeial standards.
Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission from "Sherwood-Davis & Geck" (a US-based company), it's highly probable that the testing was conducted in the United States or by labs compliant with US regulatory requirements. The data would be retrospective in the sense that the tests were performed on manufactured devices for the purpose of demonstrating equivalence for this submission.

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

This information is not applicable in the context of this 510(k) summary. This document describes the testing of a physical medical device (surgical sutures) against international and pharmacopeial standards and a predicate device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For physical device testing against established standards, the results are typically quantitative or qualitative (pass/fail) based on objective measurements and established criteria within the standards.

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. This 510(k) submission is for a physical medical device (surgical sutures) and does not involve AI, human readers, or diagnostic interpretation.

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

This information is not applicable. This submission is for a physical medical device; there are no algorithms or standalone performance studies in this context.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is the established regulatory standards and pharmacopeial requirements, coupled with the performance characteristics of the predicate device.

Biocompatibility: The "ground truth" is defined by the acceptable limits and methodologies specified in ANSI/AAMI ISO 10993-1.
Physical and Chemical Properties: The "ground truth" is defined by the specifications and test methods in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures.
Substantial Equivalence: The "ground truth" here is that the new device, despite a manufacturing change, performs equivalently to the predicate device (K930586) across all critical parameters (tensile strength, sterility, indications for use, packaging, etc.). This equivalence is assessed through comparative testing and an understanding of the impact of the manufacturing change.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning study; therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of laboratory tests and analyses demonstrating substantial equivalence to a previously cleared predicate device (K930586) and compliance with relevant standards.

The key points from the document regarding this study are:

Comparative Assessment: The main "study" described is a comparison of the proposed sutures manufactured with an automated end stiffening process to predicate sutures manufactured with a manual process. The focus is on demonstrating that the only difference (automated vs. manual end stiffening) does not alter the fundamental characteristics or safety/effectiveness.
Biocompatibility Testing: The "representative Surgical Sutures, with adhesive, were tested for biocompatibility in accordance to ANSI/AAMI ISO 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
Pharmacopeial Compliance: The sutures were shown to "meet all requirements established by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures." These pharmacopeias include specific tests for tensile strength, diameter, sterility, particulate matter, and other physical/chemical attributes.
Argument for Substantial Equivalence: Sherwood-Davis & Geck concluded that the proposed sutures are "substantially equivalent in design, composition and intended use" to the predicate, implying that the detailed test results confirmed this equivalence. The similarities cited include: composed of long-chain aliphatic polymer, sterile, same indications for use, same lengths, diameters, quantities, colors, sizes, available with and without needles, and identical packaging.

In essence, the "study" is a comprehensive set of tests and comparisons designed to confirm that the manufacturing process change does not negatively impact the biological safety or functional performance of the sutures, ensuring they remain equivalent to existing, legally marketed sutures and meet all relevant regulatory and quality standards.

Summary

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JUL 1 3 1998

510k Summary of Safety and Effectiveness

K 981582

SURGILON® (Polyamide) , OPHTHALON®, AND DERMALON® NON-ABSORBABLE SURGICAL SUTURE

Submitted by: Sherwood-Davis & Geck 4444 McDonnell Blvd. Hazelwood, MO 63042-2516

S. Tamsett, Manager Contact:

July 7, 1998 Date of Summary:

Surgilon (polyamide) Ophthalon and Dermalon Non-Absorbable Surgical Suture are braided and monafilanent suturs with a silicone coated dyed white or black with Logwood extract. These surgical sutures are composed of a long-chain aliphatic polymer Nylon 6 or Nylon 6,6. Surgilon, Dermalon and Ophthalan sutures are a class II device per 21 CFR Section 878.5020. Classification Code: 80GAR.

Sugilon (polyamide), Opthhalon, and Dermalon sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. These sutures are braided and monofilament sutures available in various lengths, diameters and quantities with or without surgical needles. They are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of tensile strength over time.

Similarities between the proposed Surgilon, Ophthalon, and Demalon sutures to currently marketed sutures are 1)all are composed of long-chain aliphatic polymer, 2)all are sterile sutures, 3)all share the same indications for use, 4) all are available in the same lengths, diameters, quantities, colors and sizes, 5) all are available with and without surgical needles and 6)all are packaged in identical Tyvek/Mylar packaging.

The only difference between the proposed vs. The predicate sutures are an automated vs. a manual needle end stiffening process. TheSugilyn, Ophthalon and Demalon Absorbable Surgical Sutures, will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the nylon strand which is then cured and cut to length. The predicate nylon suture is currently manufactured using a manual end stiffening process of winding the nylon suture material onto racks and dipping the end in a nylon resin bath, curing then cutting the suture to length.

Summary of Safety and Effectiveness

C:\temp\S 10ksuro.doc

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These representative Surgical Sutures, with adhesive, were tested for biocompatibility in accordance to ANSI/AAMI 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. Further, surgical sutures meet all requirements established by the United States Pharmacopeia (SP) and European Pharmacopoeia (EP) for surgical sutures.

Sherewood-Davis & Geck considers the proposed Surgilon, Ophthalon ,and Dermalon Surgical Sutures (w/adhesive) to be substantially equivalent in design, composition and intended use, to the currently marketed Surgilon, Dermalon, Ophthalon non-absorbable sutures covered under K930586.

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

111 13 1998

Ms. Vanada Johnson Senior Regulatory Affairs Specialist Sherwood-Davis & Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042

Re: K981582 Trade Name: Surgilon, Dermalon, Ophthalon & Ophthalmic Non-Absorbable Nylon Suture Regulatory Class: II Dated: May 1, 1998 Received: May 4, 1998

Dear Ms. Johnson:

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 that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations: .

1. The Surgilon. Dermalon & Ophthalon & Ophthalmic Non-Absorbable Nylon Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures,
1. This device may not be manufactured from any long chain aliphatic polymers other than nylon 6 and/or nylon 6,6. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Surgilon, Dermalon & Ophthalon & Ophthalmic Non-Absorbable Nylon surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

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Page 2 - Ms. Vanada Johnson

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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. 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) 594-4595. 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 1 of 1

510(K) Number (if Known)

Device Name:

Surgilon/Polyamide, Dermalon, Ophthalon and Ophthalmic Nylon Nonabsorbable Surgical Suture

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	_
OR Over-the-Counter Use	_

(Division Sign-Off)

510(k) Number	K981582
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Sherwood-Davis & Geck Surgilon, Dermalon, Ophthalon and Ophthalmic Non-Absorbable Surgical Suture

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.