"Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

"Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020. "Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon. Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5).

AI/ML Overview

This document describes the Genzyme "Cutalon" Nonabsorbable Polyamide Surgical Suture, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a novel device evaluation.

Below is an analysis structured to address your points, acknowledging that much of the information requested (like detailed performance studies, expert involvement, and statistical sample sizes for training/test sets) is not applicable or present for a 510(k) submission based on substantial equivalence to an already marketed device.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The "Cutalon" Nonabsorbable Polyamide Surgical Suture does not present a novel technology requiring de novo performance studies against specific acceptance criteria. Instead, its acceptance is based on demonstrating substantial equivalence to a predicate device (Genzyme's existing Nylon Suture) that has already met regulatory requirements. The key "acceptance criteria" here are aligning with existing standards and demonstrating no new questions of safety or effectiveness.

The "study" proving the device meets these criteria is primarily a comparison analysis and biocompatibility testing, rather than a clinical trial or performance study against quantitative metrics like accuracy, sensitivity, or specificity.

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

Acceptance Criteria (based on Substantial Equivalence)	Reported Device Performance (as per submission)
Intended Use Equivalence:	"Cutalon" Nonabsorbable Polyamide Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. This is identical to the predicate Nylon Suture.
Material Equivalence:	Composed of the long-chain aliphatic polymer extruded Nylon (Nylon 6), conforming to 21 CFR Part 878.5020. This is identical to the predicate Nylon Suture. The submission specifies "Nylon 6 or 6.6" in the comparison table, aligning with the predicate.
Manufacturing Process Equivalence:	Identical to the predicate Nylon Suture, with the exception of the packaging method. The base suture (extruded Nylon monofilament) is the same.
Function Equivalence:	The "Cutalon" Suture is identical in function to the predicate device. The wet packaging is described as enhancing suppleness, making it "easier to twist and tie," which is presented as an improvement in handling without altering the fundamental function.
Sterilization Equivalence:	Uses Gamma Irradiation (Cobalt 60), validated according to AAMI/ANSI/ISO 11137 with a Sterility Assurance Level (SAL) of $10^{-6}$. The predicate also uses Gamma Irradiation (or ETO).
Biocompatibility:	Demonstrated to be non-cytotoxic, non-hemolytic, non-allergenic, non-mutagenic, non-irritant, meeting requirements for systemic toxicity, implant requirements (USP Muscle Implant 1 week & 90 days), and USP physico-chemical. Meets requirements for long-chain aliphatic polymer Nylon 6. This aligns with safety expectations for an equivalent device and is based on specific testing (listed below).
Compliance with USP Requirements:	Genzyme "Cutalon" Sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable sutures except for diameter (the meaning of this exception is unclear without further context, but it's noted). The predicate also "Meets USP Requirement" for Suture Tensile Strength.
Packaging (Difference Acknowledged):	"Wet Packaged" (sterile) vs. "Dry Packaged" (sterile) for the predicate. This is the primary differentiating feature, intended to make the suture more supple. The safety and sterility of this new packaging method are addressed through validation of the packaging process and sterility. The FDA letter specifically notes the need for maintaining documentation regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures.
Tensile Strength:	Meets USP Requirement (consistent with predicate).

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

For substantial equivalence submissions like this, dedicated "test sets" with statistically determined sample sizes for performance evaluation (e.g., accuracy against a gold standard) are not typically required or provided.

Biocompatibility Testing: The specific sample sizes for tests like USP Muscle Implant, Sensitization, Acute Systemic Toxicity, Hemocompatibility, Cytotoxicity, and Genotoxicity are not explicitly stated in the summary. These tests typically involve animal models or in-vitro cultures. The provenance would be the testing laboratories, likely in the US, following recognized standards (ISO 10993-1). These are prospective tests performed on the "Cutalon" device.
Comparison to Predicate: The "test set" in this context is the predicate device itself and its historical performance, which has been marketed since December 1976.

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 is not applicable. No "ground truth" in the clinical sense (e.g., disease diagnosis) needed to be established by experts for comparing performance. The "ground truth" for this submission revolves around:

USP standards: These are established by pharmacopeial experts.
Biocompatibility standards (ISO 10993-1): These are established international standards by experts in toxicology and materials.
Predicate device characteristics: These were established during the original market approval (PMA N85-060 in 1976 and subsequent 510(k) K930738 in 1994) and are accepted as given.

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

Not applicable. There was no "adjudication" of performance data from a test set in this context. The FDA's review process itself involves regulatory experts evaluating the submission against established regulations and guidance documents.

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

Not applicable. This is a medical device (suture), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance metrics are irrelevant.

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

Not applicable, as this is not an AI algorithm.

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

The "ground truth" for this 510(k) submission is primarily derived from:

Regulatory Standards: United States Code of Federal Regulations (21 CFR Part 878.5020 for Nylon sutures).
Pharmacopeial Standards: United States Pharmacopeia (USP) requirements for nonabsorbable sutures.
International Biocompatibility Standards: ISO 10993-1 Biological Evaluation of Medical Devices.
Predicate Device Data: The established safety and effectiveness profile of Genzyme's existing Nylon Suture that has been on the market since 1976, which served as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device.

Summary

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JUL 7 1998

Section 2 510(k) Summary

510(k) Summary Genzyme "Cutalon" Nonabsorbable Polyamide Surgical Suture

1. DATE PREPARED

April 7, 1998

2. SPONSOR INFORMATION

Address:	Genzyme Surgical Products600 Airport RoadFall River, Massachusetts 02720
Telephone:	508-677-6679
Contact:	Jim KenneyDirector, Quality Assurance/Regulatory Affairs

3. DEVICE NAME

Proprietary Name: "Cutalon" Nonabsorbable Polyamide Surgical Suture Common/Usual Name: Nylon Nonabsorbable Polyamide Suture Classification Name: Nylon Nonabsorbable Polyamide Suture

4. DEVICE DESCRIPTION AND INTENDED USE

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5. COMPARISON TO PREDICATE DEVICE(S)

"Cutalon" Nonabsorbable Polyamide Surgical Sutures are identical in design, material, manufacturing process, function, and intended use to Nylon (Nylon 6) Nonabsorbable Surgical Sutures which are have been marketed by the Sponsor Company since 1976.

Section 3 Proposed Labeling

Draft proposed labeling for the "Cutalon" Nonabsorbable Polyamide Surgical Suture includes the actual device labeling and the package insert. Sample draft labeling for the device is provided in Appendix A.

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Section 4 Device Description

"Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components (see below description of formulation).

The packaging fluid contains: Isopropyl Alcohol 73.65% 1.2-Propylene Glycol 15.00% Water 8.25% Glycerin 2.30% Lactic Acid 0.45% Diethanolamine 0.20% Sodium Nitrite 0.10% Ammonia 0.05%

The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.

Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5). Genzyme Cutalon Sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable sutures except for diameter.

The "Cutalon" Suture is identical in design, materials (Nylon 6), manufacturing process and intended use to the Nylon Suture already marketed by Genzyme Surgical Products. This "Cutalon" Suture is simply a change in the packaging.

Genzyme's Nylon Suture has been on the market since December 1976. In Appendix D, please see a copy of NDA 85-060 FDA letter from December 1976 and also see a copy of the FDA's 510(k) letter dated July 26, 1994 which confirms that Genzyme has followed the instructions for "Suture Labeling Guidance" dated October 9, 1992.

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Design, Materials, Process, Packaging

The "Cutalon" Suture is designed to maintain sterility of the product until the time of use. Each individual suture/needle assembly is wrapped around a plastic winder and the combination is placed inside an open-ended pouch. The suture assemblies in their pouches are then loaded into the packaging machine. This machine forms a polyethylene "blister" and seals a medical grade paper lid stock onto it after it is filled with packaging fluid and product. The sealed blister is placed into a purchased film/Tyvek pouch and sealed on a bar sealer. (The bar sealers were validated for outer pouch sealing for the "wet" products and a packaging machine was validated for wet packed inner blister packaging. The pouch is designated to allow sterilization with the pouch and maintain a sterile environment until the pouch is opened. The Cutalon Nylon suture is foil-packaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose once again of the "wet" packaging is to provide a Nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.

The "wet" pouches are placed into solid bleached sulfite board boxes, with instructions for use. Polyamide suture packages are opened by peeling open the pouch. The loaded carrier is then aseptically opened in the sterile field. There is a clear film overwrap applied to the shelf box as a dust cover. Outer corrugate shipping cartons of various sizes are used to ship the suture boxes.

STERILIZATION:

a. Sterilization Method:	Gamma Irradiation (Cobalt 60)
b. Validation Method:	AAMI/ANSI/ISO 11137 Sterilization of health careproducts-Requirements for validation and routinecontrol-Radiation sterilization.
c. Sterility AssuranceLevel	$10^{-6}$

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Substantial Equivalence and Comparison Information Section 5

The "Cutalon" Nonabsorbable Polyamide Surgical Suture is identical in design, materials, manufacturing process, function and intended use to the predicate device, Genzyme's Nylon Suture.

Genzyme's Nylon Suture has been on the market since December 1976. In Appendix C, please see a copy of NDA 85-060 FDA letter from December 1976 and also see a copy of the FDA's 510(k) #K930738 letter dated July 26, 1994 which confirms that Genzyme has followed the instructions for "Suture Labeling Guidance" dated October 9, 1992.

Table 1"Cutalon" Nylon Sutures Compared to Predicate Suture Product
	"Cutalon" Suture	Nylon Suture
Intended Use	General soft tissue approximation and/or ligation	General soft tissue approximation and/or ligation
Suture Material	Nylon 6 or 6.6	Nylon 6 or 6.6
Sterilization Method	Gamma Irradiation	Gamma Irradiation or ETO
How provided	Sterile for Single Use Only	Sterile for Single Use Only
USP Sizes	6-0 thru 0	10-0 thru 5
Suture Tensile Strength	Meets USP Requirement	Meets USP Requirement
Packaging	Wet Packaged (sterile)	Dry Packaged (sterile)

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Section 6 Biocompatibility Information

Biocompatibility testing was performed on Genzyme "Cutalon" Nylon Surgical Sutures which satisfied the requirements of ISO 10993-1 Biological Evaluation of Medical Devices. The biocompatibility tests conducted were:

< USP Muscle Implant (1 week)

USP Muscle Implant (90 days)

USP Physico-Chemical

<Sensitization (saline and CSO)

USP Intracutaneous Testing (saline and CSO)

/ Acute Systemic Toxicity

Hemocompatibility

Cytotoxicity (USP Elution Method)

Genotoxicity (DMSO extract)

Genotoxicity (Saline extract)

The results of the biocompatibility testing of Genzyme "Cutalon" Nylon Surgical Sutures show the sutures to be non-cytotoxic, non-hemolytic, non-allergenic, non-mutagenic, nonirritant, meeting requirements for systemic toxicity, meeting implant requirements, and meeting USP requirements for long-chain aliphatic polymer Nylon 6. Reference Appendix D for copies of the actual test reports.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genzyme Surgical Products Mr. Stephen M. Page Director of Regulatory Affairs 600 Airport Road Fall River, Massachusetts 02720

7 1998 JUL

Re: K981322

Trade Name: "Cutalon" Nylon Polyamide Surgical Suture Regulatory Class: II Product Code: GAR Dated: April 8, 1998 Received: April 10, 1998

Dear Mr. Page:

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 "Cutalon" Nylon Polyamide 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 "Cutalon" Nylon Polyamide 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 - Mr. Stephen Page

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) 594-4639. 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,

[signature]

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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Image /page/8/Picture/0 description: The image shows a series of numbers and a letter written in a stylized, calligraphic font. The characters appear to be 'K981322'. The characters are bold and black, contrasting with the white background. The style of writing gives the impression of a handwritten or artistic representation of the alphanumeric sequence.

Device Name: "Cutalon" Nonabsorbable Polyamide Surgical Suture

Indications for Use:

(Per 21 CFR 801.109)

These indications for use are exactly the same as for the device we have on the market, Nylon Nonabsorbable Polyamide Surgical Sutures. The Nylon suture was approved for marketing by way of PreMarket Approval Application (PMA) # N85-060 "Approval Letter" for the original PMA dated July 26, 1976.

The only change between "Cutalon" and Nylon is the method of packaging. Nylon is dry packaged. "Cutalon" is wet packaged. [The difference is explained in detail in the body of this 510(k) ].

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (201.108 AFF 801.101 Prescription Use Genzyme Surgical Products of General Resto 600 Airport Road (O(k) Number Fall River, Massachusetts 02720-4740 Prescription Use

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.