AxyaFlex™ polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

AxyaFlex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. AxyaFlex™ sutures are braided for optimal handling properties.

AI/ML Overview

The provided text is a 510(k) summary for a surgical suture and does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical and chemical properties and biocompatibility.

Therefore, many of the requested categories for AI/ML device evaluation are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, while noting where information is missing or not relevant to AI/ML devices:

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

Acceptance Criteria (from USP & FDA Guidance)	Reported Device Performance
Suture Diameter requirements	Satisfied USP requirements
Suture Length requirements	Satisfied USP requirements
Knot Tensile Strength requirements	Satisfied USP requirements
Biocompatibility	Equivalent to predicate polyester material
Chemical Analyses	Equivalent to predicate polyester material
Sterilization Process	Equivalent to predicate suture manufacturers' process

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

Sample Size for Test Set: Not specified. The document mentions "summaries of studies" but does not detail the sample sizes for the tests conducted to evaluate suture diameter, length, and knot tensile strength.
Data Provenance: Not specified.

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)

Not applicable. This is a medical device (suture), not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for performance evaluation in the clinical sense. The "ground truth" here would be objective measurements against established standards (USP).

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

Not applicable. (See #3)

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 not an AI/ML device.

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

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

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

The "ground truth" implicitly used for the physical and mechanical properties (diameter, length, knot tensile strength) would be the United States Pharmacopeia (USP) standards and FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures." For biocompatibility and chemical analyses, the ground truth would be established scientific and regulatory benchmarks for safety and equivalence to predicate materials.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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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K060165

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

SEP - 1 2006

Name: Axya Medical, Inc. Contact: Howard Schraver Regulatory Affairs Consultant
100 Cummings Center Address: Suite 444C Beverly, MA 01915
Telephone: (978) 232 - 9997 Fax: (978) 232 - 9998
Date Prepared July 20, 2006

General Device Information

Product Name: AxyaFlex™ polyester suture
"Nonabsorbable poly(ethylene terephthalate) surgical suture" Classification: Product code: GAT - Class II 21 CFR 878.5000

Predicate Devices

Aesculap, Inc. Synthofil™ PET Sutures [510 (k) Number K990088]

Genzyme Surgical Nextstitch™ PET Sutures [510(k) Number K001440]

United States Surgical Corp. Nonabsorbable Dacron® sutures [510(k) Number K902873]

Sharpoint, Inc. Dacron® Sutures [510(k) Number K904263]

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K060165

Page 2 of 3

Ethicon, Inc. Mersilene® Polyester Fiber Suture A pre-enactment device

Genzyme Surgical Products "Cottony" II Dacron Polyester Nonabsorbable Suture [501(k) Number K001434]

Description

Intended Use (Indications)

AxyaFlex™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Substantial Equivalence

This submission supports the position that the AxyaFlex™ polyester suture is substantially equivalent to a number of previously cleared devices, including the Ethicon, Inc. Mersilene® polyester suture [pre-enactment] and the Genzyme Surgical Products "Cottony" II Dacron Polyester Nonabsorbable Suture.

The 510(k) Notice contains summaries of studies that were conducted to evaluate suture diameter, length, and knot tensile strength as specified in the USP and in the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA" (June 23, 2003). In addition, biocompatibility testing and chemical analyses were conducted to demonstrate that the suture material was equivalent to predicate polyester material.

The data presented demonstrate that the AxyaFlex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials.

The sutures are provided sterile. The suture material is sterilized using a process equivalent to the process used by the predicate suture manufacturers.

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K060165

Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed sutures have been used for the same clinical applications as the indications as the indications for the AxyaFlex™ polyester suture. The material from which the Axya device is fabricated has an established history of use in medical applications; and devices produced by Axya have been tested in accordance with applications, and devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

Axya Medical, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K060165

Trade/Device Name: AxyaFlex™ polyester suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: July 21, 2006 Received: July 25, 2006

Dear Mr. Schrayer:

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 - Mr. Howard L. Schrayer

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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mekerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE

KO60165 510(k) Number (if known):

Device Name: AxyaFlex™ polyester suture

Indications For Use:

AxyaFlex™ polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number 4 [K060163](https://510k.innolitics.com/search/K060163)

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.