PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.

Device Description

PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.

AI/ML Overview

This document is a 510(k) summary for a medical device called PERMATAPE™ SUTURE. The document details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here is the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it refers to industry standards and predicate device comparisons.

Acceptance Criteria (Implied)	Reported Device Performance
USP Tensile Strength for Surgical Sutures	PERMATAPE™ Suture's performance was tested per USP Tensile Strength for Surgical Sutures.
Conformance to FDA's Special Controls Guidance document for Surgical Sutures	The device follows FDA's Special Controls Guidance document for Surgical Sutures.
Bacterial endotoxin testing requirements	The proposed device met requirement of bacterial endotoxin testing.
Substantial equivalence to predicate devices in intended use, materials, sterilization method, and technological characteristics.	Based on similarities, the PERMATAPE™ suture has been shown to be substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document describes a physical medical device (surgical suture), not a software or AI/ML device that would typically involve test sets of data. The testing mentioned (USP Tensile Strength, bacterial endotoxin) would involve physical samples of the suture, but the sample sizes for these tests are not specified, nor is the "data provenance" as it would apply to data in an AI context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this document. This is a physical medical device submission, not an AI/ML device where "experts" would establish ground truth for a test set. The "ground truth" for a suture would be its physical properties, which are measured using standardized methods.

4. Adjudication method for the test set

This information is not applicable to this document. Adjudication methods like "2+1, 3+1" are relevant for AI/ML device studies where discrepancies in expert labels or model predictions need resolution. For a physical device, performance is measured against established 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 to this document. An MRMC study is relevant for AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical suture, which does not involve human "readers" or AI assistance in that context.

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

This information is not applicable to this document. The device is a surgical suture; it is not an algorithm and does not have "standalone" performance in the context of AI.

7. The type of ground truth used

For the physical characteristics of the suture, the "ground truth" is established by adherence to established industry standards and test methods, specifically:

USP Tensile Strength for Surgical Sutures
FDA's Special Controls Guidance document for Surgical Sutures
Requirements for bacterial endotoxin testing

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not an AI/ML device requiring a "training set" of data in the common sense. The manufacturing process of the suture is the "training" in a very loose analogy, but it's not a data-driven training set.

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

This information is not applicable and not provided. As explained above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for the manufacturing process would be established by quality control procedures and specifications for materials and manufacturing methods, but these details are not provided in this regulatory summary.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Medos International Sarl % Ms. Tatyana Korsunsky Depuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K162247

Trade/Device Name: Permatape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: November 14, 2016 Received: November 15, 2016

Dear Ms. Korsunsky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162247

Device Name PERMATAPE™

Indications for Use (Describe)

PERMATAPE Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY PERMATAPE™ SUTURE

Date Prepared: 08/08/2016

Submitter'sName andAddress	Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Tatyana KorsunskyRegulatory Affairs Project LeadDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA
Name ofMedical Device	Proprietary Name: PERMATAPE™ SUTUREClassification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)Common Name: Suture
SubstantialEquivalencePredicateDevices	The PERMATAPE™ SUTURE is substantially equivalent to:K040004: ORTHOCORD® Suture (DePuy Mitek) Reference Devices: K130814: RIGIDLOOP™ Cortical Fixation system (DePuy Mitek) K141259: Gryphon™ Anchor with Permacord™ (DePuy Mitek) K150438: Smith & Nephew ULTRATAPE (Smith & Nephew)
DeviceDescription	PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.
Indications forUse	PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.
TechnologicalCharacteristicsandPerformance	The proposed PERMATAPE™ is a non-absorbable surgical suture. The determination of substantial equivalence for this device was based on a detailed device description, performance data, and conformance to consensus and voluntary standards.PERMATAPE™ Suture is similar in intended use, materials, sterilization method to the
	Telephone: 508-828-3122Facsimile: 508-977-6911e-mail: tkorsuns@its.jnj.com

Traditional 510(k) – PERMATAPE™ Suture

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predicate DePuy Mitek's ORTHOCORD® (K040004) suture. Its polyethylene material is also comparable to reference predicates DePuy Mitek's RIGIDLOOP™ Cortical Fixation system (K130814) and Gryphon™ Anchor with Permacord™ (K141259). PERMATAPE™ is a flat type of suture, similar to reference predicate Smith & Nephew's ULTRATAPE (K150438).

PERMATAPE™ Suture's performance was tested per USP Tensile Strength for Surgical Sutures and follows FDA's Special Controls Guidance document for Surgical Sutures, however, it does not conform to USP Diameter and size classification due to its flat braiding. The proposed device met requirement of bacterial endotoxin testing.

Based on the similarities of the intended use, materials, technological characteristics and USP Tensile testing, the PERMATAPE™ suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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.