Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Device Description

Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).

AI/ML Overview

This document describes the FDA's decision regarding the substantial equivalence of a medical device, specifically Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture, to a predicate device.

It is crucial to understand that this document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence. It is NOT a study report for an AI/ML medical device that would involve performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, are not applicable to this document. This submission relies on the device being identical to its predicate.

Here's the breakdown based on the provided document:

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

Acceptance Criteria: Based on this 510(k) submission, the primary acceptance criterion for this device to achieve substantial equivalence is that its technological characteristics, intended use, and performance are identical to the legally marketed predicate device (K132580).

Reported Device Performance:

Criterion	Reported Performance
Functionality	Identical to the predicate device.
Technological Characteristics	Identical to the predicate device.
Intended Use	Identical to the predicate device.
Material	No material changes from the currently marketed devices.
Device Construction	No device construction changes from the currently marketed devices.
Performance Specification	No performance specification changes from the currently marketed devices.
Packaging	No packaging changes from the currently marketed devices.
Sterilization	No sterilization changes from the currently marketed devices.
Manufacturing Process	No manufacturing process changes from the currently marketed devices.
Safety and Effectiveness	The proposed device does not raise new questions of safety or effectiveness compared to the predicate device.

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

Not Applicable. This document does not describe a performance study with a test set in the context of AI/ML validation involving patient data. The basis of equivalence is the device's technical and material identity to an already cleared predicate.

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

Not Applicable. Ground truth establishment by experts is not described as part of this 510(k) submission, as it's not an AI/ML device requiring such performance validation.

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

Not Applicable. No test set or adjudication method is described.

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, and no MRMC study was conducted or is relevant to this type of device submission.

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

Not Applicable. This is not an AI/ML algorithm.

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

Not Applicable. The concept of "ground truth" as applied to AI/ML performance validation is not relevant here. The "truth" of equivalence is based on industrial and chemical specifications and previous FDA clearances.

8. The sample size for the training set:

Not Applicable. No training set is involved as this is not an AI/ML device.

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

Not Applicable. No training set ground truth was established.

In summary, this document is a regulatory submission demonstrating the substantial equivalence of a surgical suture based on its identical nature to a previously cleared predicate device. It does not contain information related to the performance testing typically associated with AI/ML medical devices.

Summary

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September 28, 2018

Ethicon, Inc. % Ms. Donna Marshall Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K181652

Trade/Device Name: Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 30, 2018 Received: August 31, 2018

Dear Ms. Marshall:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181652

Device Name

Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorable Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)

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

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K181652 p. 1 of 2

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510(k) Summary

Submitter:	Ethicon Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151USA
Contact Person:	Donna MarshallManager, Regulatory AffairsEthicon, Inc. a Johnson & Johnson companyPh: (908) 541-3990Fax: (908) 218-2595e-mail: dmarsha2@its.jnj.com

Date Prepared:	September 26, 2018
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Device Trade Name:	Coated VICRYL™ Plus Antibacterial (Polyglactin 910)Synthetic Absorbable Suture
Device Common Name:	Suture, Surgical, Absorbable
Class:	II
Classification Name:	Absorbable Poly(glycolide/L-lactide) Surgical Suture(21 CFR 878.4493)
Product Code:	GAM
Panel:	General and Plastic Surgery Devices

Predicate Device:

Device Trade Name	510(k) Number
Coated Vicryl™ Plus Antibacterial(Polyglactin 910) Absorable Suture	K132580

Device Description:

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the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).

Indications for Use:

Coated Vicry|™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Performance Data:

The technological characteristics of the proposed device is identical to the predicate device, therefore, performance data are not necessary to establish substantial equivalence.

Substantial Equivalence:

The subject device is identical to the predicate device with respect to functionality, technological characteristics and intended use. There is no material, device construction, performance specification, packaging, sterilization or manufacturing process changes to the currently marketed devices. The device differs only in the labeling (Instructions for Use) that have been revised to include the references of the latest publication of meta-analysis and guidelines for consideration of the use of triclosan-coated sutures to lower surgical site infection rates in the Actions Section. The proposed device does not raise new questions of safety or effectiveness as the predicate device and therefore substantially equivalent.

Conclusion:

Based on the intended use, fundamental scientific technology, technological characteristics and the intended use, the following subject device Coated Vicry]™ Plus Antibacterial (Polyglactin 910) Absorable Suture is considered to be substantially equivalent to the predicated device.

Trademark IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.