VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

Device Description

VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture.

VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field.

VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes.

PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes.

PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m.

PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

This document describes a 510(k) premarket notification for surgical sutures (VICRYL™, PDS™ II, and PDS™ Plus). It does NOT involve a device that utilizes AI or requires complex performance studies with acceptance criteria in the typical sense of a diagnostic or therapeutic AI medical device.

The document explicitly states: "The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence."

Therefore, a detailed breakdown of acceptance criteria and a study proving a device meets them (as would be expected for an AI/ML device) is not applicable here. The nature of this submission is to demonstrate substantial equivalence to previously cleared sutures, primarily based on identical functionality, technological characteristics, and intended use. The only change mentioned is to the labeling (Instructions for Use) for clarification, standardization, and harmonization.

However, if we try to interpret the "acceptance criteria" in the context of this specific 510(k) submission, it refers to the conditions that allow the FDA to determine the device is "substantially equivalent" to predicate devices. The "study" (or rather, the justification) for meeting these criteria is the comparison to the existing predicate devices.

Here's how we might frame the information based on the provided text, while acknowledging the limitations:

Acceptance Criteria and Justification of Substantial Equivalence for VICRYL™, PDS™ II, and PDS™ Plus Sutures

Given that this 510(k) submission is for surgical sutures and not an AI/ML diagnostic or therapeutic device, the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" differs significantly from what your detailed request implies. The core "acceptance criterion" for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" isn't a complex clinical trial with performance metrics but rather a comparison of technological characteristics, intended use, and materials.

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

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance/Characteristics
Intended Use: Device's intended use must be the same as the predicate device(s).	Identical to predicate devices:
	- VICRYL™: General soft tissue approximation and/or ligation, including ophthalmic surgery (not cardiovascular/neurological).
	- PDS™ II: Soft tissue approximation, including pediatric cardiovascular tissue (where growth is expected) and ophthalmic surgery (not adult cardiovascular/neurological). Useful for extended wound support (up to 6 weeks).
	- PDS™ Plus: Soft tissue approximation, including pediatric cardiovascular tissue (where growth is expected) and ophthalmic surgery (other than contact with cornea/sclera) (not adult cardiovascular/neurological). Useful for extended wound support (up to 6 weeks).
Technological Characteristics: Device's technological characteristics must be the same as, or similar enough to, the predicate device(s) that any differences do not raise new questions of safety or effectiveness.	Identical to predicate devices:
	- Composition (copolymer for VICRYL™, polyester for PDS™ II and PDS™ Plus).
	- Formulation details (e.g., Polyglactin 370 and calcium stearate coating for VICRYL™, Irgacare® MP for PDS™ Plus).
	- Sterility: Sterile, synthetic, absorbable.
	- Physical form (braided/monofilament, dyed/undyed).
	- Gauge sizes, lengths, types.
Material, Device Construction, Performance Specification, Packaging, Sterilization, Manufacturing Process: No material change in these aspects compared to predicate.	No changes in material, device construction, performance specification, packaging, sterilization, or manufacturing process.
Labeling: Changes to labeling must not raise new questions of safety or effectiveness.	Labeling (Instructions for Use) has been revised for clarification, standardization, and harmonization with the intent of creating Instructions for Use which can be supplied globally. No change to intended use or patient population.

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

Not applicable. This submission does not involve a "test set" in the context of evaluating performance data from a patient population or algorithmic output. The demonstration of substantial equivalence is based on the inherent design, composition, and manufacturing of the sutures, and a comparison of these attributes to predicate devices. No specific "sample size" of patients or data is mentioned for performance evaluation.

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. There is no "ground truth" establishment in the context of diagnostic accuracy for this type of medical device submission. The determination of substantial equivalence is made by the FDA's regulatory experts based on the manufacturer's submission and comparison to predicate devices, drawing upon established scientific and engineering principles for surgical sutures.

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

Not applicable. There is no "test set" or adjudication process of interpretations as would be found in a clinical study for a diagnostic device.

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 device is not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

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

Not applicable. As described, there is no "ground truth" in the diagnostic sense. The "truth" here is the established safety and effectiveness of the predicate devices, to which these new sutures are being compared for substantial equivalence in their fundamental characteristics.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML model.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 27, 2019

Ethicon, Inc. Ms. Stephanie Saati Sr. Regulatory Affairs Program Lead Route 22 West P.O. Box 151 Somerville, New Jersey 08876

Re: K183183

Trade/Device Name: VICRYL™ Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW Dated: May 23, 2019 Received: May 24, 2019

Dear Ms. Saati:

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183183

Device Name

VICRYLTM (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Indications for Use (Describe)

VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

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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Image /page/3/Picture/1 description: The image shows the Ethicon logo. The word "ETHICON" is in red, and below it is the phrase "a Johnson & Johnson company" in black cursive. The logo is simple and clean, with a focus on the company name.

510(k) Summary

Submitter:	Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Stephanie SaatiSenior Regulatory Affairs Program LeadPhone: 908-218-3318Fax: 908-218-2595Email: ssaati@its.jnj.com

Date Prepared: May 20, 2019

Device Trade Name:	VICRYL TM (Polyglactin 910) Sterile Synthetic AbsorbableSurgical Suture
Common Name:	Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulatory Classification:	Absorbable poly(glycolide/l-lactide) surgical suture (21 CFR878.4493
Class:	II
Code:	GAM
Panel:	General and Plastic Surgery Devices

Device Trade Name:	PDS TM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Common Name:	Suture, Surgical, Absorbable, Polydioxanone
Regulatory Classification:	Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840)
Class:	II
Product Code:	NEW
Panel:	General and Plastic Surgery Devices

Device Trade Name:	PDSTM Plus Antibacterial (Polydioxanone) Sterile SyntheticAbsorbable Surgical Suture
Common Name:	Suture, Surgical, Absorbable, Polydioxanone
Regulatory Classification:	Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840)
Class:	II
Product Code:	NEW
Panel:	General and Plastic Surgery Devices

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Image /page/4/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font. Below it, in a smaller, cursive font, it says "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name.

Predicate Devices:

Device	Company	Product Code	510(k)/ NDA Number
VICRYL™ (Polyglactin 910)Braided Coated and UncoatedSynthetic Absorbable Suture, Dyed& Undyed, Braided andMonofilament	Ethicon, Inc.	GAM	K946271
PDSTM II (Polydioxanone) SutureDyed & Undyed	Ethicon, Inc.	NEW	N18331
PDS™ Plus Antibacterial Suture	Ethicon, Inc.	NEW	K061037

Device Description:

VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field.

VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes.

PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes.

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Image /page/5/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below it, in a smaller, cursive font, it says "a Johnson & Johnson company". The logo is simple and clean, with a focus on the company name.

PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m.

PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.

Indications for Use:

VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture:

VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation. including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

PDS™ II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture:

PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDSTM II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture:

PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

Summary of Technological Characteristics:

The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence.

Substantial Equivalence:

The proposed devices are identical to the predicate devices with respect to functionality, technological characteristics and intended use. There is no material, device construction,

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Image /page/6/Picture/1 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is in large, red, sans-serif font. Below it, in a smaller, black, cursive font, it says "a Johnson & Johnson company."

performance specification, packaging, sterilization or manufacturing process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which have been revised for clarification, standardization, and harmonization with the intent of creating Instructions for Use which can be supplied globally. There is no change to the intended use or to the patient population for these devices. The proposed devices do not raise new questions of safety or effectiveness as the predicate devices and are therefore substantially equivalent.

Conclusion:

Based on the intended use, fundamental scientific technology, technological characteristics and the intended use, the following subject devices, VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture, PDSTM II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture, and PDSTM Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture are considered to be substantially equivalent to their predicated devices.

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.