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

Device Description

PLIASURE Suture is a synthetic absorbable sterile surgical suture composed of the homopolymer of glycolide (PGA). PLIASURE Suture is prepared by coating PGA suture material with a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. The polymers used in this product have been found to be nonpyrogenic and elicit minimal tissue reaction during absorption. The sutures are braided bicolored with a combination of dyed (D&C Violet #2) and undyed (natural) yarns. PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter.

AI/ML Overview

The provided text is a 510(k) summary for the PLIASURE™ Polyglycolide Synthetic Absorbable Suture. It details the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

The document does not explicitly state acceptance criteria in a quantitative table format with specific thresholds. Instead, it refers to broad regulatory and industry standards. The reported device performance is described in terms of meeting these standards and demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:	PLIASURE Suture's biocompatibility was evaluated in accordance with:- International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.- FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.'" May 1, 1995.The battery of testing included:- Cytotoxicity- Irritation and Sensitization- Acute Systemic Toxicity- Pyrogenicity- Genotoxicity- Implantation (for Tissue Reaction and Absorption)Conclusion: This implies the device met the biocompatibility requirements as assessed by these tests and standards.
Physical/Performance Characteristics:	USP performance testing conducted:- Suture – Diameter <861>- Suture – Needle Attachment <871>- Tensile Strength <881>Additional performance testing conducted:- In vivo tensile strength retention profile- Absorption profileUSP Compliance: PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter (this is a direct statement implying compliance in other aspects).Conclusion: These tests were performed to demonstrate substantial equivalence to the predicate device. The results are stated to have demonstrated this equivalence.
Substantial Equivalence to Predicate Devices (Overall):	PLIASURE Suture has the same intended use and main technological characteristics as the predicate devices (VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture). The performance data (biocompatibility, physical performance, in vivo evaluation of tensile strength and absorption profile) demonstrate that PLIASURE Suture is substantially equivalent to the predicate devices.
Materials:	PLIASURE Suture has the same materials as the predicate devices. Composed of the homopolymer of glycolide (PGA) and coated with a mixture of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate.
General Characteristics (e.g., sterility, non-pyrogenic):	The device is described as "sterile" and the polymers used are "nonpyrogenic."

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

The document provides very limited detail on sample sizes. For the physical/performance characteristics, it mentions "sterilized suture samples in finished form" but no specific number. For biocompatibility, it lists test types (e.g., cytotoxicity, implantation) but doesn't quantify the samples used for these tests.

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests listed (biocompatibility, in vivo performance), it is highly likely these were prospective laboratory and animal studies, but this is an inference, not a direct statement.

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 product is a surgical suture, not a diagnostic or AI-driven device that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" here is defined by the established regulatory and industry standards (e.g., USP monographs, ISO 10993) and the performance of the predicate devices. The "experts" involved would be those performing the standardized laboratory and in-vivo tests and those evaluating the results against established benchmarks, but their number and specific qualifications are not detailed in this summary.

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

Not applicable to a conventional medical device like a surgical suture. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective interpretation (e.g., medical imaging, clinical endpoint assessment by multiple readers/clinicians). This document describes objective chemical, physical, and biological testing.

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-assisted diagnostic or treatment device.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" is defined by:

Established Regulatory Standards: USP (United States Pharmacopeia) monographs for surgical sutures (e.g., Suture – Diameter <861>, Suture – Needle Attachment <871>, Tensile Strength <881>).
International Biocompatibility Standards: ISO 10993-1.
Performance of Legally Marketed Predicate Devices: The device's performance is compared against the known and accepted performance characteristics of VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture to demonstrate "substantial equivalence."
Objective Laboratory and In-Vivo Measurements: Direct measurements of physical properties (tensile strength), chemical properties (absorption profile), and biological responses (biocompatibility tests like cytotoxicity, irritation, implantation).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable. This is not an AI or machine learning device requiring a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of community and support. The profiles are connected to a wing-like shape, symbolizing protection and care.

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

March 26, 2015

Ethicon Incorporated Ms. Susan Lin, RAC Manager, Regulatory Affairs P.O. Box 151 Route 22 West Somerville, New Jersey 08876

Re: K142822

Trade/Device Name: PLIASURE™ Polyglycolide Synthetic 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: February 19, 2015 Received: February 23, 2015

Dear Ms. Lin:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

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" (21CFR 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 yours.

Jennifer R. Stevenson -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K142822

Device Name

PLIASURE™ Polyglycolide Synthetic Absorbable Suture

Indications for Use (Describe)

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

I. SUBMITTER:	Ethicon
	P.O. Box 151
	Route 22 West
	Somerville, NJ 08876
	USA
	Phone: 918-218-2256
	Fax: 918-218-2595
Date:	September 29, 2014
Contact Person:	Susan Lin

II. DEVICE

Name of Device:	PLIASURE™ Polyglycolide Synthetic Absorbable Suture
Common Device Name:	Suture, Absorbable, Synthetic, Polyglycolic Acid
Classification Name:	Absorbable Poly(glycolide/L-lactide) Surgical Suture
Regulatory Class:	Class II, 21 CFR 878.4493
Product Code:	GAM

III. PREDICATE DEVICES:

VICRYLTM Coated Suture (K022269) DEXON/DEXON II Braided Suture (K972566)

IV. DEVICE DESCRIPTION:

{4}------------------------------------------------

V. INDICATION FOR USE

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PLIASURE Suture has same materials as the predicate devices. Like the currently marketed predicate devices, PLIASURE Suture is a sterile, braided synthetic absorbable suture intended for the soft tissue approximation and/or ligation. It conforms to the USP Monograph for absorbable surgical sutures, except for diameter,

VII. PERFORMANCE DATA

Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Suture. The following performance data was provided in support of the substantial equivalence determination:

Biocompatibility Evaluation

PLIASURE Suture is considered a permanent (>30 days) tissue contact implant device.

The biocompatibility evaluation for PLIASURE Suture was conducted in accordance with International Standard ISO 10993-1"Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, " as recognized by FDA, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.""May 1, 1995. The battery of testing included the following tests:

Cytotoxicity
Irritation and Sensitization
Acute Systemic Toxicity ●
Pyrogenicity
Genotoxicity
Implantation (for Tissue Reaction and Absorption) ●

Physical/Performance Characteristics

USP performance testing including Suture – Diameter <861>. Suture – Needle Attachment <871>, and Tensile Strength <881> was conducted on the sterilized suture samples in finished form. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vivo tensile strength retention profile and absorption profile.

{5}------------------------------------------------

VIII. CONCLUSIONS

PLIASURE Suture has the same intended use as the predicate devices. The main technological characteristics of PLIASURE Suture are the same as the predicate devices. The performance data including biocompatibility testing, physical performance testing, and in vivo evaluation of tensile strength and absorption profile demonstrate that PLIASURE Suture is substantially equivalent to the predicate 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.