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

Device Description

PROLENETM Polypropylene Suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with phthalocyanine blue, Color Index Number 74160) to enhance visibility. PROLENE™ suture, also available as PROLENE™ HEMO-SEAL™ needle suture, is a needle suture combination in which the diameter of the suture swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the suture strand and the needle wire have been more closely aligned to reduce the degree of needle hole bleeding.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a modified medical device, specifically a suture. The fundamental purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to an existing legally marketed device (the predicate device) and thus does not require a full Pre-Market Approval (PMA).

Therefore, the "acceptance criteria" for this submission are not performance metrics in the typical sense of a clinical study demonstrating efficacy or accuracy for a diagnostic device. Instead, the acceptance criteria are met by demonstrating substantial equivalence to the predicate device through comparisons of design, materials, manufacturing processes, intended use, and performance testing as required by the relevant standards (in this case, USP monographs).

The "study" that proves the device meets "acceptance criteria" is a series of design verification tests, not a clinical trial or a study assessing algorithm performance.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (USP Monograph Requirements)	Reported Device Performance (Proposed Device)
USP < 871 > - Sutures - Needle Attachment Performance	Meets U.S.P. Monograph for needle attachment force (This is the key modification and the reason for the 510(k) submission).
USP < 881 > - Tensile Strength	Meets U.S.P. Monograph (Implied, as no deviation is noted and testing was conducted).
USP < 861 > - Sutures - Diameter	Meets U.S.P. Monograph - except for Diameter for 7-0 PROLENE (Identical to the predicate device's exception).
All other aspects (design, materials, sterilization, packaging, intended use)	Identical to the predicate device (PROLENE™ Polypropylene Suture K946173).

Explanation of "Acceptance Criteria" for this specific submission: The primary 'acceptance criterion' addressed by the modification is that the proposed device now meets the USP (U.S. Pharmacopeia) monograph requirements for needle attachment force, which the predicate device (specifically the HEMO-SEAL variant) did not fully meet. The submission demonstrates that the modified manufacturing process has achieved this. Other USP requirements (Tensile Strength, Diameter) were also tested to ensure that the modification did not negatively impact these properties.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text, but "Design Verification Testing" was conducted.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by ETHICON, Inc. This is a common practice for device modifications. It is a prospective set of tests on newly manufactured samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this type of device submission. The "ground truth" here is defined by objective, standardized physical performance measurements specified in USP monographs (e.g., specific force in Newtons for needle attachment, diameter in millimeters, tensile strength in Newtons per area). These are not subjective interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., by radiologists) to establish a "ground truth" when there's inter-reader variability. Here, the measurements are objective and standardized, directly compared against a numerical standard.

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 question is not applicable. This submission is for a surgical suture, not a diagnostic device or an AI-powered system that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a physical medical device (suture), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for performance testing (design verification) is:

Objective physical measurements against pre-defined, standardized specifications outlined in the United States Pharmacopeia (USP) Monograph for sutures. This includes:
- Needle Attachment Force (USP < 871 >)
- Tensile Strength (USP < 881 >)
- Diameter (USP < 861 >)

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this physical medical device and its manufacturing modification. The "training" here refers to process adjustments during manufacturing to achieve the desired physical properties.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated above. If interpreting "training set" as the initial manufacturing process development, the "ground truth" for the process adjustments would still be the objective physical measurements against USP standards.

Summary

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K133356 Page 1/3

510(k) SUMMARY

Sponsor:	ETHICON, Inc. P.O. Box 151 Route 22 West Somerville, New Jersey 08876
Contact:	Elliott Jang, RAC ETHICON, Inc. P.O. Box 151 Route 22 West Somerville, New Jersey 08876 Phone: 908-541-3817 Fax: 908-218-2595 Email: ejang1@its.jnj.com
	DEC 0 6 2013
Date of Submission:	October 28, 2013
Proprietary Name:	PROLENET™ Polypropylene Nonabsorbable Suture
Common Name:	Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation:	21 CFR 878.5010
Regulatory Class:	II
Product Code:	GAW
Predicate Devices:	Labeling Changes for Generic Suture Types, by Ethicon Inc., K946173, cleared January 9, 1995
	PROLENE Polypropylene Suture (Nonabsorbable Surgical Suture, U.S.P., Type B), by Ethicon Inc., NDA 16-374 approved April 16, 1969 followed by multiple supplements (converted from drug to PMA device in 1983 and then reclassified to class II device in 1990)
Device Description:	PROLENETM Polypropylene Suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with phthalocyanine blue, Color Index Number 74160) to enhance visibility.

ETHICON, Inc.

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PROLENE™ Polypropylene Nonabsorbable Suture Special 510(k) Pre-Market Notification

PROLENE™ suture, also available as PROLENE™ HEMO-SEAL™ needle suture, is a needle suture combination in which the diameter of the suture swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the suture strand and the needle wire have been more closely aligned to reduce the degree of needle hole bleeding.

The subject device is identical to the predicate device in all aspects, including design, materials, sterilization, and packaging. The only difference between the proposed and the predicate devices is that the proposed device now meets U.S.P. for needle attachment force and that is now reflected in the labeling.

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

Summary of Technological Characteristics of Modified Device to Predicate

The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate device. The performance modification was accomplished via adjustments to the swaging process settings. A comparison between the proposed and the predicate device is given in Table 1 below.

	Proposed Device	Predicate Device
510(k) Number	TBD	K946173
Product Code	Same	GAW
Regulation	Same	21 CFR 878.5010
Absorbable	Same	No
Intended Use	Same	PROLENE suture is indicatedfor use in general soft tissueapproximation and/or ligation,including use in cardiovascular,ophthalmic and neurologicalprocedures.
How Supplied	Same	The devices are available inone, two, or three dozen boxes.
Color	Same	Clear or Pigmented suturestrands (pigmented blue withphthalocyanine blue, ColorIndex Number 74160)
MaterialComposition	Same	Composed of an isotacticcrystalline stereoisomer ofpolypropylene, a syntheticlinear polyolefin.
Sterilization	Same	Sterilized by Ethylene Oxide
Packaging	Same	Plastic tray or paper folderplaced within sealed Tyvek -

Table 1: Device Comparison Table

ETHICON, Inc.

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PROLENE™ Polypropylene Nonabsorbable Suture Special 510(k) Pre-Market Notification

Image: [Blurred image]	copolymer overwrap.Individual overwrap pouchpackages placed withinpaperboard carton.
U.S.P.requirementsImage: [Blurred image]	Meets U.S.P.Monograph – exceptfor Diameter for 7-0PROLENE	Meets U.S.P. Monograph –except for Diameter for 7-0PROLENE, and except forNeedle Attachment for HEMO-SEAL.

Design Verification Testing (U.S.P. < 871> - Sutures - Needle Performance Data Attachment; U.S.P. < 881> - Tensile Strength; U.S.P. < 861> - Sutures -Diameter) was conducted to demonstrate the performance of the modified PROLENE™ HEMOSEAL™ Polypropylene Nonabsorbable Suture.

Based on the similarities to the predicate device identified in this Conclusions submission as well as the outcome of design verification, and that the devices have the same intended use, the same fundamental technology, and the same principle of operation, we conclude that the modified device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

Ethicon, Incorporated Mr. Elliott Jang, RAC Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville. New Jersey 08876

Re: K133356

Trade/Device Name: PROLENE™ POLYPROPYLENE NONABSORBABLE SUTURE Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: November 18, 2013 Received: November 19. 2013

Dear Mr. Jang:

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). and obsintherefore, market the device, subject to the general controls provisions of the Act. The . Fou may , increaser , 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 cither 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 or any rederal station and sequirements, 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

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· Page 2 - Mr. Elliott Jang, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k} Number (if known) K133356

Device Name

PROLENE™ POLYPROPYLENE NONABSORBABLE SUTURE

Indications for Use (Describe)

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

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.