STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Device Description

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.

AI/ML Overview

Acceptance Criteria and Device Performance for STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device

This document outlines the acceptance criteria and the study that demonstrates the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device meets these criteria. The information is extracted from the provided FDA 510(k) summary (K192144).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device are based on the USP Monograph for absorbable surgical sutures, specifically focusing on tensile strength. The claimed performance relates to meeting the knot tensile strength of equivalent non-barbed USP and EU Pharmacopoeia polydioxanone devices.

Acceptance Criteria (USP Polydioxanone Knot Tensile Strength)	Reported Device Performance (STRATAFIX™ Spiral PDS™ Plus Bidirectional Straight Tensile Strength)	Device Size (USP/EU Pharmacopoeia)
USP (kgf)	USP (kgf)	EU Metric / Ph. Eur. Designation
5.08	5.08 (meets or exceeds)	1 / 4
3.90	3.90 (meets or exceeds)	0 / 3.5
2.68	2.68 (meets or exceeds)	2-0 / 3
1.77	1.77 (meets or exceeds)	3-0 / 2
0.95	0.95 (meets or exceeds)	4-0 / 1.5
Metric / Ph. Eur. (N)	Metric / Ph. Eur. (N)
50.8	50.8 (meets or exceeds)	1 / 4
39.0	39.0 (meets or exceeds)	0 / 3.5
26.8	26.8 (meets or exceeds)	2-0 / 3
17.5	17.5 (meets or exceeds)	3-0 / 2
9.32	9.32 (meets or exceeds)	4-0 / 1.5

Note: The device's straight tensile strength is compared to the knot tensile strength of conventional non-barbed sutures, as the barbs reduce the overall tensile strength of the barbed suture itself.

2. Sample Size and Data Provenance

The document states that "Non-clinical laboratory performance testings were performed" and "Bench and Animal testings show that the device performed as intended and as claimed." However, specific sample sizes for these tests are not provided in the given text.

Sample Size for Test Set: Not specified.
Data Provenance: The tests are described as "Non-clinical laboratory performance testings" and "Bench and Animal testings." This suggests the data is likely generated in a controlled laboratory environment. The country of origin of the data is not explicitly mentioned, but given the submitter (Ethicon, Inc., New Jersey, USA) and the FDA submission, it is likely that parts of these studies were conducted in the USA or by facilities adhering to US regulatory standards. The tests are prospective in nature, as they are conducted to demonstrate compliance with standards for device clearance.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable and not provided in the given text. The evaluation of this device relies on objective physical property measurements (tensile strength, diameter, etc.) and animal studies. It does not involve human expert interpretation for establishing a "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method

This information is not applicable and not provided in the given text, as the "ground truth" for this device is established through objective physical measurements and animal model observations, not through human expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance, to assess the AI's impact on human performance. The STRATAFIX™ device is a surgical suture, and its performance is evaluated through physical and biological testing, not through human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable and not provided in the given text. The STRATAFIX™ device is a physical surgical suture, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. Type of Ground Truth Used

The ground truth for evaluating the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is based on:

Objective Physical Measurements: Adherence to the USP Monograph for absorbable surgical sutures for properties such as tensile strength (specifically, meeting the knot tensile strength of equivalent non-barbed sutures) and general characteristics (except for diameter, which has minor variations acceptable by the manufacturer).
Animal Testing: Demonstration that the "device performed as intended and as claimed" in animal models.

8. Sample Size for the Training Set

This information is not applicable and not provided in the given text. As a physical medical device (suture) rather than a machine learning algorithm, there is no "training set" in the context of data-driven model development. The development process would involve materials science and engineering principles, with testing conducted to optimize design and verify performance.

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

This information is not applicable and not provided in the given text. As there is no "training set" for this physical device, there is no ground truth established in that context. Device development and testing rely on established engineering standards and biological effects, not on a machine learning training paradigm.

Summary

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September 24, 2020

Ethicon, Inc. Joice Pappan Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K192144

Trade/Device Name: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

Dear Mr. Joice Pappan:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 25, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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March 25, 2020

Ethicon, Inc. Joice Papan Regulatory Affairs Manager Route 22 West. P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K192144

Trade/Device Name: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: February 21, 2020 Received: February 24, 2020

Dear Mr. Papan:

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

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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,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192144

Device Name

STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

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

Submitter:	Ethicon, Inc., a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, New Jersey 08876-0151USA
Contact Person:	Joice PappanRegulatory Affairs ManagerEthicon, Inc., a Johnson & Johnson companyPh: (908) 218-2113Fax: (908) 541-3868Email: Jpappan@its.jnj.com
Date Prepared:	March 20, 2020
Device Trade Name:	STRATAFIX™ Spiral PDS™ Plus BidirectionalKnotless Tissue Control Device
Device Common Name:	Suture, Surgical, Absorbable, Polydioxanone
Class:	II
Classification Name:	Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840)
Product Code:	NEW

Predicate Devices	510(k) Number
STRATAFIXTM Spiral PDSTM Plus Knotless Tissue Control Device(Primary)	K182873
Secondary: QuillTM PDO Knotless Tissue Closure Device	K120827

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Image /page/5/Picture/0 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in red, with the letters in a bold, sans-serif font. To the right of the word "ETHICON" is the word ",INC." in a smaller, sans-serif font. Below the word "ETHICON" is the phrase "a Johnson & Johnson company" in a cursive font.

Device Description:

While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.

The USP and EU Pharmacopoeia sizes of the STRATAFIX™ Spiral PDS™ Plus Bidirectional Device are further defined in Table 1.

USP DEVICESIZEDESIGNATION	EUPHARMACOPOEIADEVICE SIZE	STRATAFIX™ Spiral PDS™ PlusBidirectional
	(Metric / Ph. Eur.)DESIGNATION	USP	Metric / Ph. Eur.
1	4	1	4
0	3.5	0	3.5
2-0	3	2-0	3
3-0	2	3-0	2
4-0	1.5	4-0	1.5

Table 1. Diameter Comparison

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Image /page/6/Picture/0 description: The image contains the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font, with the ", INC." in a smaller font size. Below the company name is the text "a Johnson & Johnson company" in a cursive font.

Tensile Strength:

STRATAFIX™ Spiral PDS™ Plus Bidirectional Device straight tensile strength meets the knot tensile strength for a USP and EU Pharmacopoeia polydioxanone device of the equivalent size as shown in Table 2.

Table 2. Tensile Strength Comparison

USP DEVICE SIZEDESIGNATION	EUPHARMACOPOEIADEVICE SIZE(Metric / Ph. Eur.)DESIGNATION	Device MinimumKnot Tensile Strength
		USP (kgf)	Metric /Ph. Eur. (N)
1	4	5.08	50.8
0	3.5	3.90	39.0
2-0	3	2.68	26.8
3-0	2	1.77	17.5
4-0	1.5	0.95	9.32

Indications for Use:

STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Performance Data:

Non-clinical laboratory performance testings were performed to demonstrate that STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. These testings were performed in accordance with FDA's guidance document: "Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff" issued on June 3, 2003. Bench and Animal testings show that the device performed as intended and as claimed.

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Image /page/7/Picture/0 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters, with "INC." in smaller letters to the right. Below the company name is the text "a Johnson & Johnson company" in a cursive font. The logo is simple and clean, with a focus on the company name.

Summary of Technological Characteristics and Performance:

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device has similar technological characteristics as the predicate devices. Like the currently marketed predicate devices, STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is a sterile, monofilament synthetic absorbable suture intended for the approximation of soft tissue that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. The STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The barbs in STRATAFIX™ Spiral PDSTM Plus Bidirectional Device allow the tissue approximation without the need to tie surgical knots.

STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device will be available as a suture product with IRGACARE ®* MP, an antibacterial agent same as STRATAFIXTM Spiral PDSTM Plus Unidirectional predicate device.

Substantial Equivalence :

STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device has the same intended use and indications for use as the predicate devices. The technological differences between the subject device and the predicate devices raise no new questions of safety or effectiveness. STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device meets all criteria to demonstrate substantial equivalence to the predicate devices.

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device has shown to be appropriate for its intended use and is substantially equivalent to the predicate devices.

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

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.