STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Description

The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The device is available in a dyed and undyed version. The pigment for the dyed version is D&C Violet No. 2. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Bidirectional Device Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitation of the device use. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs allow for tissue approximation without the need to tie surgical knots.

AI/ML Overview

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document provides specific acceptance criteria for "Tensile Strength." For other characteristics, it broadly states conformance to the USP Monograph for absorbable surgical sutures, with an exception for diameter, and mentions other tests performed.

Acceptance Criteria	Reported Device Performance
Tensile Strength
USP Device Size 0 Minimum Knot Tensile Strength (kgf)	3.90
USP Device Size 2-0 Minimum Knot Tensile Strength (kgf)	2.68
USP Device Size 3-0 Minimum Knot Tensile Strength (kgf)	1.77
USP Device Size 4-0 Minimum Knot Tensile Strength (kgf)	0.95
EU Pharmacopoeia Device Size 3.5 Minimum Knot Tensile Strength (N)	39.0
EU Pharmacopoeia Device Size 3 Minimum Knot Tensile Strength (N)	26.3
EU Pharmacopoeia Device Size 2 Minimum Knot Tensile Strength (N)	17.4
EU Pharmacopoeia Device Size 1.5 Minimum Knot Tensile Strength (N)	9.32
Other Criteria
Suture Diameter	Conforms to USP Monograph, except for diameter (actual diameter of non-barbed section is one size greater than designated size with a maximum overage of 0.1 mm)
Needle Attachment Strength	Conforms to the current USP Monograph for absorbable surgical sutures
In Vitro Breaking Strength	Conforms to the current USP Monograph for absorbable surgical sutures
Ex Vivo Wound Closure Strength	Conforms to the current USP Monograph for absorbable surgical sutures

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

The document does not specify the sample sizes used for the test sets (e.g., number of sutures, number of measurements for each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission for a medical device and the tests are non-clinical laboratory performance tests, the data would typically be generated in a controlled laboratory environment, likely within the manufacturer's R&D facilities or contracted labs, rather than from human patients.

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 section is not applicable to the provided document. The "ground truth" for this type of device (surgical suture) is established through objective, quantifiable physical and chemical properties and performance characteristics, as defined by standard monographs (like USP and EU Pharmacopoeia) and engineering test methods. It does not rely on expert interpretation or consensus in the way, for example, an image analysis AI would.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human evaluators and subjective assessments, particularly when establishing ground truth for AI algorithms or clinical endpoints. The studies described here are bench and ex vivo performance tests.

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 section is not applicable. The device described is a physical surgical suture, not an AI software or a device that assists human readers in diagnostic tasks. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

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

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

The "ground truth" for the device's performance is based on established industry standards and objective physical measurements. Specifically:

USP Monograph for absorbable surgical sutures: This serves as the primary standard for characteristics like suture diameter (with an noted exception), needle attachment strength, in vitro breaking strength, and ex vivo wound closure strength.
EU Pharmacopoeia: Also referenced for device size and tensile strength.
Defined Tensile Strength values: Specific numeric criteria for minimum knot tensile strength are provided in Table 2, which are objective quantitative targets.

8. The sample size for the training set

This section is not applicable. The device is a physical product (surgical suture) and not an AI algorithm that requires a training set.

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

This section is not applicable, as there is no AI algorithm training set involved. The "ground truth" for the performance of the suture itself is established by the methods described in point 7.

Summary

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December 18, 2019

Ethicon, Inc Eleanor Zhou Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 00876-0151

Re: K192580

Trade/Device Name: STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 18, 2019 Received: September 19, 2019

Dear Eleanor Zhou:

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-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, 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) K192580

Device Name

STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

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 D)

|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, NJ 08876-0151USA
Contact Person:	Eleanor ZhouEthicon, Inc. a Johnson & Johnson companyPh: (908) 218-3198Fax: (908) 218-2595e-mail: ezhou2@its.jnj.com
510(k) Number:	K192580
Date Prepared:	December 16, 2019
Device Trade Name:	STRATAFIX™ Spiral MONOCRYL™ Plus BidirectionalKnotless Tissue Control Device
Device Common Name:	Suture, Surgical, Absorbable, Polyglcolic Acid
Class:	II
Classification Name:	Suture, Absorbable, Synthetic, Polyglcolic Acid(21 CFR 878.4493)
Product Code:	GAM

Predicate Device	510(k) Number
STRATAFIXTM Spiral MONOCRYLTM Plus Knotless Tissue Control Device(Primary)	K182873
QuillTM Self-Retaining System (SRS) comprised of MONODERMTM(Additional)	K072028

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Device Description:

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ 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 MONOCRYL™ Plus Bidirectional Device can be compared to USP knot strength of non-barbed sutures. 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 MONOCRYL™ Plus Bidirectional Device are further defined in Table 1.

USP DEVICESIZEDESIGNATION		EUPHARMACOPOEIADEVICE SIZE(Metric / Ph. Eur.)DESIGNATION	STRATAFIX™ Spiral MONOCRYL™Plus Bidirectional
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

TENSILE STRENGTH

STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Device straight tensile strength meets the knot tensile strength for a USP and EU Pharmacopoeia poliglecaprone 25 device of the equivalent size as shown in Table 2.

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USP DEVICESIZEDESIGNATION	EUPHARMACOPOEIA DEVICE SIZE(Metric / Ph. Eur.)DESIGNATION	Device MinimumKnot Tensile Strength
		USP (kgf)	Metric /Ph. Eur. (N)
0	3.5	3.90	39.0
2-0	3	2.68	26.3
3-0	2	1.77	17.4
4-0	1.5	0.95	9.32

Table 2. Tensile StrengthComparison

Indications for Use:

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

Performance Data:

Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. The testing was performed in accordance with FDA's Guidance Document: "Class II Special Controls Guidance Document: Surgical Sutures" issued on June 3, 2003. Bench testing evaluated: Suture Diameter, Needle Attachment Strength, Tensile Strength, In Vitro Breaking Strength, and Ex Vivo Wound Closure Strength.

Summary of Technological Characteristics and Performance Testing:

The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device has similar technological characteristics as the predicate devices. Like the currently marketed predicate devices, STRATAFIX™ Spiral MONOCRYL™ 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 MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The barbs in STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Device allow the tissue approximation without the need to tie surgical knots.

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

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Substantial Equivalence:

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

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device has been shown to be appropriate for its intended use and is considered to be 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.