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

Device Description

The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

The STRATAFIX™ Spiral MONOCRYL™ Plus 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. 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 Device. Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study with defined metrics.

Therefore, the specific quantitative acceptance criteria and the detailed study proving the device meets those criteria, as typically seen in an AI/ML medical device submission, are not explicitly present in this document. The document primarily describes equivalence through performance data relative to USP monographs and comparison to predicate devices.

However, I can extract the relevant information where applicable and indicate when a specific aspect is not detailed in the provided text.

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

Since this is a 510(k) for a surgical suture, the "acceptance criteria" are largely based on meeting existing USP (United States Pharmacopeia) monograph requirements for absorbable surgical sutures and demonstrating comparable performance to predicate devices. The document states:

"Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices conforms to the current USP Monograph for absorbable surgical sutures, except for diameter."

The table below summarizes the performance characteristics mentioned, with the understanding that "meets USP requirements" implicitly serves as an acceptance criterion.

Acceptance Criteria (based on USP Monograph/Predicate)	Reported Device Performance (Subject Device)
Suture Diameter	Conforms to USP Monograph (except for minor variation with a maximum overage of 0.1 mm after barbing)
Tensile Strength	Meets USP Knot Tensile requirements for Synthetic Absorbable Sutures of the same size equivalent
Needle Pull-Off	Meets USP requirements
Biocompatibility	(Implied to meet requirements through studies like Intramuscular Implantation, Subcutaneous Implantation, Irritation, Pyrogenicity)
Breaking Strength Retention (BSR)	62% @ 7 days, 27% @ 14 days
Absorption Profile	Essentially absorbed by 91 days post-implantation
Wound Holding Strength	(Bench and animal testing provided showing device performed as intended and claimed)
Wound Healing	(Bench and animal testing provided showing device performed as intended and claimed)
Bacterial Colonization	(Bench and animal testing provided showing device performed as intended and claimed for "Plus" variant)
Sterilization Method	Ethylene Oxide (comparable to predicates)

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 does not specify the exact sample sizes (number of sutures, number of animals, etc.) for each non-clinical test (bench and animal testing). It also does not explicitly state the country of origin of the data or whether the animal studies were retrospective or prospective, though animal studies are typically prospective.

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 document pertains to a physical medical device (surgical suture), not an AI/ML algorithm that requires expert ground truth labeling. Therefore, this information is not applicable and not provided. Performance is evaluated through physical and biological testing.

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

Not applicable, as this is not an AI/ML algorithm requiring human adjudication of classifications or segmentations.

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, as this is a physical medical device and not an AI-assisted diagnostic/treatment planning tool.

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

Not applicable, as this is a physical medical device and not an AI algorithm.

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

For a surgical suture, "ground truth" is established through standardized physical measurements (e.g., tensile strength testing equipment, caliper measurements for diameter) and biological assays/animal studies that assess tissue reaction, absorption, and wound healing, often against established scientific norms or predicate device performance. It is not based on expert consensus for interpretative tasks.

8. The sample size for the training set

Not applicable, as this device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable, as this device does not involve an AI/ML algorithm that requires a training set.

Summary

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

August 13, 2015

Ethicon Incorporated a Johnson & Johnson company Ms. Donna Marshall Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K151200

Trade/Device Name: STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYLTM Plus 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: July 9, 2015 Received: July 10, 2015

Dear Ms. Marshall:

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

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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 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/Resourcesfor You/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.

for

Sincerely yours.

David Krause -S

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

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Indications for Use

510(k) Number (if known) K151200

Device Name

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Indications for Use (Describe)

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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Traditional 510(k)
STRATAFIX™ Spiral MONOCRYL™ and
STRATAFIX™ Spiral MONOCRYL™ PLUS
Knotless Tissue Control Device Ethicon, Inc.

Image /page/3/Picture/1 description: The image features the logo for ETHICON, INC. The text "ETHICON, INC." is displayed in a bold, red font. Below the company name, there is a smaller tagline that reads "a Johnson & Johnson company" in a cursive font.

510(k) Summary

Submitter:	Ethicon Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151USA
Contact Person:	Donna MarshallManager, Regulatory AffairsEthicon, Inc. a Johnson & Johnson companyPh: (908) 541-3990Fax: (908) 218-2595e-mail: dmarsha2@its.jnj.com
Date Prepared:	August 12, 2015
Device Trade Name:	STRATAFIX™ Spiral MONOCRYL™Knotless Tissue Control DeviceandSTRATAFIX™ Spiral MONOCRYL™ PlusKnotless 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
MONOCRYLTM Plus Antibacterial (poliglecaprone 25) Suture	K050845
QuillTM MONODERMTM Knotless Tissue Closure Device, Variable Loop Design	K141778
	K123836
	K123409

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Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS Knotless Tissue Control Device Ethicon. Inc.

Device Description:

The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of nonbarbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device. Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

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Indications for Use:

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

Performance Data:

Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3. 2003. In addition, bench and animal testing was provided showing that the device performed as intended and as claimed.

Below you will find a list of non-clinical performance data completed for the STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices:

Bench Testing	Biocompatiblity	In-vitro/In-vivo
Suture Diameter	Intramuscular Implantation	Breaking Strength Retention
Tensile Strength	Subcutaneous Implantation	Wound Holding Strength
Needle Attachment	Irritation (Intracutaneous Reactivity)	Wound Healing
	Pyrogenicity	Bacterial Colonization

Substantial Equivalence:

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices have the same intended use and similar indications for use as the predicate devices. The technological differences between the subject devices, STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and the predicate devices raise no new questions of safety or effectiveness. STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices met all testing criteria to demonstrate substantial equivalence to the predicates devices. The following table compares the subject devices to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

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Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS Knotless Tissue Control Device Ethicon, Inc.

Comparison Table:

Comparison of Subject Device Characteristics to Predicate Devices

Characteristic	Subject Device:STRATAFIXTM SpiralMONOCRYLTM KnotlessTissue Control Device	Subject Device: STRATAFIXTMSpiral MONOCRYLTM Plus KnotlessTissue Control Device	Predicate Device:MONOCRYL PlusAntibacterial Sutures(K050845)	Predicate Device:QuillTM Knotless TissueClosure Device(Variable Loop Design)Comprised ofMONODERMTM(PGA-PCL)(K141778, K123836, K123409)
Indications for Use	STRATAFIXTM SpiralMONOCRYLTM KnotlessTissue Control Device isindicated for use in soft tissueapproximation where the useof absorbable sutures isappropriate.	STRATAFIXTM SpiralMONOCRYLTM Plus Knotless TissueControl Device is indicated for use insoft tissue approximation where the useof absorbable sutures is appropriate.	MONOCRYL PlusAntibacterial sutures areindicated for use in generalsoft tissue approximationand/or ligation, but not for usein cardiovascular orneurological tissues,microsurgery or ophthalmicsurgery.	QuillTM MONODERM device isindicated for use in soft tissueapproximation where use ofabsorbable sutures isappropriate.
Technological means forachieving intended use	Monofilament strand toapproximate tissue anchoredwithout the need to tie surgicalknots.	Monofilament strand to approximatetissue anchored without the need to tiesurgical knots.	Monofilament strand toapproximate tissue anchoredwith surgical knots.	Monofilament strand toapproximate tissue anchoredwithout the need to tie surgicalknots.
Absorbable/Suture Material	MONOCRYL is composed ofa copolymer of glycolide andε-caprolactone	MONOCRYL is composed of acopolymer of glycolide and ε-caprolactone	MONOCRYL is composed ofa copolymer of glycolide andε-caprolactone	MonodermTM (PGA-PCL) –composed of a copolymer ofglycolide and e-caprolactone
Suture Design	Monofilament strand. Singlearmed, unidirectional barbsmade by cutting into the coreof the suture strand. Containsadjustable loop.	Monofilament strand. Single armed,unidirectional barbs made by cuttinginto the core of the suture strand.Contains adjustable loop.	Monofilament strand	Uni-directional barbs along thelong axis of the monofilament
Colorant (if dyed)	Undyed	Undyed	Undyed or Dyed (D&C VioletNo.2)	Undyed or Violet (D&C VioletNo.2)
USP Suture Size	2-0 through 4-0	2-0 through 4-0	0, 1, 2-0 through 6-0	0, 2-0 through 5-0
Tensile Strength	Straight Tensile meets USP	Straight Tensile meets USP Knot	Meets USP requirement for	Straight Tensile meets USP Knot
	Knot Tensile requirements forSynthetic Absorbable Suturesof the same size equivalent	Tensile requirements for SyntheticAbsorbable Sutures of the same sizeequivalent	Synthetic Absorbable Sutures	Tensile requirements forSynthetic Absorbable Sutures ofone size smaller equivalent
Needle Pull-Off	Meets USP requirements	Meets USP requirements	Meets USP requirements	Meets USP requirements
Antibacterial Agent	Not Applicable	Irgacare MP (Triclosan)	Irgacare MP (Triclosan)	Not Applicable
Maximum Level ofAntibacterial Agent	Not Applicable	< 2360 µg/m	< 2360 µg/m	Not Applicable
Approximate % BreakingStrength Retention (BSR)	62% @ 7 days27% @ 14 days	62% @ 7 days27% @ 14 days	50 – 60% @ 7 days20 – 30% @ 14 days(undyed)	62% @ 7 days27% @ 14 days
Absorption Profile	Essentially absorbed by91days post-implantation	Essentially absorbed by 91days post-implantation	Essentially complete between91 and 119 days	Essentially complete between 90and 120 days
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Single Use?	Yes	Yes	Yes	Yes
Packaging Configuration	Plastic tray with paper lid(contains the suture) placedwithin foil pouch (sterilebarrier). Sterile foil pouchesare packaged in a sales carton.	Plastic tray with paper lid or paperfolder (contains the suture) placedwithin foil pouch (sterile barrier).Sterile foil pouches are packaged in asales carton.	Paper folder or plastic traywithin a foil pouch. Pouchesplaced within sales carton	Device wound onto innersupport card, within a SingleBarrier Foil Pouch

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Traditional 510(k) STRATAFIX™ Spiral MONOCRYL™ and STRATAFIX™ Spiral MONOCRYL™ PLUS
Knotless Tissue Control Device Ethicon, Inc.

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device have been shown to be appropriate for its intended use and are considered to be substantially equivalent to the predicate devices.

Trademark

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

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.