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

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

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

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

Device Description

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (pdioxanone). The empirical molecular formula of the polymer is (C+HgO3). The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.

STRATIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. 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 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 PDSTM Plus Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control 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 PDS™ Plus 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 Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

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 2360ug/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.

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 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 0.1mm.

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-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 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 tensile strength relative to non-barbed suture material of the same size, tving of knots in non-barbed 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 non-barbed 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 0.1mm.

AI/ML Overview

The provided document is a 510(k) Summary for several STRATAFIX™ Knotless Tissue Control Devices. It primarily discusses substantial equivalence to predicate devices based on technological characteristics and proposed labeling changes.

Crucially, this document states: "Summary of Technological Characteristics: The technological characteristics of the subject devices are identical to their predicate devices, therefore performance data are not necessary to establish substantial equivalence."

This means that the FDA determined that the applicant did not need to conduct new studies to prove the device met acceptance criteria because the device's technical characteristics, materials, and performance were considered identical to previously cleared predicate devices. The submission focuses on explaining the equivalence and justifying minor labeling changes.

Therefore, for the information requested in your prompt, the answer is largely that no new studies or performance data were deemed necessary or provided in this 510(k) submission to establish acceptance criteria for the device itself. The acceptance criteria are implicitly met by the substantial equivalence to the predicate devices, which would have undergone their own testing.

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

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as new, independent criteria for this submission. The device is considered to meet the acceptance criteria of its predicate devices due to substantial equivalence. The document highlights that the subject devices are "identical to their respective predicate devices with respect to functionality, technological characteristics, intended uses, and indications." Performance specifications are also stated as unchanged.
- Reported Device Performance: No new performance data is reported as no new studies were deemed necessary. The performance is presumed to be equivalent to the predicate devices. The document explicitly states: "performance data are not necessary to establish substantial equivalence."
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. No new test set data was generated or submitted for this 510(k) as the devices were found to be substantially equivalent to predicates without new performance studies.
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)
- Not applicable. No new test set requiring expert ground truth was generated or submitted.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No new test set requiring adjudication was generated or submitted.
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 device is a surgical suture, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical suture, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices would have been established through their original clearance processes, likely involving physical and mechanical testing, biocompatibility, and potentially animal or clinical studies to support their indicated uses.
The sample size for the training set
- Not applicable. This device is a surgical suture, not a machine learning model requiring a training set.
How the ground truth for the training set was established
- Not applicable. This device is a surgical suture, not a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2019

Ethicon, Inc. Dr. Ariell Joiner Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K182873

Trade/Device Name: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW, GAM Dated: October 11, 2018 Received: October 12, 2018

Dear Dr. Joiner:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cynthia Chang -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

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510(k) Number (if known)

K182873

Device Name

STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general 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 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."

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510(k) Number (if known)

K182873

Device Name

STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device 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)

[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.

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."

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

510(k) Number (if known)

K182873

Device Name

STRATAFIXTM Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device 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)

[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

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."

ft tissue

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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510(k) Number (if known)

K182873

Device Name

STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device 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)

| 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 .

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."

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ETHICON a Johnson shiron company

510(k) Summary

Submitter:	Ethicon, Inc. a Johnson & Johnson company
	P.O. Box 151
	Route 22 West
	Somerville, NJ 08876-0151
Contact Person:	Ariell Joiner
	Regulatory Affairs Specialist
	Phone: 908-218-2348
	Fax: 908-218-2595
	Email: ajoiner@its.jnj.com
Date Prepared:	January 07, 2019

Device Trade Name:	STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device andSTRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
Device Common Name:	Suture, Surgical, Absorbable Polydioxanone
Class:	II
Classification:	21 CFR 878.4840 – Absorbable Polydioxanone Surgical Suture
Product Code:	NEW
Panel:	General and Plastic Surgery Devices

Device Trade Name:	STRATAFIX™ Spiral MONOCRYL™ Plus Knotless TissueControl Device andSTRATAFIX™ Spiral MONOCRYL™ Knotless Tissue ControlDevice
Device Common Name:	Suture, Surgical, Absorbable, Polyglycolic Acid
Class:	II
Classification:	21 CFR 878.4493 – Absorbable poly(glycolide/l-lactide)Surgical Suture
Product Code:	GAM
Panel:	General and Plastic Surgery Devices

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Predicate Devices:

Device	Product Code	510(k) Number	Predicate for
STRATAFIX™ SymmetricPDS™ Plus Knotless TissueControl Device	NEW	K141776	Fundamental ScientificTechnology, Design, IntendedUse, Materials, Construction,Performance Characteristics
STRATAFIX™ Spiral PDS™Plus Knotless Tissue ControlDevice	NEW	K150670	Fundamental ScientificTechnology, Design, IntendedUse, Materials, Construction,Performance Characteristics
STRATAFIX™ SpiralMONOCRYL™ Plus KnotlessTissue Control Device andSTRATAFIX™ SpiralMONOCRYL™ KnotlessTissue Control Device	GAM	K151200	Fundamental ScientificTechnology, Design, IntendedUse, Materials, Construction,Performance Characteristics

Device Description:

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anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

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Indications for Use:

The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

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

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

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

Summary of Technological Characteristics:

The technological characteristics of the subject devices are identical to their predicate devices, therefore performance data are not necessary to establish substantial equivalence.

The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K141776), are antibacterial, absorbable, dyed (violet) monofilaments prepared from the polyester, poly (pdioxanone), with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other to allow for tissue approximation without the need to tie surgical knots.

The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIXTM Spiral PDS™ Plus Knotless Tissue Control Device (K150670), are both antibacterial, absorbable, dyed (violet) monofilaments prepared from the polyester, poly (pdioxanone), designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K151200), are both antibacterial, absorbable, undyed monofilaments prepared from a copolymer of glycolide and e-caprolactone, designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.

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The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and its predicate device, STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device (K151200), are both absorbable, undyed monofilaments prepared from a copolymer of glycolide and ecaprolactone, designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.

Substantial Equivalence:

The subject devices are identical to their respective predicate devices with respect to functionality, technological characteristics, intended uses, and indications. There are no changes to the material, device construction, performance specifications, sterilization or manufacturing processes, or shelf life of the currently marketed devices. The subject devices differ from their respective predicate devices only in the labeling (Instructions for Use).

The Instructions for Use of the subject device, STRATAFIX™ Symmetric PDS™M Plus Knotless Tissue Control Device, has been revised to add the following three new Warnings to the Warnings Section:

1. Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.
1. Avoid contacting STRATAFIX™ Device and associated needles with other materials (e.g. surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs.
1. Small bowel obstruction (SBO): including volvulus, bowel infarction, and significant morbidity, have been reported due to barbed suture ends hooking onto adjacent small bowel and/or mesentery, such as in peritoneal closure.

The Instructions for Use of the subject devices, STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device have been revised to move one Precaution statement, "Avoid contacting the STRATAFIX™ Device and associated needles with other materials (e.g. surgical gauze, etc.) in the surgical field to prevent ensnaring on the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs" to the Warnings Section and add the following two Warnings to the Warnings Section:

1. Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.
1. Small bowel obstruction (SBO): including volvulus, bowel infarction, and significant morbidity, have been reported due to barbed suture ends hooking onto adjacent small bowel and/or mesentery, such as in peritoneal closure.

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The subject devices do not raise new questions of safety or effectiveness and are therefore substantially equivalent to their respective predicate devices.

Conclusion:

Based on the intended use, fundamental scientific technology and, technological characteristics, the subject devices, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device are considered to be substantially equivalent to their predicate devices. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K141776), STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device (K150670), and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and the STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device (K151200), respectively.

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.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

ETHICON a Johnson shiron company

510(k) Summary

Predicate Devices:

Device Description:

Indications for Use:

Summary of Technological Characteristics:

Substantial Equivalence:

Conclusion:

§ 878.4840 Absorbable polydioxanone surgical suture.

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