STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES

K141776 · ETHICON, Inc. · NEW · Oct 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141776
• Device Name: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
• Applicant: ETHICON, Inc.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Oct 15, 2014
• Decision: SESD
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Absorbable monofilament thread made of poly(p-dioxanone) with unidirectional barbs, attached surgical needle, and fixation tab; eliminates need for surgical knots during soft tissue approximation. Used by surgeons in clinical settings for wound closure. Device contains IRGACARE® MP (triclosan) as an antibacterial agent. Provides tissue holding strength and cyclic compression resistance comparable to predicate. Benefits include simplified wound closure procedure and reduced need for knot tying.

Clinical Evidence

Bench testing and animal models used. Bench testing included tissue holding strength, initiation strength, cyclic compression, and a usability study to confirm device integrity and refine IFU. Preclinical survival study in animal models demonstrated equivalence in wound approximation and healing compared to the predicate device.

Technological Characteristics

Absorbable monofilament thread composed of poly(p-dioxanone) (C4H6O3)x. Contains antibacterial agent IRGACARE® MP (triclosan) ≤ 2360 µg/m. Dyed with D&C Violet No. 2. Features unidirectional barbs, attached surgical needle, and fixation tab. Mechanical device; no software or electronics.

Indications for Use

Indicated for general soft tissue approximation in patients requiring an absorbable suture.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K141776)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized image of an eagle. The eagle is depicted with three overlapping profiles, suggesting a sense of community and collaboration. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

October 15, 2014

Ethicon Incorporated Mr. Peter Cecchini Fellow, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K141776

Trade/Device Name: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: July 22, 2014 Received: July 23, 2014

Dear Mr. Cecchini:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.15 21:27:47 -04'00'

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) K141776

Device Name

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device

Indications for Use (Describe)

STRATAFIX™ Symmetric PDS™ Plus 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)

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

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below:

| Device Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
|----------------------------|------------------------------------------------------------------|
| Device Proprietary Name: | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue<br>Control Device |
| Submitter: | Ethicon Inc. |
| | P.O. Box 151 |
| | Route 22 West |
| | Somerville, NJ 08876 |
| | USA |
| Contact: | Peter Cecchini |
| | Fellow, Regulatory Affairs |
| | Phone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Date Prepared: | September 15, 2014 |
| Classification Regulation: | Absorbable Polydioxanone Surgical Suture, Class II, 21 |
| | CFR 878.4840 |
| Panel: | General and Plastic Surgery Devices |
| Product Code: | NEW |
| Predicate Device: | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue<br>Control Device |

Indication for Use:

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

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## Device Description:

STRATAFIX Symmetric PDS Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX Symmetric PDS Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX Symmetric PDS Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX Symmetric PDS Plus Devices consists of an absorbable monofilament thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.

## Performance Data:

Performance testing to demonstrate equivalence was conducted using performance testingbench models and performance testing-animal models. Testing results are summarized as follows.

- . Performance Testing-Bench Models:
- 1. Tissue Holding Strength The results of the tissue holding testing verify the integrity and adequacy of the STRATAFIX Symmetric PDS PLUS device performance in a simulated wound closure and support substantial equivalence to the predicate device.
- 2. Initiation Strength- The results of the initiation strength testing verify the integrity and adequacy of the device during application at the proximal end of a simulated wound closure compared to the predicate device.
- 3. Cyclic Compression- The results of the cyclic compression testing verify the integrity and adequacy of the device when subjected to a cyclic compressive load on a simulated wound closure compared to the predicate device.
- 4. Usability Study- The results of this study were used to confirm the usability of the device and to refine the Instructions for Use.
- Performance Testing-Animal Models:
- 1. Preclinical Survival Study The results of the survival study demonstrated substantial equivalence in wound approximation and healing to the predicate device.

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### Substantial Equivalence:

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices has the same intended use, design, materials and technological characteristics as the predicate device. Modification to the labeling is the only difference from the predicate device.

### Conclusions:

The STRATAFIX Symmetric PDS Plus Device has the same intended use and identical indications for use as the predicate device. In comparison, the technological characteristics are the same. The differences in labeling (IFU) between the proposed device and the predicate device raise no new questions of safety or effectiveness. STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device.

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