BIOFIBER SYTURE

K122487 · Tornier, Inc. · NWJ · Sep 17, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122487
• Device Name: BIOFIBER SYTURE
• Applicant: Tornier, Inc.
• Product Code: NWJ · General, Plastic Surgery
• Decision Date: Sep 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4494
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

BioFiber Suture is an absorbable, braided, sterile surgical suture composed of poly(4-hydroxybutyrate) (P4HB). Used by surgeons for soft tissue approximation and ligation; device provides mechanical support during healing. Available in dyed (D&C Violet No. 2) or un-dyed (natural) forms, with or without pre-attached needles. Braided design intended for optimal handling properties. Device functions as a physical implant; no electronic or software components.

Clinical Evidence

Bench testing only. Testing performed per Class II Special Controls Guidance Document for Absorbable Poly(hydroxybutyrate) Surgical Suture. Includes USP mechanical testing (strength, knot break, needle attachment), USP diameter measurements, ISO 10993-1 biocompatibility, and resorption/degradation studies.

Technological Characteristics

Material: Poly(4-hydroxybutyrate) (P4HB). Construction: Braided monofilament. USP Size: 2. Sterilization: Sterile. Compliance: USP <861> (diameter), USP <871> (needle attachment), USP <881> (tensile strength), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgery, or ophthalmic procedures.

Regulatory Classification

Identification

An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

Predicate Devices

• TephaFLEX™ Poly(4-hydroxybutyrate) Suture (K052225, K081099 and K082178)

Submission Summary (Full Text)

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K122487

# 510(k) Summary

# SEP 1 7 2012

### Tornier Inc. BioFiber Suture

Date prepared: September 13, 2012

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name

Trade name:

BioFiber Suture

#### Common name:

Suture, recombinant technology

#### Classification Number/ Classification name/Product code:

Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology are class II devices under 21 CFR § 878.4494 (product code NWJ) and are classified by the General and Plastic Surgery Devices Panel.

#### 2) Submitter

Tornier, Inc. 10801 Nesbitt Avenue Bloomington, MN 55437 Registration Number: 9100540

## 3) Company contact

Lael J. Pickett Regulatory Affairs Tornier, Inc. 10801 Nesbitt Avenue Bloomington, MN 55437 USA Telephone: [phone]/Fax: [phone] Email: [e-mail]

#### 4) Classification

Device class:

Class II

#### Classification panel:

General and Plastic Surgery Devices

Product code:

NWJ

## Special Controls:

Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical

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Suture Produced by Recombinant DNA Technology

# 5) Legally Marketed Device to which Equivalence is Claimed:

TephaFLEX™ Poly(4-hydroxybutyrate) Suture: (K052225, K081099 and K082178)

# 6) Comparison to Predicate Devices

| Feature | From: TephaFLEX poly(4-hydroxybutyrate) suture (K052225, K081099 & K082178) | To: Tornier BioFiber Suture (K122487)) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Indications for Use | For use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. | Same. |
| Design | | |
| Composition | P4HB | Same |
| Needles attached | Available with and without needles attached | Same |
| USP Size | Size 0 | Size 2 |
| Design | Monofilament | Braided |
| Colors | Un-dyed (natural) or dyed (violet) | Same |
| Performance | | |
| USP <861><br>Suture diameter | Compliant for size 0 | Compliant for Size 2, except that the diameter is slightly larger |
| USP <871><br>Suture Needle<br>Attachment | Compliant for size 0 | Compliant for Size 2 |
| USP <881><br>Tensile Strength | Compliant for size 0 | Compliant for Size 2 |

# 7) Device description

Tornier, Inc. BioFiber Suture is an absorbable, braided, sterile, surgical suture composed of poly(4-hydrobutyrate) (P4HB). BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.

# 8) Indications for Use

BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

# 9) Summary of technologies

Testing was performed in accordance with FDA's Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology . This testing included mechanical testing in accordance with USP requirement s for absorbable surgical suture (strength, knot break, needle attachment strength) and USP suture diameter measurements. Additionally, ISO 10993-1 testing for permanent implant materials was performed, as well as resorption/degradation testing and packaging evaluation.. The results of this non-clinical

^{1 21} CFR § 74.3602 D&C Violet No. 2.

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testing allow us to conclude that the BioFiber Suture described in this submission is substantially equivalent and as safe and effective as the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

2012

Tornier. Incorporated % Ms. Lael J. Pickett Regulatory Affairs 10801 Nesbitt Avenue Bloomington, Minnesota 55437

Re: K122487

Trade/Device Name: BioFiber® Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly (hydroxybutyrate) surgical suture produced by recombinant DNA technology Regulatory Class: Class II

Product Code: NWJ Dated: August 9, 2012 Received: August 15, 2012

Dear Ms. Pickett:

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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## Page 2 - Ms. Lael J. Pickett

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 go to http://www.fda.gov/AboutEDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ly yours,

for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): Device Name: Tornier, Inc. BioFiber® Suture

#### Indications for Use

BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUA ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Deyige Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k12248

Original 510(k) Application Tornier Inc. BioFiber Suture Confidential