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 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.

AI/ML Overview

This document describes the 510(k) summary for the Tornier BioFiber Suture (K122487). It focuses on demonstrating substantial equivalence to a predicate device, TephaFLEX™ Poly(4-hydroxybutyrate) Suture, rather than presenting a study to prove the device meets pre-defined acceptance criteria in the manner of a clinical trial for diagnostic devices. Therefore, many of the typical acceptance criteria and study design elements you asked for are not directly applicable or available in this type of submission.

Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations of this type of regulatory submission:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the USP (United States Pharmacopeia) standards for absorbable surgical sutures and ISO 10993-1 for biocompatibility. The performance is reported as compliance with these standards.

Feature	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Tornier BioFiber Suture)
USP <861> Suture diameter	Compliant for specified USP size	Compliant for Size 2, "except that the diameter is slightly larger"
USP <871> Suture Needle Attachment	Compliant for specified USP size	Compliant for Size 2
USP <881> Tensile Strength	Compliant for specified USP size	Compliant for Size 2
Biocompatibility	ISO 10993-1 compliant for permanent implant materials	Performed, results led to conclusion of substantial equivalence
Resorption/Degradation	Studied and evaluated	Performed, results led to conclusion of substantial equivalence
Packaging Evaluation	Studied and evaluated	Performed, results led to conclusion of substantial equivalence

Note on "Slightly Larger Diameter": This deviation from the predicate's exact specification for USP size 2 diameter is noted but must have been deemed acceptable by the FDA for the device to achieve substantial equivalence. The overall USP compliance for "Size 2" likely means it falls within the permitted range despite being on the larger side of that range.

Study Details

This submission describes non-clinical testing to support substantial equivalence, not a clinical study on human subjects with a diagnostic device. Therefore, questions 2-6 and 8-9 are not directly applicable in the way they would be for a clinical trial of a diagnostic algorithm.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. For mechanical and material testing, sample sizes would typically be determined by statistical requirements for engineering tests, but these are not provided in this summary.
Data Provenance: The 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." The tests are laboratory-based (mechanical, chemical, biological compatibility), not patient data-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not a diagnostic device involving expert interpretation of data. The "ground truth" here is compliance with established engineering and biocompatibility standards measured through standardized laboratory tests.

4. Adjudication method for the test set:

Not applicable. Results are quantitative measurements against objective standards, not subjective interpretations requiring adjudication.

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. This is a surgical suture, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device (suture), not an algorithm.

7. The type of ground truth used:

The "ground truth" consists of established, objective engineering standards (e.g., USP <861> for diameter, <871> for needle attachment, <881> for tensile strength) and biocompatibility standards (ISO 10993-1). These are quantitative benchmarks against which the device's performance is measured.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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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

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: 612-219-7350/Fax: 952-426-7601 Email: Ipickett@tornier.com

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>Suture diameter	Compliant for size 0	Compliant for Size 2, except that the diameter is slightly larger
USP <871>Suture NeedleAttachment	Compliant for size 0	Compliant for Size 2
USP <881>Tensile Strength	Compliant for size 0	Compliant for Size 2

7) Device description

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a)
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.(b)
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).