Phantom Fiber 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. Phantom Fiber BioFiber Suture is a n absorbable, braided, sterile, surgical USP size 2 suture composed of poly(4-hydrobutyrate) (P4HB) with cyanoacrylate adhesive tipped ends. Phantom Fiber 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

Here's a breakdown of the acceptance criteria and study information for the Tornier, Inc. Phantom Fiber BioFiber Suture (K130422), based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (USP Standards)	Reported Device Performance (Phantom Fiber BioFiber Suture)
USP <861> Suture diameter	Compliant for size 2, except that the diameter is slightly larger
USP <871> Suture Needle Attachment	Compliant for size 2
USP <881> Tensile Strength	Compliant for size 2

Study Details

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Tornier BioFiber Suture K122487) through non-clinical testing. It does not describe an AI/ML-based device or associated clinical studies with human readers. Therefore, several requested sections are not applicable in this context.

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample sizes for the USP-compliant tests or the non-USP tests (in-vivo degradation, residual molecular weight).
Data Provenance: Not specified. The testing appears to be laboratory-based (non-clinical).
Retrospective/Prospective: Not applicable as it's non-clinical, non-human testing.

2. 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. The "ground truth" for the performance tests (e.g., tensile strength, diameter) would be the established USP standards themselves, measured by laboratory equipment, not by human experts.

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

Not applicable. Adjudication methods are typically relevant for human-interpretable data (e.g., medical images) where there might be disagreement among reviewers. For physical performance tests, the measurements are objective.

4. 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/ML-based diagnostic or assistive device that would involve human readers.

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

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

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

The ground truth for the performance tests appears to be objective measurements against established industry standards (United States Pharmacopeia - USP). For the non-USP tests, "in-vivo degradation testing of product strength over time and residual molecular weight" would use laboratory measurements.

7. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical medical device.

Summary

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510(k) Summary for K130422

4 2013 APR

Tornier, Inc. Phantom Fiber BioFiber Suture

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

1) Device name

Trade name: Phantom Fiber 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

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

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 Suture Produced by Recombinant DNA Technology

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K130422 page 2/3

5) Legally Marketed Device to which Equivalence is Claimed

Tornier BioFiber Suture (K122487).

6) Comparison to Predicate Device

Feature	From: Tornier BioFiber Suture(K122487)	To: Tornier Phantom FiberBioFiber Suture
Indications forUse	For use in general soft tissueapproximation and/or ligation, but notfor use in cardiovascular orneurological tissues, microsurgery orophthalmic surgery.	Same.
Design
Composition	P4HB	Same
Needles attached	Available with and without needlesattached	Same
USP Size	Size 2	Same
Design	Braided	Same
Colors	Un-dyed (natural) or dyed (D&C VioletNo. 2)	Same
Performance
USP <861>Suture diameter	Compliant for size 2, except that thediameter is slightly larger	Same
USP <871>Suture NeedleAttachment	Compliant for size 2	Same
USP <881>Tensile Strength	Compliant for size 2	Same

7) Device description

8) Indications for Use

Phantom Fiber 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.

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K130422 Page 3/3

9) Summary of technologies

Phantom Fiber BioFiber Suture was subjected to FDA Special Controls required USP testing such as; suture tensile strength, suture diameter, suture needle attachment strength; as well as non USP testing. The non USP testing included in-vivo degradation testing of product strength over time and residual molecular weight. The results of this non-clinical testing allow us to conclude that the Phantom Fiber 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 4, 2013

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

Re: K130422

Trade/Device Name: Phantom Fiber 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: March 06, 2013

Received: March 12, 2013

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/AboutFDA/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nielkerson -S

Mark N. Melkerson Acting 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): K130422

Device Name: Tornier, Inc. Phantom Fiber™ BioFiber™ Suture

Indications for Use

Phantom Fiber 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 - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130422

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).