The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Device Description

The modified ActivaPin™ is identical to the currently cleared device except for the modification. The only modification to the initial 510(k) K061164 to be cleared is adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly. The change does not affect the intended use or alter the fundamental scientific technology of the device.

The ActivaPin" is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization. Pins are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 20 - 70 mm.

ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they decrade in vivo by hvdrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin"1" gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.

AI/ML Overview

The provided text describes a Special 510(k) submission for a modification to an existing device, the Bioretec ActivaPin™. The modification involves adding a Disposable Pin Applicator with a K-wire. This submission focuses on demonstrating substantial equivalence to the predicate device, not on proving general effectiveness through clinical studies with acceptance criteria in the way a novel device might.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not applicable or available within this document.

Here's why and what information is provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable / Not provided. The document states: "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." This is a qualitative statement of equivalence, not a report against specific, quantified acceptance criteria for performance. The modification is primarily about adding an accessory, and the core device performance (e.g., strength, bioabsorption) is assumed to be unchanged from the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable / Not provided. No "test set" in the context of image analysis or algorithm performance is mentioned. The assessment is based on demonstrating equivalence for the new applicator and confirming the overall device's safety and effectiveness remain unchanged.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable / Not provided. No "ground truth" establishment in a clinical or imaging context is described.

4. Adjudication Method for the Test Set:

Not applicable / Not provided. No adjudication needed for this type of submission.

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 / Not provided. This device is a medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable / Not provided. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable / Not provided. No "ground truth" in the context of medical imaging or clinical outcome data is used in this submission. The "ground truth" for a device like this would be its physical/material properties and performance in vivo, which are implicitly covered by its predicate status.

8. The Sample Size for the Training Set:

Not applicable / Not provided. No machine learning "training set" is involved.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not provided. No machine learning "training set" is involved.

Summary of what the document does state about the device and its assessment:

Device: Bioretec ActivaPin™ (a bioabsorbable pin for bone fixation)
Modification: Addition of a Disposable Pin Applicator with K-wire for installation.
Purpose of Submission: To demonstrate that this modification does not affect the intended use, alter the fundamental scientific technology, or raise new questions of safety and effectiveness compared to the predicate device (the original ActivaPin™ K061164).
Evidence for Equivalence:
- The modified device is "identical to the currently cleared device except for the modification."
- The change "does not affect the intended use or alter the fundamental scientific technology of the device."
- "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." (This is the closest the document comes to a "study," albeit briefly mentioned and without details.)
Conclusion: The FDA reviewed the 510(k) and determined the device (with the modification) is substantially equivalent to the legally marketed predicate device.

Summary

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SPECIAL 510(k) SUMMARY

AUG 3 1 2007

For the modification to Bioretec ActivaPin™ (K061164)

MANUFACTURER

Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND

Contact person:

Ms. Mari Ruotsalainen Quality Manager Phone: +358 20 778 9514 Fax: +358 3 317 0225 Mari Ruotsalainen@bioretec.com

Date prepared: June 28th, 2007

DEVICE NAME

Trade Names: Bioretec ActivaPin™, NexFix™ RFS Pin (Resorbable Fixation System) Common Name: Pin, Fixation

ESTABLISHMENT REGISTRATION NUMBER

Bioretec Ltd. has been submitted the Establishment Registration form and is waiting for an Establishment Registration Number.

DEVICE CLASSIFICATION AND PRODUCT CODE

Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY

PREDICATE DEVICES

Bioretec ActivaPin™ (K061164)

Special 510(k): Device Modification, Date: June 28th, 2007

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DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

EQUIVALENCE TO MARKETED PRODUCTS

The ActivaPin™ Bioabsorbable Pin and its instrumentation is substantially equivalent to the ActivaPin™ cited as predicate device above.

The Bioretec ActivaPin" with its modified instrumentation has the same intended use, principles of operation and technological characteristic as the predicate device. Adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly does not raise any questions of safety and effectiveness.

Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices.

Special 510(k): Device Modification, Date: June 28th, 2007

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AUG 3 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioretec Ltd. % Ms. Mari Ruotsalainen Quality Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND

Re: K071863

Trade/Device Name: Bioretec ActivaPin™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: August 1, 2007 Received: August 3, 2007

Dear Ms. Ruotsalainen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Mari Ruotsalainen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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F Indications for Use Statement

Submitter: 510(k) Number:

Device Name:

Bioretec Ltd.

K07186

ActivaPin™

Indications for Use:

The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Contraindications:

Fractures and osteotomies of diaphyseal bone.
Fractures and osteotomies in weight bearing cancellous bone.
Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed.

Prescription Use ___ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clerbau Brelup

(Division Sig Division of General, Restorative, and Neurological Devices

510(k) Number K071863

Special 510(k): Device Modification, Date: June 28th, 2007

Page 4 of 4

F-1 Page

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.