The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.

Device Description

The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The pin provides an anchoring mechanism to resident and adjacent bone at the surgical site. The pin is fabricated from a bioresorable copolymer of L and DL lactide. The pin has a low profile, round, lens shaped head an a shaft with two circular ribs. It is provided in a sterile vial.

AI/ML Overview

This 510(k) premarket notification for the IMTEC BioPin focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a study with acceptance criteria and a detailed performance report. Therefore, much of the requested information regarding acceptance criteria and study specifics is not available directly from the provided text.

The submission primarily establishes that the IMTEC BioPin has similar design, materials, configuration, sterilization methods, and technological characteristics to already marketed predicate devices, and is intended for the same indications for use. This approach is common for 510(k) submissions where a new device is compared to a legally marketed predicate device.

Here's a breakdown of the available and unavailable information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated or provided in a quantitative form within the document. The "acceptance criteria" for a 510(k) submission like this is primarily the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance: No specific quantitative performance data (e.g., success rates, complication rates, degradation times) for the IMTEC BioPin itself are reported in this document. The submission relies on the established performance and safety profiles of the predicate devices.

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

Not applicable / Not provided. This 510(k) submission does not describe a clinical or performance study with a "test set" in the sense of a controlled experiment. Instead, it relies on comparison to existing predicate devices.

3. 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 / Not provided. As no specific "test set" study is described, there's no mention of experts establishing ground truth for such a study.

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

Not applicable / Not provided.

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 device is a bioresorbable pin, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

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

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

Not applicable / Not provided. Since no specific performance study is detailed, there's no mention of how "ground truth" would have been established. The "ground truth" for a 510(k) in this context is implicitly the regulatory acceptance and safe/effective use of the predicate devices.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" described, as this is not an algorithm-based device.

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

Not applicable / Not provided.

Summary of Approach for K982951:

The core of this 510(k) submission, as presented, is the demonstration of substantial equivalence to predicate devices. This means:

Indications for Use: The IMTEC BioPin is intended for the same use as predicate devices: to stabilize bioresorbable guided tissue regeneration membranes during healing, specifically to avoid a second surgery for removal of non-resorbable pins.
Technological Characteristics: The manufacturer asserts that the IMTEC BioPin is "similar" to predicate devices in terms of design, material (bioresorbable copolymer of L and DL lactide), configuration, and sterilization method. The material, PURASORB PL, is specified, and its molecular weight is given.
Safety and Effectiveness: By demonstrating similarities to legally marketed predicate devices, the submission implicitly argues that the IMTEC BioPin will be as safe and effective as those already approved devices. The FDA's letter (K982951) confirms this determination of substantial equivalence.

In essence, for this type of device and 510(k) submission, the "acceptance criteria" are met by successfully arguing to the FDA that the new device is sufficiently similar to existing approved devices that it raises no new questions of safety or effectiveness. No new clinical performance study data would typically be required to prove this for a straightforward substantial equivalence pathway.

Summary

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K982951

JUN 21 1999

510 (k) SUMMARY

SUBMITTED BY:

M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (580) 223-4456

F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407

Date Submitted: August 20,1998

CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:

Classification Name: Screw, fixation, intraosseous (ref: 21 CFR 8722.4880); Product Code: DZL Common/ Usual Name: Membrane fixation pin.

Proprietary Name: IMTEC BioPin.

PREDICATE DEVICE:

LEADfix Bioresorbable Membrane Pin ( K974392) 3I Bioresorbable Fixation Tack (K972480) Synthes Fixation System (K974554)

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

The resorbable IMTEC BioPin pin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment. Its use is intended to avoind a second stage surgery required to remove nonresorbable tacks and pins.

PRINCIPLES OF OPERATION:

The IMTEC BioPin is a bioresorbable pin used to fix commercially available bioresorbable guided tissue regeneration membranes.

CONTRAINDICATIONS:

Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include but are not limited to, current local infection, vascular impairment at the surgical site, uncontrolled diabetes, chronic high dose steroid therapy, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which affect bone or wound healing. Specifically if allergies to polylactid and lactic acid is known

COMPLICATIONS:

Possible complications with any oral reconstructive surgery include infection, closure perforation, abcess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. Specific to this surgery is augmentation material perforation or exfoliation.

MATERIALS OF CONSTRUCTION:

IMTEC BioPin is molded from PURASORB PL, a 70/30 copolymer of L( - ) Lactide/ DL-Lactide ( Molecular Weight: 152.000) by IMTEC-SWISS, Ardmore, OK.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The design, material, configuration, method of sterilization and other technological characteristics of IMTEC BioPin are similar to the currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 21 1999

M.K. Patterson, Jr., Ph.D. Sr. Vice President Requlatory Affairs IMTEC Corporation 2401 North Commerce P.O. Box 1562 Ardmore, Oklahoma 73402 U.S.A

K982951 Re : IMTEC BioPin Trade Name: Regulatory Class: II Product Code: DZL Dated: March 22, 1999 Received: March 23, 1999

Dear Dr. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Dr. Patterson

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1___ of_1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:IMTEC BioPin

Indications For Use:

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Signature

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K982951

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.