Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone reqeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets.

Because Straumann MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.

Device Description

Straumann® MembraGel is a sterile, synthetic, biodegradable barrier membrane for single patient use. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.

AI/ML Overview

The provided text is a 510(k) summary for the Straumann® MembraGel device and subsequent FDA correspondence. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy, or a clinical trial design and results).

Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The information provided is primarily about the device itself, its intended use, and its equivalence to other legally marketed devices, rather than a performance study with detailed results against defined acceptance criteria.

Therefore, for your request, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device's function (e.g., successful regeneration rates, mechanical properties tested against benchmarks) nor does it report device performance against such metrics.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is described.
Adjudication method for the test set: No test set or adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a bone grafting material, not an algorithm.
The type of ground truth used: No ground truth is described.
The sample size for the training set: No training set is described.
How the ground truth for the training set was established: No training set or ground truth establishment is described.

The document states: "The proposed Straumann® MembraGel is substantially equivalent to the currently marketed devices. The intended use is the same as the intended uses of the predicate devices. The proposed hydrogel has the similar material composition, basic design and fundamental operating principles to the currently marketed devices." This statement is the core of a 510(k) submission, confirming that the device is similar enough to existing devices that it doesn't require a new, extensive clinical trial to prove safety and effectiveness.

In summary, the provided text describes a regulatory filing for a medical device based on substantial equivalence, not a performance study with acceptance criteria and results for an AI/algorithm-based device.

Summary

{0}------------------------------------------------

Section L 510(k) Summary

1. Applicant's Name and Address

Straumann US (on behaif of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Contact Person: Lisa Quaglia Director, Regulatory Affairs

MAY 22 2009

2. Name of the Device

Trade Name:	Straumann® MembraGel
Common Name:	Bone grafting material
Classification Name:	Barrier, Synthetic, Intraoral
Regulation Number:	§872.3930

Legally Marketed Device to which Equivalence is Claimed (Predicate Device) 3.

BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (K050446)

ATRISORB® FreeFlow™ GTR Barrier (K982865)

4. Description of the Device

5. Intended Use of the Device

Straumann® MembraGel is a biodedradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in quided bone regeneration procedures. This includes the surgical treatment of periimplant defects, bone defects, deficient alveolar ridges, and extraction sockets.

Because Straumann® MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.

6. Technological Characteristics

The proposed Straumann® MembraGel is substantially equivalent to the currently marketed devices. The intended use is the same as the intended uses of the predicate devices. The proposed hydrogel has the similar material composition, basic design and fundamental operating principles to the currently marketed devices.

Straumann US Page 6 of 24

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is printed in black and white.

Public Health Service

22 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Institut Straumann AG C/o Ms. Lisa M. Quaglia Regulatory Affairs Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K082111

Trade/Device Name: Straùmann® MembraGel Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: May 21, 2009 Received: May 22, 2009

Dear Ms. Quaglia:

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 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.

{2}------------------------------------------------

Page 2- Ms. Quaglia

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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours. ling for Assem

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indication for Use Statement

Straumann® MembraGel Device Name:

Indications for Use:

Because Straumann MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.

Kein Muley for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082111

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

510(k) Submission: Straumann® MembraGel K082111/A3 - Response to FDA Questions Proprietary and Confidential May 21, 2009 ·

Straumann US Page 7 of 24

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.