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 regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because 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, degradable barrier membrane for single patient use. It is composed of two liquid poly(ethylene glycol) (PEG) compounds forming a hydrogel upon mixing. Straumann MembraGel is applied as a viscous liquid and gels on the application site within approximately 20 to 50 seconds. Straumann MembraGel acts as a barrier that inhibits non-osteogenic soft tissue cells of the overlying soft tissue from entering the defect site thereby supporting undisturbed regeneration of alveolar bone. Degradation of Straumann MembraGel by hydrolysis starts during normal wound healing. Straumann MembraGel must be stored refrigerated between 2-8°C (36-46°F). The application volume of Straumann MembraGel is 0.8 ml for approximately 5-7cm² coverage. The Straumann MembraGel kit contains: Two glass syringes each filled with a PEG component (PEG A and PEG B) mounted in a plastic holder. Two plastic syringes each filled with an activator (Activator A and Activator B) in a plastic holder. One applicator tip (a static mixer connected to an adapter). All components are delivered sterile and must be used immediately after opening of the blister packaging in an aseptic surgical environment.

AI/ML Overview

The Straumann MembraGel is a sterile, synthetic, degradable barrier membrane intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Biocompatibility
Cytotoxicity	Cytotoxic measurements results equal to or less than the predicate data.	Non-cytotoxic
Acute Systemic Toxicity	Acute Systemic Toxicity results equal to or less than the predicate data.	Non-toxic
SQ Implantation (4 Weeks) - Rabbits	SQ Implantation results equal to or less than the predicate data.	Slight Irritant
Gelation time	20-50 seconds	Passed
In-vitro water uptake of the gelled product	Less than 20%wt within 4 hours after gelation	Passed
In-vitro degradation pattern and time	Following a defined degradation kinetics ending in complete disintegration of the MembraGel	Passed

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

The document does not explicitly state the sample sizes for the specific tests performed (e.g., number of cytotoxicity tests, number of animals for SQ implantation, number of samples for gelation time).

The data provenance is not explicitly mentioned as country of origin, but the testing was performed to support a 510(k) submission to the US FDA, implying compliance with US regulatory standards. The clinical study type is not specified (e.g., retrospective or prospective), but based on the nature of the tests (biocompatibility, in-vitro degradation), they are laboratory-based tests rather than clinical trials with human subjects. The SQ Implantation was performed on rabbits, which is an animal study.

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

This section is not applicable as the provided document describes testing for a medical device (a synthetic barrier membrane) and not an AI/software device that would require expert-established ground truth from medical images or clinical data. The "ground truth" here refers to established scientific and regulatory standards for device performance and safety.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like '2+1' or '3+1' are typically used in clinical trials or studies involving human expert review, especially for diagnostic or prognostic AI systems. Here, the "truth" is determined by measured physical, chemical, and biological properties according to predefined protocols.

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

This section is not applicable. The provided document describes a medical device (bone grafting material), not an AI system or software that would involve human readers or AI assistance.

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

This section is not applicable. The device is a physical medical product, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the Straumann MembraGel is based on:

Pre-defined specifications/standards: This includes internal specifications for gelation time, water uptake, and degradation kinetics.
Comparison to predicate device: For biocompatibility tests (cytotoxicity, acute systemic toxicity, SQ implantation), the acceptance criteria specify that results should be "equal to or less than the predicate," meaning the predicate device's established safety profile served as a benchmark.
Scientific and regulatory guidelines: The biocompatibility tests (cytotoxicity, systemic toxicity, implantation) are standard tests mandated by regulatory bodies like the FDA for medical devices, following established methodologies.

8. The Sample Size for the Training Set

This section is not applicable. The document describes a physical medical device, not a machine learning model or an AI system that would require a "training set."

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

This section is not applicable for the same reasons as point 8.

Summary

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K101956

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510(k) SUMMARY

DEC 1 6 2010

A. Submitter's Information

Name:	Straumann US (on behalf of Institut Straumann AG)
Address:	60 Minuteman Road
	Andover, MA 01810
Phone:	(800) 448-8168, ext 2575
Fax Number:	978-747-0023
Contact Person:	Janet C. Kay, Director Regulatory Affairs

B. Date Summary Prepared: August 17, 2010

C. Device Name:

Propriety Name:	Straumann MembraGel
Common/Usual Name:	Bone grafting material
Classification Name:	Barrier, Synthetic, Intraoral
Classification Number:	Class II Part 872.3930
Product Code/Review Panel	NPK

D. Predicate Device Name:

Straumann MembraGel (K082111, 5/22/09) .

E. Description of the Device

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Straumann MembraGel by hydrolysis starts during normal wound healing. Straumann MembraGel must be stored refrigerated between 2-8°C (36-46°F). The application volume of Straumann MembraGel is 0.8 ml for approximately 5-7cm² coverage.

The Straumann MembraGel kit contains:

Two glass syringes each filled with a PEG component (PEG A and PEG B) 1. mounted in a plastic holder.
Two plastic syringes each filled with an activator (Activator A and Activator 2. B) in a plastic holder.
One applicator tip (a static mixer connected to an adapter). 3.

All components are delivered sterile and must be used immediately after opening of the blister packaging in an aseptic surgical environment. See Instructions for use handling instructions.

F. Intended Use of the Device

G. Technological Characteristics

The proposed device is substantially equivalent to currently marketed device. The intended use is the same as the intended use of the predicate device. The proposed MembraGel has the same design and fundamental operating principles as the predicate device. The changes to the material composition had no impact to the final design of the product and remains substantially equivalent to the predicate device, Table 1 demonstrates the technological modifications made to MembraGel compared to the currently marketed predicate device.

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Table 1

Features	Modified Straumann MembraGel	StraumannMembraGelK082111
OperatingPrinciple	Straumann MembraGel is applied on the site inliquid form through a syringe applicator	Identical
PhysicalProperties	Initial swelling of Straumann MembraGelsamples meet internal specificationsGelation time of the Straumann® MembraGelkit between 20 and 50sA degradation pattern meets internalspecifications including complete degradation ofthe Straumann MembraGel.	Identical
TissueOcclusiveProperties	Tissue occlusive properties depend on thephysical properties of the PEG network, which isgoverned density of the crosslink. Cellocclusivity is determined by the degradationpattern and time. Thus, tissue occlusiveproperties were not impacted by thismodification.	Identical
Viscosity	The viscosity of the formulation is determinedby the Activators present in solution A and B.These solutions were not impacted by themodification described in this 510(k)	Identical
Water uptakeof the gelledproduct	The modified device was required to meet theoriginal specification	Identical

H. Performance Testing

Verification and validation testing were performed to ensure that the Straumann MembraGel functions as intended and that the modification did not impact the essential performance of the MembraGel. The Table 2 describes the testing performed on the MembraGel included:

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Table 2

Test performed	Acceptance criteria	Results
Biocompatibility
Cytotoxicity	Cytotoxic measurements results equalto or less than the predicate	Non-cytotoxic
Acute SystemicToxicity	Acute Systemic Toxicity results equalto or less than the predicate	Non-toxic
SQ Implantation (4Weeks) - Rabbits	SQ Implantation results equal to orless than the predicate	Slight Irritant1
Gelation time	20-50 sec	Passed
In-vitro wateruptake of the gelledproduct	Less than 20%wt within 4h aftergelation	Passed
In-vitro degradationpattern and time	Following a defined degradationkinetics ending in completedisintegration of the MembraGel	Passed

1 Response noted was typical for similar absorbable materials subcutaneously implanted

I. Conclusion

The results from the testing conducted, demonstrated that the Straumann MembraGel functions as intended and met pre-determined acceptance criteria.

The Straumann MembraGel is a validated system. The results of performance testing, biocompatibility testing, and risk analysis indicate that the Straumann MembraGel is substantially equivalent to the named predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 1 6 - 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Janet C. Kay Director, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

.Re: K101956

Trade/Device Name: Straumann MembraGel"" Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: December 6, 2010 Received: December 7, 2010

Dear Ms. Kay:

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.

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Page 2- Ms. Kay

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); 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.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101956

Indications for Use Statement

5l0(k) Number (if known)

Straumann MembraGel™ Device Name:

Indications for Use:

Prescription Use X (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 NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punno

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

510(k) Number:

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.