STRAUMANN MEMBRAGEL

K101956 · Straumann USA (On Behalf of Institut Straumann Ag) · NPK · Dec 16, 2010 · Dental

Device Facts

• Record ID: K101956
• Device Name: STRAUMANN MEMBRAGEL
• Applicant: Straumann USA (On Behalf of Institut Straumann Ag)
• Product Code: NPK · Dental
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Straumann MembraGel is a sterile, synthetic, degradable barrier membrane for single-patient use in oral surgery. It consists of two liquid poly(ethylene glycol) (PEG) components and two activators, supplied in a kit with a static mixer applicator. Upon application, the viscous liquid forms an in situ hydrogel within 20-50 seconds. The device acts as a physical barrier to inhibit non-osteogenic soft tissue cell infiltration into bone defect sites, supporting alveolar bone regeneration. It is applied by clinicians in an aseptic surgical environment. The hydrogel degrades via hydrolysis during wound healing. Because the material is not self-supporting, it requires concurrent use with bone graft material to maintain space. The device benefits patients by facilitating bone tissue regeneration in dental procedures.

Clinical Evidence

Bench testing only. Performance verification included biocompatibility (cytotoxicity, acute systemic toxicity, SQ implantation in rabbits), gelation time (20-50s), in-vitro water uptake (<20% wt within 4h), and degradation kinetics. All tests met pre-determined acceptance criteria.

Technological Characteristics

Synthetic, biodegradable, in situ forming hydrogel composed of poly(ethylene glycol) (PEG) compounds. Delivered as a two-component liquid system with activators via static mixer. Form factor: syringe-based applicator. Storage: refrigerated 2-8°C. Sterilization: sterile components. Non-software device.

Indications for Use

Indicated for patients requiring guided bone regeneration in oral surgery, including peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Must be used with bone graft material for space maintenance.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Straumann MembraGel (K082111)

Submission Summary (Full Text)

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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: | [phone], 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

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

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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

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.

#### 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.

101956

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## Table 1

| Features | Modified Straumann MembraGel | Straumann<br>MembraGel<br>K082111 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Operating<br>Principle | Straumann MembraGel is applied on the site in<br>liquid form through a syringe applicator | Identical |
| Physical<br>Properties | Initial swelling of Straumann MembraGel<br>samples meet internal specifications<br>Gelation time of the Straumann® MembraGel<br>kit between 20 and 50s<br>A degradation pattern meets internal<br>specifications including complete degradation of<br>the Straumann MembraGel. | Identical |
| Tissue<br>Occlusive<br>Properties | Tissue occlusive properties depend on the<br>physical properties of the PEG network, which is<br>governed density of the crosslink. Cell<br>occlusivity is determined by the degradation<br>pattern and time. Thus, tissue occlusive<br>properties were not impacted by this<br>modification. | Identical |
| Viscosity | The viscosity of the formulation is determined<br>by the Activators present in solution A and B.<br>These solutions were not impacted by the<br>modification described in this 510(k) | Identical |
| Water uptake<br>of the gelled<br>product | The modified device was required to meet the<br>original 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 equal<br>to or less than the predicate | Non-cytotoxic |
| Acute Systemic<br>Toxicity | Acute Systemic Toxicity results equal<br>to or less than the predicate | Non-toxic |
| SQ Implantation (4<br>Weeks) - Rabbits | SQ Implantation results equal to or<br>less than the predicate | Slight Irritant1 |
| Gelation time | 20-50 sec | Passed |
| In-vitro water<br>uptake of the gelled<br>product | Less than 20%wt within 4h after<br>gelation | Passed |
| In-vitro degradation<br>pattern and time | Following a defined degradation<br>kinetics ending in complete<br>disintegration 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 [phone] or [phone] 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:

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.

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: