CARRIGEN

K100883 · Etex Corp. · LYC · Dec 21, 2010 · Dental

Device Facts

• Record ID: K100883
• Device Name: CARRIGEN
• Applicant: Etex Corp.
• Product Code: LYC · Dental
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Story

CarriGen is a synthetic, biocompatible, macro-porous bone graft substitute. It consists of a powder component mixed with a solution to form a putty. The clinician applies the putty manually to dental or maxillofacial bony defects. The material is moldable in-situ and hardens at body temperature, converting to nano-crystalline hydroxyapatite. It acts as an osteoconductive scaffold that resorbs and is replaced by natural bone during the healing process. Used by dental professionals in clinical settings.

Clinical Evidence

Bench testing only. Performance data provided in accordance with the FDA Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (April 28, 2005).

Technological Characteristics

Synthetic calcium phosphate, sodium carboxymethyl cellulose, and EfferSoda (88% sodium bicarbonate, 12% sodium carbonate). Self-setting, injectable, macro-porous putty. Converts to nano-crystalline hydroxyapatite in-situ. Non-electronic, mechanical device.

Indications for Use

Indicated for filling or augmenting dental intraosseous, intraoral, and maxillofacial bony voids or gaps, including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, and cystic defects resulting from surgery or trauma.

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

• Alpha-bsm Bone Substitute Material (K091729)
• Beta-bsm Injectable Bone Substitute Material (K091729)
• Gamma-bsm Moldable Bone Substitute Material (K091729)
• EquivaBone Osteoinductive Bone Graft Substitute (K091729)

Submission Summary (Full Text)

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## Traditional 510(k) Submission – CarriGen Bone Grafting Material

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## 5. 510(k) Summary

| Submitter: | DEC 21 2010<br>ETEX Corporation<br>38 Sidney Street<br>Cambridge, MA 02139<br>Registration No.: 1225112<br>Owner/Operator No.: 9014709 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Regulatory Affairs Manager<br>Office: [phone] x160<br>Mobile: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | March 19, 2010 |
| Product Code(s): | LYC (21 CFR 872.3930) |
| Device Class: | II (21 CFR 872.3930) |
| Classification Panel: Dental Devices | |
| Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930) | |
| Proprietary Name: | CarriGen Porous Bone Substitute Material |
| Predicate Device(s): | Alpha-bsm Bone Substitute Material (ETEX Corp.,<br>K091729)<br>Beta-bsm Injectable Bone Substitute Material (ETEX<br>Corp., K091729)<br>Gamma-bsm Moldable Bone Substitute Material (ETEX<br>Corp., K091729)<br>EquivaBone Osteoinductive Bone Graft Substitute (ETEX<br>Corp., K091729) |
| Device Description: | CarriGen Porous Bone Substitute Material is a synthetic,<br>biocompatible bone graft substitute material. At the time of<br>use, the powder component is combined with a specified<br>volume of mixing solution and mixed to form a putty. The<br>resulting putty is administered to the treatment site by<br>manual application. The material can be shaped into a<br>desired form in-situ prior to implantation. After the putty<br>is applied to the treatment site, it hardens at body<br>temperature and converts to an apatitic calcium phosphate<br>material. The end product, nano-crystalline hydroxyapatite |

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(NCHA); is-of-low-crystalline-order-with-a-similar-chemical_ and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Intended Use: CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Synthetic calcium phosphate, sodium carboxymethyl Materials: cellulose and EfferSoda (a commercial formulation of 88% sodium bicarbonate and 12% sodium carbonate)

- Testing data meeting the requirements of Class II Special Performance Data: Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Mr. Christopher Klaczyk Regulatory Affairs Manager Etex Corporation 38 Sidney Street Cambridge, Massachusetts 02139

DEC2 1 2010

: .

Re: K100883

Trade/Device Name: CarriGen Porous Bone Substitute Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 7, 2010 Received: December 8, 2010

Dear Mr. Klaczyk:

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- Mr. Klaczyk

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Kunrei

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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## 4. Indications For Use

510(k) Number (if known):

Device Name:

CarriGen Porous Bone Substitute Material

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Indications for Use:

CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectorny, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number: | K100883 |
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ETEX Corporation