PERIOPHIL BIPHASIC

K092788 · Cytophil, Inc. · LYC · Dec 18, 2009 · Dental

Device Facts

• Record ID: K092788
• Device Name: PERIOPHIL BIPHASIC
• Applicant: Cytophil, Inc.
• Product Code: LYC · Dental
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Device Story

Periophil Biphasic is a synthetic bone graft substitute composed of biphasic calcium phosphate ceramic (60% hydroxyapatite, 40% beta-tricalcium phosphate). Provided as sterile granules for single-patient use. Features multidirectional interconnected porosity mimicking human cancellous bone. Implanted by clinicians in oral/maxillofacial surgical settings to fill or reconstruct osseous defects. Material slowly resorbs during remodeling, progressively replaced by host bone and soft tissue. Resorption rate designed to prevent premature degradation, supporting bone defect repair.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on biocompatibility history and preclinical testing.

Technological Characteristics

Microporous and macroporous biphasic calcium phosphate ceramic (60% hydroxyapatite, 40% beta-tricalcium phosphate). Granular form factor. Interconnected porosity structure. Sterile, single-patient use. No software or electronic components.

Indications for Use

Indicated for patients requiring bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial osseous defects resulting from surgery or trauma. Suitable for use with autogenous bone. Typical applications include periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities.

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

• MBCP (K051885)

Submission Summary (Full Text)

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### SECTION 4

, A

# 4.0 510K (k) Summary of Safety and Effectiveness

| Trade Name: | Periophil Biphasic | DEC 1 8 2005 |
|---------------------------------------------|-------------------------------------------------------------------------|--------------|
| Common Name: | Synthetic Bone Graft Material | |
| Classification Name: | Bone Filling and Augmentation Material | |
| Official Contact Name: | Victor M. Bowers<br>VP Medical Affairs | |
| Address: | Cytophil, Inc.<br>2485 Corporate Circle, Suite 2<br>East Troy, WI 53120 | |
| Phone:<br>Fax:<br>E-mail:<br>Date Prepared: | 262-642-2765<br>262-642-2745<br>[e-mail]<br>9/04/2008 | |

Kog2788

#### 4.1 Indication for Use

Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

#### 4.2 Product Description

Periophil Biphasic is a bone graft substitute. Periophil Biphasic is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (B-TCP). Periophil Biphasic is available as granules and is provided sterile for single patient use.

Periophil Biphasic is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil Biphasic slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Periophil Biphasic resorbable bone filler is intended to prevent premature resorption.

#### 4.3 Substantial Equivalence

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#### 4.8 Summary

In summary, Periophil Biphasic is substantially equivalent to the cited predicate devices. All have the same indication for use. Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

The components used in Periophil Biphasic and the predicate devices are biocompatible, based on the history and use in many medical devices as well as from preclinical testing. Periophil Biphasic is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K051885 - MBCP™ . BIOMATLANTE, ZA DES IV NATIONS, 5, rue Edouard Belin, -F- 44360 VIGNEUX DE BRETAGNE, France.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Victor M. Bowers Vice President of Medical Affairs Cytophil, Incorporated 2485 Corporate Circle, Unit 2 East Troy, Wisconsin 53120

DEC 1 8 2009

Re: K092788

Trade/Device Name: Periophil Biphasic Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 11, 2009 Received: December 16, 2009

Dear Mr. Bowers:

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.

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#### Page 2 - Mr. Bowers

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Wh 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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## SECTION 2

### 2.0 Indications for Use

510(k) Number: KO 42288

Device Name: Periophil Biphasic

Indications for Use:

Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_***_ or Over-the-Counter Use ***_***_
(Per 21 CFR 801.109)

R.S. Betz DDS /Jr Dr. K. P. Muly, (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092788