CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090

K090083 · Unicare Biomedical, Inc. · LYC · Mar 23, 2009 · Dental

Device Facts

• Record ID: K090083
• Device Name: CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
• Applicant: Unicare Biomedical, Inc.
• Product Code: LYC · Dental
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

Device Story

CytoFlex® Resorb is a resorbable barrier membrane used in dental and maxillofacial surgery. Composed of polyglycolide, polylactide, and poly(glycolide-co-lactide) copolymer. Functions as a space-making barrier to facilitate guided tissue regeneration and as a containment matrix for bone grafting materials. Supplied in various shapes and sizes in sealed pouches. Used by clinicians in surgical settings to support bone regeneration in periodontal and maxillofacial defects.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resorbable barrier membrane composed of polyglycolide, polylactide, and poly(glycolide-co-lactide) copolymer. Supplied in various shapes and sizes. Non-electronic, mechanical barrier device.

Indications for Use

Indicated for patients requiring periodontal defect treatment or maxillofacial guided tissue regeneration, including alveolar bone height/volume preservation, ridge/extraction site augmentation, sinus lifts, and cystic defect treatment. Also used as a grafting material containment matrix.

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

• Gore Resolut (K973594)
• Biomesh (K990363)
• Bioscaff Alvelac (K080308)

Submission Summary (Full Text)

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K09 0083

### MAR 2 3 2009

# SECTION 5 - 510(k) Summary or 510(k) Statement

# 510(k) Summary (As Required by Section 807.92 (c))

- 1. Submitter

| Name: | Unicare Biomedical |
|----------|------------------------------------------------|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-643-6707 |
| Date: | January 7, 2009 |

- 2. Device Name

| Trade Name: | CytoFlex® Resorb |
|------------------------|-------------------------------|
| Common Name: | Absorbable barrier membrane |
| Classification Name: | Barrier, synthetic, intraoral |
| Device Classification: | II |

- 3. Predicate Devices
Gore Resolut (K973594; W.L. Gore & Associates) Biomesh (K990363; Sam Yang Corporation) Bioscaff Alvelac (K080308; Bioscaffold International)

- 4. Device Description
CytoFlex® Resorb barriers are made from polyglycolide, polylactide and poly(glycolide-co-lactide) copolymer. CytoFlex® Resorb is a resorbable barrier membrane and is supplied in a variety of shapes and sizes in sealed pouches. CytoFlex® Resorb membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

- 5. Indication
CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

Unicare Biomedical 510 (k) Notification

Confidential

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### 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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The text is in all caps and is relatively small compared to the eagle symbol. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 3 2009

Mr. Stan Yang Vice President Unicare Biomedical, Incorporated 22971Triton Way, Unit B Laguna Hills, California 92653

K090083 Re:

> Trade/Device Name; CytoFlex® Resorb Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 7, 2009 Received: January 12, 2009

Dear Mr. Yang:

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 such 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. Yang

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

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 postmarket surveillance, please contact CDRH s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Syed Y. Mohiuddin MD.

Ginette Y. Michaud, M.D. Acting 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 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known):

CytoFlex® Resorb Device Name:

Indications for Use:

CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Unicare Biomedical 510 (k) Notification | Confidential |
|-----------------------------------------|--------------|
|-----------------------------------------|--------------|

| | <div> Sven Runner </div> <div> (Division Sign-Off) </div> <div> Division of Anesthesiology, General Hospital </div> <div> Infection Control, Dental Devices </div> |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K090083 |