CYTOFLEX

K012144 · Unicare Biomedical, Inc. · LYC · Oct 1, 2001 · Dental

Device Facts

• Record ID: K012144
• Device Name: CYTOFLEX
• Applicant: Unicare Biomedical, Inc.
• Product Code: LYC · Dental
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Device Story

CytoFlex is a non-resorbable, microporous ePTFE barrier membrane; nominal thickness 250 microns. Used as a space-making barrier in periodontal defect treatment. Implanted by clinicians during dental procedures to facilitate bone regeneration. Biocompatibility established via historical use of ePTFE. Supplied sterile in various shapes and sizes.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on material biocompatibility and comparison to legally marketed predicate devices.

Technological Characteristics

Material: Microporous ePTFE. Form factor: Membrane, 250-micron nominal thickness. Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring space-making barrier membranes for the treatment of periodontal defects. Non-resorbable, temporarily implantable material.

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

• Imtec BioBarrier membrane (K974752)
• Osteogenics Cytoplast GBR (K964342)
• Gore-tex Regenerative Material (K922627)
• TefGen-FD (K935137)

Submission Summary (Full Text)

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K012144

OCT - 1 2001

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

- 1. Submitter Unicare Biomedical Name: 25951 La Cuesta Avenue, Laguna Hills, CA 92653 Address: Stan Yang, 949-643-6707 Contact: July 6, 2001 Date:
- 2. Device Name

| Trade Name: | CytoFlexTM |
|------------------------|----------------------------------------------------------|
| Common Name: | ePTFE barrier membrane |
| Classification Name: | Implant, Endosseous for bone filling and/or augmentation |
| Device Classification: | Unclassified |

- 3. Predicate Devices
Imtec BioBarrier membrane (K974752; Imtec Corporation) Osteogenics Cytoplast GBR (K964342; Osteogenics Corporation) Gore-tex Regenerative Material (K922627; W.L. Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical)

- 4. Device Description
CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches. The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

- 5. Indication
CytoFlex™ is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

Mr. Stan Yang Vice President Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laguna Hills, California 92653

Re: K012144

Trade/Device Name: Cytoflex Regulation Number: None Regulation Name: Endosseous Implant for Bone Filling and Augmentation Regulatory Class: Unclassified Product Code: LYC Dated: July 6, 2001 Received: July 10, 2001

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.

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.

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Page 2 - Mr. Yang

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 (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) NUMBER (IF KNOWN): _KOJQ144 DEVICE NAME: CYTOFLEX™ INDICATIONS FOR USE:

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

| Prescription of Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> | or | Over-The-Counter-Use<br>(Optional format 1-2-96) | <span style="text-decoration: overline;"></span> |
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(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | 10012141 |
|---------------|----------|
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