Cytoflex Tefguard Ti-Enforced Membrane

K151344 · Unicare Biomedical, Inc. · NPK · Nov 19, 2015 · Dental

Device Facts

• Record ID: K151344
• Device Name: Cytoflex Tefguard Ti-Enforced Membrane
• Applicant: Unicare Biomedical, Inc.
• Product Code: NPK · Dental
• Decision Date: Nov 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cytoflex® Tefguard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a spacemaking barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

Device Story

Cytoflex Tef-Guard Ti-Enforced membrane is a passive, non-resorbable, implantable barrier; consists of titanium frame enclosed within two layers of ePTFE. Surgically placed under muco-periosteum by dental professionals; acts as space-making barrier to contain bone grafting material; prevents gingival tissue cell migration into bony defects; facilitates neovascularization and bone repair. Implanted for 30 days up to 6 months; single-use; provided sterile. Benefits include improved environment for bone regeneration and graft stability.

Clinical Evidence

Bench testing only. No clinical data required. Performance evaluated via tensile loading, bending, flexibility, and delamination testing compared to primary predicate. Biocompatibility verified per ISO 10993-5, 6, 7, 10, and 11. Sterilization validated per ISO 11135.

Technological Characteristics

Multi-layer non-resorbable membrane; ePTFE exterior layers with internal titanium frame. Thickness 0.25mm; density 3.5 g/dm². Sterile (EtO gas, SAL <10^-6). Single-use. Biocompatible per ISO 10993 standards.

Indications for Use

Indicated for patients requiring guided tissue regeneration for the treatment of periodontal defects and alveolar ridge augmentation.

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

• Cytoplast® Titanium reinforced high density PTFE membranes (K972278)

Reference Devices

• Neoss Ti Reinforced Membrane (K143327)

Submission Summary (Full Text)

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

November 19,2015

Unicare Biomedical, Inc. Stan Yang Vice President 23011 Moulton Parkway, J-11 Laguna Hills, California 92653

Re: K151344

Trade/Device Name: Cytoflex Tefguard Ti-enforced Eptfe Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: October 14, 2015 Received: October 19, 2015

Dear Stan 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. 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.

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

10(k) Number (if known) K151344

#### Device Name

Cytoflex® Tefguard® Ti-Enforced membrane

Indications for Use (Describe)

Cytoflex® Tefguard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a spacemaking barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# SECTION 6

# 510(K) SUMMARY

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# 510(k) Summary (As Required by 21CFR 807.92 (c))

- 1. Submitter

| Name: | Unicare Biomedical |
|----------|-----------------------------------------------------------------|
| Address: | 23011 Moulton Parkway, J-11, Laguna Hills, California 92653 USA |
| Tel: | Tel: [phone]; Fax: [phone] |
| Contact: | Stan Yang, PhD |
| Date: | June 15, 2015 |

| 2. Trade/Device Name: | Cytoflex® Tef-Guard® Ti-Enforced Membrane |
|-----------------------|-------------------------------------------|
| Common Name: | Non-resorbable barrier membrane |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Barrier, Synthetic, Intraoral |
| Regulation Class: | II |
| Product Code: | NPK |

#### 3. Predicate Devices

Primary predicate device -Cytoplast® Titanium reinforced high density PTFE membranes (K972278; Osteogenics Biomedical, Inc.) Reference predicate device -Neoss Ti Reinforced Membrane (K143327; Neoss Ltd)

- 4. Device Description
Cytoflex® Tef-Guard® Ti-Enforced membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a passive, non-load bearing material with a titanium frame enclosed within two exterior layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more

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favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. The membranes are intended to be submerged and implanted for more than 30 days and up to 6 months. The membrane is supplied sterile and available in a variety of shapes and sizes for single use only.

| Description / Model | Dimension | Thickness |
|------------------------------------------------------|-----------|-----------|
| Cytoflex® Tef-Guard® Ti-Enforced<br>membrane / T-001 | 11x21mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced<br>membrane / T-002 | 19x26mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced<br>membrane / T-003 | 23x29mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced<br>membrane / T-004 | 32x40mm | 0.25mm |

### 5. Indication

Cytoflex® Tef-Guard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

#### Comparison with Primary Predicate Device and Reference Predicate Device Q.

| Device Name /<br>Comments | Cytoflex<br>Tef-Guard<br>Ti-Enforced<br>Membrane | Cytoplast<br>Titanium<br>Reinforced<br>high density<br>PTFE<br>Membrane* | Neoss Ti<br>Reinforced<br>Membrane** | Comments |
|---------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510K ID | K 151344 | K 972278 | K 143327 | - |
| Indications for<br>use | Temporarily<br>implantable<br>material (non-<br>resorbable) for<br>use as a space-<br>making barrier<br>in the | Temporarily<br>implantable<br>material (non-<br>resorbable) for<br>use as a space-<br>making barrier<br>in the treatment | An implantable<br>temporary non-<br>resorbable<br>membrane for<br>use as a spacer<br>creation barrier<br>in the treatment | Substantially<br>Equivalent<br>indications<br>for use |

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| | treatment of<br>periodontal<br>defects and<br>alveolar ridge<br>augmentation | of periodontal<br>defects | of local oral<br>defects in<br>conjunction<br>with tissue<br>regeneration or<br>augmentation. | |
|---------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------|
| Implant sites | periodontal<br>defects &<br>alveolar ridge | periodontal<br>defects | Oral bony<br>cavity | Substantially<br>equivalent<br>implant sites |
| Design | A variety of<br>configurations.<br>May be<br>trimmed and<br>shaped to fit<br>bony defect. | A variety of<br>configurations.<br>May be<br>trimmed and<br>shaped to fit<br>bony defect. | A variety of<br>configurations.<br>May be<br>trimmed and<br>shaped to fit<br>bony defect. | Substantially<br>equivalent<br>design |
| Material | ePTFE<br>membranes<br>reinforced with<br>a Titanium<br>frame | High density<br>PTFE<br>membranes<br>reinforced with<br>a Titanium<br>frame | ePTFE and<br>dense PTFE<br>membranes<br>reinforced with<br>a Titanium<br>frame | Substantially<br>Equivalent<br>material |
| Thickness | 0.25mm | 0.23mm | 0.3mm | Substantially<br>Equivalent |
| Density | 3.5 g/dm² | 4.0 g/dm² | 3.5 g/dm² | Substantially<br>Equivalent |
| Biocompatible | Yes | Yes | Yes | Substantially<br>Equivalent |
| Sterility | Sterile by EtO<br>gas, SAL <10-6 | Sterile | Sterile | Substantially<br>Equivalent |

*Primary Predicate Device; ** Reference Predicate Device

### 7. Device Characteristics

As summarized in the comparison Table above, the designs of Cytoflex® Tef-Guard® Ti-Enforced membranes are substantially equivalent to the primary predicate device, Cytoplast Titanium Reinforced high density PTFE Membrane, and reference predicate device, Neoss Ti Reinforced Membrane. The subject and the predicate devices are passive, non-load bearing membranes for use to maintain space and shape to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells

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into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect in accordance with the guided tissue regeneration principle to repair periodontal defects and/or augment alveolar ridge. The devices are for single use only and are provided sterile with a variety of configurations for different bony size defects.

### 8. Performance Testing

The performance of Cytoflex® Tef-Guard® Ti-Enforced membrane was evaluated against the primary predicate device for tensile loading, bending, flexibility and delaminating potential. The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance.

Cytoflex® Tef-Guard® Ti-Enforced membrane is made of substantially equivalent biocompatible materials as the predicate devices. The subject device was tested according to the following ISO standards, and was found to meet the requirements of the pre-defined acceptance criteria. The results of the above testing demonstrate that the Cytoflex® Tef-Guard® Ti-Enforced membrane is substantially equivalent in safety and effectiveness, and its performance meets the requirements of its predefined acceptance criteria and intended use.

- ISO 11135 (2014) Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 10993-5 (2009) Biological evaluation of medical devices Part 5: Tests for . in vitro Cytotoxicity
- . ISO 10993-6 (2007) - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO 10993-10 (2010) Biological evaluation of medical devices Part 10: Tests . for irritation and skin sensitization
- ISO 10993-11 (2006) Biological evaluation of medical devices Part 11: Tests . for systemic toxicity in Mice

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- . ISO 10993-11 (2006) - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity in Rats following subcutaneous implantation, 4 weeks
- ISO 10993-7 (2008R2012) Biological evaluation of medical devices Part 7: . Ethylene oxide sterilization residuals
- 9. Clinical Testing

Clinical data was not required to establish the substantial equivalence of the Cytoflex® Tef-Guard® Ti-Enforced Membrane.

### 10. Conclusion

Cytoflex® Tef-Guard® Ti-Enforced Membranes are substantially equivalent to the primary predicate device in that they have similar indications for use and exhibit substantially equivalent technology and device characteristics, including thickness, dimension, density, design and material composition when compared with the predicate devices. The test results demonstrate that Cytoflex® Tef-Guard® Ti-Enforced Membranes are biocompatible and perform substantially equivalent to the primary predicate device.