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.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cytoflex® Tef-Guard® Ti-Enforced Membrane:

Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical efficacy testing. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like human reader studies, ground truth establishment for a test set, etc.) are not applicable in this context. The acceptance criteria here largely revolve around device performance characteristics and biocompatibility, demonstrated through non-clinical bench testing.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each test in a table format. Instead, it states that the device "was found to meet the requirements of the pre-defined acceptance criteria" for the listed ISO standards and that "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance."

However, based on the performance testing section and the comparison table with predicate devices, we can infer the types of criteria and the reported performance:

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Material & Design Equivalence	- Thickness: Not to exceed a certain deviation from predicate (e.g., within 0.07mm difference).- Density: Not to exceed a certain deviation from predicate (e.g., within 0.5 g/dm² difference).- Material Composition: ePTFE with Titanium frame.- Design: Multi-layer, non-resorbable, space-making barrier, trimmable, flexible.	- Thickness: 0.25mm (Predicate 1: 0.23mm; Predicate 2: 0.3mm). Considered "Substantially Equivalent."- Density: 3.5 g/dm² (Predicate 1: 4.0 g/dm²; Predicate 2: 3.5 g/dm²). Considered "Substantially Equivalent."- Material Composition: ePTFE membranes reinforced with a Titanium frame. Considered "Substantially Equivalent."- Design: A variety of configurations, trimmable and shaped to fit bony defect. Considered "Substantially Equivalent."
Functional Performance	- Tensile Loading: Performance similar to predicate.- Bending: Performance similar to predicate.- Flexibility: Performance similar to predicate.- Delaminating Potential: Performance similar to predicate.	"The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance." (No specific quantitative values provided for the subject or predicate, just a statement of equivalence).
Biocompatibility	- Cytotoxicity: No evidence of cytotoxicity (ISO 10993-5).- Local Effects after Implantation: No adverse local effects (ISO 10993-6).- Irritation & Skin Sensitization: No irritation or sensitization (ISO 10993-10).- Systemic Toxicity: No systemic toxicity (ISO 10993-11).	"Found to meet the requirements of the pre-defined acceptance criteria" for ISO 10993-5, -6, -10, -11. "Biocompatible: Yes."
Sterility	- Sterility Assurance Level (SAL): SAL < 10-6.- Sterilization Process Control: Meets requirements of ISO 11135.- Ethylene Oxide Residuals: Meets limits of ISO 10993-7.	"Sterile by EtO gas, SAL < 10-6." "Found to meet the requirements of the pre-defined acceptance criteria" for ISO 11135 and ISO 10993-7. "Sterility: Sterile."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for the performance (tensile loading, bending, flexibility, delamination) or biocompatibility tests. These tests are typically conducted in a laboratory setting on a representative number of device samples.

Provenance: This is a non-clinical 510(k) submission. The data provenance would be from laboratory bench testing and materials characterization, not from patient data or clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as there was no test set requiring expert interpretation or ground truth establishment for clinical performance. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the acceptance limits defined by the relevant ISO standards and predicate device performance.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. No MRMC clinical study was performed or required for this 510(k) submission. The device is a physical implant, not an imaging or diagnostic AI device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used

For the non-clinical testing:

Bench Test Results: The "ground truth" for functional performance tests (tensile, bending, flexibility, delamination) was derived from direct comparison to the performance of the chosen predicate device, assessed through quantitative measurements. The acceptance criterion was "substantially equivalent" performance to the predicate.
ISO Standard Requirements: For biocompatibility and sterilization, the "ground truth" was established by the requirements and limits defined within the specified ISO standards (e.g., no cytotoxicity detected according to ISO 10993-5).

8. Sample Size for the Training Set

This is not applicable. There was no "training set" in the context of an AI/ML algorithm. The device is a manufactured physical product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. There was no "training set" for this device.

Summary of Approach:

The K151344 submission for the Cytoflex® Tef-Guard® Ti-Enforced Membrane relied on demonstrating substantial equivalence to existing predicate devices. This was achieved primarily through:

Comparison of Device Characteristics: Showing similar materials, design, indications for use, thickness, density, and sterility to the predicate devices.
Non-Clinical Performance Testing: Bench testing for functional performance (tensile loading, bending, flexibility, delamination) was conducted, and the results confirmed that the subject device performed "substantially equivalent" to one of the predicate devices.
Biocompatibility and Sterilization Testing: Meeting the requirements of relevant ISO standards for biocompatibility (cytotoxicity, local effects, irritation, systemic toxicity) and sterilization (EtO sterilization, residuals).

Clinical data was specifically stated as "not required to establish the substantial equivalence." This means the FDA accepted the non-clinical data as sufficient for demonstrating safety and effectiveness comparable to the legally marketed predicate devices.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 949-305-1770; Fax: 949-334-1338
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)

1. 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-Enforcedmembrane / T-001	11x21mm	0.25mm
Cytoflex® Tef-Guard® Ti-Enforcedmembrane / T-002	19x26mm	0.25mm
Cytoflex® Tef-Guard® Ti-Enforcedmembrane / T-003	23x29mm	0.25mm
Cytoflex® Tef-Guard® Ti-Enforcedmembrane / T-004	32x40mm	0.25mm

5. Indication

Comparison with Primary Predicate Device and Reference Predicate Device Q.

Device Name /Comments	CytoflexTef-GuardTi-EnforcedMembrane	CytoplastTitaniumReinforcedhigh densityPTFEMembrane*	Neoss TiReinforcedMembrane**	Comments
510K ID	K 151344	K 972278	K 143327	-
Indications foruse	Temporarilyimplantablematerial (non-resorbable) foruse as a space-making barrierin the	Temporarilyimplantablematerial (non-resorbable) foruse as a space-making barrierin the treatment	An implantabletemporary non-resorbablemembrane foruse as a spacercreation barrierin the treatment	SubstantiallyEquivalentindicationsfor use

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	treatment ofperiodontaldefects andalveolar ridgeaugmentation	of periodontaldefects	of local oraldefects inconjunctionwith tissueregeneration oraugmentation.
Implant sites	periodontaldefects &alveolar ridge	periodontaldefects	Oral bonycavity	Substantiallyequivalentimplant sites
Design	A variety ofconfigurations.May betrimmed andshaped to fitbony defect.	A variety ofconfigurations.May betrimmed andshaped to fitbony defect.	A variety ofconfigurations.May betrimmed andshaped to fitbony defect.	Substantiallyequivalentdesign
Material	ePTFEmembranesreinforced witha Titaniumframe	High densityPTFEmembranesreinforced witha Titaniumframe	ePTFE anddense PTFEmembranesreinforced witha Titaniumframe	SubstantiallyEquivalentmaterial
Thickness	0.25mm	0.23mm	0.3mm	SubstantiallyEquivalent
Density	3.5 g/dm²	4.0 g/dm²	3.5 g/dm²	SubstantiallyEquivalent
Biocompatible	Yes	Yes	Yes	SubstantiallyEquivalent
Sterility	Sterile by EtOgas, SAL <10-6	Sterile	Sterile	SubstantiallyEquivalent

*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
1. 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.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.