(184 days)
No
The device description focuses on the material properties and mechanical function of a physical implant, with no mention of software, data processing, or AI/ML terms.
Yes
The device is used in the "treatment of periodontal defects and augmentation of alveolar ridge," which constitutes a therapeutic use.
No
Explanation: The device is described as an implantable material for tissue regeneration, not for diagnosing medical conditions. It functions as a physical barrier for guided tissue regeneration.
No
The device description clearly states it is a physical, implantable material made of ePTFE and titanium, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that the Cytoflex® Tef-Guard® Ti-Enforced membrane is a "temporarily, non-resorbable, implantable material" that is "surgically placed under the muco-periosteum". This is a device that is implanted into the body (in vivo) to aid in tissue regeneration.
- Intended Use: The intended use is 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." This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
Cytoflex® Tefguard® 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.
Product codes (comma separated list FDA assigned to the subject device)
NPK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal defects and alveolar ridge
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The subject device was tested according to the following ISO standards, and was found to meet the requirements of the pre-defined acceptance criteria:
- 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
- . 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or progress. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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
2
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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3
SECTION 6
510(K) SUMMARY
4
510(k) Summary (As Required by 21CFR 807.92 (c))
-
- 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)
-
- 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
- Device Description
5
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 | ||
| membrane / T-001 | 11x21mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced | ||
| membrane / T-002 | 19x26mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced | ||
| membrane / T-003 | 23x29mm | 0.25mm |
| Cytoflex® Tef-Guard® Ti-Enforced | ||
| 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 /
Comments | Cytoflex
Tef-Guard
Ti-Enforced
Membrane | Cytoplast
Titanium
Reinforced
high density
PTFE
Membrane* | Neoss Ti
Reinforced
Membrane** | Comments |
|---------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510K ID | K 151344 | K 972278 | K 143327 | - |
| Indications for
use | Temporarily
implantable
material (non-
resorbable) for
use as a space-
making barrier
in the | Temporarily
implantable
material (non-
resorbable) for
use as a space-
making barrier
in the treatment | An implantable
temporary non-
resorbable
membrane for
use as a spacer
creation barrier
in the treatment | Substantially
Equivalent
indications
for use |
6
| | treatment of
periodontal
defects and
alveolar ridge
augmentation | of periodontal
defects | of local oral
defects in
conjunction
with tissue
regeneration or
augmentation. | |
|---------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------|
| Implant sites | periodontal
defects &
alveolar ridge | periodontal
defects | Oral bony
cavity | Substantially
equivalent
implant sites |
| Design | A variety of
configurations.
May be
trimmed and
shaped to fit
bony defect. | A variety of
configurations.
May be
trimmed and
shaped to fit
bony defect. | A variety of
configurations.
May be
trimmed and
shaped to fit
bony defect. | Substantially
equivalent
design |
| Material | ePTFE
membranes
reinforced with
a Titanium
frame | High density
PTFE
membranes
reinforced with
a Titanium
frame | ePTFE and
dense PTFE
membranes
reinforced with
a Titanium
frame | Substantially
Equivalent
material |
| Thickness | 0.25mm | 0.23mm | 0.3mm | Substantially
Equivalent |
| Density | 3.5 g/dm² | 4.0 g/dm² | 3.5 g/dm² | Substantially
Equivalent |
| Biocompatible | Yes | Yes | Yes | Substantially
Equivalent |
| Sterility | Sterile by EtO
gas, SAL