(83 days)
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
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.
The provided document is a 510(k) summary for the Unicare Biomedical CytoFlex™ ePTFE barrier membrane, which is a medical device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria for an AI/algorithm-based device.
Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in the provided text, as it describes a physical barrier membrane, not an algorithmic or AI device.
Let's break down what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document describes a physical medical device (ePTFE barrier membrane) and its substantial equivalence to predicate devices, not an AI or algorithmic device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here would be meeting the requirements for substantial equivalence to predicates, which is a regulatory assessment, not a device performance metric.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. This information would be relevant for a study evaluating an AI/algorithmic device. The 510(k) summary for a physical device does not typically include "test datasets" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for data is not relevant for a physical barrier membrane in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical product, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of AI/algorithmic devices, is not a concept applied to this type of physical medical device submission.
8. The sample size for the training set
- Not Applicable. No training set exists for this physical device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for a training set exists for this physical device.
Summary of Relevant Information from the Document:
- Device Name: CytoFlex™ ePTFE barrier membrane
- Device Description: "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."
- Indication for Use: "A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects."
- Proof of Meeting Regulatory Requirements (not "acceptance criteria" in the AI sense): The device was found to be "substantially equivalent" to legally marketed predicate devices (Imtec BioBarrier membrane, Osteogenics Cytoplast GBR, Gore-tex Regenerative Material, TefGen-FD). "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."
The 510(k) process for a Class II device like this primarily relies on demonstrating substantial equivalence to existing devices rather than new clinical trials with predefined performance metrics and acceptance criteria as would be expected for a novel AI algorithm.
{0}------------------------------------------------
OCT - 1 2001
510(k) Summary (As Required by Section 807.92 (c))
-
- Submitter Unicare Biomedical Name: 25951 La Cuesta Avenue, Laguna Hills, CA 92653 Address: Stan Yang, 949-643-6707 Contact: July 6, 2001 Date:
-
- Device Name
| Trade Name: | CytoFlexTM |
|---|---|
| Common Name: | ePTFE barrier membrane |
| Classification Name: | Implant, Endosseous for bone filling and/or augmentation |
| Device Classification: | Unclassified |
-
- 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.
- Device Description
-
- Indication
CytoFlex™ is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
- Indication
{1}------------------------------------------------
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.
{2}------------------------------------------------
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
| Prescription of Use(Per 21 CFR 801.109) | ✓ | or | Over-The-Counter-Use(Optional format 1-2-96) | |
|---|---|---|---|---|
| --------------------------------------------- | --------------------------------------------------- | ---- | -------------------------------------------------- | -------------------------------------------------- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | 10012141 |
|---|---|
| --------------- | ---------- |
§ 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.