(83 days)
Not Found
No
The summary describes a physical barrier membrane made of ePTFE and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a "temporarily implantable material...for use as a space-making barrier in the treatment of periodontal defects," indicating it is used to treat a medical condition.
No
The device description indicates it is a non-resorbable barrier membrane used for space-making in treating periodontal defects. Its purpose is therapeutic (creating space for tissue regeneration), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "temporarily implantable material" and a "non-resorbable barrier membrane composed of microporous ePTFE material," which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The provided description clearly states that this device is a "temporarily implantable material" and a "non-resorbable barrier membrane" used as a "space-making barrier in the treatment of periodontal defects."
- Intended Use: The intended use is to be physically implanted in the body to treat a condition, not to analyze specimens taken from the body.
This device falls under the category of a medical device used for surgical or therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
Product codes
LYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974752, K964342, K922627, K935137
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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 |
|---|---|
| --------------- | ---------- |