(89 days)
Not Found
Not Found
No
The device description and intended use focus on a physical titanium mesh for bone reconstruction, with no mention of software, algorithms, or AI/ML terms.
No.
The device facilitates the reconstruction and augmentation of alveolar bone defects by providing structural support for augmentation material, rather than directly treating a disease or condition itself.
No
The device is described as a precision titanium mesh used for reconstruction and augmentation of alveolar bone defects, not for identifying or diagnosing a condition.
No
The device description explicitly states that the device is a "precision titanium mesh," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "precision titanium mesh." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for structural support and reconstruction.
N/A
Intended Use / Indications for Use
Cytoflex Mesh is indicated for use in ensuring three-dimensional reconstruction of alveolar bone defects and for facilitating augmentation with adequate fixation of the augmentation material.
Product codes
JEY
Device Description
Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh 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
alveolar bone
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)
Precision Titanium Foil (Imtec Corporation), Osteomed MSS (Osteomed Corporation), Micro-Titanium Augmentation Mesh (Howmedica-Leibinger), Ti Mini Bone Plate and Screws (Walter Lorenz Surgical, Inc.), Reconstructive Surgery System (Ti Mesh Inc.), Osteogenics Cytoplast GBR (Osteogenics Corporation), Imtec BioBarrier membrane (Imtec Corporation), Gore-tex Regenerative Material (W.L. Gore & Associates, Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510(K) Summary (As Required by Section 807.92 (c))
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- Submitter
| Name: | Unicare Biomedical |
|---|---|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-643-6707 |
| Date: | February 20, 2002 |
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- Device Name
| Trade Name: | Cytoflex Mesh |
|---|---|
| Common Name: | Precision Titanium Mesh |
| Classification Name: | Implant, Endosseous for bone filling and/or augmentation |
| Device Classification: | Unclassified |
3. Predicate Devices
Precision Titanium Foil (Imtec Corporation) Osteomed MSS (Osteomed Corporation) Micro-Titanium Augmentation Mesh (Howmedica-Leibinger) Ti Mini Bone Plate and Screws (Walter Lorenz Surgical, Inc.) Reconstructive Surgery System (Ti Mesh Inc.) Osteogenics Cytoplast GBR (Osteogenics Corporation) Imtec BioBarrier membrane (Imtec Corporation) Gore-tex Regenerative Material (W.L. Gore & Associates, Inc.)
-
- Device Description
Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.
- Device Description
-
- Indication
Cytoflex Mesh is indicated for use in ensuring three-dimensional reconstruction of alveolar bone defects and for facilitating augmentation with adequate fixation of the augmentation material.
- Indication
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized symbol that resembles a human figure in profile, with three wavy lines extending from the head.
Public Health Service
AUG 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stan Yang, Ph.D. Vice President of Operations Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laguna Hills, California 92653
Re: K021511
Trade/Device Name: Cytoflex Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Precision Titanium Mesh Regulatory Class: II Product Code: JEY Dated: May 3, 2002 Received: May 9, 2002
Dear Dr. 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.
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Page 2 - Dr. Yang
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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.qov/cdrh/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Directør Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (K) NUMBER (IF KNOWN): DEVICE NAME: CYTOFLEX™ MESH INDICATIONS FOR USE:
For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
or
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Prescription of Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional format 1-2-96)
Susan Runn
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K021511