(129 days)
Not Found
No
The summary describes a bioresorbable material for periodontal procedures and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a "space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures," which indicates it is used for treating a medical condition.
No
Explanation: The device is described as a "space-making barrier" and "grafting material containment membrane" for the treatment of periodontal defects, indicating a therapeutic or reconstructive function rather than a diagnostic one.
No
The device description clearly states it is a "bioresorbable material" and is "supplied sterile and packaged individually," indicating it is a physical, material-based device, 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 described as a "space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures" and "a grafting material containment membrane." This describes a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description focuses on the material properties and function within the body (biocompatible, cell occlusive, spacemaking).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly intended for use in vivo during a surgical procedure.
N/A
Intended Use / Indications for Use
Cytoplast Resorb Barrier Membrane is intended for use as a spacemaking barrier in the treatment of periodontal defects and quided tissue reqeneration procedures. It is also intended for use as a grafting material containment membrane.
Product codes
LYC
Device Description
Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable. The product is supplied sterile and packaged individually in various sizes.
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)
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
KA93610
510 (k) SUMMARY
1. ADMINISTRATIVE
Submitter: Osteogenics Co. 3234 64th Street Lubbock, TX 79413 (806) 792-2311
Contact Person: Chad Bartee Date of Preparation: October 22, 1999
II. DEVICE NAME
| Proprietary Name: | Cytoplast™ Resorb |
|---|---|
| Common Name: | Resorbable Regenerative Membrane |
| Classification Name: | Implant, Endosseous For Bone Filling And/Or Augmentation. |
PREDICATE DEVICES ==============================================================================================================================================================================
Gore Resolut XT Regenerative Material (K973594, W.L. Gore & Associates, Inc.)
IV. DEVICE DESCRIPTION
Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable. The product is supplied sterile and packaged individually in various sizes.
V. INTENDED USE
Cytoplast Resorb Barrier Membrane is intended for use as a spacemaking barrier in the treatment of periodontal defects and quided tissue reqeneration procedures. It is also intended for use as a grafting material containment membrane.
VI. COMPARISON TO PREDICATE DEVICES
The Cytoplast Resorb Barrier Membrane is similar in composition, and identical in function and intended use to legally marketed devices such as the Gore Resolut XT Regenerative Material.
Accordingly, Osteogenics Biomedical, Inc. has concluded that the Cytoplast Resorb Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is used on a variety of government documents and websites.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2000
Osteogenics Biomedical, Inc. C/O Mr. Richard A. Hamer Requlatory Consultant Richard Hamer Associates, Inc. 6401 Meadows West Drive Fort Worth, Texas 76132
Re : K993610 Cytoplast™ Resorb Trade Name: Requlatory Class: Unclassified Product Code: LYC February 7, 2000 Dated: May 8, 2000 Received:
Dear Mr. Hamer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Hamer
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
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| Page | 1 of 1 |
|---|---|
| ------ | -------- |
510(k) Number (if known):
Cytoplast™ Resorb Device Name:
Indications for Use:
As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures;
As a grafting material containment membrane.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Naar Minnel (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510/1 : Number _ Irya Over-the-Counter Use ાર Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)