(63 days)
Not Found
No
The summary describes a bioabsorbable implantable membrane and its physical properties and intended use in surgical procedures. There is no mention of any computational or analytical capabilities, let alone AI or ML.
Yes.
It is an implantable membrane used in surgical management and treatment of periodontal defects to aid in tissue regeneration and integration.
No
Explanation: The device description states its intended use is for surgical management and treatment of periodontal defects by aiding in tissue regeneration and containing bone graft material. It is a bioabsorbable implantable membrane, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "bioabsorbable implantable membrane" composed of "synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "implantable membrane intended for use in the surgical management and treatment of periodontal defects". This describes a device used in vivo (within the body) for surgical intervention and tissue regeneration.
- Device Description: The description details a "porous structure of synthetic bioabsorbable compressed L (-)Glycolide homopolymer fibers" designed to be implanted and interact with tissue. This is consistent with an implantable medical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro to diagnose a condition, monitor treatment, or screen for diseases. The device's function is physical and biological within the body.
Therefore, BioCELLECT™-perio is a medical device, specifically an implantable surgical device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.
Product codes
LYC
Device Description
BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.
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
APR 1 0 2002
510 (k) SUMMARY
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
(580) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: January 30,2002
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Unclassified Device. Code:LYC Common/ Usual Name:GTR Proprietary Name: BioCELLEC'T™-perio.
PREDICATE DEVICE:
Epi-Guide™ (K940643)
DEVICE DESCRIPTION:
BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2002
Mr. K. Patterson Senior Vice President IMTEC, Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K020396
Trade/Device Name: BioCELLECT™- perio Regulation Number: None Regulation Name: GTR Barrier Regulatory Class: Unclassified Product Code: LYC Dated: January 30, 2002 Received: February 6, 2002
Dear Mr. Patterson:
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. Patterson
You must comply with all the Act's requirements, including, but not limited to: registration r ou interest compry was as a manufacturing (21 CFR Part 801); good manufacturing practice and listing (21 er read 007), equality systems (QS) regulation (21 CFR Part 820); and if roquiceller 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 If you desire pochlo ad for a 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 the Ree may be country 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
A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) Number (if known): K020396
Device Name: BioCELLECT™ -perio
Indications For Use:
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.
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| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F (0(k) Number __