(475 days)
None
The provided text does not contain any K/DEN numbers for reference devices. Therefore, I cannot identify and list them.
No
The provided text describes a bone graft material (BIO-GIDE®) and its intended uses in various dental procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The information provided describes the intended use of the device BIO-GIDE®. The listed indications, such as "augmentation around implants," "localized ridge augmentation," and "filling of bone defects," describe therapeutic procedures aimed at repairing or restoring bone tissue, which are therapeutic actions.
No
Explanation: The Intended Use describes BIO-GIDE® as a membrane for augmentation and reconstruction in surgical procedures involving bone defects and implants. It is a material used for tissue regeneration, not for identifying or diagnosing diseases or conditions.
No
The provided text describes a physical membrane (BIO-GIDE®) and its intended uses in surgical procedures involving bone grafting and implants. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a membrane used in surgical procedures for bone regeneration and augmentation. This is a therapeutic and surgical application, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from a diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BIO-GIDE® device, as described, is a surgical implant used to facilitate bone healing and regeneration.
N/A
Intended Use / Indications for Use
BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: augmentation around implants placed in immediate extract sockets; - augmentation around implants placed in delayed extraction sockets; . - . localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment - - filling of bone defects after root resection, cystectomy, removal of retained teeth. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)
Product codes
NPK
Device Description
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Mr. Peter S. Reichertz Attorney Geistlich-Pharma C/O Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, N.W. Washington, D.C. 20036-5339
Re: K960724 Trade Name: Bio-Gide Resorbable Bilayer Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: April 25, 1997 Received: April 25, 1997
Dear Mr. Reichertz:
This letter corrects our substantially equivalent letter of June 11, 1997.
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 (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 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.
1
Page 2 -
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 continue 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Synette Y. Michaud MD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/1/Picture/7 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The words "FDA Centennial" are in the center of the logo.
Protesting and Promoting Public Health
2
510 (K) Number (if known) :
Device Name: BIO-GIDE® Resorbable Bilayer Membrane
Indications For Use:
(
BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants:
augmentation around implants placed in immediate extract sockets;
- augmentation around implants placed in delayed extraction sockets; .
- . localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment -
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Susan Runoer
(Division Sign-Off) Division of Dental, Infection Control, and Ganeral Hospital 510(k) Number .
Prescription Use
(Per 21 CFR 801.109) ✓
Over-The-Counter Use
(Optional Format 1-2-96)