(184 days)
Not Found
No
The summary describes a collagen membrane for dental procedures and does not mention any AI or ML components or functionalities.
No
The device is a dental membrane used for bone and tissue regeneration, not for treating existing diseases or conditions in itself.
No
The device is a resorbable collagen membrane used for augmentation and regeneration procedures, not for identifying or diagnosing medical conditions. Its intended uses involve supporting tissue growth and filling defects, which are therapeutic rather than diagnostic actions.
No
The device description clearly states it is a "collagen membrane sheet derived from bovine tissue," indicating it is a physical, resorbable material, not software.
Based on the provided information, the Kensey Nash Fibrillar Collagen Dental Membrane is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone and tissue regeneration in the mouth. These are therapeutic and structural applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is a physical membrane intended to be implanted or placed in the body. IVD devices are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the Kensey Nash Fibrillar Collagen Dental Membrane falls under the category of a medical device used for surgical and regenerative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:
- . Simultaneous use of GBR-membrane and implants.
- Augmentation around implants placed in immediate extraction sites. .
- . 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. .
- Guided bone regeneration in dehiscence defects. .
- . Guided tissue regeneration procedures in periodontal defects
Product codes
NPL
Device Description
The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
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)
Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k).
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
510(k) Summary
OCT - 2 2009
| Submitted by: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 |
|--------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Alyssa J. Schwartz, MS, RAC
Regulatory Affairs Specialist
Ph: (484) 713-2173 Fax: (484) 713-2903 |
| Date Prepared: | March 30, 2009 |
| 510(K) #: | |
| Device: | |
| Trade Name: | Kensey Nash Fibrillar Collagen Dental Membrane |
| Common/Usual Name: | Collagen Dental Membrane |
| Proposed Classification: | Barrier, Animal Source, Intraoral
21 CFR 872.3930, NPI, Class II |
Device Description:
The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
Intended Use:
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:
- . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants.
- Augmentation around implants placed in immediate extraction sites. .
- . 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. .
- Guided bone regeneration in dehiscence defects. .
- . Guided tissue regeneration procedures in periodontal defects
Predicate Devices:
| Manufacturer | Device | 510(k)# |
|---|---|---|
| Geistlich Pharma AG | Bio-Gide | K050466 |
| Collagen Matrix, Inc. | Collagen Dental Membrane - Conformable II | K062881 |
Substantial Equivalence:
Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k).
1-800-524-1984
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure. The emblem is composed of several curved lines and shapes, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-0609 Silver Spring. MD 20993-0002
Ms. Alyssa J. Schwartz Regulatory Affairs Specialist Kensey Nash Corporation 735 Pennsylvania Drive Exton, Pennsylvania 19341
OCT - 2 2009
Re: K090919
Trade/Device Name: Kensey Nash Fibrillar Collagen Dental Membrane Regulation Number: 21 CFR 872,3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 25, 2009 Received: September 28, 2009
Dear Ms.Schwartz:
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 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.
2
Page 2- Ms. Schwartz
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industry/support/index.html.
Sincerely yours,
Roc
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kensev Nash
Indications For Use Statement
510(k) Number:
Device Name:
Kensey Nash Fibrillar Collagen Dental Membrane
Indications For Use:
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:
- . Simultaneous use of GBR-membrane and implants.
- Augmentation around implants placed in immediate extraction sites. .
- . 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.
- Guided bone regeneration in dehiscence defects. ●
- . Guided tissue regeneration procedures in periodontal defects
X Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kain Huley for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090919
1-800-524-1984