(193 days)
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No
The document describes a collagen dental membrane and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a collagen dental membrane used for guided bone and tissue regeneration, which is a structural and regenerative application, not a therapeutic treatment of a disease or condition.
No
The device is a resorbable collagen membrane used for guided bone and tissue regeneration, not for diagnosing medical conditions. Its indications involve augmentation and reconstruction, which are therapeutic interventions.
No
The device description clearly states it is a "collagen membrane sheet derived from bovine tissue," indicating it is a physical, material-based device, not software.
Based on the provided information, the Kensey Nash P1076 Collagen Dental Membrane is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Kensey Nash P1076 Collagen Dental Membrane clearly indicate it is a physical implantable device used in surgical procedures within the mouth (intraoral). It is a membrane used for guided bone and tissue regeneration.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is structural and regenerative.
Therefore, the Kensey Nash P1076 Collagen Dental Membrane falls under the category of a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kensey Nash P1076 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. 9
- 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 (comma separated list FDA assigned to the subject device)
NPL
Device Description
The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing has confirmed that the Kensey Nash P1076 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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
ensev Nash
NOV - 2 2009
Submitted by:
Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341
Contact Person:
Date Prepared:
510(K) #: Device:
Trade Name:
Alyssa J. Schwartz, MS, RAC Regulatory Affairs Specialist Ph: (484) 713-2173 Fax: (484) 713-2903
April 17, 2009
Kensey Nash P1076 Collagen Dental Membrane Collagen Dental Membrane Barrier, Animal Source, Intraoral 21 CFR 872.3930, NPL, Class II
Device Description:
Common/Usual Name:
Proposed Classification:
The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
Intended Use:
The Kensey Nash P1076 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. 9
- 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 P1076 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
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ms. Alyssa J. Schwartz Regulatory Affairs Specialist Kensey Nash Corporation 735 Pennsylvania Drive -Exton, Pennsylvania 19341
NOV - 2 2009
Re: K091192
Trade/Device Name: Kensey Nash P1076 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,
Wh for
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
Indications For Use Statement
KO91192 510(k) Number:
Device Name:
Kensey Nash P1076 Collagen Dental Membrane
Indications For Use:
The Kensey Nash P1076 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
Prescription Use X (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)
Suan Puno
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091192
1-800-524-1984
KENSEY NASH CORPORATION, 735 PENNSYLVANIA DRIVE, EXTON, PA 19341 Page 30 of 331