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

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.

AI/ML Overview

The provided text is a 510(k) summary for the Kensey Nash P1076 Collagen Dental Membrane, a medical device submission to the FDA. It does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with proving a device meets specific performance criteria.

The document primarily focuses on:

Device Description: What the Kensey Nash P1076 Collagen Dental Membrane is (translucent, resorbable, rectangular collagen membrane sheet from bovine tissue, single-use, sterilized by Ethylene Oxide).
Intended Use/Indications For Use: The specific dental procedures for which the membrane is intended (e.g., GBR with implants, augmentation around implants, localized ridge augmentation, filling bone defects, guided bone and tissue regeneration).
Predicate Devices: Kensey Nash compares its device to Geistlich Pharma AG's Bio-Gide (K050466) and Collagen Matrix, Inc.'s Collagen Dental Membrane - Conformable II (K062881).
Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document states: "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 Missing Information:

The document claims that "Performance Testing has confirmed...substantial equivalence" but does not provide any details about this performance testing. Therefore, I cannot extract the information required to answer your prompt, such as:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance for a test set.
Number/qualifications of experts, adjudication methods for ground truth.
Results of any Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
Type of ground truth used.
Sample size for training set or how its ground truth was established.

Conclusion:

Based solely on the provided text, it is impossible to describe the acceptance criteria and the study that proves the device meets them because these specifics are not detailed in the 510(k) summary provided. The summary asserts that performance testing was done to demonstrate substantial equivalence, but it does not present the results or methodology of that testing.

Summary

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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:

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).

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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.

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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

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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

Regulation Number and Section

§ 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.