FOUNDATION by OLYMPUS TERUMO BIOMATERIALS CORPORATION

The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.

AI/ML Overview

The provided text is a 510(k) summary for the FOUNDATION device, a collagen-based bone filling augmentation material. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria for a new device.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance.
Sample size for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Information about standalone algorithm performance (as this is a medical device, not an AI/algorithm-based one).
The type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

The core of this submission is to show that the new FOUNDATION device is substantially equivalent to an existing FOUNDATION predicate device, with the primary difference being the country source for the bovine raw material. The submission asserts that "Appropriate controls and validations assure there is no effect on the safety, performance, and thus substantial equivalence of the new FOUNDATION compared to the predicate." This implies that the performance expectations are met by demonstrating the raw material change does not alter the established safety and performance of the predicate device, rather than through new performance metrics against specific criteria.

Summary

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KII1087

Section 5.0 510(k) Summary

NOV 2 9 2011

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Property

Submitter Name:Submitter Address:	Olympus Terumo Biomaterials CorporationShinjuku Monolith3-1 Nishi-Shinjuku 2-chomeShinjuku-kuTokyo, Japan 163-0914
Contact Person:Telephone Numberfor US Agent:	Laura Storms-Tyler, US Agent484-896-5688
Date Prepared:	August 25, 2011
Device Trade Name:	FOUNDATION
Classification Nameand Number:Class:Product CodeCommon Name:	Bone grafting material21 CFR 872.39302LYCBone grafting material, synthetic
Predicate Device:	FOUNDATION, Terumo Corporation, K040783
Statement ofIntended Use:	The FOUNDATION device is a collagen-based bone fillingaugmentation material for use in filling of extraction sockets.
Device Description,Summary ofTechnologicalCharacteristics	The FOUNDATION bone filler device is a sponge-like absorbablenatural collagen plug designed to be used as indicated.FOUNDATION consists of approximately 85-95% Type I collagenand approximately 5-15% Type III collagen from bovine dermis.
Comparison to thePredicate Device	The FOUNDATION is available as a bullet shape in three sizes (inmm: 8x15, 8x25, 15x25) and a sheet type in two sizes (mm: 25x25and 50x25). The device is provided sterile, for single use in a heat-sealed aluminum package.
	The FOUNDATION is substantially equivalent to its parentFOUNDATION predicate device in the raw material source andtype of collagen, in device design, and in product forms and sizes:
Conclusion regardingSubstantialEquivalence	The difference in the country source for the bovine raw material isthe purpose for submitting this 510(k). Appropriate controls andvalidations assure there is no effect on the safety, performance,and thus substantial equivalence of the new FOUNDATIONcompared to the predicate.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Olympus Terumo Biomaterials Corporation C/O Ms. Patsy J. Trisler Regulatory Consultant Trisler Consulting 5600 Wisonsin Avenue, # 509 Chevy Chase, Maryland 20815

NOV 2 9 2011

Re: K111087

Trade/Device Name: Foundation Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: October 24, 2011 Received: October 27, 2011

Dear Ms. Trisler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Trisler

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known): Kil 1087

Device Name:

Foundation

Indications for Use:

The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Susan Rumer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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.