TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, pelvis). Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Device Description

TricOs A Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.

AI/ML Overview

The provided text is a 510(k) summary for the TricOs A Resorbable Bone Substitute. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or the details of a study with reported device performance in the format requested.

The document discusses "assessment of nonclinical data" and states that "Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing." However, this is a very high-level statement and does not provide:

A table of acceptance criteria
Specific performance metrics (e.g., sensitivity, specificity, accuracy, or any quantifiable measure of effectiveness)
Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or details of multi-reader multi-case studies or standalone algorithm performance.
The type of ground truth used beyond "animal studies" or "functional and biocompatibility testing."
Training set sample size or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, rather than presenting a detailed clinical study report or performance evaluation against specific, quantifiable acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study that proves the device meets those criteria because the necessary information is not present in the provided text.

Summary

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and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the

OCT 1 . 2008

Page 1 of 3 Section 5, 510(k) Šummary

K 081 717

5. 510(K) SUMMARY
-------------------

DATE:	June 16, 2008
OWNER:	Baxter Healthcare Corporation
	One Deerfield Parkway
	Deerfield, IL 60015
CONTACT PERSON:	Barbara Barbeau
	Senior Director, Global Regulatory Affairs
	1620 Waukegan Road, MPGR-AL
	McGaw Park, IL 60085
	Telephone: 847-270-4174
	Fax: 847-785-5116
	Email: Barbara_Barbeau@baxter.com
DEVICE NAME:
	Trade Name:Tricos A¹ Resorbable Bone SubstituteCommon Name:Bone Void FillerClassification:Resorbable Calcium Salt Bone Void FillerClass:Class IIProduct Code:MQV	Trade Name:	Tricos A¹ Resorbable Bone Substitute	Common Name:	Bone Void Filler	Classification:	Resorbable Calcium Salt Bone Void Filler	Class:	Class II	Product Code:	MQV
Trade Name:	Tricos A¹ Resorbable Bone Substitute
Common Name:	Bone Void Filler
Classification:	Resorbable Calcium Salt Bone Void Filler
Class:	Class II
Product Code:	MQV
PREDICATE DEVICES:	Previously cleared 510(k)s for
	Baxter Healthcare Corporation, Tricos T Resorbable Bone Substitute product.

Previous 510(k)	Indication	Clearance Date
K051722	Bone void filling ofthe skeletal system	November 18, 2005
K073571	Bone void filling ofthe oral andmaxillofacial region	April 8, 2008

1 TricOs A is a trademark of Baxter Healthcare Corporation

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DEVICE DESCRIPTION:

STATEMENT OF TricOs A Resorbable Bone Substitute is indicated for INTENDED USE: use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

TECHNOLOGICAL CHARACTERISTICS:

TricOs A Resorbable Bone Substitute for the skeletal system is substantially equivalent to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K051722 with regard to intended use. TricOs A Resorbable Bone Substitute for the skeletal system is substantially equivalent to TricOs T Resorbable Bone Substitute cleared by 510(k)s K051722 and K073571 with regard to technological characteristics and performance.

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ASSESSMENT OF NONCLINICAL DATA:

Baxter Heathcare conducted a risk assessment according to the requirements of ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. The TricOs T and TricOs A device material and component specifications are similar. The device components continue to meet the same material testing standards and sterilization processing standards. Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing.

CONCLUSIONS:

The TricOs A Resorbable Bone Substitute is substantially equivalent to the predicate devices. Testing has been verified against established standards and guidelines for its intended use and demonstrates that the proposed device is as safe and effective for the intended use as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

OCT 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxter Healthcare Corporation % Ms. Valerie Followell Manager, Global Regulatory Affairs 1620 Waulkegan Road, MPGR-AL McGaw Park, Illinois 60085

Re: K081717

Trade/Device Name: TricOs A Resorbable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 06, 2008 Received: October 07, 2008

Dear Ms. Followell:

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, Or ug 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 such 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.

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.

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Page 2 – Ms. Valerie Followell

This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

New special 510(k)

Device Name:

TricOs A | Resorbable Bone Substitute

Indication(s) for Use:

Prescription Use:
21 CFR 801 Subpart D
Over-the-Counter Use:
21 CFR Subpart C

Neil RP Onder for nxm
41-51-28

Concurrence of CDRH, Office of Device Evalualizes of

Division of General, Restorative, and Neurological Devices

1 TricOs A is a trademark of Baxter Healthcare Corporation

510(k) Number K081717

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.