CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description

CaP Plus is a hiocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation, the product hardens at body temperature; then resorbs and remodels during the healing process. Each lot of DBM supplied with CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.

AI/ML Overview

This document is a 510(k) summary for the ETEX Corporation Medical Device CaP Plus, a bone void filler. It details the device description, indications for use, and basis of substantial equivalence to predicate devices. Crucially, it does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory submission for premarket notification, affirming substantial equivalence based on existing data and prior predicate devices, rather than presenting new clinical study results with acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
MRMC comparative effectiveness study results or effect size
Standalone performance study
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The document focuses on regulatory compliance through substantial equivalence, not on a detailed performance study with acceptance criteria as one would typically find for a diagnostic or AI-driven device.

Summary

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ETEX Corporation Medical Device 510(k) Submission CaP Plus

510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(H) 8.

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SUMMARY OF SAFETY AND EFFECTIVENESS

APR 2 8 2008

SPONSOR:	ETEX CorporationUniversity Park at MIT38 Sidney Street, 3rd FloorCambridge, MA 02139Phone: (617) 577-7270Fax: (617) 577-7170
510(k) CONTACT:	Pamela W. Adams, RACSenior Vice President and Chief Operating Officer
TRADE NAME:	CaP PlusEquivaboneCaP/DBM
COMMON NAME:	Bone Void FillerBone Graft MaterialBone Substitute Material
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	21 CFR 888.3045Resorbable Calcium Salt Bone Void Filler Device
PRODUCT CODE:	MQV, MBP
PREDICATE DEVICE(S):	CaP Plus Bone Substitute Material (K063050)CaP3 Bone Substitute Material (K033138)Optium DBMTM Gel & Putty (K053098)

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ETEX Corporation Medical Device 510(k) Submission CaP Plus

Device Description:

Indications for Use:

Intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Basis of Substantial Equivalence:

CaP Plus shares the same function and intended use as the predicate devices. CaP Plus was found to be substantially equivalent to the predicate devices. The safety and effectiveness of CaP Plus is adequately supported by the substantial equivalence data and test results provided with this premarket notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2008

ETEX Corporation % Ms. Pamela W. Adams, RAC Senior Vice President and Chief Operating Officer University Park at MIT 38 Sidney Street, 3rd Floor Cambridge, MA 02139

K080329 Re:

Trade/Device Name: CaP Plus Regulation Number: CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 31, 2008 Received: February 11, 2008

Dear Ms. Adams:

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 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. Pamela W Adams

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. Miller

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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ETEX Corporation Medical Device 510(k) Submission CaP Plus

510(k) Number (if known)

CaP Plus Device Name:

Indications for Use:

Prescription Use X

Over-The Counter Use

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation

Neil RR Ogle for
nxn
Division Sign-Off

Division of General, Restorative. and Neurological Devices

510(k) Number K080329

ETEX Corporation 510(k) CaP Plus Submission

01/31/2008

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.