CaP3 Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and 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. CaP3 Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Description

CaPy™ Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in bone void filler applications in the spine, pelvis, and extremities. At the time of use, the CaP3™ product material is combined with the mixing liguid (U.S.P. Sodium Chloride, 0.9%), and is mixed to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP3™ Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

AI/ML Overview

This appears to be a 510(k) summary for a bone substitute material, not a medical device driven by AI/ML or software. The provided text describes a synthetic bone graft material for filling bone voids. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training sets) are not applicable to this product.

Instead, the "acceptance criteria" and "study" for this type of medical device would typically refer to:

Biocompatibility testing: Ensuring the material is not toxic and does not cause adverse biological reactions.
Mechanical properties testing: Evaluating its strength, setting time, and other physical characteristics.
Resorption rate studies: Demonstrating how it degrades and is replaced by natural bone over time.
Osteoconductivity studies: Showing its ability to support bone growth.
Sterility testing: Ensuring the product is free from microorganisms.
Clinical or animal studies (if applicable for its classification/risk profile): Demonstrating safety and effectiveness in vivo.
Substantial equivalence comparison: The primary "study" presented here is a comparison to a predicate device (α-BSM® Bone Substitute Material (K011048)) to establish substantial equivalence based on intended use, material properties, and performance characteristics.

The provided document states:

Basis of Substantial Equivalence: "CaP3™ Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to a-BSM® Bone Substitute Materials... CaP3™ Bone Substitute Material is also similar to a-BSM® Bone Substitute Material in material properties and in product performance characteristics. Differences between the CaP3™ and a-BSM® products do not raise any new questions of safety and effectiveness."

This indicates that the "study" demonstrating it meets acceptance criteria is primarily a comparison of its properties and intended use to the predicate device, showing no new safety or effectiveness concerns. This is the standard pathway for 510(k) clearance for many non-software/AI devices.

Therefore, a table of "acceptance criteria" and "device performance" in the context of AI/ML metrics cannot be provided from this document. The "device performance" here relates to its physical, chemical, and biological properties being "similar" to the predicate, and not introducing new safety/effectiveness questions.

Summary

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510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(h) 7.

SPONSOR:	ETEX Corporation
	38 Sidney Street, 3rd Floor
	Cambridge, MA 02139
	Phone: (617) 577-7270
	Fax: (617) 577-7170
510(k) CONTACT:	Duke Lee, Ph.D.
	Chief Scientific Officer
TRADE NAME:	CaP3™ Bone Substitute Material
COMMON NAME:	Bone Void Filler
	Bone Graft Material
	Bone Substitute Material
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	21 CFR 888.3045
	Resorbable Calcium Salt Bone Void Filler Device
PRODUCT CODE:	MQV
PREDICATE DEVICES:	α-BSM® Bone Substitute Material (K011048)

SUMMARY OF SAFETY AND EFFECTIVENESS

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DEVICE DESCRIPTION:

INDICATIONS FOR USE:

CaP3™ Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and 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. CaP3™ Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

BASIS OF SUBSTANTIAL EQUIVALENCE:

CaP3™ Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to a-BSM® Bone Substitute Materials are provided sterile and as single patient, single use kits and are identical in intended use (i.e., bone void filler indications). CaP3™ Bone Substitute Material is also similar to a-BSM® Bone Substitute Material in material properties and in product performance characteristics. Differences between the CaP3™ and a-BSM® products do not raise any new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines.

Public Health Service

DEC - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Duke Lee, Ph. D. Chief Scientific Officer ETEX Corporation University Park at MIT 38 Sidney Street Cambridge, MA 02139

Re: K033138

Trade Name: CaP3 Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 26, 2003 Received: September 30, 2003

Dear Dr. Lee:

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

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Page 2 - Duke Lee, Ph.D.

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark N. Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K033138

Device Name: CaP3 Bone Substitute Material

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation Prescription Use _ OR

(Per 21 CFR 801.109)

Over-The Counter Use

for Mark N Mikkelsen

citation facetorative

:.10(k) Number

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.