Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Description

Cem-Ostetic™ Putty Injection Kit consists of a syringe filled with calcium salts. Once mixed with water, the calcium salts can be injected into a bone void or defect with a trocar. Cem-Ostetic is supplied sterile for single patient use only.

AI/ML Overview

The provided text is a 510(k) summary for the Cem-Ostetic™ Injection Kit. This document focuses on establishing substantial equivalence to a legally marketed predicate device (Cem-Ostetic™ Putty) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI/ML device.

Therefore, the requested information elements (acceptance criteria, device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and ground truth establishment for training set) are not applicable or not present in the provided document.

The document states:
"The safety and effectiveness of Cem-Ostetic™ Injection Kit are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification."

This implies that the "study" for acceptance involves demonstrating that the new injection kit is substantially equivalent to the existing Cem-Ostetic™ Putty. The "acceptance criteria" are met by showing that:

Identical Indications-for-Use: Both devices are intended to fill voids and gaps in bone structures (extremities, spine, pelvis, cranium), can be shaped by hand or injected, provide temporary support, are radio-opaque, biocompatible, and resorbable.
Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: The injection kit shares the same safety profiles as the predicate.
Very Similar Technical Characteristics: While the injection kit introduces a new delivery method (syringe and trocar), the core material (calcium salts mixed with water forming a paste) is fundamentally the same as the predicate putty.

The document does not detail specific "test results" or "materials data" beyond this declaration of similarity. It is a regulatory submission for substantial equivalence, not a detailed scientific paper on device performance in a clinical or experimental study context.

Summary

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KO4O4O5

Cem-Ostetic™ Injection Kit Technical Information Doc. Number: CEMOFDA-03 Rev.B

Page 16 of 16 DATE: February 29, 2004

8. 510(k) Summary

In accordance with the Food and Drug Admisnistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Use of the Cem-Ostetic™ Putty Injection Kit.

Submitted By:	Berkeley Advanced Biomaterials Inc.
Date:	12-30-03
Contact Person:	François Génin, Ph.D.
	Phone: 510-883-1644; Fax: 510-883-1315
Proprietary Name:	Cem-Ostetic™
Common Name:	Bone Void Filler
Classification Name and Reference:	Unclassified
Device Product Code and Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USES/INDICATIONS

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Ccm-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Cem-Ostctic™ Putty Injection Kit is substantially equivalent to the legally marketed, predicate device Cem-Ostetic™ Putty. The products have identical indications-for-use and identical contraindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-Ostetic™ Injection Kit are very similar to that of the predicate device. The safety and effectiveness of Cem-Ostetic™ Injection Kit are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification.

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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 eagle-like symbol with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

François Génin, Ph.D. President and CEO Berkeley Advanced Biomaterials, Inc. 1933 Davis Street, Suite 307 San Leandro, California 94577

Re: K040405

Trade/Device Name: Cem-Ostetic™ Bone Injection Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV and GXP Dated: February 10, 2004 Received: February 23, 2004

Dear Dr. Génin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the Cleiosure) to regars actually in the Medical Device Amendments, or to commerce prior to May 20, 1776, are encomment with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costhere Act (Act) that to not require appro the general controls provisions of the Act. The I ou may, therefore, manel the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 aborto) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations o Inay be subject to suell additional controller , Title 21, Parts 800 to 898. In addition, FDA may be found in the 0000 cements 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 mat I DA has made a determinations administered by other Federal agencies. You must or any recetal statutes and regulations and not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR Fatt 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - François Génin, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your e FDA finding of substantial equivalence of your device to a legally premaince hotheated. The 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 If you desire specific as the lates 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 other general 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,

Muriam C. Provost

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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Indications for Use

510(k) Number (if known):K040405

Device Name: Cem-Ostetic

Indications For Use:

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radioopaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriame C. Provost

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K040405

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.