TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.

Device Description

TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.

AI/ML Overview

This 510(k) summary does not contain information regarding acceptance criteria or studies proving device performance in the typical sense of a diagnostic or AI-driven device.

The device, TRACERS Bone Cement Opacifier, is an additive to provide radiopacity to bone cements for imaging purposes. Its 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device (TRACERS Bone Cement Opacifier, K991893) based on its intended use, design, and technological characteristics, rather than detailed performance metrics from a clinical study for diagnostic accuracy.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document for the following reasons:

Device Type: This is a material additive, not a diagnostic imaging device or an AI algorithm that generates predictions or diagnoses.
Regulatory Pathway: The 510(k) process for this type of device typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing of material properties or direct comparison of formulation, rather than large-scale clinical trials measuring diagnostic performance.
Lack of Performance Metrics: The document does not describe any quantifiable performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance. The radiopacity, which is its primary function, is likely assessed through physical or radiographic comparison to the predicate or standard materials, but no specific study details are shared here.

Summary of available and non-applicable information:

Table of acceptance criteria and the reported device performance:
- Not applicable / Not provided. The document does not specify quantitative acceptance criteria or detailed performance results typically associated with diagnostic or AI devices (e.g., sensitivity, specificity thresholds). The performance implicitly refers to its ability to provide radiopacity when added to bone cement, making it visible in imaging for placement and visualization. This is assessed via substantial equivalence to a predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. No test set for evaluating diagnostic performance or AI algorithm output is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. No "ground truth" establishment by experts is described as this is not a diagnostic device requiring such validation for accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not provided. This device is an additive for bone cement, not an AI or diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
The sample size for the training set:
- Not applicable / Not provided. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
- Not applicable / Not provided.

In conclusion, this 510(k) submission focuses on demonstrating substantial equivalence for a material additive rather than providing detailed performance metrics from clinical studies that would require the information requested for AI or diagnostic devices.

Summary

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IV. 510(k) Summary

KC0234Y5

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

Date Prepared A.

October 11, 2002

MAR 11 2003

B. General Information

Manufacturer: Parallax Medical. Inc. 940 Disc Drive Scotts Valley, CA 95066-4544

Contact: Linda Bradley Manager, Regulatory and Clinical Affairs (831) 439-0130, ext 251 (phone) (831) 439-1725 (fax)

C. Device Information

Trade Name:	TRACERS Bone Cement Opacifier
Common Name:	Barium Sulfate
Device Classification:	II
Classification Name:	Accessory, Barium Sulfate, Methyl Methacrylate for Cranioplasty
Product Code(s):	MYU

D. Predicate Device Identification

The subject device is substantially equivalent to TRACERS Bone Cement Opacifier (K991893).

E. Intended Use

TRACERS Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin or Codman Cranioplastic™ (Type I - Slow Set) to provide radiopacity for imaging purposes.

Product Description E

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Substantial Equivalence G.

The subject device is equivalent in intended use, design, and technological characteristics to TRACERS Bone Cement Opacifier (K991893).

H. Summary

Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.

l. Signature of Preparer

The 510(k) summary was prepared and submitted by the following Parallax Medicanemployee

Medical employee:

Linda Bradley

Manager, Regulatory and Clinical Affairs

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

MAR 11 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Bradley Manager, Regulatory and Clinical Affairs Parallax Medical. Inc. 940 Disc Drive Scotts Valley, CA 95066

Re: K023445

Trade/Device Name: Tracers Bone Cement Opacifier Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: MYU Dated: February 13, 2003 Received: February 14, 2003

Dear Ms. Bradley:

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. Insting 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. Linda Bradley

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.

Mark McMillan

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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Statement of Indications for Use III.

Indications for Use

510(k) Number (if known): K023445

Device Name: TRACERS Bone Cement Opacifier

Indications for Use:

TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K023445
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Prescription Use	OR	Over-The Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).