(88 days)
This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.
The Bone Cement Radio-Opacifier is an additive to be used with Codman Cranioplastic (K873689) to provide radiopacity to the resin and assist in placement and visualization of material.
The provided text describes a 510(k) summary for a Bone Cement Radio-Opacifier. This submission is for a medical device that acts as an additive to provide radiopacity for imaging purposes.
Based on the available information, the device is not an AI/ML-enabled medical device. It's a physical additive (Barium Sulfate, USP) to bone cement to make it visible on X-rays. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for algorithms, sample sizes for AI training/testing, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The document focuses on establishing substantial equivalence to a predicate device (Parallax Tracer Radiopaque Particles) based on identical intended use and performance attributes. The "performance testing" mentioned is likely physical/chemical testing for the radio-opacifier's ability to provide radiopacity and its impact on the functional characteristics of the bone cement.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provide radiopacity for imaging purposes when added to Codman Cranioplastic (Type 1-slow set). | "Performance testing demonstrated that the end product Cranioplastic and Bone Cement Radio-Opacifier is substantially equivalent to currently marketed Cranioplastic with Radio-Opacifier from Parallax with regard to functional characteristics." |
| Performance attributes are the same as the predicate device (Parallax Tracer Radiopaque Particles). | "Substantial equivalence to the Parallax Tracer Radiopaque Particles in that: - Intended use is the same - Performance attributes are the same" |
| Maintain the functional characteristics of the Cranioplastic. | "Substantially equivalent... with regard to functional characteristics." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for performance testing.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab testing performed by Cardinal Health in the US. This is a non-clinical evaluation of a physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. The "ground truth" would be objective measurements of radiopacity or material properties, not expert interpretations of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Testing would involve objective measurements against specifications, not subjective adjudication of results.
5. 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. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" in this context would be objective measurements of physical and chemical properties (e.g., radiopacity, set time, mechanical strength after mixing) to demonstrate equivalence to the predicate and ensure the additive doesn't compromise the bone cement's function. No specific type of "ground truth" (like pathology or outcomes data) is mentioned as it's not relevant to this device's function.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of Study Type:
This appears to be a non-clinical performance study focused on demonstrating substantial equivalence of a physical medical device (a radio-opacifying additive) to a legally marketed predicate device. The study would involve laboratory testing to compare the physical and functional characteristics of bone cement mixed with the new radio-opacifier against bone cement mixed with the predicate radio-opacifier. The specific tests (e.g., related to radiopacity, setting time, strength) are not detailed but are implied by the claim of "substantially equivalent... with regard to functional characteristics."
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OCT 3 1 2003
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health
1500 Waukegan Road McGaw Park, Illinois 60085-6787
847.473.1500
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Bone Cement Radio-Opacifier
| Sponsor: | Cardinal Health1500 Waukegan Road - MPWMMcGaw Park, IL 60085 |
|---|---|
| Contact: | Sharon NicholsManager, Regulatory Affairs |
| Telephone: | (847) 785-3311 |
| Date Prepared: | July, 2003 |
| Product Trade Name: | Bone Cement Radio-Opacifier |
| Common Name: | Barium Sulfate, USP |
| Classification: | Class II per 21 CFR §8825300 |
| Predicate Device: | Parallax Tracer Radiopaque Particles |
| Intended Use: | This device is used as an additive to Codman Cranioplastic(Type 1-slow set) to provide radiopacity for imagingpurposes. |
| Substantial Equivalence: | The Bone Cement Radio-Opacifier is substantially equivalentto the Parallax Tracer Radiopaque Particles in that:- Intended use is the same- Performance attributes are the same |
| Description: | The Bone Cement Radio-Opacifier is an additive to be usedwith Codman Cranioplastic (K873689) to provide radiopacityto the resin and assist in placement and visualization ofmaterial. |
| Summary of testing: | Based on the product performance information provided inthis notification, the subject device has been shown to besubstantially equivalent to the currently marketed predicatedevice. |
| Non-clinical Test Results: | Performance testing demonstrated that the end productCranioplastic and Bone Cement Radio-Opacifier issubstantially equivalent to currently marketed Cranioplasticwith Radio-Opacifier from Parallax with regard to functionalcharacteristics. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGraw Park, Illinois 60085-6787
Re: K032388
Trade Name: Bone Cement Radio-Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: July 31, 2003 Received: August 4, 2003
Dear Ms. Nichols:
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 - Ms. Sharon Nichols
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) 594-4639. 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,
R. Mark A. Milker
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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Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
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510(k) Number (if known):
Device Name:
Indications For Use:
Bone Cement Radio-Opacifier
This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Mark A Milkerso
(Division Sign-Off)
Division -General, Restornities and Neurological Devices
5106
§ 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).