(117 days)
Resinous Material for repairing cranial defects.
Bone Cement for Cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
The provided document, K040152, is a premarket notification for a medical device (Bone Cement for Cranioplasty) and does not describe acceptance criteria, performance studies, or AI algorithm validation in the way requested. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a performance study report for an AI or software as a medical device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
Here's what can be gathered, with caveats:
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance testing demonstrated that the proposed Bone Cement is substantially equivalent to currently marketed Cranioplastic with regard to functional characteristics."
However, it does not provide specific acceptance criteria (e.g., tensile strength range, curing time limits) or quantitative reported device performance values. It only states substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Substantially equivalent to currently marketed Cranioplastic with regard to functional characteristics. |
| No specific functional characteristics or ranges are provided | No specific performance metrics are provided |
Remaining questions (2-9) are not applicable or cannot be answered from the provided document because:
- This document is for a traditional medical device (bone cement), not an AI/software medical device. Therefore, concepts like test sets, training sets, ground truth establishment by experts, AI adjudication methods, or MRMC studies do not apply to this submission.
- The summary indicates "Non-clinical Test Results," implying physical and chemical property testing of the bone cement, not performance of a diagnostic algorithm.
Summary of non-applicable/unanswerable points:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to a physical product, not a data-driven algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for bone cement.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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MAY 1 9 2004
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of four curved lines that resemble the flight of a bird. The text "CardinalHealth" is written in a simple, 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
| Sponsor: | Cardinal Health1500 Waukegan Road - MPWMMcGaw Park, IL 60085 |
|---|---|
| Contact: | Sharon NicholsManager, Regulatory Affairs |
| Telephone: | (847) 785-3311 |
| Date Prepared: | January, 2004 |
| Product Trade Name: | Bone Cement |
| Common Name: | Methyl Methacrylate for Cranioplasty |
| Classification: | Class II per 21 CFR §882.5300 |
| Predicate Device: | Codman Cranioplastic |
| Intended Use: | Resinous Material for repairing cranial defects |
| Substantial Equivalence: | This device is substantially equivalent to the Codman Cranioplastic,Acrylic Cranioplasty Material (K873689). |
| Description: | Bone Cement for Cranioplasty (skull repair) is a self-curing acrylicthat a surgeon uses to repair a skull defect in a patient. It iscomprised of two sterile components (liquid and powder), which aremixed to form the cement. |
| Summary of testing: | Based on the product performance information provided to FDA, thesubject device has been shown to be substantially equivalent to thecurrently marketed predicate device. |
| Non-clinical Test Results: | Performance testing demonstrated that the proposed Bone Cementis substantially equivalent to currently marketed Cranioplastic withregard to functional characteristics. |
Image /page/0/Picture/6 description: The image shows a sequence of numbers, specifically '000692'. The numbers are printed in a clear, bold font, making them easily readable. The sequence appears to be a numerical code or identifier, possibly a serial number or a reference number.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2004
Sharon Nichols Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K040152
Trade/Device Name: Bone Cement for Cranioplasty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: April 12, 2004 Received: April 13, 2004
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 docs 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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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,
O Mula A. Mullan
Celia M. Witten, PhD, MD 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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INDICATION FOR USE
510(k) Number (if known): K040152
Device Name:
Bone Cement for Cranioplasty
Indications For Use: defects.
Resinous Material for repairing cranial
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The Counter Use or (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040152
§ 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).