(117 days)
No
The device description and performance studies focus on the material properties and equivalence to a predicate device, with no mention of AI or ML.
No.
The device is a material for repairing cranial defects, not a device that provides therapy.
No
Explanation: The device description states its purpose is to "repair a skull defect," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "self-curing acrylic" comprised of "two sterile components (liquid and powder)," which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Resinous Material for repairing cranial defects." This describes a material used in vivo (within the body) for surgical repair.
- Device Description: The description details a "Bone Cement for Cranioplasty" that is "self-curing acrylic that a surgeon uses to repair a skull defect in a patient." This is a surgical implant/material.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The device described is a surgical material used directly on the patient's skull.
N/A
Intended Use / Indications for Use
Resinous Material for repairing cranial defects.
Product codes
GXP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing demonstrated that the proposed Bone Cement is substantially equivalent to currently marketed Cranioplastic with regard to functional characteristics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Health
1500 Waukegan Road - MPWM
McGaw Park, IL 60085 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Nichols
Manager, 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 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. |
| Summary of testing: | Based on the product performance information provided to FDA, the
subject device has been shown to be substantially equivalent to the
currently marketed predicate device. |
| Non-clinical Test Results: | Performance testing demonstrated that the proposed Bone Cement
is substantially equivalent to currently marketed Cranioplastic with
regard 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.
1
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,
2
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
3
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