(90 days)
No
The device description and intended use clearly state it is a resinous material for cranial repair, with no mention of software, image processing, or AI/ML terms. Performance studies focus on material equivalence.
No.
The device is a material used for the physical repair of cranial defects, which is a structural restoration rather than a therapeutic treatment for a disease or condition. Its function is to replace or repair damaged bone, not to address a disease process.
No
Concert™ Cranioplast is described as a "resinous material for repair of cranial defects," indicating it is a therapeutic or restorative device, not one used for diagnosis. Its intended use is to repair, not to identify or assess.
No
The device description explicitly states it is a "resinous material," indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "repair of cranial defects." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "resinous material for repair of cranial defects." This describes a material used in surgery, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Concert™ Cranioplast is a material used for physical repair within the body.
N/A
Intended Use / Indications for Use
Concert™ Cranioplast is a resinous material for repair of cranial defects.
Product codes
GXP
Device Description
Not Found
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
Not Found
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
Non-clinical Test Results: Performance testing demonstrated that Concert™ Cranioplast is substantially equivalent to 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
510(k) Summary
510(k) Number:
JAN 2 2 2003
Date Prepared: October 2, 2002
Applicant Information:
-
Applicant: Immedica, Inc. 100 Passaic Ave. Chatham, NJ 07928
Contact: Roy B. Bogert VP, Engineering & Regulatory Affairs -
(973) 635-9040 Phone: Fax: (973) 635-9878
Device Information:
| Trade Name: | Concert™ Cranioplast |
|---|---|
| Common Name: | Methyl methacrylate for cranioplasty |
Equivalent Devices:
The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689)
Intended Use:
Concert™ Cranioplast is a resinous material for repair of cranial defects.
Comparison to Predicate Devices:
This device has the same intended use and functional characteristics as the predicate device.
Non-clinical Test Results:
Performance testing demonstrated that Concert™ Cranioplast is substantially equivalent to Cranioplastic with regard to functional characteristics.
Summary:
Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.
1
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
Mr. Roy Bogert VP. Engineering and Regulatory Affairs Immedica, Inc. 100 Passaic Avenue Chatham. NJ 07928-2848
Re: K023575
Trade Name: Immedica Concert™ Cranioplast Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: October 23, 2002 Received: October 24, 2002
Dear Mr. Bogert:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Roy Bogert
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,
for Miriam 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
3
510(k) Number (if known):
Device Name: Concert™ Cranioplast
Indications For Use:
Concert™ Cranioplast is a resinous material for repair of cranial defects.
023575
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
K(k) Number K023575
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)