(28 days)
Not Found
No
The summary describes a material (acrylic resin) for cranial repair and mentions only formulation changes and IFU updates. There is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is indicated for the "repair of cranial defects," which is a medical intervention aimed at treating a health condition.
No
The text states that Cranioplastic® is "indicated for the repair of cranial defects" and describes it as a "self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects." This indicates it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description clearly states it is a self-curing, methylmethacrylate (MMA) based acrylic resin, which is a physical material, 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 "for the repair of cranial defects." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "self-curing, methylmethacrylate (MMA) based acrylic resin." This is a material used for implantation or repair within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. Cranioplastic® is used inside the body for structural repair.
N/A
Intended Use / Indications for Use
Cranioplastic® is indicated for the repair of cranial defects.
Product codes
GXP
Device Description
Cranioplastic® is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects. The following modifications are being made:
A change is being made to the formulation of the liquid and powder components of the acrylic cement and the Instructions for Use (IFU) is being updated.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510K SUMMARY SECTION 4
| NAME OF FIRM: | JUL 30 2007
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham
MA 02767-0350 |
|--------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Rachel Creane
Senior Regulatory Affairs Specialist |
| TRADE NAME: | Cranioplastic® |
| COMMON NAME: | Methyl Methacrylate (MMA) |
| CLASSIFICATION: | Class II; 21 CFR 882.5300 |
| DEVICE PRODUCT CODE: | GXP |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | Cranioplastic®(K873689)
SmartSet GMV Endurance Gentamicin Bone Cement
(K033382) |
DEVICE DESCRIPTION:
Cranioplastic® is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects. The following modifications are being made:
A change is being made to the formulation of the liquid and powder components of the acrylic cement and the Instructions for Use (IFU) is being updated.
INTENDED USE AND INDICATIONS:
Cranioplastic® is indicated for the repair of cranial defects.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of Cranioplastic® to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to Cranioplastic® (K873689) and SmartSet GMV Endurance Gentamicin Bone Cement (K033382).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Codman & Shurtleff, Inc. % Ms. Rachel Creane Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350
Re: K071791
Trade/Device Name: Cranioplastic® Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: June 28, 2007 Received: July 02, 2007
Dear Ms. Creane:
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 -- Ms. Rachel Creane
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 (240) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 5 INDICATIONS STATEMENT
510(k) Number (if known):
Device Name: Cranioplastic®
Indications for Use:
Cranioplastic® is indicated for the repair of cranial defects.
Prescription Use ਮ (Part 21 CFR 801.Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare buchun
Division of General, Restorative, and Neurological Devices
510(k) Number K071791