(152 days)
Not Found
Not Found
No
The summary describes a physical fixation system for cranial bone flaps and burr holes, with no mention of software, image processing, AI, or ML.
No
The device is described as a fixation system for cranial bone flaps and burr holes, which is a structural or supportive function rather than one designed to treat or prevent a disease or condition for therapeutic benefit.
No
The device is described as "CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy," indicating it is a surgical fixation device, not a diagnostic one.
No
The intended use clearly describes a "Cranial Bone Flap Fixation System" which is a physical implantable device used for fixation, not a software-only product.
Based on the provided information, the CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "covering burr holes and for fixation of cranial bone flaps after craniotomy." This describes a surgical implant used directly on a patient's body during a procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The CranioClamp does not perform any such testing.
- Anatomical Site: The anatomical site is "cranial," which refers to the skull, where the device is implanted.
The description clearly indicates a medical device used in vivo (within the body) for structural support and fixation, not a diagnostic test performed in vitro (outside the body).
N/A
Intended Use / Indications for Use
The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy
Product codes
GXR, HBW
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
Prescription Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
Prosurg, Inc c/o Mr. Ashvin Desai 2193 Trade Zone Blvd San Jose CA 95131
AUG 15 2007
Re: K071138 Trade/Device Name: CranioClamp™ - Bioabsorbable Cranial Bone Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: Class II Product Code: GXR, HBW Dated: July 30, 2007 Received: August 2, 2007
Dear Mr. Desai:
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.
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Page 2 -- Mr. Ashvin Desai
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.
ff 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bonellin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K071138
CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System Device Name:
Indications For Use:
The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (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)
Barbara Buehrle
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of General, Restorative, and Neurological Devices
510(k) Number K071138