(80 days)
Not Found
Not Found
No
The summary describes a motor for cranial perforations and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a "Perforator Motor" used for "cranial perforations," which indicates it is a surgical tool designed to create openings rather than directly treat a medical condition.
No.
The device's intended use is to be a perforator motor for cranial perforations, which describes a surgical tool performing a physical action, not a device used for diagnosis.
No
The device description is not found, but the intended use clearly describes a "Perforator Motor" and an "adapter," which are hardware components.
Based on the provided information, the XK-95 Perforator Motor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cranial perforations" and is used "in conjunction with various cranial perforator adapter". This describes a surgical tool used directly on a patient's body.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description doesn't mention analyzing samples, detecting substances, or providing diagnostic information based on biological samples.
Therefore, the XK-95 Perforator Motor is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The XK-95 Perforator Motor is intended to be used in conjunction with various cranial adapter for cranial perforations.
Product codes
HBB
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Komet Medical c/o Mr. Courtney S. Paradice 2188 Knoll Drive Ventura, California 93003
K991625 Re:
Trade Name: Komet Medical Xk-95 Perforator Motor Regulatory Class: II Product Code: HBB Dated: May 3, 1999 Received: May 11, 1999
Dear Mr. Paradice:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Courtney S. Paradice
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639, Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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899/6025
INDICATION OF USE
The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.
vision Sign-Off
(Division Sign-Off)
Division of General Restorative Devices 14991625
510(k) Number
Prescription Use __
(Per 21 CFR 801.109)