(203 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No.
The intended use describes a device that provides power to operate other neurological tools, not to treat a condition itself.
No
The device provides power to operate other neurological procedures or attachments, which sounds like an auxiliary tool rather than a diagnostic one.
No
The provided text describes a "High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili". The phrase "provide power to ope proc or attachments" strongly suggests a hardware component that delivers power, which is inconsistent with a software-only device. The lack of a Device Description further prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use during neurological to provide power to ope proc or attachments acı assurili". This describes a device used during a medical procedure (neurological), likely to power surgical tools or attachments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. This device's description points towards a surgical or procedural tool, not an IVD.
N/A
Intended Use / Indications for Use
High Speed Drall Syst प्राह-95 for use during neurological to provide power to ope proc or attachments acı assurili
Product codes
HBE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
neurological
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the 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 eagle or bird symbol with three horizontal lines forming its body and wings. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Courtney S. Paradice Komet Medical 1679 Kellogg Springs Drive Atlanta, Georgia 30338
Re: K984035 Trade Name: XK-95 High Speed Motor Drill System Regulatory Class: II Product Code: HBE Dated: March 2, 1999 Received: March 5, 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 (QS) 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.
1
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
2
_of Page
510(k) Number (if known): 984035
Device Name:
FDA's Statement of the Indications For Use for device:
High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use
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