(21 days)
K913659C
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The device is described as a "PIVOTING COMPENSATION FILTER," which suggests a physical or digital filter applied to images, not an AI/ML-driven analysis.
No
The device is a filter used for examinations (diagnosis), not for treating a disease or condition.
No
Explanation: The device is described as a "PIVOTING COMPENSATION FILTER" used for examinations. Filters manipulate imaging data, but the description doesn't state that it interprets or analyzes the images to diagnose a condition. It is equivalent to a "Little Prism," which is likely an accessory for image acquisition or quality, not a diagnostic tool itself.
Unknown
The summary does not provide enough information to determine if the device is software-only. It describes a "filter" for images, which could be implemented in software, but it doesn't explicitly state that it is solely software and doesn't mention any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ROTATIONAL examinations of digital and dsa cerebral arteriograms." This describes a device used during an imaging procedure to modify the X-ray beam, not a device used to test samples (like blood, urine, or tissue) outside the body.
- Device Description: "PIVOTING COMPENSATION FILTERS FOR THE HEAD" further supports the idea of a physical component used in imaging equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is related to optimizing the image acquisition process itself, not analyzing biological samples.
N/A
Intended Use / Indications for Use
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.
Product codes (comma separated list FDA assigned to the subject device)
90 KPR
Device Description
PIVOTING COMPENSATION FILTERS FOR THE HEAD, PCF Head
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital and dsa cerebral arteriograms
Anatomical Site
Head (Cerebral Arteriograms)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K913659C
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jean A: Vézina, M.D. President and Medical Advisor OCTOSTOP, INC. Casier Postal 1476 Succ. St-Laurent, Montreal .. QC., Canada H4L 4ZI
Re: K972766 Pivoting Compensating Filters for the Head (Cerebral Arteriograms) Dated: July 8, 1997 Received: July 24, 1997 . Regulatory Class: II 21 CFR 892.1680/Procode: 90 KPR
AUG 1 4 1997
Dear Dr. Vézina:
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, 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 (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 (OS) 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 Radiation Control provisions, or other Federal laws or regulations.
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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_PIVOTING COMPENSATION FILTERS FOR THE HEAD, PCF Head
Indications For Use:
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elbert A. Sevyer
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K972746
Prescription Use_ (Per 21 CFR 801.109)
:
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)