(51 days)
Not Found
Not Found
No
The device is a sterile drape for an image intensifier, which is a passive accessory and does not involve image processing or any mention of AI/ML.
No
The device is a sterile drape for imaging equipment, not a device used for treating a disease or condition.
No
Explanation: The device is a sterile cover for an image intensifier, which is a component of an X-ray machine. It does not perform any diagnostic function itself.
No
The device is described as an "Image Intensifier Drape," which is a physical cover for a medical device. This indicates it is a hardware component, not software.
Based on the provided information, the MINRAD™ DRTS™ Image Intensifier Drape is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a sterile cover for a medical device (an image intensifier on a C-Arm X-ray machine). This is a physical barrier for infection control during a medical procedure.
- Lack of Diagnostic Function: IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not interact with patient specimens or provide any diagnostic information.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a physical drape, not a diagnostic test.
- No Mention of Diagnostic Processes: There is no mention of analyzing samples, detecting analytes, or any other activity associated with in vitro diagnostics.
Therefore, the MINRAD™ DRTS™ Image Intensifier Drape is a medical device used in a clinical setting, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MINRAD™ DRTS™ Image Intensifier Drape is intended to provide a closed, sterile cover for the Image Intensifier cud of all presently marketed, mobile C-Arm X-ray machines.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Not Found
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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 U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 1997
John McNeirney Vice President MINRAD™ Inc. 6576 East Quake Street Orchard Park, NY 14127 Re:
K973073 DRTSTM Image Intensifier Drape Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. McNeirney:
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 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 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 vitro 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.
hĩ liau 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The MINRAD™ DRTS™ Image Intensifier Drape is intended to provide a closed, sterile
cover for the Image Intensifier cud of all presently marketed, mobile C-Arm X-ray machines.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K973073
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)