(59 days)
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No
The 510(k) summary describes a sterile drape for a remote control and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a sterile cover for instruments used in the sterile field and does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as a "cover for the hand held, DRTS remote control" to provide a sterile barrier and protect the instrument. Its function is not diagnostic in nature.
No
The device is described as a "Remote Control Drape," which is a physical cover for a remote control. This description clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a sterile cover for a remote control or similar instrument used in the sterile surgical field. It's designed to maintain sterility and protect the instrument.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Performing tests or measurements on biological specimens.
The device is a sterile barrier and protective cover for a non-biological instrument used in a surgical setting. This falls under the category of a surgical accessory or drape, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DRTS™ Remote Control Drape is intended to provide a sealed, sterile, see through cover for the hand held, DRTS remote control, or any similar sized instrument, when its use is required in the sterile field. Secondarily, the Remote Control Drape will protect the contained instrument from damage or contamination caused by unintended contact with body fluids, surgical solutions or other contaminants in the surgical field.
Product codes
90 JAA
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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 and Human Services. The logo consists of 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 pattern around the eagle.
OCT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
16 1997
John McNeirney Vice President MINRAD™ Inc. 6576 East Ouake Street Orchard Park, NY 14127 Re:
K973067 DRST™ Remote Control Drape Dated: August 12, 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 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 (OS) 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beein 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 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" (2) 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,
hì 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
K97.5067
7. Indications for Use
The DRTS™ Remote Control Drape is intended to provide a sealed, sterile, see through cover for the hand held, DRTS remote control, or any similar sized instrument, when its use is required in the sterile field. Secondarily, the Remote Control Drape will protect the contained instrument from damage or contamination caused by unintended contact with body fluids, surgical solutions or other contaminants in the surgical field.
David A. Sejmm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)