DRTS IMAGE INTENSIFIER DRAPE

K973073 · Minrad, Inc. · JAA · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K973073
• Device Name: DRTS IMAGE INTENSIFIER DRAPE
• Applicant: Minrad, Inc.
• Product Code: JAA · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

The MINRAD™ DRTS™ Image Intensifier Drape is a sterile, protective cover designed for the image intensifier end of mobile C-Arm X-ray machines. It functions as a physical barrier to maintain a sterile field during surgical or diagnostic procedures where C-Arm equipment is utilized. The drape is applied by clinical staff in an OR or clinical setting to prevent cross-contamination between the non-sterile X-ray equipment and the sterile surgical environment. By providing a closed, sterile enclosure, it allows the use of mobile imaging systems within the sterile field, facilitating intraoperative imaging while protecting the patient and the sterile environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, disposable drape designed to fit the image intensifier end of mobile C-Arm X-ray systems. Acts as a physical barrier. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a sterile barrier for the image intensifier component of mobile C-Arm X-ray systems during clinical procedures.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)