DRTS REMOTE CONTROL DRAPE

K973067 · Minrad, Inc. · JAA · Oct 16, 1997 · Radiology

Device Facts

• Record ID: K973067
• Device Name: DRTS REMOTE CONTROL DRAPE
• Applicant: Minrad, Inc.
• Product Code: JAA · Radiology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

DRTS™ Remote Control Drape is a sterile, transparent, sealed cover designed for handheld remote controls or similar instruments. Used in surgical environments to maintain sterility of the field while allowing operation of the enclosed device. Protects instruments from damage or contamination by body fluids and surgical solutions. Operated by surgical staff within the sterile field. Benefits include maintaining sterile integrity of the operating room environment and protecting equipment from fluid ingress.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, transparent, sealed drape/cover. Form factor designed to fit handheld remote controls or similar-sized instruments. Material properties provide a barrier against fluids and contaminants.

Indications for Use

Indicated for use as a sterile, protective barrier for handheld remote controls or similar-sized instruments within a surgical sterile field to prevent contamination from body fluids or surgical solutions.

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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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 [phone]. Additionally, for questions on the promotion 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" (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 [phone] or [phone] 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

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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)