DUAL RADIATION TARGETING SYSTEM DRTS DRAPE

K973162 · Hogan & Hartson · IWE · Nov 20, 1997 · Radiology

Device Facts

• Record ID: K973162
• Device Name: DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
• Applicant: Hogan & Hartson
• Product Code: IWE · Radiology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5780
• Device Class: Class 1

Intended Use

The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.

Device Story

The DRTS™ Drape is a sterile plastic equipment cover designed for the Dual Radiation Targeting System (DRTS™). It features an optically flat, clear window to allow undistorted transmission of the DRTS™ laser beam. Used in operating rooms or surgical environments, the drape is applied over the DRTS™ device when mounted on an x-ray machine. It acts as a physical barrier to prevent contamination of the device by patient fluids or tissues during surgical procedures. The drape is intended for use by surgical staff.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile plastic bag; includes an optically flat, clear window for laser transmission. Designed as an equipment cover/drape for the DRTS™ system.

Indications for Use

Indicated for use in an operating room environment to cover the DRTS™ device when mounted on an x-ray machine to protect the device from contamination with patient fluids or tissues.

Regulatory Classification

Identification

A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

Predicate Devices

• Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982
• Contour Fabricators Number CFI-600

Submission Summary (Full Text)

{0}------------------------------------------------

K973162

# MINRAD DRTS™ Drape 510(k) Summary

NOV 20 1997

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Contact Person: Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Phone: [phone] Facsimile: [phone]

Date Prepared: August 21, 1997

# Name of Device and Name/Address of Sponsor

DRTS™ Drape MINRAD, Inc. 6576 East Quaker Street Orchard Park, NY 14127

### Device Name

| Trade Name: | Dual Radiation Targeting System DRTS™ Drape |
|----------------------|-------------------------------------------------|
| Common Names: | Equipment Cover, Equipment Drape |
| Classification Name: | Light Beam Patient Position Indicator Accessory |

#### Predicate Devices

(1) Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982 (2) Contour Fabricators Number CFI-600, equipment drape

#### Intended Use

The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.

## Technological Characteristics and Substantial Equivalence

The DRTS™ Drape is a sterile plastic bag to cover the DRTS™ Dual Radiation Targeting System. The drape contains an optically flat clear window that will allow undistorted transmission of the laser beam from the DRTS™ to the patient. Any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Chris Healy Hogan & Hartson c/o Minrad, Inc. 6576 East Quaker St. Orchard Park, NY 14127 Re:

K973162 Dual Radiation Targeting System DRTS Drape Dated: August 21, 1997 Received: August 22, 1997 Regulatory class: II 21 CFR 892.5780/Procode: 90 IWE 21 CFR 878.4370/Procode: 79 KKX

Dear Mr. Healy:

: \$2

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 inclosure) 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 II (Special Controls) or 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 of 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 (2). 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.

h.T.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

{2}------------------------------------------------

# MINRAD 510(K) Notification DRTS™ Drape INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K973162

Device Name:

DRTS™ Drape

Indications for Use:

The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lind L. de yong
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K973162

র্ম Prescription Use _ (Per 21 C.F.R. § 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________