(90 days)
Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982, Contour Fabricators Number CFI-600, equipment drape
Not Found
No
The device description and intended use clearly indicate it is a sterile plastic drape for covering a medical device, with no mention of software, algorithms, or data processing.
No
The DRTS™ Drape is described as a sterile plastic bag intended to prevent contamination of another device (DRTS™ device) in a surgical environment, not to directly treat or diagnose a medical condition in a patient.
No
Explanation: The DRTS™ Drape is described as a sterile plastic bag to cover a separate device (DRTS™ Dual Radiation Targeting System) to prevent contamination. It does not perform any diagnostic function itself. The provided text also does not contain information about the DRTS™ Dual Radiation Targeting System being a diagnostic device.
No
The device description clearly states it is a "sterile plastic bag" and contains a "clear window," indicating it is a physical, hardware-based device, not software.
Based on the provided information, the DRTS™ Drape is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- DRTS™ Drape Function: The DRTS™ Drape is a sterile plastic bag designed to cover a medical device (the DRTS™) during surgical procedures. Its purpose is to prevent contamination of the device, not to analyze patient specimens.
The intended use, device description, and lack of any mention of analyzing biological samples clearly indicate that this device falls outside the scope of In Vitro Diagnostics. It is a surgical accessory designed for device protection.
N/A
Intended Use / Indications for Use
The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.
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.
Product codes
90 IWE, 79 KKX
Device Description
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.
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
Operating room or other surgical environment
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)
Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982, Contour Fabricators Number CFI-600, equipment drape
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5780 Light beam patient position indicator.
(a)
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.(b)
Classification. Class I (general controls). The 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
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: (202) 637-5794 Facsimile: (202) 637-5910
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 (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.
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):
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 _________________________________________________________________________________________________________________________________________________________