MD-6W WIRELESS CRITICAL DATA VIEWER

{0}------------------------------------------------ KD42923 ## DEC 17 2004 # 510(k) Summary for MD-6W Wireless Critical Data Viewer #### 1. SPONSOR The MicroOptical Corporation 33 Southwest Park Westwood, MA | Contact Person: | Paul Zavracky, Ph.D., President | |-----------------|---------------------------------| | Telephone: | 781-326-8111 | Date Prepared: October 20, 2004 #### 2. DEVICE NAME | Proprietary Name: | MD-6W Wireless Critical Data Viewer | |-----------------------------|-------------------------------------| | Common/Usual Name: | Head-mounted display system | | Classification Information: | | Head-mounted display systems have been classified as Class II devices under the following classification name: | Name | Product Code | 21 CFR Ref. | Panel | |-----------------------------|--------------|-------------|-----------------| | Laparoscope and accessories | GCJ | 876.1500 | General Surgery | #### 3. PREDICATE DEVICES The MD-6W Wireless Critical Data Viewer is substantially equivalent to MicroOptical's MD-6 Critical Data Viewer, 510(k) No. K040244. #### 4. DEVICE DESCRIPTION The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger. {1}------------------------------------------------ #### ഗ് INTENDED USE The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to vital signs of a patient undergoing surgery. #### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The MD-6W Wireless Critical Data Viewer is similar to the predicate device in terms of indication, display format, field of view, and focal range. #### 7 PERFORMANCE TESTING The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white and has a simple, official design. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 17 2004 The MicroOptical Corporation c/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760 Re: K042923 Trade/Device Name: MD-6W Wireless Critical Data Viewer Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 20, 2004 Received: October 20, 2004 Dear Mr. Dillon: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Daniel J. Dillon This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): MD-6W Wireless Critical Data Viewer Device Name: Indications for Use: The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K042723 October 20, 2004 Image /page/4/Picture/15 description: The image shows the text "Page vi". The text is centered on the page and is written in a simple, sans-serif font. The word "Page" is capitalized, and the Roman numeral "vi" is written in lowercase. The background of the image is black.