VITASCORE

{0}------------------------------------------------ Date: K072014 #### 5 510(k) Summary This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 6 July 2007 This premarket notification has been submitted by Vitascore B.V. and covers the Vitascore polysomnography scoring software. #### Submitter Vitascore B.V Kromstraat 3 NL 5421 XZ Gemert The Netherlands Phone: +31 (0) 492 - 365290 or +31 (0)45 - 5428888 Email: wim.martens@vitascore.nl NOV 0 8 2007 #### Contact person Wim Martens (Frank Aniba) General Manager (QA Manager) Vitascore B.V. ### Identification The trade name is: The common name for this type of device is: The classification name is: Vitascore Polysomnography scoring software MNR Ventilatory effort Recorder The above as stated in 21 CFR, part 868.2375, has been classified as regulatory Class II. #### Predicate device Vitascore is substantially equivalent to the 'Compumedics Sleep Monitoring System', cleared under 510(k) number K955841. Vitascore is a software program to - score respiratory events � - . score sleep stages and arousal - indicate markers as for lights off/on . - produce customizable statistical reports. ● Vitascore acts on - long-term recordings that include all physiological signals that are required for clinical . PolySomnoGraphy according to established standards for subsequent - diagnosis of sleep- and sleep-related disorders . Vitascore includes - a workflow concept to handle the processing of sleep recordings . {1}------------------------------------------------ | Version: 1.0 | Vitascore (510(k)) Premarket<br>Notification | Date: | 17-July-2007 | |--------------|----------------------------------------------|-------|--------------| |--------------|----------------------------------------------|-------|--------------| - optionally: automatic pre-scoring of respiratory events and sleep and arousal and EEG . frequency analysis This pre-analysis yields particular summary trend curves that facilitate the manual re-scoring. Registered Polysomnographic Technicians and Physicians will use the program on prerecorded PSG sleep recordings on stand-alone PC's or in a networked environment. ### Intended use The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders. The Vitascore software is intended to be used for analysis (semi-automatic and manual rescoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. Vitascore is to be used under supervision of a physician #### Substantial Equivalence The modified Vitascore system has the following similarities to those which previously received 510(k) concurrence: - . Has the same intended use, - Use the same operating principle, . - Incorporate the same basic design, . - Incorporates similar materials, and . - Is manufactured and packaged using the same materials and processes. . Conclusion: Given the similarity between the modified Vitascore system vs. the Compumedics Sleep Monitoring System' predicate device, cleared under 510(k) number K955841, we believe the device, as changed, does not raise any new issues of safety and effectiveness and is substantially equivalent to the predicate device previously cleared. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## NOV 0 8 2007 Mr. Wim Martens General Manager Quality Assurance Manager Vitascore B.V. Kromstraat 3 Gemert, Netherlands 5421 XZ Re: K072014 Trade/Device Name: Vitascore Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 25, 2007 Received: October 29, 2007 Dear Mr. Martens: 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. {3}------------------------------------------------ Page 2 - Mr. Martens 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. 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) 276-0120. 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/industry/support/index.html. Sincerely yours, Neil R.P. Gyl Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | Version: 1.0 | Vitascore (510(k)) Premarket<br>Notification | Date: | 17-July-2007 | |--------------|----------------------------------------------|-------|--------------| |--------------|----------------------------------------------|-------|--------------| #### Indications for Use Statement 4 # Indication for Use 510(k) number (if known): K072014 Device Name: Vitascore Indications For Use: The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders. The Vitascore software is intended to be used for analysis (semi-automatic and manual rescoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. Vitascore is to be used under supervision of a physician. Prescription Use V (Part 21 CFR 801 subpart D) AND/ OR Over-The-Counter Use (Part 21 CFR 801 subpart D) #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Milt Michel W.A. Boothroyd, General Manager, Tel, Doncafter 66661 Page 1 of 1