VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2

{0}------------------------------------------------ JAN 1 0 2005 Image /page/0/Picture/2 description: The image shows the logo for ViOptix. The logo consists of the word "ViOptix" in a simple, sans-serif font. The "V" and "O" are connected, and the "x" is stylized to resemble a person with their arms raised. The person is represented by a circle for the head and two angled lines for the arms and body. 44061-B Old Warm Springs Blvd Fremont, CA 94538 510-226-2860 info@vioptix.com SUMMARY 510-226-5860 510-226-5864 Submitter's name: Address: ViOptix, Inc. 44061-B Old Warms Springs Blvd. Fremont, CA 94538 Phone: Fax number: Name of contact person: Name of the device: Classification name: Trade or proprietary name: Common or usual name: Greg Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Date the summary was prepared: September 27, 2004 ViOptix ODISsey Tissue Oximeter Tissue Oximeter Tissue Spectrometer The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: > K012759 and K023938, InSpectra Tissue Spectrometer System, Model 325, manufactured by Hutchinson Technology Inc. and the Biospectrometer NB Oximeter Model 1111 K963903, also manufactured by Hutchinson Technology. Oximeter Description of the device: The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor. {1}------------------------------------------------ Indications: The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. Summary of the technological characteristics of our device compared to the predicate device: ### Technological Characteristics The technological characteristics of the ODISsey ™ Tissue Oximeter, Model Oxy-2 are similar to those of the cited predicate devices, as well as similar devices based on near-infrared technology. These devices are equivalent in terms of design, functionality, principles of operation, performance specifications and indications for use. When compared to the predicate device, ODISsey ™ Tissue Oximeter, Model Oxy-2 does not raise new technological issues. #### Indications for Use . Oximeters and perfusion monitors are used to measure oxygen saturation in the arteries or tissues, or to assess the amount of oxygen delivered to the tissues. Substantial equivalence for the ODISsey ™ Tissue Oximeter, Model Oxy-2 is supported by the predicate devices with identical indications for use. ### Performance Testing Bench testing, biocompatibility testing, and animal studies, were performed to demonstrate the product functions as intended. The ODISsey ™ Tissue Oximeter, Model Oxy-2 is designed to comply with the requirements of electrical safety, laser safety, and electromagnetic compatibility requirements. ### Animal Testing The ViOptix ODISsey™ Tissue Oximeter product performance was evaluated against a "gold standard" CO-Oximeter and a FDA cleared predicate device from Hutchinson Testing was performed by measuring tissue oxygen saturation (StO2) on three dog limbs surgically removed and perfused with an extracorporeal blood circulation system. Oxygen perfusion was controlled and monitored by {2}------------------------------------------------ a Radiometer OSM3™ Hemoximeter (CO-Oximeter). The ViOptix StO2 values were then compared with those from the CO-Oximeter and a Hutchinson's InSpectra™ Tissue Spectrometer. These results show excellent correlation with both the "gold standard" and the predicate device. ## CONCLUSION Based on the design, technology, performance and functional testing, intended use, and clinical evaluation, the ODISsey ™ Tissue Oximeter, Model Oxy-2 is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. The ODISsey ™ Tissue Oximeter, Model Oxy-2 raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of the ODISsey ™ Tissue Oximeter, Model Oxy-2. {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The image is in black and white. JAN 1 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ViOptix, Inc. c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Re: K042657 Trade Name: ODISsey Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: MUD Dated: December 27, 2004 Received: December 28, 2004 Dear Mr. Holland: We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bocure is substantially equivalent (for the indications relerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the encrosule) to regars manatinent date of the Medical Device American France Friend Free d. Frya commerce prior to may 26, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been recalismou in accera approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Rel) market the device, subject to the general controls provisions of the Act. The I ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of as tice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (500 a0070) ins existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations and may be subject to suell additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 – Page 2 - Mr. Greg Holland Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dris issuation or our device complies with other requirements of the Act that IDA has made a deceminations administered by other Federal agencies. You must of ally rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Part 807), labeling (21 CFR Part 807), good maximal (20); and If applicable, the electronic (200), 1959 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decizens over device as described in your Section 510(k) I his letter will anow you to begin mankeang your antial equivalence of your device to a legally premarket notification. The PDA miams of basification 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 If you desire specific acvice for Jour acon 2011 276-0120. Also, please note the regulation entitled, Comaci the Office of Compulance in (21CFR Part 807.97). You may obtain Misoranting by relective to promantonibilities under the Act from the Division of Small other general information on your response 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, B. Blumma for D.D. Zuckerman, MD Brand D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): Device Name: ViOptix ODISsey Tissue Oximeter Indications For Use: The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimated The VOplix ODISSey Tissue Oximotor is wolume of tissue. This is performed the percent oxygen saturation (SCS2) in a violes, hospitals, ambulatory care and Emergency Medical Services. The ODISsey Tissue Oximeter is indicated for use in monitoring patients The ODISSey Trisue Oximeter to muleations of skeletal muscle or when there is a suspicion of compromised circulation. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (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) Blummera (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of ____________________________________________________________________________________________________________________________________________________________________