OLYMPIX MINI-PASTEURMATIC (58210)

{0}------------------------------------------------ K972193 Attachment C Page 1 of 4 SEP - 5 1997 ## SAFETY AND EFFECTIVENESS SUMMARY "This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Contact Person: Joseph Stefanile Olympic Medical 5900 First Ave. S. Seattle, WA 98108 206-767-3500 Common or usual name of device Trade or proprietary name Classification name (if known) Predicate device(s) to which substantial equivalence is being claimed Mini-Pasteurizer Olympic Mini-Pasteurmatic™ 80 LDS Olvmpic Pasteurmatic ## Device Description - Brief explanation of how the device functions. 1. The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters. - 2. Basic scientific concepts that form the basis for the device. Pasteurization - Hot water disinfection (pasteurization) is a high-level, nontoxic disinfection process that is particularly useful for items such as respiratory therapy and anesthesia breathing circuits. {1}------------------------------------------------ - 3. Significant physical and performance characteristics of the device. (Ex. device design and physical properties) | Model | Olympic Mini-Pasteurmatic | |-------------------------------------|-----------------------------------------------------------------------------------------| | Controls | Power Switch with separate indicator lightCycle StartPaper Advance | | Signals | Power OnCycle OnCycle Time DisplayCycle Temperature Display including °C or °FLow Water | | Interlock | Raising lid stops cycle | | Electrical Approval | CSA, Class 8711-02, Electromedical Appliances | | FDA Reference | Number not yet assigned | | Size | 26"W x 21-3/4"D x 28"H (lid raised) | | Electrical | 115 VAC, 60 Hz, less than 15 Amps | | Accessories | Mesh Parts Bags | | Warranty | Two Years; Five Year available | | Loading Volume | 0.46 cubic feet | | Cycle Time | 30 minutes | | Water Temp<br>Calibration Set Point | Not User Adjustable<br>Factory set to 166°F | - Intended Use of the device 4. Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers. - Does the indication statement (4) differ from those of the predicate device? 5. Check one: Differs (complete section 6) X Does not differ (skip to section 7) : {2}------------------------------------------------ - Explanation of what the differences are not critical to the intended use of the 6. device and why the differences do not affect the safety or effectiveness of the device. N/A - The technological characteristics of the device compared to the predicate product. 7. See Comparison Chart on following page. - A brief description of tests and their results. 8. Tests were performed to verify the following: - Water temperature remains within specified tolerances • - Overtemperature thermostat performance . - . Cold water start time - Conclusions drawn from these tests that demonstrate the device is safe, effective, 9. and performs as well or better than the legally marketed device. The modified device and the predicate device are functionally identical for all parameters affecting safety and effectiveness. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a bird in flight or a human figure in motion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 1997 Mr. Joseph P. Stefanile Official Correspondent Olympic Medical Corporation _ 5900 First Avenue South Seattle, Washington 98108 Re : K972193 Olympic Mini-Pasteurmatic (58210) Trade Name: Requlatory Class: Unclassified Product Code: LDS Dated: June 6, 1997 Received: June 10, 1997 Dear Mr. Stefanile: 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 indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {4}------------------------------------------------ ## Page 2 - Mr. Stefanile through 542 of the Act for devices under the Electronic cm-ough Size on Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. _ The EDA ----finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produces or mits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion 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 Obcained IIOm the Broibion or 6ma-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): K972193 Olympic Mini-Pasteurmatic Device Name: Indications For Use: ir Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dentai, Infaction Control, anr General Hospital Devices K) Number K972193 Prescription Use ***_*** OR Over-The-Counter Use **_** (Per 21 CFR 801.109) OR (Optional Format 1-2-96)