(64 days)
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously.
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000 watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer.
Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.
The provided text describes the Olympic Pasteurmatic 3000 and 3500, medical washer-disinfectors, and their substantial equivalence to a predicate device. However, it does not contain a detailed study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, I cannot provide the requested information in the specified format from the provided text. The document states: "Tests were performed to demonstrate that the performance of the Pasteurmatic 3000 and Pasteurmatic 3500 meet or exceed that of the predicate device," but it does not elaborate on what those tests were, what the acceptance criteria for those tests were, or what the reported performance was.
Missing Information:
- Detailed Acceptance Criteria and Performance Table: The document does not specify quantitative acceptance criteria for cleaning or high-level disinfection effectiveness (e.g., specific log reduction of microorganisms, cleanliness metrics). It only states the intended use involves "killing vegetative bacteria and viruses in a hot water bath at 160°-170°F for 30 minutes."
- Sample Size and Data Provenance: No information on sample sizes for test sets or data provenance (country, retrospective/prospective).
- Ground Truth Establishment (Experts, Adjudication, Qualifications): No mention of experts, ground truth establishment methods, or adjudication. This kind of information is typically relevant for interpretative devices (e.g., AI in radiology), not for a physical disinfection device.
- MRMC Comparative Effectiveness Study: No such study is mentioned as the device is a physical disinfector, not an AI-assisted diagnostic tool.
- Standalone Performance Study: No detailed standalone performance study is explicitly described with results. The statement "Tests were performed to demonstrate that the performance... meet or exceed that of the predicate device" implies such tests were done, but the details are absent.
- Type of Ground Truth: Not applicable in the context of the provided information about this device.
- Training Set Information: Not applicable as this is a physical device, not an AI/machine learning model.
Given the nature of the device (medical washer-disinfector) and the content of the 510(k) summary, the standard format for reporting AI/diagnostic device studies does not directly apply here. The 510(k) pathway primarily relies on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through functional and performance comparisons, rather than extensive de novo clinical trials with specific statistical endpoints often seen for novel diagnostic or AI devices.
{0}------------------------------------------------
JUN 2 0 2008
Section 1 - Administrative Information
1.1 - 510(k) Summary of Safety & Effectiveness
1.1.1 Classification
Class II
Owner/Contact 1.1.2
Steve C. Hesler Director, Quality Assurance and Regulatory Affairs Olympic Medical, Division of Natus 5900 First Ave. S. Seattle, WA 98108 Phone (206) 268-5151 Fax (206) 762-5104 Prepared: 6/20/2008
1.1.3 Device Name
| Trade Name: | Olympic Pasteurmatic 3000Olympic Pasteurmatic 3500 |
|---|---|
| Common Name: | Medical washer-disinfector |
| Classification Name: | Device, Pasteurization, Hot Water(21 CFR 880.6992, Product Code MEC) |
| Regulatory Class: | II |
| ERN: | 3018859 |
1.1.4 Predicate Device
Olympic Pasteurmatic System (K953645).
Device Description 1.1.5
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously.
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000
{1}------------------------------------------------
watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer.
Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.
1.1.6 Intended Use
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160° -~170° F for 30 minutes.
Comparison to Predicate Device 1.1.7
The Pasteurmatic 3000 and Pasteurmatic 3500 perform all the functions of the Olympic Pasteurmatic system using a digital user interface in place of the electromechanical timer and controls used in the predicate device. Additional convenience features have been added to the Pasteurmatic 3000 and Pasteurmatic 3500.
1.1.8 Summary of Comparison Tests
Tests were performed to demonstrate that the performance of the Pasteurmatic 3000 and Pasteurmatic 3500 meet or exceed that of the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
. .
Mr. Steve Hesler Director, Quality Assurance and Regulatory Affairs Olympic Medical Corporation Division of Natus 5900 First Avenue, South Seattle, Washington 98108
Re: K081094
Trade/Device Name: Olympic Pasteurmatic, Models 3000 and 3500 Regulation Number: 880.6992 Regulation Name: Medical Washer-Disinfector Regulatory Class: II Product Code: MEC Dated: May 22, 2008 Received: May 23, 2008
Dear Mr. Hesler:
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. Hesler
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) promarket 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/industry/support/index.html.
Sincerely yours.
Sutie H. Michailoms.
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}------------------------------------------------
Indications for Use
510(k) Number:
Device Name: Olympic Pasteurmatic 3000 and Pasteurmatic 3500
Indications For Use:
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula W. Murphey, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control Dental Devices
Page 1 of
510(k) Number:
§ 880.6992 Medical washer-disinfector.
(a)
Identification. A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
(2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.