OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500

K081094 · Olympic Medical Corp. · MEC · Jun 20, 2008 · General Hospital

Device Facts

• Record ID: K081094
• Device Name: OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
• Applicant: Olympic Medical Corp.
• Product Code: MEC · General Hospital
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6992
• Device Class: Class 2

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 by killing vegetative bacteria and viruses, in a hot water bath at ~160° -~170° F for 30 minutes.

Device Story

The Olympic Pasteurmatic 3000 and 3500 are medical washer-disinfectors for respiratory therapy and anesthesia equipment. The device uses a stainless steel tank and rotating baskets to immerse parts in 160° - 170° F water for 30 minutes. The rotation forces water through tubes to displace air bubbles, ensuring contact for high-level disinfection. The 3000 model features 9,000 watts of heating capacity, while the 3500 features 15,000 watts for faster heating. The system is operated by clinical staff in healthcare settings. It replaces electromechanical controls from the predicate with a digital user interface. The device benefits patients by providing high-level disinfection of reusable equipment, reducing the risk of cross-contamination.

Clinical Evidence

Bench testing only. Performance testing was conducted to demonstrate that the Pasteurmatic 3000 and 3500 meet or exceed the performance of the predicate device.

Technological Characteristics

Medical washer-disinfector; stainless steel tank and rotating basket construction; heating elements (9,000W for 3000 model, 15,000W for 3500 model); digital user interface; hot water immersion (160° - 170° F) disinfection principle.

Indications for Use

Indicated for cleaning and high-level disinfection of reusable and disposable respiratory therapy and anesthesia equipment via hot water immersion (160° - 170° F) for 30 minutes to kill vegetative bacteria and viruses.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Olympic Pasteurmatic System (K953645)

Submission Summary (Full Text)

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K081094

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 [phone] Fax [phone] Prepared: 6/20/2008

### 1.1.3 Device Name

| Trade Name: | Olympic Pasteurmatic 3000<br>Olympic Pasteurmatic 3500 |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Medical washer-disinfector |
| Classification Name: | Device, Pasteurization, Hot Water<br>(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

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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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number:

K081094

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:

K081094