PRIMUS STEAM STERILIZERS

K991575 · Primus Sterilizer Co., Inc. · FLE · Dec 3, 1999 · General Hospital

Device Facts

• Record ID: K991575
• Device Name: PRIMUS STEAM STERILIZERS
• Applicant: Primus Sterilizer Co., Inc.
• Product Code: FLE · General Hospital
• Decision Date: Dec 3, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials.

Device Story

PRIMUS PSS series steam sterilizers; rectangular 316L stainless steel chambers; sliding doors. Available in Multifunction (prevacuum/gravity) or Laboratory/Lo (prevacuum/gravity/low-temp) configurations. Used in hospital ORs, central sterile supply, and clinical labs. Operates via saturated steam; factory-set cycles for hard goods, wrapped goods, and liquids. Features fail-safe controls providing warnings/signals for malfunctions or unmet conditions. Healthcare providers load items; device performs sterilization; output is sterile material. Benefits include efficient sterilization of heat/moisture stable items.

Clinical Evidence

Bench testing only. Validation performed per AAMI ST8-1994. Testing demonstrated complete kill of biological indicators with a sterility assurance level of less than 10^-6 across vacuum, gravity, and liquid cycles.

Technological Characteristics

316L stainless steel rectangular chambers; jacketed design. Saturated steam sterilization. Configurations: Multifunction (prevacuum/gravity) and Laboratory/Lo (prevacuum/gravity/low-temp). Safety standards: UL 544, CAN/CSA C22.2 NO. 601.1, ASME Section VIII Div 1, NFPA 99. Fail-safe control system for monitoring cycle conditions and malfunctions.

Indications for Use

Indicated for use in hospital operating suites, central sterile supply, and clinical laboratories for the steam sterilization of non-porous and porous, heat and moisture stable materials.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Submission Summary (Full Text)

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12/3/99

K991575

Reference: 21 CFR, Part 807.87(h) Information required in a premarket notification submission.

- A 510(k) summary as described in Sec. 807.92 or a 510(k) statement as (h) described in Sec. 807.93.
### A 510(K) SUMMARY PERTAINIING TO THE SAFETY AND EFFECTIVENESS OF THE PRIMUS PSS SERIES STERILIZER

| Manufacturer: | PRIMUS Sterilizer Co., Inc.<br>117 South 25th Street<br>Omaha, NE 68131 |
|----------------|-------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact: | Jeff Reed, Engineering Manager |
| Date Prepared: | May 3, 1999 |

#### Introduction

The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration.

The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values:

| CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME | DRY TIME | RECOMMENDED<br>LOAD |
|------------|-------------------|-------------------|------------|---------------------|
| GRAVITY | 132° C | 4 MINUTES | 1 MINUTE | HARD GOODS |
| VACUUM | 132° C | 4 MINUTES | 15 MINUTES | WRAPPED GOODS |
| LIQUIDS | 121° C | 30 MINUTES | *8 MINUTES | LIQUIDS |
| TEST (VAC) | 132° C | 4 MINUTES | 3 MINUTES | BOWIE-DICK TEST |

*Liquid Cycle is Cool Time

# Validation

Evaluation of the sterilizer function and exposure time recommendations has been completed to validate the safety and effectiveness of the PRIMUS PSS series

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sterilizer. The test plan was derived from AAMI ST8 1994 Volume 1. All tests were performed satisfactory showing complete kill of biological indicators with appropriate sterility assurance level of less than 106.

Results of the validation studies conducted demonstrate the sterilizers perform as intended with the results shown below:

- Compliance to AAMI ST8-1994. This standard establishes the minimum . performance for hospital sterilizers that use saturated steam as the sterilizing agent. The standard is applicable for sterilizers with a volume greater than two cubic feet. The PRIMUS PSS series sterilizer vacuum, gravity, and liquids cycles validated per AAMI-ST8 standard.
- Compliance to AAMI ST8-1994. This standard establishes the minimum . construction hospital sterilizers that use saturated steam as the sterilizing agent. The PRIMUS PSS series sterilizers meet or exceed this standard in design and construction.

### Safety

The PRIMUS PSS series sterilizers are constructed and tested to meet or exceed the requirements of various national safety codes and standards. The PSS series sterilizers comply with the following requirements:

- Underwriters Laboratory (UL) Electromedical Code 544 as certified by the ETL ● Testing Labs, Inc.
- Canadian Standards Association CAN/CSA C22.2 NO. 601.1 as certified by the . ETL Testing Labs, Inc.
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for . unfired pressure vessels.
- California Seismic Pre-Approval. .
- National Fire Protection Association Standard 99. ●

The technology designed into the PRIMUS PSS series sterilizers provides for fail safe controls that give appropriate warnings and signals when required conditions have not been met or malfunctions occur.

To assure of proper operation and sterilization, all items to be processed must be properly cleaned and the manufacturer's instructions must be followed. The sterilizer must be maintained according to the instructions found in the maintenance section of the manual and each type of load must be validated following the applicable standard.

## Operator Information

PRIMUS provides information in the Operators Manual that is intended to ensure safe and effective use of the sterilizer. Furthermore, it is recommended that any end user

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consult any applicable AAMI standards to assure safe and effective use of the sterilizer for its intended purpose.

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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that overlap and intersect, creating a sense of movement and dynamism. The seal is black and white and has a simple, clean design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Mr. R. Jeff Reed Engineering Manager Primus Sterilizer Co., Inc. 117 South 25th Street Omaha, Nebraska 68131

K991575 Re : PRIMUS Steam Sterilizers Trade Name: Regulatory Class: II Product Code: FIF Dated: November 24, 1999 November 26, 1999 Received:

#### Dear Mr. Reed:

We have reviewed your Section 510(k) notification of intent to we have reviewed your section brown and we have determined the market the device referenced above (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 commerce prior to May 20, 1970, devices that have been Medical bevree imendince with the provisions of the Federal Food, Drug, and Cosmetic Act (Act ). You may, therefore, Food, Drug, and Cosmecre Acc (nor, -------------------------------------------------------------------------------------------------------------------------------------------The general controls provisions of the Act of the Act. of the Act. The goncear for annual registration, listing of Include requirementacturing 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 be Bublect to Bach adazour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal heguintially equivalent determination assumes compliance with Subscancially Octuring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMP inspections, the Food and Drug Administration (PDA) will werify such assumptions. Failure to comply with the GMP vertif Such abbambult in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any

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Page 2 - Mr. Reed

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 marked.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please coonha the the Office of Compliance at [phone]. 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 Assistence at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" -

Sincerely yours,

Patricio Cucerita / for

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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Ver/ 3 - 4/24/96

Applicant: PRIMUS Sterilizer Co., Inc.

510(k) Number: Not known at this time of application

Device Name: PRIMUS Steam Sterilizers

Indications For Use:

The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations:

13" x 13" x 23" Multi-Functional Sterilizer 13" x 13" x 23" Laboratory/Lo 16" x 16" x 26" Multi-Functional Sterilizer 16" x 16" x 26" Laboratory/Lo 20" x 20" x 38" Multi-Functional Sterilizer 20" x 20" x 38" Laboratory/Lo 26" x 26" x 39" Multi-Functional Sterilizer 26" x 26" x 39" Laboratory/Lo 26" x 26" x 49" Multi-Functional Sterilizer 26" x 26" x 49" Laboratory/Lo 26" x 26" x 67" Multi-Functional Sterilizer 26" x 26" x 67" Laboratory/Lo 26" x 36" x 39" Multi-Functional Sterilizer 26" x 36" x 39" Laboratory/Lo 26" x 36" x 48" Multi-Functional Sterilizer 26" x 36" x 48" Laboratory/Lo 26" x 36" x 60" Multi-Functional Sterilizer 26" x 36" x 60" Laboratory/Lo 26" x 63" x 48" Multi-Functional Sterilizer 26" x 63" x 48" Laboratory/Lo 26" x 63" x 76" Multi-Functional Sterilizer 26" x 63" x 76" Laboratory/Lo

Single Door Single Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door

Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the wacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.

Olus S. Lin

(Division Sign-Off) Division of Dental, Infection Cont and General Hospital De 510/k) Number

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