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

Device Description

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 TEMP	STERILIZE TIME	DRY TIME	RECOMMENDED 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

AI/ML Overview

The provided text describes the acceptance criteria and the validation study for the PRIMUS PSS series sterilizer.

Acceptance Criteria and Device Performance

The acceptance criteria for the PRIMUS PSS series sterilizer are primarily based on achieving complete sterilization, demonstrated by the complete kill of biological indicators with an appropriate sterility assurance level (SAL) of less than 10-6. This is in compliance with the AAMI ST8-1994 standard for performance and construction of hospital sterilizers.

Acceptance Criteria	Reported Device Performance
Complete kill of biological indicators	Complete kill of biological indicators with SAL < 10-6
Sterility Assurance Level (SAL) < 10-6	SAL < 10-6
Compliance to AAMI ST8-1994 (Performance)	Complied with AAMI ST8-1994 for vacuum, gravity, and liquids cycles
Compliance to AAMI ST8-1994 (Construction)	Met or exceeded AAMI ST8-1994 in design and construction
Compliance to UL Electromedical Code 544	Complied (certified by ETL Testing Labs, Inc.)
Compliance to CSA CAN/CSA C22.2 NO. 601.1	Complied (certified by ETL Testing Labs, Inc.)
Compliance to ASME, Section VIII, Division 1	Complied
California Seismic Pre-Approval	Complied
NFPA Standard 99	Complied

Study Details

The provided text outlines a standalone (i.e., algorithm only without human-in-the-loop performance) validation study for the sterilizer's function and exposure time recommendations.

1. Sample Sized Used for the Test Set and Data Provenance:
* Test Set Sample Size: Not explicitly stated as a number of sterilizer cycles or loads. The document refers to "All tests," which implies a comprehensive testing regimen, but specific numbers are not given.
* Data Provenance: The document does not specify the country of origin. The study appears to be prospective, as it describes validation tests conducted to demonstrate safety and effectiveness.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* Number of Experts: Not applicable. The ground truth for sterilizers is established through scientific and microbiological testing against defined standards, not through expert human interpretation in the same way as an imaging diagnostic device.
* Qualifications of Experts: N/A.

3. Adjudication Method for the Test Set:
* Adjudication Method: Not applicable in the traditional sense. The "ground truth" for sterilization is determined by the objective outcome of biological indicator tests (complete kill or not) and adherence to physical parameters set by the AAMI ST8-1994 standard. There is no mention of a human adjudication process for interpreting these results; rather, it's a pass/fail against established criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* This is not applicable to a sterilizer device. MRMC studies are typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images, and the AI system is designed to assist or replace that interpretation. A sterilizer's performance is objective and not based on human reader interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance study was done. The validation described is focused solely on the sterilizer's ability to achieve sterilization based on its design and operational cycles, without human interpretation of results beyond verifying biological indicator kill. The sterilizer itself is the "device" or "algorithm" in this context.

6. The type of ground truth used:
* The ground truth used is primarily objective performance data reflecting the sterilization efficacy. This includes:
* Biological indicator kill: Direct evidence of microbial inactivation.
* Sterility Assurance Level (SAL) < 10-6: A quantifiable measure of the probability of a single viable microorganism remaining after sterilization.
* Compliance to AAMI ST8-1994: An industry standard that defines performance requirements for steam sterilizers.
* Compliance to other safety and construction standards (UL, CSA, ASME, etc.): Ensuring the device is built to established engineering and safety specifications.

7. The sample size for the training set:
* Not applicable in the context of an AI training set. The sterilizer is a physical device, and its design and operational parameters are 'trained' through engineering design, prototyping, and testing, rather than an AI model training on a dataset. The "cycles" listed (Gravity, Vacuum, Liquids) are the operational modes, not training iterations for an AI.

8. How the ground truth for the training set was established:
* Not applicable for an AI training set. The "ground truth" for the sterilizer's design and operational parameters would have been established through established engineering principles, scientific understanding of sterilization processes (time, temperature, pressure relationships), and adherence to regulatory and industry standards like AAMI ST8-1994, which dictate optimal conditions for achieving sterility. These principles guide the design and manufacturing of the device.

Summary

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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.117 South 25th StreetOmaha, NE 68131
	Phone: 402-344-4200Fax: 402-344-4242
Contact:	Jeff Reed, Engineering Manager
Date Prepared:	May 3, 1999

Introduction

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

CYCLES	STERILIZETEMP	STERILIZETIME	DRY TIME	RECOMMENDEDLOAD
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please coonha the 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 Assistence at its toll-free number (800) 638-2041 or (301) 443-6597 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

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:

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

Olus S. Lin

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

P-I

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).