PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8

K093333 · Primus Sterilizer Company, LLC · FLE · Apr 2, 2010 · General Hospital

Device Facts

• Record ID: K093333
• Device Name: PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
• Applicant: Primus Sterilizer Company, LLC
• Product Code: FLE · General Hospital
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PRIMUS PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterliization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens.

Device Story

Steam sterilizer (autoclave) series for hospital/clinical use; processes non-porous and porous, heat/moisture-stable materials (instruments, hard goods, linens). Operates via vacuum, gravity, liquid, and test (Bowie-Dick) cycles. Features stainless steel chambers (316L internal surface) and optional carbon steel reinforced doors; available in horizontal or vertical sliding door configurations; some models pit-mounted for floor cart access. Controlled by validated software providing fail-safe monitoring, warnings, and signals for cycle conditions/malfunctions. Healthcare providers load materials, select factory-preset cycles, and monitor performance via chemical/biological indicators. Benefits include standardized, validated sterilization assurance (SAL 10^-6) for medical equipment.

Clinical Evidence

Bench testing only. Performance validated against ANSI/AAMI ST8:2001 consensus standards. Sterilization efficacy confirmed using biological indicators (BI) for each cycle type to achieve a Sterility Assurance Level (SAL) of 10^-6. Electrical safety verified per AAMI/ANSI/IEC 60601-1-2 and UL/CSA 61010 standards. 100% Factory Acceptance Testing performed on all units.

Technological Characteristics

Steam sterilizer with 316L stainless steel chambers and optional 304 stainless steel jackets. ASME Section VIII, Division 1 pressure vessel construction. Operates via saturated steam. Connectivity includes fail-safe control software. Electrical safety per IEC 60601-1-2, UL 61010A-1/2-041, and CAN/CSA C22.2 No. 1010. Sterilization validated per ANSI/AAMI ST8:2001.

Indications for Use

Indicated for steam sterilization of non-porous and porous, heat and moisture stable materials, including wrapped and unwrapped surgical instruments, hard goods, and linens in hospital operating suites, central sterile supply, and clinical laboratories.

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.

Predicate Devices

• K991575
• K082817

Submission Summary (Full Text)

{0}------------------------------------------------

1093333

# APR - 2 2010

#### Section 5

## A 510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF PRIMUS PSS8 STEAM STERILIZERS

| Manufacturer: | PRIMUS Sterilizer Company, LLC.<br>117 South 25th Street<br>Omaha NE 68131<br>Phone: [phone]<br>Fax: [phone] |
|----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Connie Mansfield, Mgr., Marketing Communications & Regulatory Compliance<br>Omaha NE 68131<br>Phone: [phone] Ext 1229 |
| Date Prepared: | March 12, 2009 |

### Introduction:

The PRIMUS PSS8 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 and K082817.

The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers: offered in either horizontal or vertical sliding door applications. The PSS8-J, K and M units may be pit-mounted, allowing the optional floor carts to roll directly in to the chamber. All sterilizer doors are designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available.

PSS sterilizer units offered under this request for clearance are available in the following configurations. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration.

| PSS8-AA-M** | (16" x 16" x 26" Multi-Functional Sterilizer) | Single or Double Drains |
|---------------|-----------------------------------------------|-------------------------|
| PSS8-A-M** | (20" x 20" x 38" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-B-M** | (26" x 26" x 39" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-C-M** | (26" x 26" x 49" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-D-M** | (26" x 26" x 67" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-E-M** | (26" x 36" x 39" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-F-M** | (26" x 36" x 48" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-G-M** | (26" x 36" x 60" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-G.1-M*** | (32" x 36" x 48" Multi-Functional Sterilizer) | Single or Double Drains |
| PSS8-J-M** | (26" x 63" x 48" Multi-Functional Sterilizer) | Single or |

or Door OL Door OT Door DI Door or Door or Door Dr Double Door

Door

Door

Door

Section 5 Page 1 of 4

{1}------------------------------------------------

| PSS8-K-M** | (26" x 63" x 76" Multi-Functional Sterilizer) | Single or |
|-------------|-----------------------------------------------|-------------|
| | | Double Door |
| PSS8-M-M*** | (35" x 57" x 60" Multi-Function Sterilizer) | Single or |
| | | Double Door |

PRIMUS Steam Sterilizers models defined above are as described in Section 4 "Indications for Use Statement" and contained within this submission

The PRIMUS PSS8 series sterilizers are offered with factory pre-set sterilization cycles described within the Indication for Use Table (See attached Table og 3).

#### Safety

The PRIMUS PSS8 Steam Sterilizer Series have been validated against FDA recognized consensus standards for electrical safety:

- AAMI / ANSI / IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment -- Part 1-2: . Collateral Standard - General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests.
Additionally PRIMUS declares conformance to applicable industry and electrical codes as follows

- . UL 61010A-1, IEC 61010-1 Amendment 2, and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials & for Laboratory Process, IEC 61010-2-041, UL 61010A-2-041.
- CNL indicates the product was evaluated to the Canadian Standard for Laboratory Equipment, CAN/CSA-● C22.2 No. 1010 and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials and Laboratory Process, CAN/CSA-C22.2 No. 1010.2-041-96.
- PRIMUS PSS8 Pressure Vessels are designed, manufactured and tested in accordance with American . Society of Mechanical Engineers (ASME), Section VIII, Division 1 Unfired Pressure Vessels.

Validated software designed into the PRIMUS PSS8 series sterilizer provides for fail-safe controls that give appropriate warnings and signals when required conditions have not been met or if unit malfunctions. The technology designed into the PRIMUS PSS Steam Sterlizer Series provides for fail safe controls that provide end users with appropriate warnings and signals when required conditions have not been met or malfunctions occurs. Safety warnings and signals are challenged and verified on each unit, as a function of routine process control testing, during a 100% Factory Acceptance Test conducted at final inspection. Results are documented and maintained in the Device History Record (DHR).

#### Effectiveness:

PRIMUS has validated sterilizer performance for each load cycle type to ensure that the exposure time, provided in the directions for use statements, have been proven to assure the safety and effectiveness of the PRIMUS PSS8 series sterilizer. Internal validation protocols are documented and deemed to be comply to the ANSI/AAMI ST8:2001, Hospital steam sterilizers - (Sterility); a harmonized standard recognized FDA as applicable to the validation of steam sterilizers intended for use in hospitals and other health care facilities and that have a volume greater than 2 cubic feet (ft') (56 liter {L] ) with no exclusions taken. The recognized standard established the minimum construction requirements and performance requirements for hospital sterilizers, using saturated steam as the sterilizing agent.

Declarations of Conformance made by PRIMUS to recognized standards are based on a verification of product performance data, that was independently validated with BI indicators exposed during validation for each cycle type published within the Indications for Use statement. Data output from the validation report was reviewed and found to meet Sterility Assurance Level (SAL) of 10th when the sterilizer is used and maintained as directed.

#### Operator Information

PRIMUS provides information in the User's Manual that is intended to ensure safe and effective use of the sterilizer. Additional information concerning recommended practices for end users in monitoring sterilizer performance can be found in the ANSI/AAMI ST79:2006 Comprehensive guide to steam sterility assurance in the health

{2}------------------------------------------------

care facilities or other applicable standards to assure safe and effective use of the steam sterilization processes for application.

Based on the testing and comparison to the consensus standard, PRIMUS concludes that each of the chamber sizes included under this submission performs as intended and raises no new safety or effectiveness issues when used as directed.

Connie L. Mangold

Mgr., Marketing Communications and Regulation Compliance PRIMUS Sterilizer Company, LLC

{3}------------------------------------------------

| Cycle # | Cycle Type | Sterilize Temp | Sterilize Time (min) | Dry Time (min) | No. of Pre-vacs | 16x16x26 | 20x20x38 | 26x26x39 | 26x26x49 | 26x26x67 | 26x36x39 | 26x36x48 | 26x36x60 | 32x36x48 | 26x63x48 | 26x63x76 | 35x57x60 | |
|-----------------------------|------------|--------------------|----------------------|----------------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|-------------------------------|
| 2 | Vacuum | 132°C<br>(270°F) | 4 | 1 | 3 | N/A | 1 | 1 | 1 | N/A | 1 | 1 | N/A | 1 | N/A | N/A | N/A | Porous Single |
| 3 | Vacuum | 132°C<br>(270°F) | 4 | 30 | 3 | N/A | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | Instrument<br>each tray |
| 4 | Vacuum | 132°C<br>(270°F) | "4 | 30 | 3 | N/A | 2 | 4 | 6 | N/A | 6 | 12 | N/A | 15 | N/A | N/A | N/A | 9x6, 12 lbs. |
| 6 | Gravity | 121.1°C<br>(250°F) | 30 | 30 | 0 | N/A | 2 | 2 | 4 | 6 | 12 | 16 | 16 | 16 | 30 | 60 | 42 | maximum size:<br>pounds |
| 7 | Liquids | 121.1°C<br>(250°F) | 30 | 15* | 0 | 57 | 111 | 149 | 189 | N/A | 207 | 255 | N/A | 284 | N/A | N/A | N/A | Plate glass<br>ml or smaller. |
| 8 | Test (VAC) | 132°C<br>(270°F) | 3-1/2 | 2 | 3 | N/A | 136 | 181 | 228 | 313 | 252 | 309 | 388 | 390 | 543 | 860 | 615 | |
| | | | | | | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | 1 Test<br>Pack | |
| | | | | | | Shelving | Loading Eq. | Shelving | Loading Eq. | Shelving | Loading Eq. | Shelving | Loading Eq. | Shelving | Loading Eq. | Shelving | Loading Eq. | |
| Maximum Load Configurations | | | | | | | | | | | | | | | | | | |

** Dry time in LIQUIDS cycle is liquid cool time.

WARNING

THE INTENDED USE OF A LIQUID CYCLE IS NOT FOR STERILIZING MATERIALS FOR DIRECT PATIENT CONTACT

WARNING

PRIMUS RECOMMENDS THE VALIDATED FACTORY PRESET CYCLES. CHANGES TO THE CYCLE PARAMETERS,
PER ANSI/AAM ST79:2006, ARE NOT RECOMMENDED. CONTACT PRIMUS FOR FURTHER INFORMATION.

NOTE

STERILIZE TEMP PARAMETER IS PROGRAMMED TO ENSURE STERILIZE TEMP MEETS ANSI/AAM ST8
REQUIREMENTS FOR EACH FACTORY VALIDATED CYCLE.

{4}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR - 2 2010

Ms. Connie Mansfield Manager, Marketing Communications Primus Sterilizer Company, LLC 117 South 250 Street Omaha, Nebraska 68131

Re: K093333

Trade/Device Name: PRIMUS Steam Sterilizers Regulation Number: 21CFR 880.6880 Regulation Name: Steam Sterilization Regulatory Class: II Product Code: FLE Dated: March 26, 2010 Received: March 26, 2010

Dear Ms. Mansfield:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{5}------------------------------------------------

Page 2 - Ms. Mansfield

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

#### Section 4

#### Indications for Use Statement

Applicant: PRIMUS Sterilizer Company, LLC

510(k) Number: K0933333

Device Name: PRIMUS Steam Sterilizers

Indication for Use:

The PRIMUS PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterliization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSSS Steam Sterilizer Series are available in the following configurations:

| PSS8-AA-M** | (16" x 16" x 26" Multi-Functional Sterilizer) | Single or<br>Double Door |
|---------------|-----------------------------------------------|--------------------------|
| PSS8-A-M** | (20" x 20" x 38" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-B-M** | (26" x 26" x 39" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-C-M** | (26" x 26" x 49" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-D-M** | (26" x 26" x 67" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-E-M** | (26" x 36" x 39" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-F-M** | (26" x 36" x 48" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-G-M** | (26" x 36" x 60" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-G.1-M*** | (32" x 36" x 48" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-J-M** | (26" x 63" x 48" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-K-M** | (26" x 63" x 76" Multi-Functional Sterilizer) | Single or<br>Double Door |
| PSS8-M-M*** | (35" x 57" x 60" Multi-Function Sterilizer) | Single or<br>Double Door |

Sterilizers are available in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles.

· PRIMUS Sterilizer Company, LLC recommends that a suitable chemical indicator or biological challenge test be used on a periodic basis to test effectiveness of the sterilizer in accordance with health care facilities docurented plan for monitoring SAL 10d performance.

The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens. The cycles to be cleared for each of the models listed above are found in the table below:

{7}------------------------------------------------

| Load Type | Cycle # | Cycle Type | Sterilize Temp | Sterilize Time (min) | Dry Time (min) | No. of Pre-vacs | 16x16x26 | 20x20x38 | 26x26x39 | 26x26x49 | 26x26x67 | 26x36x39 | 26x36x48 | 26x36x60 | 32x36x48 | 26x63x48 | 26x63x76 | 35x57x60 | |
|-----------------------------------------------------------------|---------|------------|--------------------|----------------------|----------------|-----------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|----|
| Unwrapped Nonporous Single Instrument | 2 | Vacuum | 132°C<br>(270°F) | 4 | 1 | 3 | N/A | 1 | 1 | 1 | N/A | 1 | 1 | N/A | 1 | N/A | N/A | N/A | |
| | | | | | | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Shelving | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |
| Double wrapped instrument trays 16 pounds each tray | 3 | Vacuum | 132°C<br>(270°F) | 4 | 30 | 3 | N/A | 2 | 4 | 6 | 8 | 6 | 12 | 14 | 15 | 30 | 60 | 42 | |
| | | | | | | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Shelving | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |
| Textile packs 9x9x6, 12 lbs. | 4 | Vacuum | 132°C<br>(270°F) | 4 | 30 | 3 | N/A | 4 | 6 | 12 | 12 | 14 | 12 | 16 | 18 | 16 | 30 | 60 | 42 |
| | | | | | | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Shelving | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |
| Fabric packs maximum size:<br>12x12x20, 12 pounds | 6 | Gravity | 121.1°C<br>(250°F) | 30 | 30 | 0 | N/A | 2 | 2 | 4 | 6 | 9 | 12 | 14 | 16 | 20 | 50 | 40 | |
| | | | | | | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Shelving | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |
| Vented borosilicate glass containers, 1000 ml or smaller, 4"x7" | 7 | Liquids | 121.1°C<br>(250°F) | 30 | 15* | 0 | N/A | 57 | 111 | 149 | 189 | 207 | 255 | N/A | 284 | N/A | N/A | N/A | |
| | | | | | | | N/A | 136 | 181 | 228 | 313 | 252 | 309 | 388 | 390 | 543 | 860 | 615 | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |
| Bowie-Dick Test | 8 | Test (VAC) | 132°C<br>(270°F) | 3-1/2 | | 2 | | | | | | | | | | | | | |
| | | | | | | | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | 1 Test Pack | |
| | | | | | | | | | | | | | | | | | | Shelving | |
| | | | | | | | | | | | | | | | | | | Loading Eq. | |

.

.

: