Who is the manufacturer of PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

Primus Sterilizer Company, LLC filed the 510(k) submission for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (K233132).

What is the FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

FLE. It is classified under 21 CFR 880.6880 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Q: What are the predicate devices for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474).

K233132 · Primus Sterilizer Company, LLC · FLE · Dec 19, 2023 · General Hospital

Device Facts

Record ID	K233132
Device Name	PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
Applicant	Primus Sterilizer Company, LLC
Product Code	FLE · General Hospital
Decision Date	Dec 19, 2023
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.6880
Device Class	Class 2

Intended Use

The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

Device Story

Steam sterilizer (autoclave) for surgery, central sterile, and surgery centers; utilizes pressurized steam to sterilize heat/moisture-stable medical materials. Device features 316L stainless steel chamber, jacket, and vertical sliding doors. Operates via PLC (IDEC FC6A or Allen Bradley CompactLogix) with HMI touch screen; provides 11 pre-programmed cycles (Prevac, Gravity, SFPP, Immediate Use, Leak Test). Operator selects cycle via touch screen; system monitors process parameters; thermal printer provides cycle data record. Benefits include efficient sterilization of surgical instruments/fabric packs; ensures sterility assurance level of 10^-6. Safety features include emergency stop, pressure relief valves, and door interlocks.

Clinical Evidence

No clinical data. Bench testing only. Performance testing demonstrated compliance with ANSI/AAMI ST8:2013/(R)2018, electrical safety (UL 61010-1/2-040), EMC (IEC 60601-1-2), and pressure vessel requirements (ASME Section VIII).

Technological Characteristics

Steam sterilizer; 316L stainless steel chamber (10 Ra finish), 304 stainless steel jacket. Dimensions: PSS11-HA (20"x20"x38"), PSS11-HB (26"x30"x29"). Energy: Steam (building-supplied or electric generator). Control: PLC (IDEC FC6A or Allen Bradley CompactLogix). Connectivity: Ethernet printing. Sterilization: Pressurized steam. Standards: ANSI/AAMI ST8, ASME Section VIII, UL 61010, IEC 60601-1-2.

Indications for Use

Indicated for steam sterilization of heat and moisture stable, non-porous and porous medical materials in surgery, central sterile, and surgery centers. Contraindicated for materials that cannot withstand operating temperatures.

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

PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474)

Related Devices

K221474 — PRIMUS Healthcare Sterilizer (Model PSS11-HC) · Primus Sterilizer Company, LLC · Feb 10, 2023
K033538 — BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 · Sauter AG · Feb 2, 2004
K021223 — BELIMED STEAM STERILIZER, MODEL TOP 5000 · Sauter AG · Jun 26, 2002
K082817 — PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M · Primus Sterilizer Company, LLC · May 21, 2009
K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 · Primus Sterilizer Company, LLC · Apr 2, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 19, 2023 PRIMUS Sterilizer Company, LLC % Ankur Naik Managing Director IZiel Healthcare Pentagon P1, Office No. 601 and 604, Magarpatta City, Hadapsar, Pune 411028, Maharashtra India Re: K233132 Trade/Device Name: PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 26, 2023 Received: September 27, 2023 Dear Ankur Naik: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Christopher K. Dugard -2 Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control {2}------------------------------------------------ and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233132 Device Name PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) Indications for Use (Describe) The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer. A table describing the Cycle, Exp. time, Dry time, Recommended load, and maximum items per chamber size is available on the next page. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Table 1:Factory Programmed Sterilization Cycles for PRIMUS Healthcare Sterilizer Model PSS11-HA and PSS11-HB. | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | |--------------------------------------------------|------------------|--------------|-------------|-------------------------------------------------------------------------------|----------------------|--------------------------------------|----------------------|-----------------------------------------| | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | PREVAC 1 (vac) | 270°F (132°C) | 4 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | PREVAC 2 (vac) | 275°F (135°C) | 3 min | 30 min | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Steam- Flush Pressure | 270°F (132°C) | 4 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | Pulse 1 | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Steam- Flush Pressure | 275°F (135°C) | 3 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | Pulse 2 | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Immediate Use - PREVAC | 270°F (132°C) | 4 min | 1 min | Unwrapped non- porous single instrument | 25lb | 1 | 25lb | 1 | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | | | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | Immediate Use - Gravity (Notes 1- 3) | 270°F (132°C) | 4 min | 1 min | Unwrapped non- porous instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | Immediate Use - Gravity (Notes 1- 3) | 270°F (132°C) | 4 min | 1 min | Unwrapped non- porous single instrument | 25lb | 1 | 25lb | 1 | | Immediate Use - Gravity (Notes 1- 3) | 270°F (132°C) | 4 min | 1 min | Unwrapped non- porous instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | Immediate Use - Gravity (Notes 1- 3) | 270°F (132°C) | 10 min | 1 min | Unwrapped porous or non-porous single instrument | 25lb | 1 | 25lb | 1 | | Immediate Use - Gravity (Notes 1- 3) | 270°F (132°C) | 10 min | 1 min | Unwrapped porous & non-porous instrument trays. up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | GRAVITY 1 | 250°F (121°C) | 30 min | 30 min | Unwrapped non- porous single instrument | 25lb | 1 | 25lb | 1 | | GRAVITY 1 | 250°F (121°C) | 30 min | 30 min | Unwrapped non- porous instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | GRAVITY 2 | 270°F (132°C) | 15 min | 30 min | Unwrapped non- porous single instrument | 25lb | 1 | 25lb | 1 | | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | | | | | Unwrapped non- porous instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | Bowie Dick Test (vac) | 275°F (132°C) | 3.5 min | 3 min | Bowie-Dick Test Pack or equivalent (1) in an EMPTY chamber | - | 1 Test Pack | - | 1 Test Pack | | Leak Test (Note 4) | N/A | N/A | N/A | Empty chamber | N/A | N/A | N/A | N/A | {5}------------------------------------------------ {6}------------------------------------------------ # PRIMUS Healthcare Sterilizer Abbreviated 510(k): Premarket Notification {7}------------------------------------------------ ### TABLE NOTES - 1. Load configurations during testing validations follow ANSI/AAMI ST8:2013 standard for Hospital Steam Sterilizers where applicable. All fabric packs and instrument trays are constructed as described in ANSI/AAMI ST8. For guidance on loading the sterilizer, refer to ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. - 2. At the end of an immediate use or express cycle items may NOT be dry. - 3. The recommended exposure time and temperature for unwrapped, non-porous, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C). - 4. Vacuum leak test parameters are not adjustable. The cycle run for leak test includes 15 minutes of dry cycle, 5 min for equalization within the chamber, and 15 mins for the leak test run. {8}------------------------------------------------ # 510(k) SUMMARY - K233132 510(k) summary of safety and effectiveness for PRIMUS Healthcare Sterilizer models PSS11HA and PSS11-HB are provided in accordance with 21 CFR 807.92. | Date: | 18 December 2023 | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter (Owner): | Patrick Hansen, PE VP Engineering PRIMUS Sterilizer Company, LLC 7936 Forest City Road Suite 100 Orlando, fl 32810 Telephone No.: +1-402-3444200-1214 Fax No.: +1-402-344-4242 Email: phansen@spire-is.com | | 510(k) Contact Person: | Ankur Naik Managing Director IZiel Healthcare Pentagon P1, Office No. 601 and 604, Magarpatta City, Hadapsar, Pune 411028, Maharashtra, India. P: +91 72762 12555 M: +91 7069553814 Email: ankur.naik@izielhealthcare.com | | Device Trade Name: | PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) | | Regulation Number: | 880.6880 | | Regulation Description: | 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. | | Review Panel: | General Hospital | | Device Class: | Class II | | Product Code: | FLE | | Predicate Device: | 1. PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474) Regulation number: 21 CFR 880.6880 Regulation Name: Steam Sterilization Regulatory Class: II Product Code: FLE Review panel: General Hospital | ## Device Description: The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and {9}------------------------------------------------ PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit is equipped with a height-adjustable steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single-door freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Steam Sterilizer consists of the following components and accessories: # 1. Jacket Assembly (sterilizer vessel) A Type 316L stainless steel chamber and a Type 304 stainless steel jacket are welded together to form the sterilizer vessel. The sterilizer vessel is ASME rated at 45 psig (3.06 Bar) and insulated. Steam-supply opening inside the chamber is shielded by a Type 316L stainless steel baffle. The unique design of the chamber jacket allows for an even distribution of heat and prevents the formation of condensation on the chamber walls. #### 2. Chamber Finish The sterilizer features a 316L SS (stainless steel) brilliant PRI-Mirror chamber finish found in all PRIMUS models achieving a 10 Ra (0.026 microns) measurement. The chamber has a full-length steam baffle and two drains positioned in the chamber to maximize steam distribution and cross-flow within the chamber. #### 3. Chamber Door Door is constructed of a single formed piece of Type 316L stainless steel. The door is insulated to reduce the surface temperature of the stainless-steel door cover. Sterilizers have either single or double doors. They are equipped with manual or hydraulically powered vertical sliding door(s). All doors are sealed with a continuous silicone O-Ring gasket, recessed within the chamber head ring. #### Insulation ব Superior heat loss reduction is achieved with one-inch fiberglass insulation overlaid with 0.05-inch aluminum sheet metal. #### 5. Chamber Drain System Drain system is designed to prevent pollutants from entering into the water-supply system and sterilizer. {10}------------------------------------------------ #### 6. Drain Water Quench (Piping System) The piping system provides automatic condensing of chamber steam and discharges to the floor drain. Cooling water is added to ensure discharge temperature is below 60°C (140°F). A separate temperature switch is included to regulate the volume of water so as not to exceed the required amount necessary to achieve the target temperature. The steam piping is constructed of stainless steel (standard) or brass and copper (optional) and includes a steam strainer and brass pressure regulator. ## 7. Vacuum system Chamber pressure is reduced during the conditioning phase and drying phase through the means of either a standard water ejector or a liquid ring vacuum pump. Following the drying phase, the chamber is returned to atmospheric pressure by admitting air through a 0.3-micron bacteria-retentive filter. #### Steam Source 8. Sterilizers are piped, valved, and trapped to receive building-supplied steam delivered at 50 to 80 psiq (344.7 to 551.6 kPa) dynamic. If a building steam source is not available, an electric carbon-steel steam generator or electric stainless steel steam generator may be provided to supply steam to the sterilizer. #### 9. Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB consists of a PLC control system with standard eleven pre-programmed, validated cycles to meet specific processing requirements. User access, profiles, simplified screens, cycle names, and additional options can be configured or toggled on/off easily in the user-friendly menus. All control configurations are performed through the touch screen display. Four levels of authorization come standard with increasing varying access permissions. Standard levels include default, operator, technician, and administrator. Additional levels can be custom configured. The operator has an interface with a touch screen and thermal printer which is located on the load or nonsterile end of the sterilizer. The thermal Printer located below the touch screen, provides an easy-to-read printed record of all pertinent {11}------------------------------------------------ cycle data on 2-1/4" wide paper. Data is automatically printed at the beginning and end of each cycle and at transition points during the cycle. A duplicate print can be obtained of the last cvcle run. ## Device Configurations: Below, Table 1 lists the details of the PSS11-HA and PSS11-HB models of the PRIMUS Healthcare Steam Sterilizer, along with their validated load capacity in accordance with the AAMI ST8 guidelines. # Table 1: Available Sterilizer configurations | Configuration (W x H x L) | Chamber Capacity | Model # | |------------------------------------------|-------------------------|----------| | PRIMUS Steam Sterilizer, 20" x 20" x 38" | 8.8 ft3 / 249 L | PSS11-HA | | PRIMUS Steam Sterilizer, 26" x 30" x 29" | 13.09 ft $^{3}$ / 371 L | PSS11-HB | ## Intended use / Indications for Use: The PRIMUS Healthcare Sterilizer (Models PS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer. # Factory Programmed Sterilization Cycles The PRIMUS Healthcare Sterilizers are validated on standard cycles as per AAMI standard ST8:2013. {12}------------------------------------------------ Table 2:Factory Programmed Sterilization Cycles for PRIMUS Healthcare Sterilizer Model PSS11-HA and PSS11-HB. | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | |--------------------------------------------------|------------------|--------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------|----------------------|-----------------------------------------| | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | PREVAC 1 (vac) | 270°F (132°C) | 4 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | PREVAC 2 (vac) | 275°F (135°C) | 3 min | 30 min | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Steam- Flush Pressure Pulse 1 | 270°F (132°C) | 4 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Steam- Flush Pressure Pulse 2 | 275°F (135°C) | 3 min | 30 mins | Double-wrapped instrument trays, up to 25 lb per tray | 75lb | 3 | 200lb | 8 | | | | | | Fabric packs | 1.2lb | 6 | 2.4lb | 12 | | | | | | Single Fabric Pack | 0.2lb | 1 | 0.2lb | 1 | | Immediate Use - PREVAC | 270°F (132°C) | 4 min | 1 min | Unwrapped non- porous single instrument | 25lb | 1 | 25lb | 1 | | | | | | Unwrapped non- porous instrument | 75lb | 3 | 200lb | 8 | | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | Immediate Use - Gravity (Notes 1- 3) | 270ºF (132°C) | 4 min | 1 min | Unwrapped non- porous single instrument Unwrapped non- porous instrument trays, up to 25 lb per tray | 25lb | 1 | 25lb | 1 | | | | | | | 75lb | 3 | 200lb | 8 | | Immediate Use - Gravity (Notes 1- 3) | 270ºF (132°C) | 10 min | 1 min | Unwrapped porous or non-porous single instrument Unwrapped porous & non-porous instrument trays. up to 25 lb per tray | 25lb | 1 | 25lb | 1 | | | | | | | 75lb | 3 | 200lb | 8 | | GRAVITY 1 | 250ºF (121°C) | 30 min | 30 min | Unwrapped non- porous single instrument Unwrapped non- porous instrument trays, up to 25 lb per tray | 25lb | 1 | 25lb | 1 | | | | | | | 75lb | 3 | 200lb | 8 | | GRAVITY 2 | 270ºF (132°C) | 15 min | 30 min | Unwrapped non- porous single instrument Unwrapped non- porous instrument trays, up to 25 lb per tray | 25lb | 1 | 25lb | 1 | | | | | | | 75lb | 3 | 200lb | 8 | | | Factory Settings | | | | PSS11-HA | | PSS11-HB | | | Cycle | Exp. Temp. | Exp. Time | Dry Time | Recommended Load (Note 1) | Total Load Weight | Maximum Items per Chamber Size | Total Load Weight | Maximum Items per Chamber Size | | Bowie Dick Test (vac) | 275°F (132°C) | 3.5 min | 3 min | Bowie-Dick Test Pack or equivalent (1) in an EMPTY chamber | - | 1 Test Pack | - | 1 Test Pack | | Leak Test (Note 4) | N/A | N/A | N/A | Empty chamber | N/A | N/A | N/A | N/A | {13}------------------------------------------------ {14}------------------------------------------------ # TABLE NOTES - 1. Load configurations during testing validations follow ANSI/AAMI ST8:2013 standard for Hospital Steam Sterilizers where applicable. All fabric packs and instrument trays are constructed as described in ANSI/AAMI ST8. For guidance on loading the sterilizer, refer to ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities. - 2. At the end of an immediate use or express cycle items may NOT be dry. - 3. The recommended exposure time and temperature for unwrapped, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C). - 4. Vacuum leak test parameters are not adjustable. The cycle run for leak test includes 15 minutes of dry cycle, 5 min for equalization within the chamber and 15 mins for the leak test run. {15}------------------------------------------------ # Technological Characteristics Comparison PRIMUS Healthcare Sterilizer (Model PSS11-HC), previously cleared under K221474, has been selected as the predicate device for this submission for the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB). The detailed comparison between the subject device and the predicate device is provided in the table below: | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | PRIMUS Healthcare Sterilizer (Models PSS11- HA and PSS11-HB) | PRIMUS Healthcare Sterilizer (Model PSS11- HC) | Not Applicable | | Manufacturer | PRIMUS Sterilizer Company, LLC | PRIMUS Sterilizer Company, LLC | Not Applicable | | Regulation Number | 880.6880 | 880.6880 | Identical | | Product Code | FLE | FLE | Identical | | Product Class | II | II | Identical | | Intended Use / Indications for Use | The PRIMUS Healthcare Sterilizer (Models PSS11- HA and PSS11- HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non- porous and porous, heat and moisture stable materials. The sterilizer | The PRIMUS Healthcare Sterilizer (Model PSS11- HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non- porous and porous, heat and moisture stable materials. The sterilizer can be used on various | Identical | | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | | | can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer | materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer. | | | Operating Principle | Steam is the sterilizing agent | Steam is the sterilizing agent. | Identical | | Sterilization Cycles Offered | All models are offered with: Prevac, Gravity, SFPP, Immediate Use, Leak test | All models are offered with: Prevac, Gravity, SFPP, Immediate Use, Leak test | Identical | | Sterilization Cycle Parameters | • Prevac (VAC) cycle: • Prevac 1 -Exposure for 4 minutes at 132°C • Prevac 2 -Exposure for 3 minutes at 135°C Immediate Use (Prevac): • Exposure for 4 minutes at 132°C | • Prevac (VAC) cycle: • Prevac 1 -Exposure for 4 minutes at 132°C • Prevac 2 -Exposure for 3 minutes at 135°C Immediate Use (Prevac): • Exposure for 4 minutes at 132°C | Identical | | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | | | Immediate Use – Gravity: • Exposure for 4 minutes at 132°C • Exposure for 10 minutes at 132°C | Immediate Use – Gravity: • Exposure for 4 minutes at 132°C • Exposure for 10 minutes at 132°C | Identical | | | Gravity: • Gravity 1 - Exposure for 30 minutes at 121°C • Gravity 2 - Exposure for 15 minutes at 132°C | Gravity: • Gravity 1 - Exposure for 30 minutes at 121°C • Gravity 2 - Exposure for 15 minutes at 132°C | Identical | | | Steam-Flush Pressure Pulse (SFPP): • SFPP 1 - Exposure for 4 minutes at 132°C • SFPP 2 - Exposure for 3 minutes at 135°C | Steam-Flush Pressure Pulse (SFPP): • SFPP 1 - Exposure for 4 minutes at 132°C • SFPP 2 - Exposure for 3 minutes at 135°C | Identical | | | Bowie Dick Test (DART): • Exposure for 3.5 minutes at 132°C | Bowie Dick Test (DART): • Exposure for 3.5 minutes at 132°C | Identical | | Sterility Assurance Level (SAL) | 10-6 | 10-6 | Identical | | Chamber Sizes | PSS11-HA: 20" x 20" x 38" PSS11-HB: 26" x 30" x 29" | 26" x 30" x 41" | The volume of the chamber for the subject devices are lower when compared to the volume of the Predicate device. | | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | | | | | However, the subject devices are validated with ST8, and the device passed the test. Hence, this does not raise any concerns related to the safety and efficacy of the device. | | Chamber Door | Type 316L Stainless-steel Vertical Sliding | Type 316L Stainless-steel Vertical Sliding | Identical | | Instrument tray load | 25 lbs each tray | 25 lbs each tray | Identical | | Fabric pack | 25 lbs | 25 lbs | Identical | | Control Technology | PLC Controller (Idec FC6A Micro system & Allen Bradley CompactLogix system), Touch Screen, 800 x 600 Pixel Display, Ink on Paper Impact Printer, Ethernet printing & PRI-SND | PLC Controller (Idec FC6A Micro system & Allen Bradley CompactLogix system), Touch Screen, 800 x 600 Pixel Display, Ink on Paper Impact Printer, Ethernet printing & PRI-SND | Identical | | Printer technology | Thermal printer (Ink-on- paper impact printer) | Thermal printer (Ink-on- paper impact printer) | Identical | | Factory Programmed Sterilization Cycles | 11 pre-programmed cycles | 11 pre-programmed cycles | Identical. | | Safety Devices | • Emergency Stop Button | • Emergency Stop Button | Identical | | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | | | • Pressure Relief Valve • Door and Gasket Safety Switch • Door interlocks (double door units only) | • Pressure Relief Valve • Door and Gasket Safety Switch • Door interlocks (double door units only) | | | Built according to Standard | ANSI/AAMI ST8:2013/(R) 2018 Hospital Steam Sterilizers | ANSI/AAMI ST8:2013/(R) 2018 Hospital Steam Sterilizers | Identical | | Electrical Safety Standard | UL 61010-1:2012 (Ed.3+R:29 April 2016), UL 61010-2-040:2016 (Ed.2), (R2017) CSA C22.2#61010-1-12:2012 Ed.3+U1;U2, CSA C22.2#61010-2- 040:2016 Ed.2 | UL 61010-1:2012 (Ed.3+R:29 April 2016), UL 61010-2-040:2016 (Ed.2), (R2017) CSA C22.2#61010-1-12:2012 Ed.3+U1;U2, CSA C22.2#61010-2- 040:2016 Ed.2 | Identical | | Safety Valves | ASME Approved | ASME Approved | Identical | | Pressure Vessels | ASME Certified | ASME Certified | Identical | | Power boilers | ASME Code, Section I, Part PMB | ASME Code, Section I, Part PMB | Identical | | Chamber pressure | 45 psig | 45 psig | Identical | | Air filter | 0.3 micron (optional 0.2 micron) | 0.3 micron (optional 0.2 micron) | Identical | | Electrical supply | Volts: 110 Phase: Single Amps: 10 | Volts: 110 Phase: Single Amps: 10 | Identical | | Comparable Properties | Subject Device | Predicate Device (K221474) | Comparison Results | | Steam Source pressure | 50 to 80 psig Dynamic | 50 to 80 psig Dynamic | Identical | | Water Pressure | 50 to 70 psig Dynamic | 50 to 70 psig Dynamic | Identical | | Air Pressure | 60 to 80 psig Dynamic | 60 to 80 psig Dynamic | Identical | | Piping construction material | Brass | Brass | Identical…

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!