(83 days)
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.
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 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:
- Jacket Assembly (sterilizer vessel)
- Chamber Finish
- Chamber Door
- Insulation
- Chamber Drain System
- Drain Water Quench (Piping System)
- Vacuum system
- Steam Source
- 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 provided document describes the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) and its non-clinical testing to demonstrate substantial equivalence to a predicate device (PRIMUS Healthcare Sterilizer, Model PSS11-HC, K221474).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Electrical Safety | To ensure that the device and its components meet the electrical safety requirements | Compliance with standard specification UL 61010-1:2012 Ed.3+R:29 Apr 2016 and UL 61010-2-040:2016 | Pass |
| EMC | To verify that the device meets EMC requirements | Compliance with IEC 60601-1-2 ed 4.0 (2014-02) | Pass |
| Low-voltage switchgear and control gear assemblies | To verify that the low voltage switchgear and control gear assemblies meets the standard requirement. | Compliance with IEC 61439-2 Low-voltage switchgear and control gear assemblies - Part 2: Power switchgear and control gear assemblies | Pass |
| Pressure Vessel Testing | To verify that the pressure vessel used for the Steam sterilizer meets the requirements for pressure vessel and is safe for use. | Compliance with standard ASME Boiler and pressure vessel code, Section VIII division 1 | Pass |
| Control panel | To verify the control panel meets the requirement of UL 508A:2013 | Compliance with standard Industrial Control Panels UL 508A:2013 | Pass |
| Performance testing | To verify that all the cycles in the PRIMUS healthcare steam sterilizer meets the performance criteria defined in ANSI/AAMI/ST8 | Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018) | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify general "samples" in terms of number of devices for these tests. Instead, it states that the performance testing was conducted on "all the cycles in the PRIMUS healthcare steam sterilizer." This implies that the tests were performed on the device models (PSS11-HA and PSS11-HB) and their defined sterilization cycles as per the standards.
The document indicates "Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors." It does not provide information on the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "ground truth" for a medical device like a sterilizer is typically established by recognized national and international standards (e.g., ANSI/AAMI ST8, ASME codes, IEC standards) and their specified testing methodologies, rather than expert consensus on individual cases. The tests described are engineering and performance validation tests against these established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective human assessment of diagnostic output, particularly for AI/machine learning devices. The document concerns a steam sterilizer, and the tests are objective engineering and performance validations against predefined standards.
5. 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 information is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a steam sterilizer, not an algorithm, and its performance is assessed directly, not through an algorithm in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the PRIMUS Healthcare Sterilizer is based on compliance with established national and international standards. Specifically, for performance testing, it is "Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018)." Other ground truths are compliance with relevant electrical safety (UL, CSA), EMC (IEC), control panel (UL), and pressure vessel (ASME) standards.
8. The sample size for the training set
This information is not applicable. The device is a hardware sterilizer, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
{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 | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| PREVAC1 (vac) | 270°F(132°C) | 4min | 30mins | Double-wrappedinstrument 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 | ||||
| PREVAC2 (vac) | 275°F(135°C) | 3min | 30min | Double-wrappedinstrument 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-FlushPressure | 270°F(132°C) | 4min | 30mins | Double-wrappedinstrument 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-FlushPressure | 275°F(135°C) | 3min | 30mins | Double-wrappedinstrument 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 | ||||
| ImmediateUse -PREVAC | 270°F(132°C) | 4min | 1min | Unwrapped non-porous singleinstrument | 25lb | 1 | 25lb | 1 |
| Factory Settings | PSS11-HA | PSS11-HB | ||||||
| Cycle | Exp.Temp. | Exp.Time | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| ImmediateUse -Gravity(Notes 1-3) | 270°F(132°C) | 4 min | 1min | Unwrapped non-porous instrumenttrays, up to 25 lbper tray | 75lb | 3 | 200lb | 8 |
| ImmediateUse -Gravity(Notes 1-3) | 270°F(132°C) | 4min | 1min | Unwrapped non-porous singleinstrument | 25lb | 1 | 25lb | 1 |
| ImmediateUse -Gravity(Notes 1-3) | 270°F(132°C) | 4min | 1min | Unwrapped non-porous instrumenttrays, up to 25 lbper tray | 75lb | 3 | 200lb | 8 |
| ImmediateUse -Gravity(Notes 1-3) | 270°F(132°C) | 10min | 1min | Unwrapped porousor non-poroussingle instrument | 25lb | 1 | 25lb | 1 |
| ImmediateUse -Gravity(Notes 1-3) | 270°F(132°C) | 10min | 1min | Unwrapped porous& non-porousinstrument trays.up to 25 lb per tray | 75lb | 3 | 200lb | 8 |
| GRAVITY1 | 250°F(121°C) | 30min | 30min | Unwrapped non-porous singleinstrument | 25lb | 1 | 25lb | 1 |
| GRAVITY1 | 250°F(121°C) | 30min | 30min | Unwrapped non-porous instrumenttrays, up to 25 lbper tray | 75lb | 3 | 200lb | 8 |
| GRAVITY2 | 270°F(132°C) | 15min | 30min | Unwrapped non-porous singleinstrument | 25lb | 1 | 25lb | 1 |
| Factory Settings | PSS11-HA | PSS11-HB | ||||||
| Cycle | Exp.Temp. | Exp.Time | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| Unwrapped non-porous instrumenttrays, up to 25 lbper tray | 75lb | 3 | 200lb | 8 | ||||
| BowieDick Test(vac) | 275°F(132°C) | 3.5min | 3min | Bowie-Dick TestPack or equivalent(1) in an EMPTYchamber | - | 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
-
- 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.
-
- At the end of an immediate use or express cycle items may NOT be dry.
-
- 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).
-
- 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, PEVP EngineeringPRIMUS Sterilizer Company, LLC7936 Forest City RoadSuite 100 Orlando, fl 32810Telephone No.: +1-402-3444200-1214Fax No.: +1-402-344-4242Email: phansen@spire-is.com |
| 510(k) Contact Person: | Ankur NaikManaging DirectorIZiel HealthcarePentagon P1, Office No. 601 and 604, MagarpattaCity, Hadapsar, Pune 411028, Maharashtra, India.P: +91 72762 12555 M: +91 7069553814Email: 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 880.6880Regulation Name: Steam SterilizationRegulatory Class: IIProduct Code: FLEReview 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 | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| PREVAC1 (vac) | 270°F(132°C) | 4min | 30mins | Double-wrappedinstrument 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 | ||||
| PREVAC2 (vac) | 275°F(135°C) | 3min | 30min | Double-wrappedinstrument 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-FlushPressurePulse 1 | 270°F(132°C) | 4min | 30mins | Double-wrappedinstrument 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-FlushPressurePulse 2 | 275°F(135°C) | 3min | 30mins | Double-wrappedinstrument 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 | ||||
| ImmediateUse -PREVAC | 270°F(132°C) | 4min | 1min | Unwrapped non-porous singleinstrument | 25lb | 1 | 25lb | 1 |
| Unwrapped non-porous instrument | 75lb | 3 | 200lb | 8 | ||||
| Factory Settings | PSS11-HA | PSS11-HB | ||||||
| Cycle | Exp.Temp. | Exp.Time | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| ImmediateUse -Gravity(Notes 1-3) | 270ºF(132°C) | 4min | 1min | Unwrapped non-porous singleinstrumentUnwrapped non-porous instrumenttrays, up to 25 lbper tray | 25lb | 1 | 25lb | 1 |
| 75lb | 3 | 200lb | 8 | |||||
| ImmediateUse -Gravity(Notes 1-3) | 270ºF(132°C) | 10min | 1min | Unwrapped porousor non-poroussingle instrumentUnwrapped porous& non-porousinstrument trays.up to 25 lb per tray | 25lb | 1 | 25lb | 1 |
| 75lb | 3 | 200lb | 8 | |||||
| GRAVITY1 | 250ºF(121°C) | 30min | 30min | Unwrapped non-porous singleinstrumentUnwrapped non-porous instrumenttrays, up to 25 lbper tray | 25lb | 1 | 25lb | 1 |
| 75lb | 3 | 200lb | 8 | |||||
| GRAVITY2 | 270ºF(132°C) | 15min | 30min | Unwrapped non-porous singleinstrumentUnwrapped non-porous instrumenttrays, up to 25 lbper tray | 25lb | 1 | 25lb | 1 |
| 75lb | 3 | 200lb | 8 | |||||
| Factory Settings | PSS11-HA | PSS11-HB | ||||||
| Cycle | Exp.Temp. | Exp.Time | DryTime | RecommendedLoad(Note 1) | Total LoadWeight | MaximumItems perChamber Size | Total LoadWeight | MaximumItems perChamberSize |
| BowieDick Test(vac) | 275°F(132°C) | 3.5min | 3min | Bowie-Dick TestPack or equivalent(1) in an EMPTYchamber | - | 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
-
- 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.
-
- At the end of an immediate use or express cycle items may NOT be dry.
-
- The recommended exposure time and temperature for unwrapped, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C).
-
- 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 HealthcareSterilizer (Models PSS11-HA and PSS11-HB) | PRIMUS HealthcareSterilizer (Model PSS11-HC) | Not Applicable |
| Manufacturer | PRIMUS SterilizerCompany, LLC | PRIMUS SterilizerCompany, LLC | Not Applicable |
| Regulation Number | 880.6880 | 880.6880 | Identical |
| Product Code | FLE | FLE | Identical |
| Product Class | II | II | Identical |
| Intended Use / Indicationsfor Use | The PRIMUS HealthcareSterilizer (Models PSS11-HA and PSS11- HB) isdesigned for use insurgery, central sterile, andsurgery centers. ThePRIMUS HealthcareSterilizer provides efficientsteam sterilization of non-porous and porous, heatand moisture stablematerials. The sterilizer | The PRIMUS HealthcareSterilizer (Model PSS11-HC) is designed for use insurgery, central sterile, andsurgery centers. ThePRIMUS HealthcareSterilizer provides efficientsteam sterilization of non-porous and porous, heatand moisture stablematerials. The sterilizercan be used on various | Identical |
| Comparable Properties | Subject Device | Predicate Device(K221474) | Comparison Results |
| can be used on variousmaterials that withstandoperating temperatures;however, the materials thatcannot withstand operatingtemperatures should notbe sterilized using thePRIMUS HealthcareSterilizer | materials that withstandoperating temperatures;however, the materials thatcannot withstand operatingtemperatures should notbe sterilized using thePRIMUS HealthcareSterilizer. | ||
| Operating Principle | Steam is the sterilizingagent | Steam is the sterilizingagent. | Identical |
| Sterilization Cycles Offered | All models are offered with:Prevac,Gravity,SFPP,ImmediateUse,Leak test | All models are offered with:Prevac,Gravity,SFPP,ImmediateUse,Leak test | Identical |
| Sterilization CycleParameters | • Prevac (VAC) cycle:• Prevac 1 -Exposure for4 minutes at 132°C• Prevac 2 -Exposure for3 minutes at 135°CImmediate Use (Prevac):• Exposure for 4 minutesat 132°C | • Prevac (VAC) cycle:• Prevac 1 -Exposure for4 minutes at 132°C• Prevac 2 -Exposure for3 minutes at 135°CImmediate Use (Prevac):• Exposure for 4 minutesat 132°C | Identical |
| Comparable Properties | Subject Device | Predicate Device(K221474) | Comparison Results |
| Immediate Use – Gravity:• Exposure for 4 minutesat 132°C• Exposure for 10 minutesat 132°C | Immediate Use – Gravity:• Exposure for 4 minutesat 132°C• Exposure for 10 minutesat 132°C | Identical | |
| Gravity:• Gravity 1 - Exposure for30 minutes at 121°C• Gravity 2 - Exposure for15 minutes at 132°C | Gravity:• Gravity 1 - Exposure for30 minutes at 121°C• Gravity 2 - Exposure for15 minutes at 132°C | Identical | |
| Steam-Flush PressurePulse (SFPP):• SFPP 1 - Exposure for 4minutes at 132°C• SFPP 2 - Exposure for 3minutes at 135°C | Steam-Flush PressurePulse (SFPP):• SFPP 1 - Exposure for 4minutes at 132°C• SFPP 2 - Exposure for 3minutes at 135°C | Identical | |
| Bowie Dick Test (DART):• Exposure for 3.5minutes at 132°C | Bowie Dick Test (DART):• Exposure for 3.5minutes 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 thechamber for the subjectdevices are lower whencompared to the volume ofthe 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-steelVertical Sliding | Type 316L Stainless-steelVertical 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 FC6AMicro system & AllenBradley CompactLogixsystem),Touch Screen,800 x 600 Pixel Display,Ink on Paper ImpactPrinter, Ethernet printing &PRI-SND | PLC Controller (Idec FC6AMicro system & AllenBradley CompactLogixsystem),Touch Screen,800 x 600 Pixel Display,Ink on Paper ImpactPrinter, Ethernet printing &PRI-SND | Identical |
| Printer technology | Thermal printer (Ink-on-paper impact printer) | Thermal printer (Ink-on-paper impact printer) | Identical |
| Factory ProgrammedSterilization Cycles | 11 pre-programmed cycles | 11 pre-programmed cycles | Identical. |
| Safety Devices | • Emergency StopButton | • Emergency StopButton | Identical |
| Comparable Properties | Subject Device | Predicate Device(K221474) | Comparison Results |
| • Pressure Relief Valve• Door and GasketSafety Switch• Door interlocks(double door unitsonly) | • Pressure Relief Valve• Door and GasketSafety Switch• Door interlocks(double door unitsonly) | ||
| Built according to Standard | ANSI/AAMI ST8:2013/(R)2018 Hospital SteamSterilizers | ANSI/AAMI ST8:2013/(R)2018 Hospital SteamSterilizers | Identical |
| Electrical Safety Standard | UL 61010-1:2012(Ed.3+R:29 April 2016),UL 61010-2-040:2016(Ed.2),(R2017) CSAC22.2#61010-1-12:2012Ed.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) CSAC22.2#61010-1-12:2012Ed.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 0.2micron) | 0.3 micron (optional 0.2micron) | Identical |
| Electrical supply | Volts: 110Phase: SingleAmps: 10 | Volts: 110Phase: SingleAmps: 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 constructionmaterial | Brass | Brass | Identical |
| Fitting material | Copper | Copper | Identical |
Table 3: Technological Characteristics Comparison
{16}------------------------------------------------
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
{20}------------------------------------------------
{21}------------------------------------------------
Summary of non-clinical testing
PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) complies with the requirements of FDA Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities and the subject device performance test demonstrates that it meets the acceptance criteria of the test methods described below:
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Electrical Safety | To ensure thatthe device andits componentsmeet theelectrical safetyrequirements | Compliance with meetingstandard specification UL61010-1:2012 Ed.3+R:29 Apr2016 and UL 61010-2-040:2016 | Pass |
| EMC | To verify thatthe devicemeets EMCrequirements | Compliance with IEC 60601-1-2 ed 4.0 (2014-02) | Pass |
| Low-voltageswitchgear andcontrol gearassemblies | To verify thatthe low voltageswitchgear andcontrol gearassembliesmeets thestandardrequirement. | Compliance with IEC 61439-2Low-voltage switchgear andcontrol gear assemblies -Part 2: Power switchgear andcontrol gear assemblies | Pass |
| Pressure VesselTesting | To verify thatthe pressurevessel used forthe Steamsterilizer meetstherequirements forpressure vessel | Compliance with standardASME Boiler and pressurevessel code, Section VIIIdivision 1 | Pass |
| TestMethodology | Purpose | Acceptance Criteria | Results |
| and is safe foruse. | |||
| Control panel | To verify thecontrol panelmeets therequirement ofUL 508A:2013 | Compliance with standardIndustrial Control Panels UL508A:2013 | Pass |
| Performancetesting | To verify that allthe cycles in thePRIMUShealthcaresteam sterilizermeets theperformancecriteria definedinANSI/AAMI/ST8 | Compliance to performancerequirements defined inANSI/AAMI/ST8:2013(R2018) | Pass |
{22}------------------------------------------------
The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks after risk control measures.
Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors.
The PRIMUS Healthcare Sterilizer complies with the following standards:
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ANSI AAMI ST8:2013/(R)2018 - Hospital Steam Sterilizers
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life ● cycle processes [Including Amendment 1 (2016)]
- ASME Section VIII: BPVC Section VIII-Rules for Construction of Pressure Vessels Division 1
- UL 61010-2-040 Ed. 2-2016 Safety Requirements For Electrical Equipment ● For Measurement, Control, And Laboratory Use - Part 2-040: Particular
{23}------------------------------------------------
Requirements For Sterilizers And Washer-Disinfectors Used To Treat Medical Materials
- UL 61010-1 UL Standard for Safety Electrical Equipment For Measurement, . Control, and Laboratory Use; Part 1: General Requirements
- . NFPA 70, National Electrical Code (NEC) is the benchmark for safe electrical design, installation, and inspection to protect people and property from electrical hazards.
- CSA C22.2 NO. 61010-2-040:21 Safety requirements for electrical equipment . for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (Adopted IEC 61010-2-040:2020, third edition, 2020-05, with Canadian deviations)
- Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in . Health Care Facilities
- IEC 61439-2:2020 Low-voltage switchgear and control gear assemblies - Part 2: Power switchgear and control gear assemblies
- ISO 14971:2019 Medical devices Application of risk management to medical ● devices
- ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -● Information to be supplied by the manufacturer.
- ISO 15223-1 Fourth edition 2021-07 Medical devices Symbols to be used ● with information to be supplied by the manufacturer - Part 1: General requirements information to be supplied - Part 1: General requirements.
- UL 508A, Edition 3 Industrial Control Panels ●
Summary of Clinical Testing
Clinical studies are not required for the PRIMUS Healthcare Sterilizer (Models PS11-HA and PSS11-HB).
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, effective, and performs as well as the legally marketed predicate device PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474).
§ 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).