PRIMUS Healthcare Sterilizer (Model PSS11-HC)

K221474 · Primus Sterilizer Company, LLC · FLE · Feb 10, 2023 · General Hospital

Device Facts

• Record ID: K221474
• Device Name: PRIMUS Healthcare Sterilizer (Model PSS11-HC)
• Applicant: Primus Sterilizer Company, LLC
• Product Code: FLE · General Hospital
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

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 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 healthcare facilities; uses pressurized steam to sterilize non-porous and porous, heat/moisture-stable medical materials. Features 316L stainless steel chamber, jacket, and door; vertical sliding door with silicone gasket; vacuum system (water ejector or liquid ring pump); and PLC-based control system. Operated via touch screen; provides thermal printer records. Used in surgery/central sterile departments. Benefits patient by ensuring sterility of medical instruments. Integrates safety features: emergency stop, pressure relief valves, door interlocks, and drain water quench system. Validated cycles include Prevac, Gravity, Steam-Flush Pressure Pulse (SFPP), and leak tests. Complies with ANSI/AAMI ST8:2013.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ANSI/AAMI ST8:2013 requirements for steam sterilizers, including electrical safety (UL 61010-1/2-040), EMC (IEC 60601-1-2), and pressure vessel integrity (ASME Section VIII).

Technological Characteristics

Materials: 316L/304 stainless steel chamber/jacket. Principle: Steam sterilization. Energy: Building steam or electric generator. Dimensions: 26"x30"x41". Connectivity: Ethernet printing. Sterilization: Pressurized steam. Software: PLC-based (Idec FC6A/Allen Bradley CompactLogix). Standards: ANSI/AAMI ST8:2013, ASME Section VIII, UL 61010-1/2-040, IEC 61439-2.

Indications for Use

Indicated for sterilization of non-porous and porous, heat and moisture stable 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 PSS8 Steam Sterilizer Series (K093333)
• AMSCO CHIMERON Small Steam Sterilizer (K111223)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 10, 2023

PRIMUS Sterilizer Company, LLC % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 India

Re: K221474

Trade/Device Name: PRIMUS Healthcare Sterilizer (Model PSS11-HC) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 12, 2023 Received: January 12, 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray III -S

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K221474

Device Name

PRIMUS Healthcare Sterilizer (Model PSS11-HC)

#### Indications for Use (Describe)

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 moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures 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 ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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| Cycle | Factory Settings | | | Recommended Load<br>(Note 1) | Total Load<br>Weight | Maximum<br>Items per<br>Chamber Size |
|-------------------------------------------|------------------|--------------|-------------|----------------------------------------------------------------------------|----------------------|--------------------------------------|
| | Exp. Temp. | Exp.<br>Time | Dry<br>Time | | | HC |
| PREVAC 1<br>(vac) | 270°F<br>(132°C) | 4 min | 30 mins | Double-wrapped instrument<br>trays, up to 25 lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| PREVAC 2<br>(vac) | 275°F<br>(135°C) | 3 min | 30 min | Double-wrapped instrument<br>trays, up to 25 lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Steam-Flush<br>Pressure | 270°F<br>(132°C) | 4 min | 30 mins | Double-wrapped instrument<br>trays, up to 25 lb per tray | 225lb | 9 |
| Pulse 1 | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Steam-Flush<br>Pressure | 275°F<br>(135°C) | 3 min | 30 mins | Double-wrapped instrument<br>trays, up to 25 lb per tray | 225lb | 9 |
| Pulse 2 | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Immediate<br>Use -<br>PREVAC | 270°F<br>(132°C) | 4 min | 1 min | Unwrapped non-porous single<br>instrument | 25lb | 1 |
| | | | | Unwrapped non-porous<br>instrument trays, up to 25 lb per<br>tray | 25lb | 1 |
| Immediate<br>Use - Gravity<br>(Notes 1-3) | 270°F<br>(132°C) | 4 min | 1 min | Unwrapped non-porous single<br>instrument | 25lb | 1 |
| | | | | Unwrapped non-porous<br>instrument trays, up to 25 lb per<br>tray | 25lb | 1 |
| Cycle | Factory Settings | | | Recommended Load<br>(Note 1) | Total Load<br>Weight | Maximum<br>Items per<br>Chamber Size |
| | Exp. Temp. | Exp.<br>Time | Dry<br>Time | | | HC |
| Immediate<br>Use - Gravity<br>(Notes 1-3) | 270°F<br>(132°C) | 10 min | 1 min | Unwrapped porous or non-<br>porous single instrument | 25lb | 1 |
| | | | | Unwrapped porous & non-porous<br>instrument trays. up to 25 lb per<br>tray | 25lb | 1 |
| GRAVITY 1 | 250°F<br>(121°C) | 30 min | 30 min | Double Wrapped instrument trays | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| GRAVITY 2 | 270°F<br>(132°C) | 15 min | 30 min | Double Wrapped instrument trays | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| Bowie Dick<br>Test (vac) | 275°F<br>(132°C) | 3.5 min | 3 min | Bowie-Dick Test Pack or<br>equivalent (1) in an EMPTY<br>chamber | - | 1 Test Pack |
| Leak Test<br>(Note 4) | N/A | N/A | N/A | Empty chamber | N/A | N/A |

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### PRIMUS Healthcare Sterilizer Abbreviated 510(k): Premarket Notification

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#### 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.

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## 510(k) SUMMARY – K221474

510(k) summary for PRIMUS Healthcare Sterilizer is provided in accordance with 21 CFR 807.92.

| Date: | 10 February, 2023 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter (Owner): | Patrick Hansen, PE<br>VP Engineering<br>PRIMUS Sterilizer Company, LLC<br>9736 Forest City Road<br>Suite 100 Orlando, fl 32810<br>Telephone No.: [phone]<br>Fax No.: [phone]<br>Email: [e-mail] |
| 510(k) Contact Person: | Ankur Naik<br>Managing Director<br>IZiel Healthcare<br>14, Hadapsar Industrial Estate<br>Hadapsar, Pune – 411013, India.<br>P: [phone]<br>M: [phone]<br>Email: [e-mail] |
| Device Trade Name: | PRIMUS Healthcare Sterilizer (Model PSS11-HC) |
| Regulation Number: | 880.6880 |
| Regulation Description: | A steam sterilizer (autoclave) is a device that is<br>intended for use by a health care provider to sterilize<br>medical products by means of pressurized steam. |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Product Code: | FLE |
| Predicate Device: | 1. PRIMUS PSS8 Steam Sterilizer Series<br>(K093333)<br>Regulation number: 21 CFR 880.6880<br>Regulation Name: Steam Sterilization<br>Regulatory Class: II<br>Product Code: FLE<br>Review panel: General Hospital<br>2. AMSCO CHIMERON Small Steam Sterilizer<br>(K111223)<br>Regulation number: 21 CFR 880.6880<br>Regulation Name: Steam Sterilization<br>Regulatory Class: II<br>Product Code: FLE<br>Review panel: General Hospital |

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### Device Description:

PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer 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 Series 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.

#### Chamber Finish 2.

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.

#### Chamber Door 3.

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.

#### ব Insulation

Superior heat loss reduction is achieved with one-inch fiberglass insulation overlaid with 0.05-inch aluminum sheet metal.

#### Chamber Drain System 5.

Drain system is designed to prevent pollutants from entering into the water-supply system and sterilizer

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#### 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:

The PRIMUS Healthcare Sterilizer 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 confiqured.

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 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 cycle run.

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#### Device Configurations:

Table 1 below lists the details of PRIMUS Healthcare Sterilizer with validated load capacity in compliance with AAMI ST8 guidelines.

### Table 1: Available Sterilizer configurations

| Configuration (W x H x L) | Chamber Capacity | Model # |
|--------------------------------------|-------------------|----------|
| PRIMUS Steam Sterilizer, 26"x30"x41" | 18.51 ft3 / 626 L | PSS11-HC |

#### Intended use / Indications for Use:

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 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.

| Cycle | Factory Settings | | | Recommended<br>Load<br>(Note 1) | Total<br>Load<br>weight | Maximum<br>Items per<br>Chamber<br>Size |
|--------------------------------------------------|------------------|--------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------|
| | Exp.<br>Temp. | Exp.<br>Time | Dry<br>Time | | | HC |
| PREVAC<br>1 (vac) | 270°F<br>(132°C) | 4<br>min | 30<br>mins | Double-<br>wrapped<br>instrument<br>trays, up to 25<br>lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric<br>Pack | 0.2lb | 1 |
| PREVAC<br>2 (vac) | 275°F<br>(135°C) | 3<br>min | 30<br>min | Double-<br>wrapped<br>instrument<br>trays, up to 25<br>lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| Cycle | Factory Settings | | | Recommended<br>Load<br>(Note 1) | Total<br>Load<br>weight | Maximum<br>Items per<br>Chamber<br>Size |
| | Exp.<br>Temp. | Exp.<br>Time | Dry<br>Time | | | HC |
| Steam-<br>Flush<br>Pressure<br>Pulse 1 | 270°F<br>(132°C) | 4<br>min | 30<br>mins | Single Fabric<br>Pack | 0.2lb | 1 |
| | | | | Double-<br>wrapped<br>instrument<br>trays, up to 25<br>lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric<br>Pack | 0.2lb | 1 |
| Steam-<br>Flush<br>Pressure<br>Pulse 2 | 275°F<br>(135°C) | 3<br>min | 30<br>mins | Double-<br>wrapped<br>instrument<br>trays, up to 25<br>lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric<br>Pack | 0.2lb | 1 |
| Immediate<br>Use -<br>PREVAC | 270°F<br>(132°C) | 4<br>min | 1<br>min | Unwrapped<br>non-porous<br>single<br>instrument | 25lb | 1 |
| | | | | Unwrapped<br>non-porous<br>instrument<br>trays, up to 25<br>lb per tray | 25lb | 1 |
| Immediate<br>Use -<br>Gravity<br>(Notes 1-<br>3) | 270°F<br>(132°C) | 4<br>min | 1<br>min | Unwrapped<br>non-porous<br>single<br>instrument | 25lb | 1 |
| | | | | Unwrapped<br>non-porous<br>instrument<br>trays, up to 25<br>lb per tray | 25lb | 1 |
| Cycle | Factory Settings | | | Recommended<br>Load<br>(Note 1) | Total<br>Load<br>weight | Maximum<br>Items per<br>Chamber<br>Size |
| | Exp.<br>Temp. | Exp.<br>Time | Dry<br>Time | | | HC |
| Immediate<br>Use -<br>Gravity<br>(Notes 1-3) | 270°F<br>(132°C) | 10<br>min | 1<br>min | Unwrapped<br>porous or non-<br>porous single<br>instrument<br>Unwrapped<br>porous & non-<br>porous<br>instrument<br>trays. up to 25<br>lb per tray | 25lb<br>25lb | 1<br>1 |
| GRAVITY<br>1 | 250°F<br>(121°C) | 30<br>min | 30<br>min | Double<br>Wrapped<br>instrument trays<br>Fabric packs | 225lb<br>3lb | 9<br>17 |
| GRAVITY<br>2 | 270°F<br>(132°C) | 15<br>min | 30<br>min | Double<br>Wrapped<br>instrument trays<br>Fabric packs | 225lb<br>3lb | 9<br>17 |
| Bowie<br>Dick Test<br>(vac) | 275°F<br>(132°C) | 3.5<br>min | 3<br>min | Bowie-Dick<br>Test Pack or<br>equivalent (1) in<br>an EMPTY<br>chamber | | 1 Test Pack |
| Leak Test<br>(Note 4) | N/A | N/A | N/A | Empty chamber | | N/A |

#### Table 2: Factory Programmed Sterilization Cycles for PRIMUS Healthcare Sterilizer

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#### 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 travs are constructed as described in ANSI/AAMI ST8. For quidance 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.

#### Comparison to Predicate Devices

Two predicate devices are selected in this submission for the PRIMUS Healthcare Sterilizer.

Predicate device 1: PRIMUS PSS8 Steam Sterilizer Series (K093333)

Predicate device 2: Amsco Chimeron Small Steam Sterilizer (K111223)

The details of the comparison between the subject device and predicate devices are provided below:

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| Comparable<br>Properties | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) | Comparison Results |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | PRIMUS Healthcare<br>Sterilizer | PRIMUS Steam<br>Sterilizers | Amsco Chimeron<br>Small Steam Sterilizer | Not Applicable |
| Manufacturer | PRIMUS Sterilizer<br>Company, LLC | PRIMUS Sterilizer<br>Company, LLC | Steris Healthcare | Not Applicable |
| Regulation Number | 880.6880 | 880.6880 | 880.6880 | Identical |
| Product Code | FLE | FLE | FLE | Identical |
| Product Class | II | II | II | Identical |
| Intended Use /<br>Indications for Use | The PRIMUS<br>Healthcare Sterilizer<br>model HC is designed<br>for use in surgery,<br>central sterile, and<br>surgery centers. The<br>PRIMUS Healthcare<br>Sterilizer provides<br>efficient steam<br>sterilization of non-<br>porous and porous,<br>heat and moisture<br>stable materials. The<br>sterilizer can be used<br>on various materials<br>that withstand<br>operating<br>temperatures; | The PRIMUS PSS8<br>Steam Sterilizer<br>Series are designed<br>for use in the hospital<br>operating suites,<br>central sterile supply<br>and clinical<br>laboratories. The<br>PRIMUS PSS8<br>Steam Sterilizer<br>Series provide<br>efficient steam<br>sterilization of non-<br>porous and porous,<br>heat and moisture<br>stable materials. | Amsco Chimeron<br>Small Steam Sterilizer<br>models 16, 16C,<br>16CS, 16S, 20, 20C,<br>20CS and 20S are<br>designed for<br>sterilization of heat<br>and moisture-stable<br>materials in<br>healthcare facilities. | Identical |
| Comparable<br>Properties | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) | Comparison Results |
| | materials that cannot<br>withstand operating<br>temperatures should<br>not be sterilized using<br>the PRIMUS<br>Healthcare Sterilizer. | | | |
| Operating Principle | Steam is the<br>sterilizing agent. | Steam is the<br>sterilizing agent. | Steam is the<br>sterilizing agent. | Identical |
| Sterilization Cycles<br>Offered | Model is offered with:<br>Prevac,<br>Gravity,<br>SFPP,<br>Leak test | All models are offered<br>with:<br>Vacuum,<br>Gravity,<br>Liquids,<br>Test (Vac) | Prevac,<br>Gravity,<br>SFPP (Models 16CS,<br>16S, 20CS & 20S<br>only),<br>Liquids,<br>Leak test. | Identical |
| Sterilization Cycle<br>Parameters | Prevac (VAC) cycle:<br>• Prevac 1 -<br>Exposure for 4<br>minutes at 132°C<br>• Prevac 2 -<br>Exposure for 3<br>minutes at 135°C | Prevac (VAC) cycle:<br>• Exposure for 4<br>minutes at 132°C | Prevac (VAC) cycle:<br>• Exposure for 4<br>minutes at 132°C<br>• Exposure for 3<br>minutes at 135°C | The Prevac 1 cycle is<br>identical.<br>The Prevac 2 cycle is<br>identical to predicate<br>2. |
| | Immediate Use<br>(Prevac):<br>• Exposure for 4<br>minutes at 132°C | Not available | Immediate Use<br>(Prevac):<br>• Exposure for 4<br>minutes at 132°C | Identical to predicate<br>2 |
| Comparable<br>Properties | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) | Comparison Results |
| | Immediate Use –<br>Gravity:<br>• Exposure for 4<br>minutes at 132°C<br>• Exposure for 10<br>minutes at 132°C | Not available | Immediate Use –<br>Gravity:<br>• Exposure for 3<br>minutes at 132°C<br>• Exposure for 10<br>minutes at 132°C | Similar to predicate 2.<br>The difference in<br>exposure times is<br>minimal and the cycle<br>itself has been<br>validated. |
| | Gravity:<br>• Gravity 1 –<br>Exposure for 30<br>minutes at 121°C<br>• Gravity 2 -<br>Exposure for 15<br>minutes at 132°C | Gravity:<br>• Exposure for 30<br>minutes at 121.1°C | Gravity:<br>• Exposure for 30<br>minutes at 121°C<br>• Exposure for 15<br>minutes at 132°C<br>• Exposure for 25<br>minutes at 132°C | Gravity 1 cycle is<br>identical.<br><br>Gravity 2 cycle is<br>identical with<br>predicate 2. |
| | Steam-Flush<br>Pressure Pulse<br>(SFPP):<br>• SFPP 1 - Exposure<br>for 4 minutes at<br>132°C<br>• SFPP 2 - Exposure<br>for 3 minutes at<br>135°C | Not Available | Steam-Flush<br>Pressure Pulse<br>(SFPP):<br>• Exposure for 4<br>minutes at 132°C<br>• Exposure for 3<br>minutes at 135°C | Identical to predicate<br>2. |
| | Bowie Dick Test<br>(DART):<br>• Exposure for 3.5<br>minutes at 132°C | Bowie Dick Test<br>(DART):<br>• Exposure for 3.5<br>minutes at 132°C | Bowie Dick Test<br>(DART):<br>• Exposure for 3.5<br>minutes at 132°C | Identical |
| Comparable<br>Properties | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) | Comparison Results |
| Sterility Assurance<br>Level (SAL) | 10-6 | 10-6 | 10-6 | Identical |
| | Chamber Sizes | 26" x 30" x 41" | Multi-functional<br>Sterilizer<br>16" x 16" x 26" (Model<br>PSS8-AA-M)<br>20" x 20" x 38" (Model<br>PSS8-A-M)<br>26" x 26" x 39" (Model<br>PSS8-B-M)<br>26" x 26" x 49” (Model<br>PSS8-C-M)<br>26" x 26" x 67" (Model<br>PSS8-D-M)<br>26" x 36" x 39" (Model<br>PSS8-E-M)<br>26" x 36" x 48" (Model<br>PSS8-F-M)<br>26" x 36" x 60" (Model<br>PSS8-G-M)<br>32" x 36" x 48" (Model<br>PSS8-G.1-M)<br>26" x 63" x 48" (Model<br>PSS8-J-M)<br>26" x 63" x 76" (Model<br>PSS8-K-M) | 16" x 16" x 26"<br>(Models 16, 16C,<br>16CS and 16S)<br>20" x 20" x 38"<br>(Models 20, 20C,<br>20CS and 20S) |
| Comparable<br>Properties | | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) |
| Chamber Door | Type 316L Stainless-steel<br>Vertical Sliding | Type 316L Stainless-steel<br>Vertical & Horizontal<br>Sliding | Type 316L Stainless-steel<br>Vertical Sliding (26" x 26") | Identical |
| Instrument tray load | 25 lbs each tray | 12 lbs each tray | 25 lbs each tray | Identical to predicate 2 |
| Fabric pack | 25 lbs | 12 lbs | 25 lbs | Identical to predicate 2 |
| Control Technology | PLC Controller (Idec<br>FC6A Micro system &<br>Allen Bradley<br>CompactLogix<br>system),<br>Touch Screen,<br>800 x 600 Pixel<br>Display,<br>Ink on Paper Impact<br>Printer, Ethernet<br>printing & PRI-SND | PLC Controller (PSS8<br>Trinity control) – door<br>closed screen,<br>Touch screen | Embedded controller,<br>Touch Screen,<br>320 x 240 Pixel<br>Display,<br>Ink on Paper Printer | Similar. The proposed<br>device has advanced<br>control, display and<br>printing features<br>compared to<br>predicate device<br>which provides easy-to-read printed<br>records and delivers<br>realistic images and<br>the brightest displays.<br>The firmware has<br>been validated. |
| Comparable<br>Properties | Subject Device | Predicate Device 1<br>(K093333) | Predicate Device 2<br>(K111223) | Comparison Results |
| Printer technology | Thermal printer (Ink-<br>on-paper impact<br>printer) | Thermal printer (dot-<br>matrix technology and<br>32 characters per line<br>printing) | Thermal printer (Ink-<br>on-paper impact<br>printer) | Identical to predicate<br>2. |
| Factory Programmed<br>Sterilization Cycles | 11 pre-programmed<br>cycles.…