Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard sterilization processes controlled by a PLC and HMI, with no mention of AI or ML capabilities.

Therapeutic

No. A therapeutic device is intended to treat or cure a disease or condition. This device is a sterilizer, which is used to sterilize medical equipment, not to directly treat patients.

Diagnostic

No

The device is a sterilizer designed to clean medical instruments and materials, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components including a jacket assembly, chamber door, vacuum system, steam source, and a physical control system (PLC and HMI). While software is mentioned as part of the control system, it is integral to the operation of the physical sterilizer unit.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to sterilize medical devices and materials using steam. This is a process performed on instruments before they are used on a patient or for diagnostic purposes.
Device Description: The description details a steam sterilizer, its components, and control systems. These are all related to the physical process of sterilization, not to analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This sterilizer does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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.

Product codes (comma separated list FDA assigned to the subject device)

FLE

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 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): 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: 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: 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: Superior heat loss reduction is achieved with one-inch fiberglass insulation overlaid with 0.05-inch aluminum sheet metal.
Chamber Drain System: Drain system is designed to prevent pollutants from entering into the water-supply system and sterilizer.
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.
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: 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.
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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The PRIMUS Healthcare Sterilizer (Models PS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted, which included Electrical Safety, EMC, Low-voltage switchgear and control gear assemblies, Pressure Vessel Testing, Control panel, and Performance testing. All tests resulted in a "Pass", indicating compliance with relevant standards such as UL 61010-1:2012, IEC 60601-1-2 ed 4.0, IEC 61439-2, ASME Boiler and pressure vessel code, UL 508A:2013, and ANSI/AAMI/ST8:2013 (R2018). Clinical studies were not required. The conclusion from nonclinical tests is that the device is safe, effective, and performs as well as the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K221474

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).

Summary

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)

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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-

| 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-
| 270°F
(132°C) | 4
min | 1
min | Unwrapped non-
porous single
instrument | 25lb | 1 | 25lb | 1 |
| Immediate
Use -
Gravity
(Notes 1-
| 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-
| 270°F
(132°C) | 10
min | 1
min | Unwrapped porous
or non-porous
single instrument | 25lb | 1 | 25lb | 1 |
| Immediate
Use -
Gravity
(Notes 1-
| 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.
1. At the end of an immediate use or express cycle items may NOT be dry.
1. 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).
1. 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-

| 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-
| 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.
1. At the end of an immediate use or express cycle items may NOT be dry.
1. The recommended exposure time and temperature for unwrapped, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C).
1. 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"

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:

| Test

Methodology	Purpose	Acceptance Criteria	Results
Electrical Safety	To ensure that
the device and
its components
meet the
electrical safety
requirements	Compliance with meeting
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	Compliance with standard
ASME Boiler and pressure
vessel code, Section VIII
division 1	Pass
Test
Methodology	Purpose	Acceptance Criteria	Results
	and is safe for
use.
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

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).