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.

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), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the PRIMUS Healthcare Sterilizer (Model PSS11-HC) meets these criteria. It's important to note that this document is for a steam sterilizer, not an AI/ML medical device, so some of the requested information (like number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to AI/ML diagnostic or prognostic devices.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Name of 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 to 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 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 Data Provenance

The document does not specify a "sample size" in the context of a test set for data (like images or patient records) as this device is a physical sterilizer. Instead, testing involves the sterilizer itself and its components.

Sample Size: Not applicable in the traditional sense of data samples. The testing relates to the device itself and its processes.
Data Provenance: Not applicable. The testing is based on engineering and performance validation of a manufactured device against established standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. For a physical sterilizer, "ground truth" is established by adherence to engineering and performance standards (e.g., specific temperatures, pressures, biological indicator kill rates). There is no "expert consensus" on ground truth for diagnostic image interpretation in this context. The validation is against defined physical and biological parameters.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation tasks where human readers might disagree. For a sterilizer, the tests are objective: either the device meets the physical parameters and sterilization efficacy requirements, or it does not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic or prognostic AI/ML medical devices where human readers' performance with and without AI assistance is compared. This document concerns a physical steam sterilizer.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an algorithm, but a physical device. Its "performance" is inherently "standalone" in that it performs its function (sterilization) independently, but its use requires human interaction (loading, initiating cycles, maintenance).

7. The Type of Ground Truth Used

The "ground truth" for the PRIMUS Healthcare Sterilizer is based on established industry and regulatory standards for steam sterilization. This includes:

Physical parameters (temperature, pressure, time) according to specific cycles.
Demonstrated sterilization efficacy (implied by compliance with standards like ANSI/AAMI ST8), which typically involves biological and chemical indicator testing.
Compliance with electrical safety, EMC, and pressure vessel codes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 )
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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(Note 1)	Total LoadWeight	MaximumItems perChamber Size
	Exp. Temp.	Exp.Time	DryTime			HC
PREVAC 1(vac)	270°F(132°C)	4 min	30 mins	Double-wrapped instrumenttrays, up to 25 lb per tray	225lb	9
				Fabric packs	3lb	17
				Single Fabric Pack	0.2lb	1
PREVAC 2(vac)	275°F(135°C)	3 min	30 min	Double-wrapped instrumenttrays, up to 25 lb per tray	225lb	9
				Fabric packs	3lb	17
				Single Fabric Pack	0.2lb	1
Steam-FlushPressure	270°F(132°C)	4 min	30 mins	Double-wrapped instrumenttrays, up to 25 lb per tray	225lb	9
Pulse 1				Fabric packs	3lb	17
				Single Fabric Pack	0.2lb	1
Steam-FlushPressure	275°F(135°C)	3 min	30 mins	Double-wrapped instrumenttrays, up to 25 lb per tray	225lb	9
Pulse 2				Fabric packs	3lb	17
				Single Fabric Pack	0.2lb	1
ImmediateUse -PREVAC	270°F(132°C)	4 min	1 min	Unwrapped non-porous singleinstrument	25lb	1
				Unwrapped non-porousinstrument trays, up to 25 lb pertray	25lb	1
ImmediateUse - Gravity(Notes 1-3)	270°F(132°C)	4 min	1 min	Unwrapped non-porous singleinstrument	25lb	1
				Unwrapped non-porousinstrument trays, up to 25 lb pertray	25lb	1
Cycle	Factory Settings			Recommended Load(Note 1)	Total LoadWeight	MaximumItems perChamber Size
	Exp. Temp.	Exp.Time	DryTime			HC
ImmediateUse - Gravity(Notes 1-3)	270°F(132°C)	10 min	1 min	Unwrapped porous or non-porous single instrument	25lb	1
				Unwrapped porous & non-porousinstrument trays. up to 25 lb pertray	25lb	1
GRAVITY 1	250°F(121°C)	30 min	30 min	Double Wrapped instrument trays	225lb	9
				Fabric packs	3lb	17
GRAVITY 2	270°F(132°C)	15 min	30 min	Double Wrapped instrument trays	225lb	9
				Fabric packs	3lb	17
Bowie DickTest (vac)	275°F(132°C)	3.5 min	3 min	Bowie-Dick Test Pack orequivalent (1) in an EMPTYchamber	-	1 Test Pack
Leak Test(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.
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.

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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, PEVP EngineeringPRIMUS Sterilizer Company, LLC9736 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 Healthcare14, Hadapsar Industrial EstateHadapsar, Pune – 411013, India.P: +91 72762 12555M: +91 7069553814Email: ankur.naik@izielhealthcare.com
Device Trade Name:	PRIMUS Healthcare Sterilizer (Model PSS11-HC)
Regulation Number:	880.6880
Regulation Description:	A steam sterilizer (autoclave) is a device that isintended for use by a health care provider to sterilizemedical 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(K093333)Regulation number: 21 CFR 880.6880Regulation Name: Steam SterilizationRegulatory Class: IIProduct Code: FLEReview panel: General Hospital2. AMSCO CHIMERON Small Steam Sterilizer(K111223)Regulation number: 21 CFR 880.6880Regulation Name: Steam SterilizationRegulatory Class: IIProduct Code: FLEReview panel: General Hospital

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Device Description:

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			RecommendedLoad(Note 1)	TotalLoadweight	MaximumItems perChamberSize
	Exp.Temp.	Exp.Time	DryTime			HC
PREVAC1 (vac)	270°F(132°C)	4min	30mins	Double-wrappedinstrumenttrays, up to 25lb per tray	225lb	9
				Fabric packs	3lb	17
				Single FabricPack	0.2lb	1
PREVAC2 (vac)	275°F(135°C)	3min	30min	Double-wrappedinstrumenttrays, up to 25lb per tray	225lb	9
				Fabric packs	3lb	17
Cycle	Factory Settings			RecommendedLoad(Note 1)	TotalLoadweight	MaximumItems perChamberSize
	Exp.Temp.	Exp.Time	DryTime			HC
Steam-FlushPressurePulse 1	270°F(132°C)	4min	30mins	Single FabricPack	0.2lb	1
				Double-wrappedinstrumenttrays, up to 25lb per tray	225lb	9
				Fabric packs	3lb	17
				Single FabricPack	0.2lb	1
Steam-FlushPressurePulse 2	275°F(135°C)	3min	30mins	Double-wrappedinstrumenttrays, up to 25lb per tray	225lb	9
				Fabric packs	3lb	17
				Single FabricPack	0.2lb	1
ImmediateUse -PREVAC	270°F(132°C)	4min	1min	Unwrappednon-poroussingleinstrument	25lb	1
				Unwrappednon-porousinstrumenttrays, up to 25lb per tray	25lb	1
ImmediateUse -Gravity(Notes 1-3)	270°F(132°C)	4min	1min	Unwrappednon-poroussingleinstrument	25lb	1
				Unwrappednon-porousinstrumenttrays, up to 25lb per tray	25lb	1
Cycle	Factory Settings			RecommendedLoad(Note 1)	TotalLoadweight	MaximumItems perChamberSize
	Exp.Temp.	Exp.Time	DryTime			HC
ImmediateUse -Gravity(Notes 1-3)	270°F(132°C)	10min	1min	Unwrappedporous or non-porous singleinstrumentUnwrappedporous & non-porousinstrumenttrays. up to 25lb per tray	25lb25lb	11
GRAVITY1	250°F(121°C)	30min	30min	DoubleWrappedinstrument traysFabric packs	225lb3lb	917
GRAVITY2	270°F(132°C)	15min	30min	DoubleWrappedinstrument traysFabric packs	225lb3lb	917
BowieDick Test(vac)	275°F(132°C)	3.5min	3min	Bowie-DickTest Pack orequivalent (1) inan EMPTYchamber		1 Test Pack
Leak Test(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.
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.

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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ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
Product Name	PRIMUS HealthcareSterilizer	PRIMUS SteamSterilizers	Amsco ChimeronSmall Steam Sterilizer	Not Applicable
Manufacturer	PRIMUS SterilizerCompany, LLC	PRIMUS SterilizerCompany, 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 /Indications for Use	The PRIMUSHealthcare Sterilizermodel HC is designedfor use in surgery,central sterile, andsurgery centers. ThePRIMUS HealthcareSterilizer providesefficient steamsterilization of non-porous and porous,heat and moisturestable materials. Thesterilizer can be usedon various materialsthat withstandoperatingtemperatures;	The PRIMUS PSS8Steam SterilizerSeries are designedfor use in the hospitaloperating suites,central sterile supplyand clinicallaboratories. ThePRIMUS PSS8Steam SterilizerSeries provideefficient steamsterilization of non-porous and porous,heat and moisturestable materials.	Amsco ChimeronSmall Steam Sterilizermodels 16, 16C,16CS, 16S, 20, 20C,20CS and 20S aredesigned forsterilization of heatand moisture-stablematerials inhealthcare facilities.	Identical
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
	materials that cannotwithstand operatingtemperatures shouldnot be sterilized usingthe PRIMUSHealthcare Sterilizer.
Operating Principle	Steam is thesterilizing agent.	Steam is thesterilizing agent.	Steam is thesterilizing agent.	Identical
Sterilization CyclesOffered	Model is offered with:Prevac,Gravity,SFPP,Leak test	All models are offeredwith:Vacuum,Gravity,Liquids,Test (Vac)	Prevac,Gravity,SFPP (Models 16CS,16S, 20CS & 20Sonly),Liquids,Leak test.	Identical
Sterilization CycleParameters	Prevac (VAC) cycle:• Prevac 1 -Exposure for 4minutes at 132°C• Prevac 2 -Exposure for 3minutes at 135°C	Prevac (VAC) cycle:• Exposure for 4minutes at 132°C	Prevac (VAC) cycle:• Exposure for 4minutes at 132°C• Exposure for 3minutes at 135°C	The Prevac 1 cycle isidentical.The Prevac 2 cycle isidentical to predicate2.
	Immediate Use(Prevac):• Exposure for 4minutes at 132°C	Not available	Immediate Use(Prevac):• Exposure for 4minutes at 132°C	Identical to predicate2
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
	Immediate Use –Gravity:• Exposure for 4minutes at 132°C• Exposure for 10minutes at 132°C	Not available	Immediate Use –Gravity:• Exposure for 3minutes at 132°C• Exposure for 10minutes at 132°C	Similar to predicate 2.The difference inexposure times isminimal and the cycleitself has beenvalidated.
	Gravity:• Gravity 1 –Exposure for 30minutes at 121°C• Gravity 2 -Exposure for 15minutes at 132°C	Gravity:• Exposure for 30minutes at 121.1°C	Gravity:• Exposure for 30minutes at 121°C• Exposure for 15minutes at 132°C• Exposure for 25minutes at 132°C	Gravity 1 cycle isidentical.Gravity 2 cycle isidentical withpredicate 2.
	Steam-FlushPressure Pulse(SFPP):• SFPP 1 - Exposurefor 4 minutes at132°C• SFPP 2 - Exposurefor 3 minutes at135°C	Not Available	Steam-FlushPressure Pulse(SFPP):• Exposure for 4minutes at 132°C• Exposure for 3minutes at 135°C	Identical to predicate2.
	Bowie Dick Test(DART):• Exposure for 3.5minutes at 132°C	Bowie Dick Test(DART):• Exposure for 3.5minutes at 132°C	Bowie Dick Test(DART):• Exposure for 3.5minutes at 132°C	Identical
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
Sterility AssuranceLevel (SAL)	10-6	10-6	10-6	Identical
	Chamber Sizes	26" x 30" x 41"	Multi-functionalSterilizer16" x 16" x 26" (ModelPSS8-AA-M)20" x 20" x 38" (ModelPSS8-A-M)26" x 26" x 39" (ModelPSS8-B-M)26" x 26" x 49” (ModelPSS8-C-M)26" x 26" x 67" (ModelPSS8-D-M)26" x 36" x 39" (ModelPSS8-E-M)26" x 36" x 48" (ModelPSS8-F-M)26" x 36" x 60" (ModelPSS8-G-M)32" x 36" x 48" (ModelPSS8-G.1-M)26" x 63" x 48" (ModelPSS8-J-M)26" x 63" x 76" (ModelPSS8-K-M)	16" x 16" x 26"(Models 16, 16C,16CS and 16S)20" x 20" x 38"(Models 20, 20C,20CS and 20S)
ComparableProperties		Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)
Chamber Door	Type 316L Stainless-steelVertical Sliding	Type 316L Stainless-steelVertical & HorizontalSliding	Type 316L Stainless-steelVertical 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 (IdecFC6A Micro system &Allen BradleyCompactLogixsystem),Touch Screen,800 x 600 PixelDisplay,Ink on Paper ImpactPrinter, Ethernetprinting & PRI-SND	PLC Controller (PSS8Trinity control) – doorclosed screen,Touch screen	Embedded controller,Touch Screen,320 x 240 PixelDisplay,Ink on Paper Printer	Similar. The proposeddevice has advancedcontrol, display andprinting featurescompared topredicate devicewhich provides easy-to-read printedrecords and deliversrealistic images andthe brightest displays.The firmware hasbeen validated.
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
Printer technology	Thermal printer (Ink-on-paper impactprinter)	Thermal printer (dot-matrix technology and32 characters per lineprinting)	Thermal printer (Ink-on-paper impactprinter)	Identical to predicate2.
Factory ProgrammedSterilization Cycles	11 pre-programmedcycles.	6 pre-programmedcycles	Unknown	SimilarThe subject deviceuses PSS11controller that allowsfor more pre-programmed cycleswhich help to meetspecific processingrequirements.
Safety Devices	Emergency StopButtonPressure Relief ValveDoor and GasketSafety SwitchDoor interlocks(double door unitsonly)	Pressure Relief ValveDoor and GasketPressure SwitchesDoor interlock	Pressure Relief ValveChamber Float SwitchEmergency StopSwitch	Identical
Built according toStandard	ANSI/AAMI ST8:2013Hospital Steam	ANSI/AAMI ST8:2013Hospital Steam	ANSI/AAMI ST8:2013Hospital Steam	Identical
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
Electrical SafetyStandard	SterilizersUL 61010-1:2012(Ed.3+R:29 April2016),UL 61010-2-040:2016(Ed.2),(R2017) CSAC22.2#61010-1-12:2012 Ed.3+U1;U2,CSA C22.2#61010-2-040:2016 Ed.2	SterilizersAAMI / ANSI / IEC60601-1-2 (SecondEdition 2001),UL 61010A-1, IEC61010-1 Amendment2,IEC 61010-2-041, UL61010A-2-041,CAN/CSA-C22.2 No.1010.2-041-96.	SterilizersANSI / UL 61010-1(Ed.2),CAN/CSA C22.2 No.61010-1 (Ed.2),UL 61010A-2-041(Ed.1),CAN/CSA C22.2 No.1010.2.041 (R2004)	Similar
Safety Valves	ASME Approved	ASME Approved	Unknown	Identical
Pressure Vessels	ASME Certified	ASME Certified	ASME Certified	Identical
Power boilers	ASME Code, SectionI, Part PMB	Unknown	ASME Code, SectionI, Part PMB	Identical
Chamber pressure	45 psig	45 psig	50 psig	Identical to predicate1
Air filter	0.3 micron (optional0.2 micron)	0.3 micron	Unknown	Identical
Electrical supply	Volts: 110Phase: SingleAmps: 10	Volts: 110Phase: SingleAmps: 10	Volts: 120Phase: SingleAmps: 2.0	Identical to predicate1
Steam Sourcepressure	50 to 80 psigDynamic	50 to 80 psigDynamic	50 to 80 psigDynamic	Identical
Water Pressure	50 to 70 psigDynamic	50 to 70 psigDynamic	30 to 50 psigDynamic	Identical to predicate1
Air Pressure	60 to 80 psi Dynamic	60 to 80 psi Dynamic	Unknown	Identical
Piping constructionmaterial	Brass	Brass	Brass	Identical
ComparableProperties	Subject Device	Predicate Device 1(K093333)	Predicate Device 2(K111223)	Comparison Results
Fitting material	Copper	Copper	Unknown	Identical

Table 3: Technological Characteristics Comparison Table between the Subject Device and Predicate Device

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Performance Data

PRIMUS Healthcare Sterilizer 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:

Name of TestMethodology	Purpose	Acceptance Criteria	Results
Electrical Safety	To ensure thatthe device andits componentsmeet theelectrical safetyrequirements	Compliance tomeeting standardspecification UL61010-1:2012Ed.3+R:29 Apr 2016and UL 61010-2-040:2016	Pass
EMC	To verify that thedevice meetsEMCrequirements	Compliance with IEC60601-1-2 ed 4.0(2014-02)	Pass
Low-voltageswitchgear andcontrol gearassemblies	To verify thattheLow-voltageswitchgear andcontrol gearassembliesmeets thestandardrequirement.	Compliance with IEC61439-2 Low-voltageswitchgear andcontrol gearassemblies - Part 2:Power switchgearand control gearassemblies	Pass
Pressure VesselTesting	To verify that thepressure vesselused for theSteam sterilizermeets therequirements forpressure vesseland is safe foruse.	Compliance withstandard ASMEBoiler and pressurevessel code, SectionVIII division 1	Pass
Name of TestMethodology	Purpose	Acceptance Criteria	Results
Control panel	To verify thecontrol panelmeets therequirement ofUL 508A:2013	Compliance withstandard IndustrialControl Panels UL508A:2013	Pass
Performancetesting	To verify that allthe cycles in thePRIMUShealthcaresteam sterilizermeets theperformancecriteria definedinANSI/AAMI/ST8.	Compliance toperformancerequirements definedinANSI/AAMI/ST8:2013(R2018)	Pass

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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 out both in-house and by outsourcing to appropriate third-party vendors. The design verification, design validation, and performance testing activities have been documented.

The PRIMUS Healthcare Sterilizers comply 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

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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 switchqear and control gear assemblies Part . 2: Power switchgear and control gear assemblies
ISO 14971:2012 Medical devices Application of risk management to medical ● devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical ● devices.
. ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
. UL 508A, Edition 3 Industrial Control Panels

Summary of Clinical Testing

Clinical studies are not required.

Conclusion

The conclusion drawn from the nonclinical tests that demonstrate that the device is as safe as effective and performs as well as better than legally marketed device.

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).