(266 days)
Not Found
No
The document describes a steam sterilizer with standard components and control systems, with no mention of AI or ML capabilities.
No.
The device is a sterilizer that prepares materials for therapeutic use; it does not directly diagnose, treat, or prevent disease.
No
Explanation: The device is a sterilizer that cleans and prepares instruments for use. It does not perform any diagnostic functions on patients.
No
The device description clearly outlines numerous hardware components including a jacket assembly, chamber, door, insulation, drain system, vacuum system, steam source, and control system. It is a physical sterilizer, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "efficient steam sterilization of non-porous and moisture stable materials" in healthcare settings like surgery and central sterile. This is a process for sterilizing medical devices and materials, not for performing diagnostic tests on biological samples.
- Device Description: The description details the components of a steam sterilizer (jacket assembly, chamber, doors, etc.). These are components of a sterilization system, not a diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a sterilizer used to prepare medical equipment for use, which falls under a different regulatory category than IVDs.
N/A
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 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.
Product codes
FLE
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:
-
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:
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.
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
surgery, central sterile, and surgery centers. Over-The-Counter Use
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
The device's performance was evaluated through nonclinical tests. The tests assessed Electrical Safety, EMC, Low-voltage switchgear and control gear assemblies, Pressure Vessel Testing, Control panel, and Performance testing. All tests passed, demonstrating compliance with relevant standards such as UL 61010-1, IEC 60601-1-2, IEC 61439-2, ASME Section VIII, UL 508A, and ANSI/AAMI/ST8. No clinical studies were required.
Key Metrics
Not Found
Predicate Device(s)
PRIMUS PSS8 Steam Sterilizer Series (K093333), AMSCO CHIMERON Small Steam Sterilizer (K111223)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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 ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Cycle | Factory Settings | | | Recommended Load
(Note 1) | Total Load
Weight | Maximum
Items per
Chamber Size |
|-------------------------------------------|------------------|--------------|-------------|----------------------------------------------------------------------------|----------------------|--------------------------------------|
| | Exp. Temp. | Exp.
Time | Dry
Time | | | HC |
| PREVAC 1
(vac) | 270°F
(132°C) | 4 min | 30 mins | Double-wrapped instrument
trays, 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 instrument
trays, up to 25 lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Steam-Flush
Pressure | 270°F
(132°C) | 4 min | 30 mins | Double-wrapped instrument
trays, up to 25 lb per tray | 225lb | 9 |
| Pulse 1 | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Steam-Flush
Pressure | 275°F
(135°C) | 3 min | 30 mins | Double-wrapped instrument
trays, up to 25 lb per tray | 225lb | 9 |
| Pulse 2 | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric Pack | 0.2lb | 1 |
| Immediate
Use -
PREVAC | 270°F
(132°C) | 4 min | 1 min | Unwrapped non-porous single
instrument | 25lb | 1 |
| | | | | Unwrapped non-porous
instrument trays, up to 25 lb per
tray | 25lb | 1 |
| Immediate
Use - Gravity
(Notes 1-3) | 270°F
(132°C) | 4 min | 1 min | Unwrapped non-porous single
instrument | 25lb | 1 |
| | | | | Unwrapped non-porous
instrument trays, up to 25 lb per
tray | 25lb | 1 |
| Cycle | Factory Settings | | | Recommended Load
(Note 1) | Total Load
Weight | Maximum
Items per
Chamber Size |
| | Exp. Temp. | Exp.
Time | Dry
Time | | | HC |
| Immediate
Use - Gravity
(Notes 1-3) | 270°F
(132°C) | 10 min | 1 min | Unwrapped porous or non-
porous single instrument | 25lb | 1 |
| | | | | Unwrapped porous & non-porous
instrument trays. up to 25 lb per
tray | 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 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 |
| Leak Test
(Note 4) | N/A | N/A | N/A | Empty chamber | N/A | N/A |
4
PRIMUS Healthcare Sterilizer Abbreviated 510(k): Premarket Notification
5
TABLE NOTES
-
- Load configurations during testing validations follow ANSI/AAMI ST8:2013 standard for Hospital Steam Sterilizers where applicable. All fabric packs and instrument trays are constructed as described in ANSI/AAMI ST8. For guidance on loading the sterilizer, refer to ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.
-
- At the end of an immediate use or express cycle items may NOT be dry.
-
- The recommended exposure time and temperature for unwrapped, non-porous, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C).
-
- Vacuum leak test parameters are not adjustable. The cycle run for leak test includes 15 minutes of dry cycle, 5 min for equalization within the chamber and 15 mins for the leak test run.
6
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 |
| VP Engineering | |
| PRIMUS Sterilizer Company, LLC | |
| 9736 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 | |
| 14, Hadapsar Industrial Estate | |
| Hadapsar, Pune – 411013, India. | |
| P: +91 72762 12555 | |
| M: +91 7069553814 | |
| Email: 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 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 PSS8 Steam Sterilizer Series |
| (K093333) | |
| Regulation number: 21 CFR 880.6880 | |
| Regulation Name: Steam Sterilization | |
| Regulatory Class: II | |
| Product Code: FLE | |
| Review panel: General Hospital |
- AMSCO CHIMERON Small Steam Sterilizer
(K111223)
Regulation number: 21 CFR 880.6880
Regulation Name: Steam Sterilization
Regulatory Class: II
Product Code: FLE
Review panel: General Hospital |
7
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
8
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.
9
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
Load
(Note 1) | Total
Load
weight | Maximum
Items per
Chamber
Size |
|--------------------------------------------------|------------------|--------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------|
| | Exp.
Temp. | Exp.
Time | Dry
Time | | | HC |
| PREVAC
1 (vac) | 270°F
(132°C) | 4
min | 30
mins | Double-
wrapped
instrument
trays, 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
instrument
trays, up to 25
lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| Cycle | Factory Settings | | | Recommended
Load
(Note 1) | Total
Load
weight | Maximum
Items per
Chamber
Size |
| | Exp.
Temp. | Exp.
Time | Dry
Time | | | HC |
| Steam-
Flush
Pressure
Pulse 1 | 270°F
(132°C) | 4
min | 30
mins | Single Fabric
Pack | 0.2lb | 1 |
| | | | | Double-
wrapped
instrument
trays, up to 25
lb per tray | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric
Pack | 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 | 225lb | 9 |
| | | | | Fabric packs | 3lb | 17 |
| | | | | Single Fabric
Pack | 0.2lb | 1 |
| Immediate
Use -
PREVAC | 270°F
(132°C) | 4
min | 1
min | Unwrapped
non-porous
single
instrument | 25lb | 1 |
| | | | | Unwrapped
non-porous
instrument
trays, up to 25
lb per tray | 25lb | 1 |
| Immediate
Use -
Gravity
(Notes 1-
3) | 270°F
(132°C) | 4
min | 1
min | Unwrapped
non-porous
single
instrument | 25lb | 1 |
| | | | | Unwrapped
non-porous
instrument
trays, up to 25
lb per tray | 25lb | 1 |
| Cycle | Factory Settings | | | Recommended
Load
(Note 1) | Total
Load
weight | Maximum
Items per
Chamber
Size |
| | Exp.
Temp. | Exp.
Time | Dry
Time | | | HC |
| Immediate
Use -
Gravity
(Notes 1-3) | 270°F
(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
25lb | 1
1 |
| GRAVITY
1 | 250°F
(121°C) | 30
min | 30
min | Double
Wrapped
instrument trays
Fabric packs | 225lb
3lb | 9
17 |
| GRAVITY
2 | 270°F
(132°C) | 15
min | 30
min | Double
Wrapped
instrument trays
Fabric packs | 225lb
3lb | 9
17 |
| 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 |
| Leak Test
(Note 4) | N/A | N/A | N/A | Empty chamber | | N/A |
Table 2: Factory Programmed Sterilization Cycles for PRIMUS Healthcare Sterilizer
10
11
12
TABLE NOTES
-
- 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.
-
- At the end of an immediate use or express cycle items may NOT be dry.
-
- The recommended exposure time and temperature for unwrapped, non-porous, immediate use cycle loads (e.g., metal instruments) is 3 minutes at 275°F (135°C).
-
- Vacuum leak test parameters are not adjustable. The cycle run for leak test includes 15 minutes of dry cycle, 5 min for equalization within the chamber and 15 mins for the leak test run.
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:
13
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | PRIMUS Healthcare
Sterilizer | PRIMUS Steam
Sterilizers | Amsco Chimeron
Small Steam Sterilizer | Not Applicable |
| Manufacturer | PRIMUS Sterilizer
Company, LLC | PRIMUS Sterilizer
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 /
Indications for Use | The PRIMUS
Healthcare Sterilizer
model 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; | The PRIMUS PSS8
Steam Sterilizer
Series are designed
for use in the hospital
operating suites,
central sterile supply
and clinical
laboratories. The
PRIMUS PSS8
Steam Sterilizer
Series provide
efficient steam
sterilization of non-
porous and porous,
heat and moisture
stable materials. | Amsco Chimeron
Small Steam Sterilizer
models 16, 16C,
16CS, 16S, 20, 20C,
20CS and 20S are
designed for
sterilization of heat
and moisture-stable
materials in
healthcare facilities. | Identical |
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
| | 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. | Steam is the
sterilizing agent. | Identical |
| Sterilization Cycles
Offered | Model is offered with:
Prevac,
Gravity,
SFPP,
Leak test | All models are offered
with:
Vacuum,
Gravity,
Liquids,
Test (Vac) | Prevac,
Gravity,
SFPP (Models 16CS,
16S, 20CS & 20S
only),
Liquids,
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 | Prevac (VAC) cycle:
• Exposure for 4
minutes at 132°C | Prevac (VAC) cycle:
• Exposure for 4
minutes at 132°C
• Exposure for 3
minutes at 135°C | The Prevac 1 cycle is
identical.
The Prevac 2 cycle is
identical to predicate
2. |
| | Immediate Use
(Prevac):
• Exposure for 4
minutes at 132°C | Not available | Immediate Use
(Prevac):
• Exposure for 4
minutes at 132°C | Identical to predicate
2 |
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
| | Immediate Use –
Gravity:
• Exposure for 4
minutes at 132°C
• Exposure for 10
minutes at 132°C | Not available | Immediate Use –
Gravity:
• Exposure for 3
minutes at 132°C
• Exposure for 10
minutes at 132°C | Similar to predicate 2.
The difference in
exposure times is
minimal and the cycle
itself has been
validated. |
| | Gravity:
• Gravity 1 –
Exposure for 30
minutes at 121°C
• Gravity 2 -
Exposure for 15
minutes at 132°C | Gravity:
• Exposure for 30
minutes at 121.1°C | Gravity:
• Exposure for 30
minutes at 121°C
• Exposure for 15
minutes at 132°C
• Exposure for 25
minutes at 132°C | Gravity 1 cycle is
identical.
Gravity 2 cycle is
identical with
predicate 2. |
| | Steam-Flush
Pressure Pulse
(SFPP):
• SFPP 1 - Exposure
for 4 minutes at
132°C
• SFPP 2 - Exposure
for 3 minutes at
135°C | Not Available | Steam-Flush
Pressure Pulse
(SFPP):
• Exposure for 4
minutes at 132°C
• Exposure for 3
minutes at 135°C | Identical to predicate
2. |
| | Bowie Dick Test
(DART):
• Exposure for 3.5
minutes at 132°C | 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 |
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
| Sterility Assurance
Level (SAL) | 10-6 | 10-6 | 10-6 | Identical |
| | Chamber Sizes | 26" x 30" x 41" | Multi-functional
Sterilizer
16" x 16" x 26" (Model
PSS8-AA-M)
20" x 20" x 38" (Model
PSS8-A-M)
26" x 26" x 39" (Model
PSS8-B-M)
26" x 26" x 49” (Model
PSS8-C-M)
26" x 26" x 67" (Model
PSS8-D-M)
26" x 36" x 39" (Model
PSS8-E-M)
26" x 36" x 48" (Model
PSS8-F-M)
26" x 36" x 60" (Model
PSS8-G-M)
32" x 36" x 48" (Model
PSS8-G.1-M)
26" x 63" x 48" (Model
PSS8-J-M)
26" x 63" x 76" (Model
PSS8-K-M) | 16" x 16" x 26"
(Models 16, 16C,
16CS and 16S)
20" x 20" x 38"
(Models 20, 20C,
20CS and 20S) |
| Comparable
Properties | | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) |
| Chamber Door | Type 316L Stainless-steel
Vertical Sliding | Type 316L Stainless-steel
Vertical & Horizontal
Sliding | Type 316L Stainless-steel
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
FC6A Micro system &
Allen Bradley
CompactLogix
system),
Touch Screen,
800 x 600 Pixel
Display,
Ink on Paper Impact
Printer, Ethernet
printing & PRI-SND | PLC Controller (PSS8
Trinity control) – door
closed screen,
Touch screen | Embedded controller,
Touch Screen,
320 x 240 Pixel
Display,
Ink on Paper Printer | Similar. The proposed
device has advanced
control, display and
printing features
compared to
predicate device
which provides easy-to-read printed
records and delivers
realistic images and
the brightest displays.
The firmware has
been validated. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
| Printer technology | Thermal printer (Ink-
on-paper impact
printer) | Thermal printer (dot-
matrix technology and
32 characters per line
printing) | Thermal printer (Ink-
on-paper impact
printer) | Identical to predicate
2. |
| Factory Programmed
Sterilization Cycles | 11 pre-programmed
cycles. | 6 pre-programmed
cycles | Unknown | Similar
The subject device
uses PSS11
controller that allows
for more pre-
programmed cycles
which help to meet
specific processing
requirements. |
| Safety Devices | Emergency Stop
Button
Pressure Relief Valve
Door and Gasket
Safety Switch
Door interlocks
(double door units
only) | Pressure Relief Valve
Door and Gasket
Pressure Switches
Door interlock | Pressure Relief Valve
Chamber Float Switch
Emergency Stop
Switch | Identical |
| Built according to
Standard | ANSI/AAMI ST8:2013
Hospital Steam | ANSI/AAMI ST8:2013
Hospital Steam | ANSI/AAMI ST8:2013
Hospital Steam | Identical |
| Comparable
Properties | Subject Device | Predicate Device 1
(K093333) | Predicate Device 2
(K111223) | Comparison Results |
| Electrical Safety
Standard | Sterilizers
UL 61010-1:2012
(Ed.3+R:29 April
2016),
UL 61010-2-040:2016
(Ed.2),
(R2017) CSA
C22.2#61010-1-
12:2012 Ed.3+U1;U2,
CSA C22.2#61010-2-
040:2016 Ed.2 | Sterilizers
AAMI / ANSI / IEC
60601-1-2 (Second
Edition 2001),
UL 61010A-1, IEC
61010-1 Amendment
2,
IEC 61010-2-041, UL
61010A-2-041,
CAN/CSA-C22.2 No.
1010.2-041-96. | Sterilizers
ANSI / 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, Section
I, Part PMB | Unknown | ASME Code, Section
I, Part PMB | Identical |
| Chamber pressure | 45 psig | 45 psig | 50 psig | Identical to predicate
1 |
| Air filter | 0.3 micron (optional
0.2 micron) | 0.3 micron | Unknown | Identical |
| Electrical supply | Volts: 110
Phase: Single
Amps: 10 | Volts: 110
Phase: Single
Amps: 10 | Volts: 120
Phase: Single
Amps: 2.0 | Identical to predicate
1 |
| Steam Source
pressure | 50 to 80 psig
Dynamic | 50 to 80 psig
Dynamic | 50 to 80 psig
Dynamic | Identical |
| Water Pressure | 50 to 70 psig
Dynamic | 50 to 70 psig
Dynamic | 30 to 50 psig
Dynamic | Identical to predicate
1 |
| Air Pressure | 60 to 80 psi Dynamic | 60 to 80 psi Dynamic | Unknown | Identical |
| Piping construction
material | Brass | Brass | Brass | Identical |
| Comparable
Properties | 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
14
15
16
17
18
19
20
21
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 Test
| Methodology | Purpose | Acceptance Criteria | 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 | ||
| theLow-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 | ||
| Name of Test | |||
| Methodology | Purpose | Acceptance Criteria | Results |
| 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 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
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 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.