(238 days)
The PRIMUS PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard linens.
The PRIMUS PSS5 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 except for larger chamber sizes. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers; offered in either horizontal or vertical sliding door applications. The PSS-M unit may be pit-mounted, allowing the optional floor cars to roll directly in to the chamber. All large sized sterilizers have pneumatically powered horizontal operating doors, designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available. PSS sterilizer units offered under this request for clearance are available in Multi-function or Laboratory/Lo configurations. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration, whereas the Laboratory/Lo units offer vacuum, gravity, and low operating temperature configuration.
The provided text describes the PRIMUS PSS5 Steam Sterilizers and includes information related to its safety and effectiveness. However, it does not contain the specific type of acceptance criteria or a study design in the format requested for a medical AI/ML device (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, training/test set sizes for AI models, expert qualifications for ground truth, etc.).
The document is a 510(k) summary for a steam sterilizer, which is a physical medical device, not a software or AI/ML-based diagnostic or prognostic tool. Therefore, the questions related to AI/ML device evaluation metrics and study design cannot be fully answered from the provided text.
Here's an attempt to extract relevant information given the context of the document:
1. A table of acceptance criteria and the reported device performance
Since this is a physical sterilizer and not an AI/ML device, the acceptance criteria are not in terms of traditional diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to sterilization efficacy and safety compliance with recognized standards.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety | Conformance to electrical safety standards: AAMI / ANSI / IEC 60601-1-2. Conformance to industry/electrical codes: UL 61010A-1, IEC 61010-1 Amendment 2, IEC 61010-2-041, UL 61010A-2-041. Conformance to Canadian Standard for Laboratory Equipment: CAN/CSA-C22.2 No. 1010, CAN/CSA-C22.2 No. 1010.2-041-96. Pressure Vessels designed, manufactured, and tested to: ASME, Section VIII, Division 1 Unfired Pressure Vessels. Software design for fail-safe controls, warnings, and signals. | "The PRIMUS PSS Steam Sterilizer Series have been validated against FDA recognized consensus standards for electrical safety: AAMI / ANSI / IEC 60601-1-2, ... Additionally PRIMUS declares conformance to applicable industry and electrical codes as follows ... UL 61010A-1, IEC 61010-1 Amendment 2, ... CNL [Canadian Standard] indicates the product was evaluated to the Canadian Standard... PRIMUS PSS5 Pressure Vessels are designed, manufactured and tested in accordance with American Society of Mechanical Engineers (ASME)... Validated software designed into the PRIMUS PSS5 series sterilizer provides for fail-safe controls that give appropriate warnings and signals..." |
| Effectiveness (Sterilization) | Compliance with ANSI/AAMI ST8:2001 (Hospital steam sterility) minimum construction and performance requirements. Achieving a Sterility Assurance Level (SAL) of 10⁻⁶ when used and maintained as directed. Individual load cycle types (Unwrapped Nonporous Single Instrument, Double wrapped instrument, Textile packs, Vented borosilicate glass containers, Bowie-Dick Test) to meet specific temperature, time, and pre-vac requirements as detailed in the "Indications for Use Table". | "Internal validation protocols are documented and deemed to be comply to the ANSUAAMI ST8:2001... Data output from the validation report was reviewed and found to meet Sterility Assurance Level (SAL) of 10⁻⁶ when the sterilizer is used and maintained as directed." The tables in the document (pages 3 and 6) detail the specific parameters (Sterilize Temp, Sterilize Time, Dry Time, No. of Pre-vacs) for each load type, indicating these are the validated operational parameters for effective sterilization. |
The study that proves the device meets these criteria is an internal validation conducted by PRIMUS, which involved exposing biological indicators and reviewing data output to confirm the SAL of 10⁻⁶. This validation adheres to the ANSI/AAMI ST8:2001 standard.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The validation mentions "I indicators were exposed during validation for each cycle type," but the specific number (sample size) of indicators or the methodology of the test set is not detailed. The provenance (country of origin, retrospective/prospective) is also not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not relevant or provided for a steam sterilizer. Ground truth for sterilization efficacy is established through scientific principles and validated biological indicators, not typically by human experts reviewing visual or diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this type of device and study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML diagnostic device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device. The "algorithm" refers to the sterilizer's controlled cycles, which operate autonomously once initiated by a human. Its performance is evaluated on its own ability to sterilize.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the effectiveness of the sterilizer is a Sterility Assurance Level (SAL) of 10⁻⁶, which is a widely accepted scientific standard for terminal sterilization. This is typically established through the use of biological indicators (e.g., spores of highly resistant microorganisms) which, after exposure to the sterilization cycle, are cultured to determine if any viable organisms remain. This is a scientific and objective measure rather than expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
Not applicable. Steam sterilizers do not use "training sets" in the AI/ML sense. Their operational parameters are determined through engineering design, scientific principles of sterilization, and validation studies.
9. How the ground truth for the training set was established
Not applicable for a physical sterilizer. The operational parameters (temperature, time, pressure, vacuum cycles) are established based on scientific understanding of microbial inactivation kinetics and validated against industry standards (e.g., ANSI/AAMI ST8:2001) to achieve the desired SAL.
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Section 5
A 510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF PRIMUS PSS5 STEAM STERILIZERS
MAY 21 2009
| Manufacturer: | PRIMUS Sterilizer Company, LLC. | |||||||
|---|---|---|---|---|---|---|---|---|
| 117 South 25th StreetOmaha NE 68131 | ||||||||
| Phone: 402-344-4200 | ||||||||
| Fax: 402-344-4242 | ||||||||
| Contact: | Connie Mansfield, Marketing Mgr. | |||||||
| Omaha NE 68131 | ||||||||
| Phone: 402-344-4200 Ext 1229 | ||||||||
| Date Prepared: | May 4, 2009 |
Introduction:
The PRIMUS PSS5 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 except for larger chamber sizes.
The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers; offered in either horizontal or vertical sliding door applications. The PSS-M unit may be pit-mounted, allowing the optional floor cars to roll directly in to the chamber. All large sized sterilizers have pneumatically powered horizontal operating doors, designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available.
PSS sterilizer units offered under this request for clearance are available in Multi-function or Laboratory/Lo configurations. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration, whereas the Laboratory/Lo units offer vacuum, gravity, and low operating temperature configuration.
PRIMUS Steam Sterilizers models contained within this submission are:
The PRIMUS PSS5 series sterilizers are offered with factory pre-set sterilization cycles described within the Indication for Use Table (See attached Table pg 3).
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Safety
The PRIMUS PSS Steam Sterilizer Series have been validated against FDA recognized consensus standards for electrical safety:
-
AAMI / ANSI / IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: . Collateral Standard - General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
Additionally PRIMUS declares conformance to applicable industry and electrical codes as follows -
. UL 61010A-1, IEC 61010-1 Amendment 2, and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials & for Laboratory Process, IEC 61010-2-041, UL 61010A-2-041.
-
. CNL indicates the product was evaluated to the Canadian Standard for Laboratory Equipment, CAN/CSA-C22.2 No. 1010 and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials and Laboratory Process, CAN/CSA-C22.2 No. 1010.2-041-96.
-
. PRIMUS PSS5 Pressure Vessels are designed, manufactured and tested in accordance with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 Unfired Pressure Vessels.
Validated software designed into the PRIMUS PSS5 series sterilizer provides for fail-safe controls that give appropriate warnings and signals when required conditions have not or if unit maffunctions. The technology designed into the PRIMUS PSS5 Steam Sterilizer Series provides for fail safe controls that provide end users with appropriate warnings and signals when required conditions have not been met or malfunctions occurs. Safety warnings and signals are challenged and verified on each unit, as a function of routine process control testing, during a 100% Factory Acceptance Test conducted at final inspection. Results are documented and maintained in the DHR.
Effectiveness:
PRIMUS has validated sterilizer performance for each load cycle type to ensure that the exposure time, provided in the directions for use statements, have been proven to assure the safety and effectiveness of the PRIMUS PSSS series sterilizer. Internal validation protocols are documented and deemed to be comply to the ANSUAAMI ST8:2001. Hospital steam sterility); a harmonized standard recognized FDA as applicable to the validation of steam sterilizers intended for use in hospitals and other health care facilities and that have a volume greater than 2 cubic feet (ft') (56 liter [L] ) with no exclusions taken. The recognized standard established the minimum construction requirements and performance requirements for hospital sterilizers, using saturated steam as the sterilizing agent.
Declarations of Conformance made by PRIMUS to recognized standards are based on a verification of product performance data, that was independently validated with I indicators were exposed during validation for each cycle type published within the Indications for Use statement. Data output from the validation report was reviewed and found to meet Sterility Assurance Level (SAL) of 10° when the sterilizer is used and maintained as directed.
Operator Information
PRIMUS provides information in the User's Manual that is intended to ensure safe and effective use of the sterilizer. Additional information concerning recommended practices for end users in monitoring sterilizer performance can be found in the ANSI/AAMI ST79:2006 Comprehensive guide to steam sterility assurance in the health care facilities or other applicable standards to assure safe and effective use of the steam sterilization processes for application.
Based on the testing and comparison to the consensus standard, PRIMUS concludes that each of the chamber sizes included under this submission performs as intended and raises no new safety or effectiveness issues when used as directed.
Connie L. Mansfield
Marketing Manager PRIMUS Sterilizer Company, LLC
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| Load Type | Cycle # | Cycle Type | Sterilize Temp | Sterilize Time (min) | Dry Time (min) | No. of Pre-vacs | Maximum Loading Guidelines | ||
|---|---|---|---|---|---|---|---|---|---|
| Chamber Size 26"x36"x 48" | Chamber Size 35"x57"x 82" | Shelving or Optional Loading Equipment | |||||||
| Unwrapped Nonporous Single Instrument | 2 | Vacuum | 132°C (270°F) | 4 | 1 | 3 | 1 | N/A | Shelving |
| 1 | 1 | Loading Eq. | |||||||
| Double wrapped instrument 16 lbs each tray | 3 | Vacuum | 132°C (270°F) | 4 | 30 | 3 | 12 | N/A | Shelving |
| 12 | 42 | Loading Eq. | |||||||
| Textile packs maximum. size: 9" x 9" x 6", 11.3 lb/ft³ | 4 | Vacuum | 132°C (270°F) | 4 | 30 | 3 | 16 | N/A | Shelving |
| 16 | 42 | Loading Eq. | |||||||
| Textile packs maximum size: 9" x 9" x 6", 11.3 Ib/ft³ | 6 | Gravity | 121.1°C (250°F) | 30 | 30 | 0 | 12 | N/A | Shelving |
| 12 | 40 | Loading Eq. | |||||||
| Vented borosilicate glass containers, 1,000 ml Erlenmeyer flask 4" dia x 7" | 7 | Liquids | 121.1°C (250°F) | 30 | 15* | 0 | 200 | N/A | Shelving |
| 240 | 480 | Loading Eq. | |||||||
| Bowie-Dick Test | 8 | Test (VAC) | 134°C (273°F) | 3-1/2 | 2 | 3 | 1 Test Pack | 1 Test Pack | N/A |
- Est Total Cycle Time includes all phases of the cycle (e.g., purge).
** Dry time in LIQUIDS cycle is liquid cool time.
Image /page/2/Picture/5 description: The image shows two warning signs stacked on top of each other. Each sign is a yellow triangle with a black border. Inside each triangle is a black exclamation point. The word "WARNING" is printed in black letters below the top triangle.
WARNING
THE INTENDED USE OF A LIQUID CYCLE IS NOT FOR STERILIZING MATERIALS FOR DIRECT PATIENT CONTACT.
PRIMUS RECOMMENDS THE VALIDATED FACTORY PRESET CYCLES. CHANGES TO THE CYCLE PARAMETERS, PER ANSI/AAMI ST79:2006, ARE NOT RECOMMENDED. CONTACT PRIMUS FOR FURTHER INFORMATION.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 21 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Primus Sterilizer Company, LLC. C/o Mr. Mark Job Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K082817
Trade/Device Name: PRIMUS Steam Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 7, 2009 Received: May 8, 2009
Dear Mr. Job:
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. 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.
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 statutes and regulations administered by other Federal agencies.
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Page 2- Mr. Job
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Kenny
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4
Indications for Use Statement
Applicant: PRIMUS Sterilizer Company, LLC
K082817 510(k) Number:
Device Name: PRIMUS Steam Sterilizers
Indication for Use:
The PRIMUS PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSSS Steam Sterilizer Series are available in the following configurations:
| PSS5-G.1-M*** | (32" x 36" x 48" Multi-Functional Sterilizer) | Single or |
|---|---|---|
| PSS5-G.1-L*** | (32" x 36" x 48" Laboratory/Lo) | Double Door |
| PSS5-M-M*** | (35" x 57" x 60" Multi-Function Sterilizer) | Single or |
| PSS5-M-L*** | (35" x 57" x 60" Laboratory/Lo) | Double Door |
Sterilizers are available both in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles and Laboratory/Lo-Temperature Models.
The Laboratory/Low Temperature models feature a cycle for pasteurization processes of items such as infant formula and other liquids requiring lower temperature sterilization. PRIMUS Sterilizer Company, LLC directions for use cautions this OPTION IS NOT RECOMMENDED FOR REPROCESSING ITEMS FOR DIRECT PATIENT CONTACT.
PRIMUS Sterilizer Company, LLC recommends that a suitable chemical indicator or biological challenge test be used on a periodic basis to test effectiveness of the sterilizer in accordance with health care facilities documented plan for monitoring SAL 104 performance.
The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard linens. The cycles to be cleared for each of the models listed above are found in the table below:
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| Load Type | Cycle # | Cycle Type | Sterilize Temp | Sterilize Time (min) | Dry Time (min) | No. of Pre-vacs | Maximum Loading Guidelines | ||
|---|---|---|---|---|---|---|---|---|---|
| Chamber Size 26"x36"x 48" | Chamber Size 35"x57"x 60" | Shelving or Optional Loading Equipment | |||||||
| Unwrapped Nonporous Single Instrument | 2 | Vacuum | 132°C (270°F) | 4 | 1 | 3 | 1 | N/A | Shelving |
| 1 | 1 | Loading Eq. | |||||||
| Double wrapped instrument 16 lbs each tray | 3 | Vacuum | 132°C (270°F) | 4 | 30 | 3 | 12 | N/A | Shelving |
| 12 | 42 | Loading Eq. | |||||||
| Textile packs maximum. size: 9" x 9" x 6", 11.3 lb/ft³ | 4 | Vacuum | 132°C (270°F) | 4 | 30 | 3 | 16 | N/A | Shelving |
| 16 | 42 | Loading Eq. | |||||||
| Textile packs maximum size: 9" x 9" x 6", 11.3 Ib/ft³ | 6 | Gravity | 121.1°C (250°F) | 30 | 30 | 0 | 12 | N/A | Shelving |
| 12 | 40 | Loading Eq. | |||||||
| Vented borosilicate glass containers, 1,000 ml Erlenmeyer flask 4" dia x 7" | 7 | Liquids | 121.1°C (250°F) | 30 | 15* | 0 | 200 | N/A | Shelving |
| 240 | 480 | Loading Eq. | |||||||
| Bowie-Dick Test | 8 | Test (VAC) | 134°C (273°F) | 3-1/2 | 2 | 3 | 1 Test Pack | 1 Test Pack | N/A |
Est Total Cycle Time includes all phases of the cycle (e.g., purge).
** Dry time in LIQUIDS cycle is liquid cool time.
Image /page/6/Picture/4 description: The image contains two identical warning signs. Each sign is a black triangle with a black exclamation point inside. Below each triangle, the word "WARNING" is printed in black, block letters. The signs appear to be a standard warning symbol used to indicate potential hazards or dangers.
THE INTENDED USE OF A LIQUID CYCLE IS NOT FOR STERILIZING MATERIALS FOR DIRECT PATIENT CONTACT.
PRIMUS RECOMMENDS THE VALIDATED FACTORY PRESET CYCLES. CHANGES TO THE CYCLE PARAMETERS, PER ANSIPAAMI ST79:2006, ARE NOT RECOMMENDED. CONTACT PRIMUS FOR FURTHER INFORMATION.
(Please Do Not Write Below This Line - Continue on Another Page if needed)
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter UseXXX(Part 21 CFR 01 Subpart C) |
|---|---|---|
| ------------------------------------------------- | -------- | ----------------------------------------------------------- |
ODE Concurrence:
Shula A Murphy 49
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082817
CDRH, Office of Device Evaluation ODE)
510(k) Number
§ 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).