(211 days)
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No
The document describes a steam sterilizer with pre-set cycles and validated performance based on established standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a steam sterilizer designed to sterilize medical instruments and materials, not for direct therapeutic treatment of patients.
No
Explanation: The device is a sterilizer designed to sterilize medical materials and equipment. Its function is to kill microorganisms, not to diagnose medical conditions in patients. While sterility is important in a healthcare setting, the device's direct purpose is not diagnostic.
No
The device description clearly states it is a series of steam sterilizers with physical components like chambers, doors, and configurations for different sizes and functionalities. It is a hardware device with integrated software for controlling the sterilization cycles.
Based on the provided text, the PRIMUS PSS Series Steam Sterilizers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical devices and materials in hospital settings and laboratories. This is a process to render items free of microorganisms, not to perform tests on biological samples to diagnose conditions.
- Device Description: The device is described as a steam sterilizer, a Class II medical device used for sterilization.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Performance Studies: The performance studies focus on the effectiveness of the sterilization process (killing biological indicators), not on the accuracy or reliability of diagnostic results.
In summary, the PRIMUS PSS Series Steam Sterilizers are devices used for the sterilization of medical equipment and materials, which is a crucial step in healthcare but is distinct from the function of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations:
13" x 13" x 23" Multi-Functional Sterilizer
13" x 13" x 23" Laboratory/Lo
16" x 16" x 26" Multi-Functional Sterilizer
16" x 16" x 26" Laboratory/Lo
20" x 20" x 38" Multi-Functional Sterilizer
20" x 20" x 38" Laboratory/Lo
26" x 26" x 39" Multi-Functional Sterilizer
26" x 26" x 39" Laboratory/Lo
26" x 26" x 49" Multi-Functional Sterilizer
26" x 26" x 49" Laboratory/Lo
26" x 26" x 67" Multi-Functional Sterilizer
26" x 26" x 67" Laboratory/Lo
26" x 36" x 39" Multi-Functional Sterilizer
26" x 36" x 39" Laboratory/Lo
26" x 36" x 48" Multi-Functional Sterilizer
26" x 36" x 48" Laboratory/Lo
26" x 36" x 60" Multi-Functional Sterilizer
26" x 36" x 60" Laboratory/Lo
26" x 63" x 48" Multi-Functional Sterilizer
26" x 63" x 48" Laboratory/Lo
26" x 63" x 76" Multi-Functional Sterilizer
26" x 63" x 76" Laboratory/Lo
Single Door
Single Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Single or Double Door
Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the vacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.
Product codes (comma separated list FDA assigned to the subject device)
FIF
Device Description
The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration.
The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values:
CYCLES: GRAVITY, STERILIZE TEMP: 132° C, STERILIZE TIME: 4 MINUTES, DRY TIME: 1 MINUTE, RECOMMENDED LOAD: HARD GOODS
CYCLES: VACUUM, STERILIZE TEMP: 132° C, STERILIZE TIME: 4 MINUTES, DRY TIME: 15 MINUTES, RECOMMENDED LOAD: WRAPPED GOODS
CYCLES: LIQUIDS, STERILIZE TEMP: 121° C, STERILIZE TIME: 30 MINUTES, DRY TIME: *8 MINUTES, RECOMMENDED LOAD: LIQUIDS
CYCLES: TEST (VAC), STERILIZE TEMP: 132° C, STERILIZE TIME: 4 MINUTES, DRY TIME: 3 MINUTES, RECOMMENDED LOAD: BOWIE-DICK TEST
*Liquid Cycle is Cool Time
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Hospital operating suites, central sterile supply and clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the sterilizer function and exposure time recommendations has been completed to validate the safety and effectiveness of the PRIMUS PSS series sterilizer. The test plan was derived from AAMI ST8 1994 Volume 1. All tests were performed satisfactory showing complete kill of biological indicators with appropriate sterility assurance level of less than 106.
Results of the validation studies conducted demonstrate the sterilizers perform as intended with the results shown below:
- Compliance to AAMI ST8-1994. This standard establishes the minimum performance for hospital sterilizers that use saturated steam as the sterilizing agent. The standard is applicable for sterilizers with a volume greater than two cubic feet. The PRIMUS PSS series sterilizer vacuum, gravity, and liquids cycles validated per AAMI-ST8 standard.
- Compliance to AAMI ST8-1994. This standard establishes the minimum construction hospital sterilizers that use saturated steam as the sterilizing agent. The PRIMUS PSS series sterilizers meet or exceed this standard in design and construction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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12/3/99
Reference: 21 CFR, Part 807.87(h) Information required in a premarket notification submission.
- A 510(k) summary as described in Sec. 807.92 or a 510(k) statement as (h) described in Sec. 807.93.
A 510(K) SUMMARY PERTAINIING TO THE SAFETY AND EFFECTIVENESS OF THE PRIMUS PSS SERIES STERILIZER
| Manufacturer: | PRIMUS Sterilizer Co., Inc.
117 South 25th Street
Omaha, NE 68131 |
|----------------|-------------------------------------------------------------------------|
| | Phone: 402-344-4200
Fax: 402-344-4242 |
| Contact: | Jeff Reed, Engineering Manager |
| Date Prepared: | May 3, 1999 |
Introduction
The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration.
The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values:
| CYCLES | STERILIZE
TEMP | STERILIZE
TIME | DRY TIME | RECOMMENDED
LOAD |
|------------|-------------------|-------------------|------------|---------------------|
| GRAVITY | 132° C | 4 MINUTES | 1 MINUTE | HARD GOODS |
| VACUUM | 132° C | 4 MINUTES | 15 MINUTES | WRAPPED GOODS |
| LIQUIDS | 121° C | 30 MINUTES | *8 MINUTES | LIQUIDS |
| TEST (VAC) | 132° C | 4 MINUTES | 3 MINUTES | BOWIE-DICK TEST |
*Liquid Cycle is Cool Time
Validation
Evaluation of the sterilizer function and exposure time recommendations has been completed to validate the safety and effectiveness of the PRIMUS PSS series
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1
sterilizer. The test plan was derived from AAMI ST8 1994 Volume 1. All tests were performed satisfactory showing complete kill of biological indicators with appropriate sterility assurance level of less than 106.
Results of the validation studies conducted demonstrate the sterilizers perform as intended with the results shown below:
- Compliance to AAMI ST8-1994. This standard establishes the minimum . performance for hospital sterilizers that use saturated steam as the sterilizing agent. The standard is applicable for sterilizers with a volume greater than two cubic feet. The PRIMUS PSS series sterilizer vacuum, gravity, and liquids cycles validated per AAMI-ST8 standard.
- Compliance to AAMI ST8-1994. This standard establishes the minimum . construction hospital sterilizers that use saturated steam as the sterilizing agent. The PRIMUS PSS series sterilizers meet or exceed this standard in design and construction.
Safety
The PRIMUS PSS series sterilizers are constructed and tested to meet or exceed the requirements of various national safety codes and standards. The PSS series sterilizers comply with the following requirements:
- Underwriters Laboratory (UL) Electromedical Code 544 as certified by the ETL ● Testing Labs, Inc.
- Canadian Standards Association CAN/CSA C22.2 NO. 601.1 as certified by the . ETL Testing Labs, Inc.
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for . unfired pressure vessels.
- California Seismic Pre-Approval. .
- National Fire Protection Association Standard 99. ●
The technology designed into the PRIMUS PSS series sterilizers provides for fail safe controls that give appropriate warnings and signals when required conditions have not been met or malfunctions occur.
To assure of proper operation and sterilization, all items to be processed must be properly cleaned and the manufacturer's instructions must be followed. The sterilizer must be maintained according to the instructions found in the maintenance section of the manual and each type of load must be validated following the applicable standard.
Operator Information
PRIMUS provides information in the Operators Manual that is intended to ensure safe and effective use of the sterilizer. Furthermore, it is recommended that any end user
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consult any applicable AAMI standards to assure safe and effective use of the sterilizer for its intended purpose.
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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that overlap and intersect, creating a sense of movement and dynamism. The seal is black and white and has a simple, clean design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1999
Mr. R. Jeff Reed Engineering Manager Primus Sterilizer Co., Inc. 117 South 25th Street Omaha, Nebraska 68131
K991575 Re : PRIMUS Steam Sterilizers Trade Name: Regulatory Class: II Product Code: FIF Dated: November 24, 1999 November 26, 1999 Received:
Dear Mr. Reed:
We have reviewed your Section 510(k) notification of intent to we have reviewed your section brown and we have determined the market the device referenced above (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the commerce prior to May 20, 1970, devices that have been Medical bevree imendince with the provisions of the Federal Food, Drug, and Cosmetic Act (Act ). You may, therefore, Food, Drug, and Cosmecre Acc (nor, -------------------------------------------------------------------------------------------------------------------------------------------The general controls provisions of the Act of the Act. of the Act. The goncear for annual registration, listing of Include requirementacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be Bublect to Bach adazour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal heguintially equivalent determination assumes compliance with Subscancially Octuring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMP inspections, the Food and Drug Administration (PDA) will werify such assumptions. Failure to comply with the GMP vertif Such abbambult in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any
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Page 2 - Mr. Reed
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the marked.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please coonha the the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistence at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" -
Sincerely yours,
Patricio Cucerita / for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Ver/ 3 - 4/24/96
Applicant: PRIMUS Sterilizer Co., Inc.
510(k) Number: Not known at this time of application
Device Name: PRIMUS Steam Sterilizers
Indications For Use:
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations:
13" x 13" x 23" Multi-Functional Sterilizer 13" x 13" x 23" Laboratory/Lo 16" x 16" x 26" Multi-Functional Sterilizer 16" x 16" x 26" Laboratory/Lo 20" x 20" x 38" Multi-Functional Sterilizer 20" x 20" x 38" Laboratory/Lo 26" x 26" x 39" Multi-Functional Sterilizer 26" x 26" x 39" Laboratory/Lo 26" x 26" x 49" Multi-Functional Sterilizer 26" x 26" x 49" Laboratory/Lo 26" x 26" x 67" Multi-Functional Sterilizer 26" x 26" x 67" Laboratory/Lo 26" x 36" x 39" Multi-Functional Sterilizer 26" x 36" x 39" Laboratory/Lo 26" x 36" x 48" Multi-Functional Sterilizer 26" x 36" x 48" Laboratory/Lo 26" x 36" x 60" Multi-Functional Sterilizer 26" x 36" x 60" Laboratory/Lo 26" x 63" x 48" Multi-Functional Sterilizer 26" x 63" x 48" Laboratory/Lo 26" x 63" x 76" Multi-Functional Sterilizer 26" x 63" x 76" Laboratory/Lo
Single Door Single Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door Single or Double Door
Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the wacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.
Olus S. Lin
(Division Sign-Off) Division of Dental, Infection Cont and General Hospital De 510/k) Number
P-I