(98 days)
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows: - 26" x 26" x 49" (Model HC 800) .
- 26" x 26" x 61" (Model HC 1000) .
The provided text describes a steam sterilizer and its specifications rather than an AI/ML powered device. Therefore, typical acceptance criteria, study methodologies, and performance metrics associated with AI/ML devices (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment for training/test sets) are not applicable.
The document mainly focuses on the factory-programmed sterilization cycles, cycle values, and recommended load capacities for the STERIS Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000. It's a 510(k) summary for a conventional medical device seeking substantial equivalence to a predicate device.
However, I can extract the acceptance criteria (defined by the device's operational parameters) and the "study" that proves it meets these criteria based on the provided information, interpreting "performance" as the ability to achieve the specified sterilization cycles.
Here's the information re-framed for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are its ability to perform the specified sterilization cycles at defined temperatures, times, and dry times, with recommended load capacities. The reported device performance is that it is equipped with and capable of executing these cycles.
| Cycle Type | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load Performance (Examples) |
|---|---|---|---|---|
| Prevac (270°F) | 270°F (132°C) | 4 minutes | 30 minutes | Able to sterilize Double wrapped instrument trays (max 25 lbs (11.3 kg) each) and Fabric Packs; up to 12 wrapped instrument trays / 16 fabric packs (HC-800), 15/20 (HC-1000). |
| Prevac (270°F) | 270°F (132°C) | 4 minutes | 5 minutes | Able to sterilize Single Fabric Pack. |
| Gravity (250°F) | 250°F (121°C) | 30 minutes | 15 minutes | Able to sterilize Fabric Packs; up to 16 fabric packs (HC-800), 20 (HC-1000). |
| Liquid (250°F) | 250°F (121°C) | 45 minutes | N/A | Able to sterilize 3 containers with 1000 ml liquid each. (Non-patient contact use only). |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Able to perform Bowie-Dick Test Pack, DART Test Pack cycle. |
| SFPP (270°F) | 270°F (132°C) | 4 minutes | 30 minutes | Able to sterilize Double wrapped instrument trays (max 25 lbs (11.3 kg) each) and Fabric Packs; up to 12 wrapped instrument trays / 16 fabric packs (HC-800), 15/20 (HC-1000). |
| Other cycles listed for Prevacuum and SFPP models are similarly specified. | TBD | TBD | TBD | TBD |
Study to Prove Device Meets Acceptance Criteria:
The document is a 510(k) summary, which typically references underlying validation studies but does not provide details of the studies themselves. For a sterilizer, the "study" would be sterilization validation testing in accordance with recognized standards (e.g., AAMI, ISO) to demonstrate that the device consistently achieves sterility assurance levels (SAL) under its specified cycles and loading conditions. The summary states:
- "A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5." (Table 5-5 is not provided in the excerpt).
- The FDA's letter (Page 5) states: "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..."
This indicates that STERIS performed the necessary validation testing (e.g., biological indicator testing, physical parameter monitoring, microbial challenge testing) to demonstrate that the Amsco Evolution Steam Sterilizer could reliably achieve the specified sterilization parameters and sterilize the indicated loads. The results of these tests (summarized but not detailed here) were submitted to the FDA to support the claim of substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are not applicable to this submission. The document describes a steam sterilizer, a non-AI/ML medical device. Therefore, concepts like "test set," "data provenance," "experts," "adjudication," "MRMC studies," "AI assistance," "standalone algorithm performance," "ground truth," and "training set" in the context of AI/ML are not relevant.
For a steam sterilizer, the "ground truth" would be the successful killing of microbial spores (demonstrating sterility) confirmed through laboratory methods (e.g., biological indicator results, microbial challenge tests), and the "test set" would be the series of sterilization cycles performed under various worst-case loading and operating conditions during validation. The number of 'samples' would refer to the number of sterilization cycles performed and the number of biological and physical indicators evaluated. However, those details are not present in this 510(k) summary.
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K091731 STERIS®
510(k) Summary For Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone:(440) 392-7695 Fax No: (440) 357-9198
Summary Date:
June 10, 2009
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Amsco Evolution Medium Steam Sterilizer |
|---|---|
| Models: | HC-800 and HC-1200 |
| Common/Usual Name: | Steam Sterilizer |
| Classification Name: | Steam Sterilizer (21 CFR 880.6880)Product Code 80 FLE |
2. Predicate Device
K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008.
Description of Device 3.
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows:
- 26" x 26" x 49" (Model HC 800) .
- 26" x 26" x 61" (Model HC 1000) .
Intended Use 4.
The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and . DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
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STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION STERIO ABDREVIEW Steam Sterilizer (Models HC-800 and HC-1000)
The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 for recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| DART Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
*The liquid cycle is for non-patient contact use only.
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The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is The Amseo Lyonation Necatall Brown and sterilization cycles and cycle values (Table 4-2):
| Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) | |
|---|---|
| Sterilizer factory-programmed sterilization cvcles and cvcle values |
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer recommended loads per sterilizer size | ||
|---|---|---|
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
| 26" x 26" x 49" | 12 | 16 |
| 26" x 26" x 61" | 15 | 20 |
Table 4-3. Amsco Evolution Medium Steam
The following table is a guideline for liquid cycle processing:
Table 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle Guideline
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The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- · 26" x 26" x 49" (Model HC 800)
- 26" x 26" x 61" (Model HC 1000) .
Description of Safety and Substantial Equivalence 5.
A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-5.
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SEP 17 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert F. Sullivan Senior Director of FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K091731
Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880. 6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 13, 2009 Received: August 14, 2009
Dear Mr. Sullivan;
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.
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Page 2 - Mr. Sullivan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA. has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 yours.
Anthony O. Winston ber.
Susan Runner, D.D.S., M.A. Acting Division 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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Indications for Use
510(k) Number (if known):
Device Name:
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
Indications For Use:
The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are r no rimboo of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART . (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the Fillowing factory-programmed sterilization cycles and cycle values (Table 4-1):
| Cycles | SterilizeTemperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 for recommendedquantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2): '
| Cycles | Sterilize Temperature | Sterilize Time | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3 for recommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg) each. Refer to Table 4-3 for recommended quantities. |
Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 4-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 4-3 forrecommended quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 4-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 4-3 forrecommended quantities. |
| Liquid | 250°F (121°C) | 45 minutes | N/A | Refer to Table 4-4 forrecommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3 ½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
*The liquid cycle is for non-patient contact use only.
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer recommended loads per sterilizer size | ||
|---|---|---|
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
| 26" x 26" x 49" | 12 | 16 |
| 26" x 26" x 61" | 15 | 20 |
Table 4-3. Amsco Evolution Medium Steam
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The following table is a guideline for liquid cycle processing:
Table 4-4. Amsco Evolution Medium Steam
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
Sterilizer Liquid Cycle Guideline
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 49" (Model HC 800) .
- 26" x 26" x 61" (Model HC 1000)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K 09173 i Shuli M. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091731
§ 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).