(107 days)
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Maximum Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 forrecommended 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 Table2 for recommended quantities. |
| Prevac | 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 2 forrecommended quantities. |
| Prevac-IUSS | 270°F (132°C) | 4 minutes | 1 minute | Immediate use – single unwrappedtray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,maximum weight 25 lbs (11.3 kg)each. Refer to Table 2 forrecommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.
The provided FDA 510(k) summary describes the AMSCO 600 Steam Sterilizer and its nonclinical testing. This document is a premarket notification for a medical device and thus the "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to be deemed substantially equivalent to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance: Meets requirements of ANSI/AAMI ST8 | Meets requirements of ANSI/AAMI ST8 |
| General Electrical Safety: Meets requirements of IEC 61010-1 | Meets requirements of IEC 61010-1 |
| Sterilizer Electrical Safety: Meets requirements of IEC 61010-2-40 | Meets requirements of IEC 61010-2-40 |
| Electromagnetic Compatibility: Meets requirements of FCC 47 CFR Part 15 - Subpart B | Meets requirements of FCC 47 CFR Part 15 - Subpart B |
| Pressure Vessel Safety: Meets requirements of ASME Boiler Pressure Vessel Code, Section VIII (Division 1) | Meets requirements of ASME Boiler Pressure Vessel Code, Section VIII (Division 1) |
| Sterility Assurance Level (SAL): 10^-6 | 10^-6 |
| Ability to sterilize heat and moisture-stable materials: As defined by factory-programmed cycles (various temperatures, times, and dry times for different loads like fabric packs and instrument trays) | The device is designed for sterilization of heat and moisture-stable materials and includes the specified factory-programmed cycles (Table 1 and 2 in the document). The "Performance" test (meeting ANSI/AAMI ST8) would encompass validation of these cycles. |
| Full Loads: The ability to sterilize specified maximum loads for different sterilizer sizes (e.g., 39", 51", 63" models for wrapped instrument trays and fabric packs). | Proposed sterilizer can sterilize larger loads, and maximum load configurations validated per ANSI/AAMI ST8 (as stated in the comparison table under "Full Loads"). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing and references compliance with standards like ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, and ASME Boiler Pressure Vessel Code, Section VIII (Division 1).
- Sample Size: The document does not specify the sample size for these nonclinical tests in terms of specific units tested (e.g., number of sterilizers, number of loads processed). It states that "The testing demonstrated that subject device met the acceptance criteria described in these standards."
- Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. Nonclinical testing typically involves laboratory or in-house validation rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For nonclinical tests of a steam sterilizer, "ground truth" would typically be established by established engineering standards and methodologies, rather than expert human consensus on clinical images or outcomes.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to nonclinical engineering and performance testing of a steam sterilizer. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results (e.g., by multiple radiologists).
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The AMSCO 600 Steam Sterilizer is an automated sterilization device and does not involve human readers for interpretation in the context of its primary function.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the AMSCO 600 Steam Sterilizer. It is a physical device that performs a function (sterilization) based on programmed cycles, not an algorithm that interprets data. Its performance is inherent in its operation and validated against physical and microbiological standards.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets the acceptance criteria is based on:
- Engineering and Performance Standards: Compliance with recognized international and national standards (ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, ASME Boiler Pressure Vessel Code, Section VIII (Division 1)). These standards define acceptable performance metrics for sterilization, electrical safety, EMC, and pressure vessel integrity.
- Microbiological Sterility Assurance: The specification of a Sterility Assurance Level (SAL) of 10^-6 implies that the ground truth for sterilization efficacy is the reduction of microbial population to a probability of 1 in a million, which is typically demonstrated through biological indicator challenges and physical parameter monitoring.
8. The Sample Size for the Training Set
This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set and associated ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2019
STERIS Corporation Anthony Piotrkowski Director of Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K183410
Trade/Device Name: AMSCO 600 Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 1, 2019 Received: March 4, 2019
Dear Anthony Piotrkowski:
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 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. 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) K183410
Device Name
AMSCO 600 Steam Sterilizer
Indications for Use (Describe)
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Maximum Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 forrecommended 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 Table2 for recommended quantities. |
| Prevac | 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 2 forrecommended quantities. |
| Prevac-IUSS | 270°F (132°C) | 4 minutes | 1 minute | Immediate use – single unwrappedtray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,maximum weight 25 lbs (11.3 kg)each. Refer to Table 2 forrecommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART TestPack |
| Leak Test | N/A | N/A | N/A | N/A |
Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values
Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size
| Sterilizer Size | Wrapped Instrument Trays | Fabric Packs |
|---|---|---|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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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)
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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in a bold, sans-serif font at the top of the image, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.
510(k) Summary For AMSCO 600 Steam Sterilizer
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Tony Piotrkowski Contact: Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com
Summary Date: March 1, 2019
Premarket Notification Number: K183410
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION AMSCO 600 Steam Sterilizer
Device Name 1.
| Trade Name: | AMSCO 600 Steam Sterilizer |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Steam Sterilizer |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
2. Predicate Device
K112403 AMSCO Chimeron Steam Sterilizer (later renamed AMSCO 400)
3. Description of Device
The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.
The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).
Intended Use/Indications for Use 4.
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factory-
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STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION AMSCO 600 Steam Sterilizer
programmed cycles (Table 1):
| Cycles | SterilizeTemperature | SterilizeTime | DryTime | Maximum RecommendedLoad |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25 lbs.(11.3 kg) each and Fabric Packs.Refer to Table 2 forrecommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25 lbs.(11.3 kg) each. Refer to Table 2for recommended quantities. |
| Prevac-IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - singleunwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25 lbs.(11.3 kg) each. Refer to Table 2for recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DARTTest Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle |
|---|
| values |
Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26.5" x 26.5" x 39" | 9 | 12 |
| 26.5" x 26.5" x 51" | 12 | 16 |
| 26.5" x 26.5" x 63" | 15 | 20 |
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5. Technological Characteristics
Table 3. Technological Characteristics Comparison Table for AMSCO 600 and AMSCO Chimeron
| Feature | AMSCO 600 Steam Sterilizer(K183410) | AMSCO Chimeron SteamSterilizer(Predicate Device/K112403) | Comparison |
|---|---|---|---|
| IntendedUse | The AMSCO 600 Steam Sterilizeris designed for sterilization of heatand moisture-stable materials usedin healthcare facilities. | The AMSCO Chimeron MediumSteam Sterilizer (Models 39SL and39CSL) are designed forsterilization of heat and moisture-stable materials used in healthcarefacilities. | Same |
| CriticalProcessParameters | • Time• Chamber Temperature• Pressure | • Time• Chamber Temperature• Pressure | Same |
| Control | Embedded Controller | Embedded Controller | Same |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated Steam | Saturated Steam | Same |
| Utilities | Steam, Water, Electricity, Air | Steam, Water, Electricity, Air | Same |
| ChamberMaterial | 316L Stainless Steel | 316L Stainless Steel | Same |
| NominalChamberSize | • 26" w x 26" h x 39" d• 26" w x 26" h x 49" d• 26" w x 26" h x 61" d | 26" w x 26" h x 39" d | Proposed offered inadditional sizes, allvalidated perANSI/AAMI ST8 |
| Door | 304L Stainless Steel26" x 26" Power vertical sliding | 316L Stainless Steel26" x 26" Power vertical sliding | Both stainless steel,same operation |
| ChamberPressureRating | 45 psig, 300°F | 45 psig, 300°F | Same |
| Door Seal | Steam activated door seal | Steam activated door seal | Same |
| ExternalProcessMonitors | • Electronic Control• Printer | • Electronic Control• Printer | Same |
| Feature | AMSCO 600 Steam Sterilizer(K183410) | AMSCO Chimeron SteamSterilizer(Predicate Device/K112403) | Comparison |
|---|---|---|---|
| InternalProcessMonitors | Temperature-Dual element RTD located inchamber drain- RTD located in the jacket drain- RTD located in heat exchangerPressure-Pressure transducer in chamber | Temperature-Dual element RTD located inchamber drain- RTD located in the jacket drain- RTD located in heat exchangerPressure-Pressure transducer in chamber | Same |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2006 | Proposed sterilizermeets currentrevision of thesterilizer standard |
| Accessories | BI, CI, Pouches, Trays, Wraps,Tape, Containers, Shelves,Loading Equipment | BI, CI, Pouches, Trays, Wraps,Tape, Containers, Shelves,Loading Equipment | Same |
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| Test Cycles | Warm Up, Leak Test, DART(Bowie Dick) Test | Warm Up, Leak Test, DART(Bowie Dick) Test | Same |
|---|---|---|---|
| Cycles | 270F, Prevac, 4' Full fabric pack270F, Prevac, 4' Full tray270F, Prevac, 4' one fabric pack270F, Prevac, 4' IUSS275F, Prevac, 3' Full fabric250F, Gravity, 30' Full tray | 270F, Prevac, 4' Full fabric pack270F, Prevac, 4' Full tray270F, Prevac, 4' one fabric pack270F, Prevac, 4' IUSS275F, Prevac, 3' Full fabric250F, Gravity, 30' Full tray250F, Gravity, 30' Full fabric270F, Gravity, 15' Full tray270F, Gravity, 25' Full fabric270F, Gravity, 3' IUSS270F, Gravity, 10' IUSS250F, Liquid, 45', 80-1L bottles | All cycles availableon the proposedsterilizer were alsoavailable on thepredicate |
| Full Loads | • 39": 9, 25-lb double wrappedtrays or 12, fabric packs• 51": 12, 25-lb double wrappedtrays or 16, fabric packs• 63": 15, 25-lb double wrappedtrays or 20, fabric packs | 4, 25-lb double wrapped trays or12, fabric packs | Proposed sterilizercan sterilize largerloads – maximumload configurationsvalidated perANSI/AAMI ST8 |
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION AMSCO 600 Steam Sterilizer
The proposed device has the same intended use and similar indications for use as the predicate with similar technological characteristics. The subject device slightly differ in their design and indications and features to the predicate device.
Summary of Nonclinical Tests 6.
The AMSCO 600 Steam Sterilizer nonclinical test was performed according to the standards described below in Table 4. The testing demonstrated that subject device met the acceptance criteria described in these standards.
| Test | Result | Conclusion |
|---|---|---|
| Performance | Meets requirements of ANSI/AAMI ST8 | PASS |
| General ElectricalSafety | Meets requirements of IEC 61010-1 | PASS |
| Sterilizer ElectricalSafety | Meets requirements of IEC 61010-2-40 | PASS |
| ElectromagneticCompatibility | Meets requirements of FCC 47 CFR Part 15 -Subpart B | PASS |
| Pressure VesselSafety | Meets requirements of ASME Boiler PressureVessel Code, Section VIII (Division 1) | PASS |
Table 4: Non-Clinical Testing of AMSCO 600 Steam Sterilizer
7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device K112403, Class II (21 CFR 880.6860), product code FLE.
§ 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).