(101 days)
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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, Liguid, Leak Test and DART (Bowie-. Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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 39" (660 mm x 660 mm x 991 mm) Model HC-600 .
- Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .
This document is a 510(k) premarket notification for the Amsco Evolution Medium Steam Sterilizer. It focuses on demonstrating substantial equivalence to a predicate device after certain modifications. Therefore, the "study" referred to is the verification and validation activities conducted to ensure the modifications do not affect the safety or effectiveness of the device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Results of Verification / Validation |
|---|---|---|---|
| Control replacement | Performance testing | Per ST8 | Pass |
| Electrical safety | Per IEC 61010-1 | Pass | |
| Software modifications | Software validation | Software shall be appropriately verified and validated | Pass |
| Vacuum pump replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket modification | Door operation check | Proper function after multiple cycles | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of sterilizers tested, number of cycles run). The "test set" in this context refers to the modified sterilizer models (HC-600 and HC-1500) on which the verification and validation activities were performed. The data provenance is not specified beyond "STERIS Corporation" where the studies were conducted. The studies appear to be prospective, as they are verification and validation activities performed on the modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not provided. The acceptance criteria reference industry standards (ST8, IEC 61010-1) and internal functional requirements ("Proper actuation, no alarms," "Proper function after multiple cycles"). It's implied that engineering and regulatory experts at STERIS established these criteria, but their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of performance testing for a sterilizer, "adjudication" in the sense of expert review for ambiguous results is unlikely to be a primary method. The results ("Pass") indicate direct verification against objective criteria.
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
This is not applicable. The device is a steam sterilizer, not an AI-powered diagnostic tool requiring human readability of results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a steam sterilizer, not an algorithm. The software modifications were validated to ensure the sterilizer's proper functioning, not as a standalone diagnostic.
7. The Type of Ground Truth Used
The ground truth for these verification activities is a combination of:
- Industry Standards: AAMI ST8 (often referred to as ST8) for steam sterilization performance and IEC 61010-1 for electrical safety. These are recognized international/national standards for medical device safety and performance.
- Engineering Specifications/Functional Requirements: "Software shall be appropriately verified and validated", "Proper actuation, no alarms", "Proper function after multiple cycles". These are internal specifications derived from the device's design and intended function.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical sterilizer and not an AI/machine learning model that undergoes a "training set" phase.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2018
STERIS Corporation Tony Piotrkowski Sr. Manager, Regulatory Affairs 5960 Heislev Rd. Mentor, Ohio 44060
Re: K173485
Trade/Device Name: Amsco Evolution Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Sterilizer, Steam Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017
Dear Mr. Tony 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173485
Device Name
Amsco Evolution Medium Steam Sterilizer
Indications for Use (Describe)
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisturestable 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, Liguid, Leak Test and DART (Bowie-. Dick) cycles.
The Amsco Evolution Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amsco Evolution Medium Steam Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each andFabric Packs. Refer toTable 5-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Gravity | 250°F (121°C) | 30 minutes | 15minutes | Fabric Packs. Refer toTable 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15minutes | Fabric Packs. Refer toTable 5-3 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.
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The Amsco Evolution Medium Steam Fluse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
| Cycles | Sterilize | Sterilize | Dry Time | Recommended Load |
|---|---|---|---|---|
| Temperature | Time | |||
| SFPP | 270°F (132°C) | 4 minutes | 30minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 5-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each and FabricPacks. Refer to Table 5-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15minutes | Fabric Packs. Refer toTable 5-3 forrecommended quantities. |
| SFPP | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack |
| Prevac | 275°F (135°C) | 3 minutes | 30minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 forrecommended quantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30minutes | Double wrappedinstrument trays,maximum weight 25 lbs(11.3 kg) each. Refer toTable 5-3 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.
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The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Model Number | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|---|
| 26" x 26" x 39" | HC-600 | 9 | 12 |
| 26" x 37 ½" x 60" | HC-1500 | 20 | 36 |
Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline
| Number ofContainers | Volume of Liquid In OneContainer | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
- The liquid cycle is for non-patient contact use only.
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm), Model HC-600 .
- . 26" x 37½" x 60" (660mm x 950mm x 1524mm), Model HC-1500
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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/6/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, sans-serif font at the top of the image. Below the word is a graphic of several horizontal wavy lines, stacked on top of each other. The lines are blue.
510(k) Summary For Amsco Evolution Medium Steam Sterilizer
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Tony Piotrkowski Senior Manager, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 e-mail: tony_piotrkowski@steris.com
Submission Date: February 12, 2018
Premarket Notification Number: K173485
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
Trade Name: Amsco® Evolution Medium 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
AMSCO Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), K082435.
3. Description of Device
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 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 39" (660 mm x 660 mm x 991 mm) Model HC-600 .
- Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .
4. Intended Use
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stabile 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 following factory-programmed sterilization cycles and cycle values (Table 6-1):
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| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. FabricPacks. Refer to Table 6-3for 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 6-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 forrecommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | Fabric Packs. Refer toTable 6-3 for recommendedquantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | $3 \frac{1}{2}$ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. FabricPacks. Refer to Table 6-3for recommendedquantities. |
| SFPP | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. FabricPacks. Refer to Table 6-3for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer toTable 6-3 for recommendedquantities. |
| SFPP | 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 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 6-4 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 |
Table 6-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed Sterilization cycles and cycle values
*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 6-2):
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Table 6-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
*The liquid cycle is for non-patient contact use only.
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The following table (Table 6-3) lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Model Number | WrappedInstrument Trays | Fabric Packs |
|---|---|---|---|
| 26" x 26" x 39" | HC-600 | 9 | 12 |
| 26" x 37 ½" x 60" | HC-1500 | 20 | 36 |
Table 6-3. Amsco Evolution Medium Steam Sterilizer recommended loads
The following table (Table 6-4) provides a guideline for liguid cycle processing. The liquid cycle is for non-patient contact use only.
Table 6-4. Amsco Evolution Medium Steam Sterilizer liquid cycle processing guideline
| Number of Containers | Volume of Liquid InOne Container | Minimum RecommendedSterilize Time at 250°F (121°C) |
|---|---|---|
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Medium Steam Sterilizer is offered in the following chamber sizes:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm) Model HC-600 ●
- 26'' x 37½' x 60'' (660mm x 950mm x 1524mm) ● Model HC-1500
ട്. Discussion of Technological Comparison and Verification Activities
The Evolution Medium Sterilizers are the same as the predicate devices except for the specific modifications described in this submission. There are no differences in the indications for use or technology (including features, materials, and principles of operation) between the proposed and predicate devices. Therefore, the differences between the proposed and predicate devices are limited to the described modifications, and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
The following table summarizes the verification activities that were performed with their respective acceptance criteria to ensure that these modifications do not affect the safety or effectiveness of the Evolution Medium Steam Sterilizers.
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K173485 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500)
| DeviceModification | Verification /ValidationActivity | AcceptanceCriteria | Results ofVerification/Validation |
|---|---|---|---|
| Control replacement | Performance testingElectrical safety | Per ST8Per IEC 61010-1 | Pass |
| Software modifications | Software validation | Software shall be appropriatelyverified and validated | Pass |
| Vacuum pumpreplacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriatelyverified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracketmodification | Door operation check | Proper function aftermultiple cycles | Pass |
6. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device (K082435), Class II (21 CFR 880.6880), 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).