(102 days)
The Amsco Evolution Series Steam Sterilizer Models HC-3000 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 Amso Evolution Series Prevacum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 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 | 15 minutes | 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 | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | 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.
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 5-3 forrecommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 5-3 forrecommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table5-3 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 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Table 5-2. Amso Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and ycle values | ||||
| *The liquid cycle is for non-patient contact use only. |
The Amsco Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 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 Floorloader Steam Sterilizer Models are as follows: - 26" x 61" x 49" (Model HC 2000) .
- 26'' x 61'' x 72'' (Model HC 3000)
The document describes the Amsco Evolution Floorloader Steam Sterilizer (HC-2000 and HC-3000) and its substantial equivalence to a predicate device. The information provided primarily focuses on the device's technical specifications, intended use, and the verification activities conducted for specific modifications. It does not contain a typical "study" proving device performance against acceptance criteria in the sense of a clinical trial or an AI algorithm's performance study with expert ground truth.
Instead, the "acceptance criteria" and "device performance" relate to engineering verification and validation activities for modifications made to an existing device.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the 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 | |
| Door gasket replacement | Door operation check | Proper function and no alarms after multiple cycles | 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 the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The verification activities described are typical engineering tests, not studies with "test sets" of data in the context of an AI/algorithm.
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 provided. The acceptance criteria primarily refer to engineering standards (e.g., ST8, IEC 61010-1) and functional tests, not expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As these are engineering verification tests, an adjudication method for a test set (as typically used in clinical studies) would not be applicable.
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 information is not provided. This document pertains to a steam sterilizer, a medical device, but it is not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is not an algorithm or AI system, so the concept of standalone performance for an algorithm does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the verification activities appears to be based on established engineering standards and functional requirements. For example, "Per ST8" or "Per IEC 61010-1" explicitly states the standard utilized. For functional checks like "Door operation check," the ground truth is "Proper function and no alarms after multiple cycles." This is an objective functional outcome, not based on expert consensus, pathology, or outcomes data in a medical diagnostic sense.
8. The sample size for the training set
This information is not provided. This device is a steam sterilizer, not an AI or machine learning system that would have a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable to the device described.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K173493
Trade/Device Name: Amsco Evolution Floorloader Steam Sterilizer HC-2000 And HC-3000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 12, 2017 Received: December 26, 2017
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. 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 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.
{1}------------------------------------------------
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
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)
Device Name
Amsco Evolution Floorloader Steam Sterilizer (HC-2000 and HC-3000)
Indications for Use (Describe)
The Amsco Evolution Series Steam Sterilizer Models HC-3000 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 Amso Evolution Series Prevacum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amso Evolution Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
| 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 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 | 15 minutes | 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 | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 25 minutes | 15 minutes | 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.
{3}------------------------------------------------
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):
| Cycles | SterilizeTemperature | SterilizeTime | Dry Time | Recommended Load |
|---|---|---|---|---|
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 5-3 forrecommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 5-3 forrecommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table5-3 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 4-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 5-3 for recommendedquantities. |
| Liquid* | 250°F (121°C) | 45 minutes | N/A | Refer to Table 5-4 forrecommended quantities. |
| DARTWarm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
Table 5-2. Amso Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and ycle values
*The liquid cycle is for non-patient contact use only.
{4}------------------------------------------------
The following table lists STERIS's recommended loads by sterilizer size:
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 61" x 49" HC-2000 | 15 | 40 |
| 26" x 61" x 72" HC-3000 | 25 | 60 |
Table 5-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size
The following table is a guideline for liquid cycle processing:
Table 5-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| Number of | Volume of Liquid In One | Minimum Recommended |
|---|---|---|
| Containers | Container | Sterilize Time at 250°F (121°C) |
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- Model HC 2000 26" x 61" x 49" .
- . Model HC – 3000 26" x 61" x 72"
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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 all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue.
510(k) Summary For Amsco Evolution Floorloader 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: K173493
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{7}------------------------------------------------
Device Name 1.
Trade Name: Amsco Evolution Floorloader Steam Sterilizer HC-2000 And HC-3000
| 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 Floorloader Steam Sterilizer (Models HC-2000 and HC-3000), K092490.
3. Description of Device
The Amsco Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 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 Floorloader Steam Sterilizer Models are as follows:
- 26" x 61" x 49" (Model HC 2000) .
- 26'' x 61'' x 72'' (Model HC 3000)
4. Intended Use
The Amsco Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 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.
{8}------------------------------------------------
The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-1):
| 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 andFabric Packs. Refer toTable 6-3 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 6-3 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 6-3 for recommendedquantities. |
| Gravity | 270°F (132°C) | 15 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each. Refer toTable 6-3 for recommendedquantities. |
| Gravity | 250°F (121°C) | 30 minutes | 45 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 ½ minutes | 1 minute | Bowie-Dick Test Pack,DART Test Pack |
| Leak Test | N/A | N/A | N/A | N/A |
| Cycles | SterilizeTemperature | Sterilize Time | Dry Time | Recommended Load |
| SFPP | 270°F (132°C) | 4 minutes | 45 minutes | Double wrapped instrumenttrays, maximum weight 25lbs (11.3 kg) each and FabricPacks. Refer to Table 6-3 forrecommended quantities. |
| SFPP | 275°F (135°C) | 3 minutes | 45 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 and FabricPacks. Refer to Table 6-3 forrecommended quantities. |
| Gravity | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs. Refer to Table6-3 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 | 45 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 Series Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
*The liquid cycle is for non-patient contact use only.
{9}------------------------------------------------
The Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 6-2):
Table 6-2. Amsco Evolution Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cvcle values
*The liquid cycle is for non-patient contact use only.
{10}------------------------------------------------
The following table lists STERIS's recommended loads by sterilizer size:
Table 6-3. Amsco Evolution Series Steam Sterilizer recommended loads per sterilizer size
| Sterilizer Size | Wrapped InstrumentTrays | Fabric Packs |
|---|---|---|
| 26" x 61" x 49" HC-2000 | 15 | 40 |
| 26" x 61" x 72" HC-3000 | 25 | 60 |
The following table is a guideline for liquid cycle processing:
Table 6-4. Amsco Evolution Series Steam Sterilizer Liquid Cycle Guideline
| Number of | Volume of Liquid In One | Minimum Recommended |
|---|---|---|
| Containers | Container | Sterilize Time at 250°F (121°C) |
| 3 | 1000 ml | 45 minutes |
The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
- Model HC 2000 26" x 61" x 49" ●
- Model HC 3000 226' x 61" x 72" ●
ട്. Description of Safety and Substantial Equivalence
The Evolution Floorloader 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 Floorloader Steam Sterilizers.
| DeviceModification | Verification /ValidationActivity | AcceptanceCriteria | Results ofVerification/Validation |
|---|---|---|---|
| Control replacement | Performance testingElectrical safety | Per ST8Per IEC 61010-1 | Pass |
| Door gasket replacement | Door operation check | Proper function and noalarms after multiple cycles | Pass |
{11}------------------------------------------------
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173493 Amsco Evolution Floorloader Steam Sterilizer
| DeviceModification | Verification /ValidationActivity | AcceptanceCriteria | Results ofVerification/Validation |
|---|---|---|---|
| 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 (K092490), 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).