The Amsco 400 Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

Prevacuum (Models 16, 16C and 20, 20C) – are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are equipped with SFPP, . Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles

Device Description

The AMSCO 400 Steam 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 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.

AI/ML Overview

The provided document is a 510(k) summary for STERIS AMSCO 400 Small and Medium Steam Sterilizers. It describes the device, its intended use, and a summary of nonclinical tests performed to demonstrate substantial equivalence to predicate devices.

Key takeaway: This document is NOT about an AI/ML powered medical device. It's about a steam sterilizer that underwent a modification to replace an obsolete control chip. The performance testing described is related to ensuring the sterilizer still functions as intended and meets safety and functional requirements, not evaluating an AI algorithm's diagnostic or predictive capabilities.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and study design (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training set) is not applicable to this document.

However, I can extract the acceptance criteria and performance data related to the sterilizer's functionality.

Acceptance Criteria and Reported Device Performance (Table for Sterilizer Functionality)

The core acceptance criterion for this device modification is demonstrating that the updated sterilizer performs as safe, as effective, and performs as well or better than the legally marketed predicate device. This is assessed by ensuring all safety and functional tests related to the software (which controls the sterilizer) pass.

Acceptance Criteria (General)	Reported Device Performance
Maintain the same indications for use as the predicate device.	The modified sterilizers have the same indications for use as the predicate devices.
Maintain the same intended use as the predicate device.	The modified sterilizers have the same intended use as the predicate devices.
Maintain the same technological characteristics (features and principles of operation) as the predicate device, or any differences raise no new concerns of safety and effectiveness.	There are no differences in technology (including features and principles of operation) between the proposed and predicate devices. The differences are limited to the described modifications (replacement of an obsolete control chip), and these proposed changes raise no new concerns of safety and effectiveness.
Software validation per IEC 62304.	All safety and functional tests pass.

Inapplicability of AI/ML Specific Information for this Device (due to device type):

Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. For this device (steam sterilizer), testing involves functional performance validation. The document states "Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design." The exact number of test cycles or sterilization runs is not specified in this summary but would be part of the full validation report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's function would be objective measurements (temperature, pressure, time) and sterility indicators, not expert consensus on interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software validation" is for the control system of a physical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a steam sterilizer, ground truth would be established through objective measures like:
- Biological indicators (presence/absence of microbial growth after sterilization).
- Chemical indicators (changes in color/form indicating exposure to sterilization conditions).
- Physical monitoring (temperature and pressure sensors within the sterilizer chamber matching specified cycle parameters).
The sample size for the training set: Not applicable. There is no AI/ML training involved.
How the ground truth for the training set was established: Not applicable. There is no AI/ML training involved.

In summary, the provided document relates to a traditional medical device (steam sterilizer) undergoing a minor modification (chip replacement) and its regulatory clearance based on demonstrating continued performance equivalence to predicate devices, rather than an AI/ML-powered device. Therefore, the detailed questions about AI/ML specific study design are not addressed in this document.

Summary

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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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

October 28, 2021

STERIS Corporation % Anthoy Piotrkowski Director, Regulatory Affairs STERIS Corporation 5960 Heislev Rd Mentor, OH 44060

Re: K212424

Trade/Device Name: AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 24, 2021 Received: September 27, 2021

Dear Anthoy 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212424/S001 Device Name

Amsco 400 Small Steam Sterilizer

Indications for Use (Describe)

Prevacuum (Models 16, 16C and 20, 20C) – are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are equipped with SFPP, . Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

Table 4-1.

Amsco 400 Small Prevacuum Steam Sterilizer Models 16, 16, 20, 20C factory-validated sterlization cycles and cycle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F(132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Prevac	270°F(132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each and Fabric Packs. Refer to Table4-3 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 25lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Prevac(ImmediateUse)	270°F(132°C)	4 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	250°F(121°C)	30minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity	270°F(132°C)	15minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	250°F(121°C)	30minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	270°F(132°C)	25minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity(ImmediateUse)	270°F(132°C)	3 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer toTable 4-3 for recommended quantities.

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Gravity(ImmediateUse)	270°F(132°C)	10minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer toTable 4-3 for recommended quantities.
Liquid*	250°F(121°C)	45minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4-4 forrecommended full load quantities.
DARTWarm-Up	270°F(132°C)	3 minutes	1 minute	N/A
DART	270°F(132°C)	3 ½minutes	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 400 Small Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 4-2):

Table 4-2.

Amsco 400 Small Steam Flush Pressure-Pulse (SFPP)Sterilizer Models 16S, 16CS, 20S, factory-validated sterilization cycles and cycle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
SFPP	270°F(132°C)	4minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each and Fabric Packs.Refer to Table 4-3 for recommended quantities.
SFPP	270°F(132°C)	4minutes	20 minutes	Fabric Packs. Refer to Table 4-3 forrecommended quantities.
SFPP	275°F(135°C)	3minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities.
SFPP	270°F(132°C)	4minutes	5 minutes	Single Fabric Pack
Prevac	270°F(132°C)	4minutes	20 minutes	Fabric Packs. Refer to Table 4-3 forrecommended quantities.
Prevac	270°F(132°C)	4minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each and Fabric Packs.Refer to Table 4-3 for recommended quantities.
Prevac	270°F(132°C)	4minutes	5 minutes	Single Fabric Pack
Prevac	275°F(135°C)	3minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities.
Prevac(ImmediateUse)	270°F(132°C)	4minutes	1 minutes	Unwrapped instrument tray with a singleinstrument or multiple unwrapped instrumenttrays, maximum weight 25 lbs (11.3 kg) each.Refer to Table 4-3 for recommended quantities.
Gravity	250°F(121°C)	30minutes	15 minutes	Fabric Packs. Refer to Table 4-3 forrecommended quantities.
Gravity	270°F(132°C)	15minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities.
Gravity	250°F(121°C)	30minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table 4-3for recommended quantities.
Gravity	270°F(132°C)	25minutes	15 minutes	Fabric Packs. Refer to Table 4-3 forrecommended quantities.

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Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Gravity(ImmediateUse)	270°F(132°C)	3minutes	1 minutes	Unwrapped instrument tray with a singleinstrument or multiple unwrapped instrumenttrays, non-porous load, maximum weight 25 lbs(11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity(ImmediateUse)	270°F(132°C)	10minutes	1 minutes	Unwrapped instrument tray with a singleinstrument or multiple unwrapped instrumenttrays, non-porous load, maximum weight 25 lbs(11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Liquid*	250°F(121°C)	45minutes	N/A	Validated with 3 1000ml bottles. Refer to Table4-4 for recommended full load quantities.
DARTWarm-Up	270°F(132°C)	3minutes	1 minute	N/A
DART	270°F(132°C)	3 ½minutes	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 Size	Wrapped Instrument Trays	Fabric Packs
16" x 16" x 26"	2	4
20" x 20" x 38"	3	6

The following table is a guideline for liquid cycle processing:

Table 4-4 Amsco 400 Small Steam Sterilizer Liquid* Cycle Guideline

Sterilizer Size	Number of Containers for full load	Number of Containers for validation	Volume of Liquid In One Container	Minimum Recommended Sterilize Time at 250°F (121°C)
16" x 16" x 26"	15	3	1000 ml	45 minutes
20" x 20" x 38"	32	3	1000 ml	45 minutes

*The liquid cycle is for non-patient contact use only.

The Amsco 400 Small Steam Sterilizer is offered in the following chamber sizes:

16" x 16" x 26" (Models 16, 16C, 16CS, and 16S) ●
20" x 20" x 38" (Models 20, 20C, 20CS, and 20S) .

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K212424/S001 Device Name

AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL)

Indications for Use (Describe)

Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. ●
The AMSCO 400 Medium Prevacuum Steam Sterilizers are equipped with the following factoryprogrammed sterilization cycles and cycle values (Table 4.5):

Table 4.5.

AMSCO 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cycle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each and Fabric Packs. Refer to Table4.6 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 25lbs (11.3 kg) each. Refer to Table 4.6 for recommendedquantities.
Prevac(ImmediateUse)	270°F (132°C)	4 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table A-2 forrecommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4.6 for recommendedquantities.
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4.6 for recommendedquantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Gravity(ImmediateUse)	270°F (132°C)	3 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer to Table4.6 for recommended quantities.
Gravity(ImmediateUse)	270°F (132°C)	10 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer to Table4.6 for recommended quantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4.7 forrecommended full load quantities.
DARTWarm-Up	270°F (132°C)	3 minutes	1 minute	N/A
Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
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

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*The liquid cycle is for non-patient contact use only.

The following table lists STERIS' full loads by sterilizer size:

Table 4.6

AMSCO 400 Medium Steam Sterilizer full load per sterilizer size

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 26" x 39"	4	12

The following table is a guideline for liquid cycle processing:

Table 4.7 AMSCO 400 Medium Steam Sterilizer Liquid Cycle Guideline

Sterilizer Size	Number of Containers for full load	Number of Containers for validation	Volume of Liquid In One Container	Minimum Recommended Sterilize Time at 250°F (121°C)
26" x 26" x 39"	80	3	1000 ml	45 minutes

*The liquid cycle is for non-patient contact use only.

The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 26" x 39" (Models 39SL and 39CSL) ●
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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Indications for Use

510(k) Number (if known) K212424/S001 Device Name

AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60CH, 36CSL, 48CSL and 60CSL)

Indications for Use (Describe)

The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles
The Amsco 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.8):

Table 4.8.

Amsco 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cycle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F(132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4.9 for recommendedquantities.
Prevac	270°F(132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each and Fabric Packs. Refer to Table 4.9for 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 25lbs (11.3 kg) each. Refer to Table 4.9 for recommendedquantities.
Gravity	250°F(121°C)	30minutes	15 minutes	Fabric Packs. Refer to Table 4.9 for recommendedquantities.
Gravity	270°F(132°C)	15minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4.9 for recommendedquantities.
Gravity	250°F(121°C)	30minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4.9 for recommendedquantities.
Gravity	270°F(132°C)	25minutes	15 minutes	Fabric Packs. Refer to Table 4.9 for recommendedquantities.
Liquid*	250°F(121°C)	45minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4.10 forrecommended full load quantities.
DARTWarm-Up	270°F(132°C)	3 minutes	1 minute	N/A
DART	270°F(132°C)	3 ½minutes	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:

Table 4.9
Amsco 400 Medium Steam Sterilizer recommended loads per sterilizer size

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 37.5" x 36"	9	18

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26" x 37.5" x 48"	12	30
26" x 37.5" x 60"	15	36

The following table is a guideline for liquid cycle processing:

Table 4.10 AMSCO 400 Medium Steam Sterilizer Liquid Cycle Guideline

Sterilizer Size	Number of Containers for full load	Number of Containers for validation	Volume of Liquid In One Container	Minimum Recommended Sterilize Time at 250°F (121°C)
26" x 37.5" x 36"	112	3	1000 ml	45 minutes
26" x 37.5" x 48"	154	3	1000 ml	45 minutes
26" x 37.5" x 60"	196	3	1000 ml	45 minutes

*The liquid cycle is for non-patient contact use only.

The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 37.5" x 36" (Models 36H, 36CH, 36CH, 36CSL, 36CSL) ●
26" x 37.5" x 48" (Models 48H, 48CH, 48CH, 48CSL) ●
26" x 37.5" x 60" (Models 60H, 48CH, 48CH, 48CSL) ●

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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K212424/S001 510(k) Summary For AMSCO 400 Small Steam Sterilizers

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: (440) 392-7437 Email:

Summary Date: August 3, 2021

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Device Name 1.

Trade Name:	AMSCO 400 Small Steam Sterilizer (cleared asAMSCO Chimeron Small 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 Devices

K111223 - AMSCO Chimeron Small Steam Sterilizer (renamed AMSCO 400 before commercialization)

The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.

3. Description of Devices

4. Intended Use / Indications for Use

The Amsco 400 Small Steam Sterilizer models 16, 16CS, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

Prevacuum (Models 16, 16C and 20, 20C) are equipped with Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
. Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) - are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

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The Amsco 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):

Table 4-1.

Amsco 400 Small Prevacuum Steam Sterilizer Models 16, 16, 20, 20C factory-validated sterilization cycles and cycle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each and Fabric Packs. Refer to Table 4-3for 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 25lbs (11.3 kg) each. Refer to Table 4-3 for recommendedquantities.
Prevac(ImmediateUse)	270°F (132°C)	4 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4-3 for recommendedquantities.
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays, maximum weight 25lbs (11.3 kg) each. Refer to Table 4-3 for recommendedquantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity(ImmediateUse)	270°F (132°C)	3 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer to Table4-3 for recommended quantities.
Gravity(ImmediateUse)	270°F (132°C)	10 minutes	1 minutes	Unwrapped instrument tray with a single instrument ormultiple unwrapped instrument trays, non-porous load,maximum weight 25 lbs (11.3 kg) each. Refer to Table4-3 for recommended quantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4-4 forrecommended full load quantities.
DARTWarm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3 ½minutes	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 instrument trays, maximum weight25 lbs (11.3 kg) each and Fabric Packs. Refer toTable 4-3 for recommended quantities.
SFPP	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
SFPP	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
SFPP	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each and Fabric Packs. Refer toTable 4-3 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 weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Prevac(ImmediateUse)	270°F (132°C)	4 minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	250°F (121°C)	30minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity	270°F (132°C)	15minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	250°F (121°C)	30minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4-3 forrecommended quantities.
Gravity	270°F (132°C)	25minutes	15 minutes	Fabric Packs. Refer to Table 4-3 for recommendedquantities.
Gravity(ImmediateUse)	270°F (132°C)	3 minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, non-porousload, maximum weight 25 lbs (11.3 kg) each. Referto Table 4-3 for recommended quantities.
Gravity(ImmediateUse)	270°F (132°C)	10minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, non-porousload, maximum weight 25 lbs (11.3 kg) each. Referto Table 4-3 for recommended quantities.
Liquid*	250°F (121°C)	45minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4-4for recommended full load quantities.
Cycles	Sterilize Temperature	Sterilize Time	Dry Time	Recommended Load
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 400 Small Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-2):

Table 4-2.

Amsco 400 Small Steam Flush Pressure-Pulse (SFPP)Sterilizer Models 16S, 16CS, 20S, 20CS factory-validated sterilization cycles and cycle values

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*The liquid cycle is for non-patient contact use only.

The following table lists STERIS's recommended loads by sterilizer size:

Table 4-3
-----------	--

Amsco 400 Small Steam Sterilizer recommended loads per sterilizer size

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
16" x 16" x 26"	2	4
20" x 20" x 38"	3	6

The following table is a guideline for liquid cycle processing:

Sterilizer Size	Number of Containersfor full load	Number of Containersfor validation	Volume of LiquidIn One Container	Minimum RecommendedSterilize Time at 250°F(121°C)
16" x 16" x 26"	15	3	1000 ml	45 minutes
20" x 20" x 38"	32	3	1000 ml	45 minutes

Table 4-4 Amsco 400 Small Steam Sterilizer Liquid* Cycle Guideline

*The liquid cycle is for non-patient contact use only.

The Amsco 400 Small Steam Sterilizer is offered in the following chamber sizes:

16" x 16" x 26" (Models 16, 16C, 16CS, and 16S) ●
20" x 20" x 38" (Models 20, 20C, 20CS, and 20S) ●

5. Summary of Nonclinical Tests

The modified sterilizers have the same indications for use, intended use and same technological characteristics as the predicate devices. Performance testing to demonstrate substantial equivalence to the predicate, using the same methods as were used to validate the original design, is summarized below.

Test	Result	Conclusion
Software validation per IEC 62304	All safety and functional tests pass	PASS

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6. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Small Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K111223, Class II (21 CFR 880.6880), product code FLE.

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K212424/S001 510(k) Summary For AMSCO 400 Medium 26" x 26" Steam Sterilizers

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: (440) 392-7437 tony_piotrkowski@steris.com Email:

Summary Date: August 3, 2021

{17}------------------------------------------------

Device Name 6.

Trade Name:	AMSCO 400 Medium26" x 26" Steam Sterilizer
Device Class:	Class II
Common/usual Name:	Steam Sterilizer
Classification Name:	Sterilizer, Steam
Classification Number:	21 CFR 880.6880
Product Code:	FLE

7. Predicate Devices

K112403 - Chimeron Medium 26" x 26" Steam Sterilizer (renamed AMSCO 400 before commercialization)

The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.

8. Description of Devices

9. Intended Use / Indications for Use

Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART ● (Bowie-Dick) cycles.
The AMSCO 400 Medium Prevacuum Steam Sterilizers are equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.5):

{18}------------------------------------------------

Table 4.5.

AMSCO 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cycle values

AMSCO 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cycle values
Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each and Fabric Packs. Refer toTable 4.6 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 weight25 lbs (11.3 kg) each. Refer to Table 4.6 forrecommended quantities.
Prevac(ImmediateUse)	270°F (132°C)	4 minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, maximumweight 25 lbs (11.3 kg) each. Refer to Table A-2 forrecommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Gravity	270°F (132°C)	15 minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4.6 forrecommended quantities.
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays, maximum weight25 lbs (11.3 kg) each. Refer to Table 4.6 forrecommended quantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer to Table 4.6 for recommendedquantities.
Gravity(ImmediateUse)	270°F (132°C)	3 minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, non-porousload, maximum weight 25 lbs (11.3 kg) each. Refer toTable 4.6 for recommended quantities.
Gravity(ImmediateUse)	270°F (132°C)	10 minutes	1 minutes	Unwrapped instrument tray with a single instrumentor multiple unwrapped instrument trays, non-porousload, maximum weight 25 lbs (11.3 kg) each. Refer toTable 4.6 for recommended quantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4.7 forrecommended full load 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' full loads by sterilizer size:

Table 4.6
AMSCO 400 Medium Steam Sterilizer full load per sterilizer size
Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 26" x 39"	4	12

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The following table is a guideline for liquid cycle processing:

Table 4.7 AMSCO 400 Medium Steam Sterilizer Liquid Cycle Guideline

Sterilizer Size	Number ofContainersfor fullload	Number ofContainersfor validation	Volume ofLiquid In OneContainer	MinimumRecommendedSterilize Time at250°F (121°C)
26" x 26" x 39"	80	3	1000 ml	45 minutes

*The liquid cycle is for non-patient contact use only.

The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:

26' x 26' x 39" (Models 39SL and 39CSL) ●

10. Summary of Nonclinical Tests

Test	Result	Conclusion
Software validation per IEC 62304	All safety and functional tests pass	PASS

6. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Medium 26" x 26" Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K112403, Class II (21 CFR 880.6880), product code FLE.

{20}------------------------------------------------

K212424/S001 510(k) Summary For AMSCO 400 Medium Steam Sterilizers

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: (440) 392-7437 Email: tony_piotrkowski@steris.com

Summary Date: August 3, 2021

{21}------------------------------------------------

Device Name 11.

Trade Name:	AMSCO 400 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

12. Predicate Devices

K112055 - AMSCO 400 Medium Steam Sterilizer (renamed AMSCO 400 before commercialization)

The proposed device is identical to the predicate except for the modification to replace an obsolete control chip.

13. Description of Devices

14. Intended Use / Indications for Use

Prevacuum equipped with Prevacuum, Gravity, Liquid, Leak Test and DART ● (Bowie-Dick) cycles
The Amsco 400 Small Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4.8):

{22}------------------------------------------------

Table 4.8.

Amsco 400 Medium Prevacuum Steam Sterilizer factory-validated sterilization cycles and cvcle values

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 4.9 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 4.9 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 4.9 for recommended quantities.
Gravity	250°F (121°C)	30 minutes	15 minutes	Fabric Packs. Refer to Table 4.9 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 4.9 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 4.9 for recommended quantities.
Gravity	270°F (132°C)	25 minutes	15 minutes	Fabric Packs. Refer to Table 4.9 for recommended quantities.
Liquid*	250°F (121°C)	45 minutes	N/A	Validated with 3 1000ml bottles. Refer to Table 4.10 for recommended full load 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:

Table 4.9

Amsco 400 Medium Steam Sterilizer recommended loads per sterilizer size

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 37.5" x 36"	9	18
26" x 37.5" x 48"	12	30
26" x 37.5" x 60"	15	36

The following table is a guideline for liquid cycle processing:

{23}------------------------------------------------

Table 4.10

AMSCO 400 Medium Steam Sterilizer Liquid Cycle Guideline

Sterilizer Size	Number of Containers for full load	Number of Containers for validation	Volume of Liquid In One Container	Minimum Recommended Sterilize Time at 250°F (121°C)
26" x 37.5" x 36"	112	3	1000 ml	45 minutes
26" x 37.5" x 48"	154	3	1000 ml	45 minutes
26" x 37.5" x 60"	196	3	1000 ml	45 minutes

*The liquid cycle is for non-patient contact use only.

The AMSCO 400 Medium Steam Sterilizer is offered in the following chamber sizes:

26" x 37.5" x 36" (Models 36H, 36CH, 36SL, 36CSL)
26" x 37.5" x 48" (Models 48H, 48CH, 48CH, 48CSL) ●
26" x 37.5" x 60" (Models 60H, 48CH, 48CH, 48CSL)

15. Summary of Nonclinical Tests

Test	Result	Conclusion
Software validation per IEC 62304	All safety and functional tests pass	PASS

6. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the AMSCO 400 Medium Steam Sterilizer is as safe, as effective and performs as well or better than the legally marketed predicate device K112055, Class II (21 CFR 880.6880), product code FLE.

Regulation Number and Section

§ 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).