The STERIS Amsco Reliance Family of Washer / Disinfectors are indicated for use in the cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid instruments such as forceps and clamp, and other similar and related articles found in healthcare facilities.

Device Description

The Amsco Reliance Family of Washer/Disinfectors are mechanical, computercontrolled Washer/Disinfectors. They are designed with pre-programmed cycles intended specifically for surgical instruments, delicate instrumentation (gentle cycle), utensils, glassware, plastic goods, anesthesia/respiratory goods and equipment decontamination. Additional cycles are available for customized programming to meet specific operating requirements.

Essentially, the Amsco Reliance Family of Washer/Disinfectors operate as follows: the load items are placed in the chamber where they are exposed to pressurized fluids delivered through a circulation system driven by a pump and controlled by a programmable computer. Injection pumps allow the automatic delivery of the selected chemicals in the sump water. Available configurations include steam or electrical heating of the sump water; and the drying option (electrically heated on some models. steam heated on others). The cabinet, chamber, and circulation system (including the pump) are primarily constructed of stainless steel.

The available cycle phases can be summarized as follows:

1. cold tap water pre-wash for the removal of gross soil;
soaking in an enzymatic solution to break down proteinaceous materials; 2.
1. detergent wash to complete the soil removal:
sonic cleaning to remove fine debris in crevices:
hot tap water rinse to remove detergent and soil residues:
thermal rinse to disinfect the load items;
1. pure water rinse and instrument lubrication:
1. drvina.

Note: Phases 2 and 4 are not offered on all models. Phases 2, 4, 7 and 8 are optional features.

The available accessories include a variety of single and multi-level loading racks, and transfer carts. Some models offer conveyor systems used to automate the loading of racks into the chamber, to initiate the proper cycle by reading a bar code tag located on the loading rack, and to provide queuing capacity.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study presented in the provided text for the Amsco® Reliance® Family of Washer/Disinfectors, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on performance tests for cleaning, residue removal, thermal low-level disinfection, equipment decontamination, and instrument lubrication. The most detailed acceptance criteria and results are given for residue testing.

Test Property (Chemical)	Type of Item Tested	Acceptance Criteria (mg/item)	Reported Device Performance (mg/item)¹
STERIS Liqui-Jet (Residue)	Surgical Instruments	0.79	0.023
	Micro Surgery Instruments	0.79	0.069
	Suction Tips	6.34	0.08
	Respiratory Equipment	12.66	4.1
Enzy Care II (Detergent Fraction) (Residue)	Surgical Instruments	4.8	0.11
	Micro Surgery Instruments	4.8	0.4
	Suction Tips	9.5	0.31
Enzy Care II (Enzyme Fraction) (Residue)	Surgical Instruments	14.5	<0.8
	Micro Surgery Instruments	14.5	<3.9
	Suction Tips	29	<3.7
Descaler (Residue)	Surgical Instruments	2.9	0.016
	Micro Surgery Instruments	2.9	0.016
	Suction Tips	5.8	0.016
	Respiratory Equipment	46.4	0.016
NpH-Klenz® (Residue)	Rigid MIS Instruments	2.8	0.262
Klenzyme® (Detergent Fraction) (Residue)	Rigid MIS Instruments	7.7	0.632
Klenzyme® (Enzyme Fraction) (Residue)	Rigid MIS Instruments	15.5	<0.272
Cleaning	Representative Load (with blood soil)	No visible residual soil	Achieved no visible residual soil
Thermal Low-Level Disinfection	Commonly processed items (with microorganisms)	Logarithmic reduction of test organisms	Greater than 8 logarithmic reductions achieved
Equipment Decontamination	Critical areas of device and loading racks	No biofilm formation or growth of heterotrophic microorganisms	No biofilm formation or growth detected
Instrument Lubrication	Hinged instruments	No impedance to subsequent sterilization	No growth detected after sterilization

¹Results obtained with the Amsco Reliance 444 Single-Chamber Washer/Disinfector, considered representative for the family.

2. Sample Size Used for the Test Set and Data Provenance

Cleaning: The document mentions "covering test items with blood a representative soil" and "colling of Washer/Disinfectors provided soil." It does not specify the exact number of test items or repetitions.
Residues: The table lists items by category (e.g., "Surgical Instruments," "Micro Surgery Instruments," "Suction Tips," "Respiratory Equipment," "Rigid MIS Instruments"). It does not specify the precise number of individual items tested within each category. The results are presented as single values for each category, suggesting either an average or a single worst-case measurement.
Thermal Low-Level Disinfection: A "sample test" was conducted using "vials containing known concentrations of microorganisms." No specific number of vials or repetitions is provided. It notes testing was done with the "MIS rack," implying a specific configuration was used.
Equipment Decontamination: Testing involved "operating the Washer/Disinfector with various loading racks for 3 consecutive weeks" and "swabbing the surfaces of critical areas...on a weekly basis." It does not specify the number of swab samples or types of racks.
Instrument Lubrication: Testing involved "inoculating hinged instruments with bacterial spores." No specific number of instruments is given.

Data Provenance: The studies were conducted either in STERIS facilities or subcontracted, in keeping with applicable quality systems regulations (Good Laboratory Practice, 21CFR §58). This indicates a controlled laboratory setting. The data is prospective as it involves controlled testing to demonstrate the device's performance. The country of origin for the studies is not explicitly stated beyond being linked to STERIS Corporation (located in Ohio, USA) and adhering to US regulations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth was established through objective measurements and scientific protocols rather than expert consensus on subjective observations. For example:

Cleaning: Visual inspection for residual soil (an objective assessment against a "no visible residual soil" criterion).
Residues: Conductivity measurements and enzyme activity assays.
Thermal Low-Level Disinfection: Measuring logarithmic reductions of known concentrations of microorganisms.
Equipment Decontamination: Culturing swabs for biofilm or microbial growth.
Instrument Lubrication: Sterility testing for bacterial growth.

4. Adjudication Method for the Test Set

Not applicable. As noted in point 3, the ground truth was established through objective laboratory testing and measurements, not subjective evaluations requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, where AI provides assistance to human readers. The Amsco Reliance Washer/Disinfector is a cleaning and disinfection device, not a diagnostic tool requiring human-in-the-loop interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies conducted were standalone performance evaluations. The device's cleaning, disinfection, and residue removal capabilities were assessed directly without human intervention in the operational cycle or in the interpretation of the primary performance metrics (e.g., amount of residue, log reduction of microbes). The "computer-controlled" nature of the device inherently means its core operation is algorithmic.

7. Type of Ground Truth Used

The ground truth used in these studies was primarily objective laboratory measurements and scientific principles, including:

Chemical assays: For residue levels (conductivity increase, enzyme activity to relieve color).
Microbiological testing: For disinfection efficacy (logarithmic reduction of test organisms) and equipment decontamination (culturing for microbial growth/biofilm).
Visual inspection: For cleanliness (absence of visible soil).
Sterility testing: For lubricated instruments (absence of bacterial growth).

These are empirical measures against established scientific and safety standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical, computer-controlled washer/disinfector, not an AI or machine learning algorithm that requires a "training set" in the conventional sense (i.e., data for machine learning model development). The "pre-programmed cycles" are based on engineering design and validated protocols, not adaptive learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The operational parameters and control logic for the device's cycles were established through engineering design, scientific principles, and validation testing (the performance tests detailed in the document), rather than through a machine learning training process.

Summary

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MAY 3 1 2000

XG83068 510(k) SUMMARY

This pre-market notification was submitted by the following individual:

Raymond Ursick. Vice-President, Regulatory Affairs and Quality Systems STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060 Tel: 440-354-2600

This 510(k) summary was prepared on May 12, 2000.

Device identification
Trade name	Amsco® Reliance® Family of Washer/Disinfectors
Common name	Washer/Disinfector
Classification	II (As recommended by classification panel)

Predicate devices
Name	Model 7550 Washer/Disinfector
	T-21 Decontaminating Machine
Manufacturer	MDT/Castle
	HAMO, USA, Inc.
Classification	NOT CLASSIFIED
	NOT CLASSIFIED
510(k) number	K911087
	K911120

DEVICE DESCRIPTION

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chemicals in the sump water. Available configurations include steam or electrical heating of the sump water; and the drying option (electrically heated on some models. steam heated on others). The cabinet, chamber, and circulation system (including the pump) are primarily constructed of stainless steel.

The available cycle phases can be summarized as follows:

1. cold tap water pre-wash for the removal of gross soil;
soaking in an enzymatic solution to break down proteinaceous materials; 2.
1. detergent wash to complete the soil removal:
sonic cleaning to remove fine debris in crevices: র্ব
ട്. hot tap water rinse to remove detergent and soil residues:
thermal rinse to disinfect the load items; റ.
1. pure water rinse and instrument lubrication:
1. drvina.

Note: Phases 2 and 4 are not offered on all models. Phases 2, 4, 7 and 8 are optional features.

INTENDED USE

The Amsco Reliance Family of Washer/Disinfectors are indicated for use in the cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, and other similar and related articles found in healthcare facilities.

SUBSTANTIAL EQUIVALENCE - TECHNOLOGICAL COMPARISON

In most respects, including intended use, operating principle, energy sources, construction materials and control technology, the Amsco Reliance Family of Washer/Disinfectors are quite similar to both predicate devices. All use impingement and chemical means to remove soil, contaminants and residues from used medical devices and provide hot water thermal disinfection, in order to render them safe for handling and further processing by healthcare facility personnel. The devices are constructed primarily of stainless steel with rotating spray arms in a closed chamber. Hot water and detergents are circulated in varying cycles, in order to wash and disinfect a variety of medical devices approved for reuse. Microprocessors are used to provide cycle control.

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There is a notable difference in the cycle parameters structure, which is attibutable to There is a notable difference in the cycle paramoced screenshish the fact of accomplish the
the fact that the MDT/Castle predicate device uses the wash phase to accomplish th the fact that the MDT/Castle predicate Election Framily of Washer/
thermal disinfection whereas the HAMO and Alliance Family of Washer/ thermal disimection whereas the fixhe and Antionally, the MDT/Castle device has a Disinfectors uses the themial hise phase. A longer thermal disinfection phase time.
high-level disinfection claim which requires a formal disinfection also in the restricted high-level disintection claim which requires a leinfection claim is restricted to The Amsco Reliance Family of Wasileiner that this level is suitable for contact low-level disinfection, based on the understanding that the lover is one.
with intact skin, and therefore compatible with the safe handling of processed items by healthcare facility staff.

PERFORMANCE TESTS - TEST SCHEME DESCRIPTION

In order to demonstrate the actual performance levels achieved by the Amsco Reliance In order to demonstrate the actual penomismes to simulated-use type-tests have been Family of Washer/Disimectors, a sches of of the cleaning, rinsing of residues and conducted. These included assessment of the clouns of the areas of the (thermal) disintection encles, in ropresentially be colonized by heterotrophic machine and accessones that occated potentially challenge test to prove that the microorganisms have been submitted to a whiles are effective to prevent any recommended equipment decomamination processor inmersion the twas conducted to bacterial growin inside the unit. I Thany, a instrument lubricant on hinged surgical demonstrate that the practice of applying interfere with subsequent sterilization.

TEST RESULTS - CLEANING

Side-by-side testing was performed with the HAMO device to verify the Amsco Reliance Side-by-side testing was penomiculum to clean a representative load. The test method Family of viasneriDisiniector's ability to clour a representative soil, and performing a consisted of covering test nems with blood of the presence of visible residual visual inspection of hems and probecaing to colling of Washer/Disinfectors provided soll. It was shown that the Amoso Rollance Parison and when used as directed.

TEST RESULTS - RESIDUES

Testing was performed to establish the efficacy of the rinse phases to remove detergent Testing was performed to establish the emsels known to be non-toxic to patients and and enzymatic residues on load terns to technologictivity increase of test solution
users. The test method consisted of measuring the conductivity increase of test solution users. The test method consisted on measuring the son test tems to determine the caused by the elution of lonic detergent roomatic residue levels were measured by quantitles of residues. The non-lonic enzymatic roclase 10 relieve the following table shows

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K98.3068

Chemical	Items	Acceptance Criteria (mg/item)	Results (mg/item)1
STERIS Liqui Jet	Surgical Instruments	0.79	0.023
	Micro Surgery Instruments	0.79	0.069
	Suction Tips	6.34	0.08
	Respiratory Equipment	12.66	4.1
Enzy Care II(detergent fraction)	Surgical Instruments	4.8	0.11
	Micro Surgery Instruments	4.8	0.4
	Suction Tips	9.5	0.31
Enzy Care II(enzyme fraction)	Surgical Instruments	14.5	<0.8
	Micro Surgery Instruments	14.5	<3.9
	Suction Tips	29	<3.7
Descaler	Surgical Instruments	2.9	0.016
	Micro Surgery Instruments	2.9	0.016
	Suction Tips	5.8	0.016
	Respiratory Equipment	46.4	0.016
NpH-Klenz®	Rigid MIS Instruments	2.8	0.262
Klenzyme®(detergent Fraction)	Rigid MIS Instruments	7.7	0.632
Klenzyme®(enzyme fraction)	Rigid MIS Instruments	15.5	<0.272

the acceptance criteria and results for each item family and chemical tested.

Note 1: Test results as obtained with the Amsco Reliance 444 Single-Chamber Washer/Disinfector, and are considered as representative of the results obtained for the Family of Washer/Disinfectors. Note 2: The MIS rack only applies to the Amsco Reliance 444 Single-Chamber Washer/Disinfector.

TEST RESULTS - THERMAL LOW-LEVEL DISINFECTION

Challenge testing was performed to verify the ability of the Amsco Reliance Family of Washer/Disinfectors to achieve low-level disinfection of commonly processed items. The test method consisted of placing vials containing known concentrations of microorganisms in the coldest areas of the chamber and measuring logarithmic reductions after processing through the thermal rinse treatment.

A sample test conducted with the MIS rack on the Amsco Reliance 444 Single-Chamber Washer/Disinfector, using microorganisms recognized as suitable to test lowlevel disinfection, demonstrated that greater than 8 logarithmic reductions of the test organisms was achieved.

TEST RESULTS - EQUIPMENT DECONTAMINATION

Testing was performed to validate that the equipment decontamination procedures in the device labeling are effective to prevent the formation of biofilm or growth of heterotrophic microorganisms in critical areas of the device.

The test method consisted of operating the Washer/Disinfector with various loading racks for 3 consecutive weeks and, on a weekly basis, swabbing the surfaces of critical areas of the machine and loading racks, and culturing to detect the presence of biofilm

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KG83068

formation.

The test reports conclude that in its current design, the Washer/Disinfector and its accessories, when submitted to the recommended decontamination procedure, are not likely to develop biofilm on identified critical areas.

TEST RESULTS - INSTRUMENT LUBRICATION

Testing was performed to verify that the process of lubricating an item prior to terminal processing did not affect the item's ability to be sterilized.

The test method consisted of inoculating hinged instruments with bacterial spores, dipping them into full strength instrument lubricant before sterilization and testing them for sterility.

The test report shows that no growth could be detected on any of the lubricated as well as unlubricated instruments, demonstrating that the practice of lubricating instruments in the Washer/Disinfector at any concentration will not impede the ability to sterilize them subsequently.

CONCLUSIONS

Whereas, the test conditions were designed to be representative conditions within the intended use of the Washer/Disinfector;

Whereas, these tests have been conducted in keeping with applicable quality systems requlations (Good Laboratory Practice, 21CFR §58), whether conducted in STERIS facilities or subcontracted;

Whereas, per STERIS Corporation's intent, the above mentioned test conditions were designed to be adequate, complete and challenging to all aspects relating to the performance, safety and effectiveness of the device for its intended use;

STERIS Corporation considers the Amsco Reliance Family of Washer/Disinfectors to be safe, effective, and is substantially equivalent to the predicate devices.

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Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or bird-like figure. The emblem is composed of three curved lines that form the shape of the bird's head and body.

MAY 3 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Raymond Ursick Vice-President, Requlatory Affairs and Quality Systems STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re : K983068 Trade Name: Amsco® Reliance Family of Washer-Disinfectors Regulatory Class: Unclassified Product Code: LDS Dated: March 20, 2000 Received: March 21, 2000

Dear Mr. Ursick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ursick

This letter will allow you to begin marketing your device as Inis lecter will arrow your market notification. The FDA described in four tial equivalence of your device to a legally Finding of subscancial equires. In a classification for your marketed predicate actro your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoorle and additionally 809.10 for in regulacion (ir devices), please contact the Office of Villy diagnobere at (301) 594-4692. Additionally, for questions on Compilance at (301) 534 4022. Indias device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible suall Manufacturers Assistance obtained from cho bring (800) 638-2041 or (301) 443-6597 or at at feb corr rreo hamber to://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Burn

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983068 STERIS Amsco Reliance Family of Washer / Disinfectors

INDICATIONS FOR USE STATEMENT

DEVICE NAME: STERIS Amsco Reliance Family of Washer / Disinfectors

INDICATIONS FOR USE:

(Please Do Not Write Below This Line - Continue on Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number

Regulation Number and Section

§ 880.6991 Medical washer.

(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.