(637 days)
No
The description details a computer-controlled mechanical washer/disinfector with pre-programmed cycles and optional features. There is no mention of AI or ML in the device description, intended use, or performance studies. The control is described as "programmable computer," which is standard for automated systems and does not imply AI/ML.
No.
This device is a washer/disinfector used for cleaning and low-level disinfection of medical instruments and items, not for treating a disease or condition in a patient. It is a reprocessor of medical devices.
No
This device is a washer/disinfector used for cleaning and low-level disinfection of medical instruments and articles, not for diagnosing conditions or diseases.
No
The device is a mechanical, computer-controlled washer/disinfector with physical components like a chamber, circulation system, pump, and heating elements. While it has a programmable computer, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cleaning and low-level disinfection of reusable medical articles. This is a process performed on medical devices themselves, not on biological specimens from a human body for the purpose of providing diagnostic information.
- Device Description: The device is a mechanical washer/disinfector that uses physical and chemical processes to clean and disinfect items. It does not analyze biological samples or provide diagnostic results.
- Performance Studies: The performance studies focus on the efficacy of cleaning, disinfection, and residue removal from the medical articles being processed. They do not involve the analysis of human specimens or the generation of diagnostic data.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
LDS
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:
-
- cold tap water pre-wash for the removal of gross soil;
- soaking in an enzymatic solution to break down proteinaceous materials; 2.
-
- 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;
-
- pure water rinse and instrument lubrication:
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Side-by-side testing was performed with the HAMO device to verify the Amsco Reliance Family of Washer/Disinfector’s ability to clean a representative load. The test method consisted of covering test items with blood and proteinaceous soil, and performing a visual inspection of items and probes to confirm the presence of visible residual soil.
Summary of Performance Studies
PERFORMANCE TESTS - TEST SCHEME DESCRIPTION: In order to demonstrate the actual performance levels achieved by the Amsco Reliance Family of Washer/Disinfectors, a scheme of simulated-use type-tests have been conducted. These included assessment of the cleaning, rinsing of residues and conducted (thermal) disinfection cycles, in representially be colonized by heterotrophic machine and accessories that occated potentially challenge test to prove that the microorganisms have been submitted to a while are effective to prevent any recommended equipment decomposition processor immersion. The test was conducted to bacterial growth inside the unit. Finally, 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 Family of Washer/Disinfector's ability to clean a representative load. The test method consisted of covering test items with blood and proteinaceous soil, and performing a visual inspection of items and probes to confirm the presence of visible residual soil. It was shown that the Amsco Reliance Family of Washer/Disinfectors provided cleaning performance comparable to the predicate device when used as directed.
TEST RESULTS - RESIDUES: Testing was performed to establish the efficacy of the rinse phases to remove detergent and enzymatic residues on load items to levels known to be non-toxic to patients and users. The test method consisted of measuring the conductivity increase of test solution caused by the elution of ionic detergent from test items to determine the quantities of residues. The non-ionic enzymatic residues were measured by protein assay.
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 low-level 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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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
1
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:
-
- cold tap water pre-wash for the removal of gross soil;
- soaking in an enzymatic solution to break down proteinaceous materials; 2.
-
- 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.
-
- pure water rinse and instrument lubrication:
-
- 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.
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.
2
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
3
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 |