(28 days)
The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications. The 24" Wide Pass-thru model will be mounted in a wall opening. Doors (upper and lower compartment) added to the rear of the cabinet will allow users to load supplies in compartments from outside the operating room, while doors on the front side will allow access to compartments when inside the operating room. The upper compartment of this model holds up to 20( 1-liter) liquid bottles, or 6 ( 1liter) liquid (IV or Irrigation solution) bags; the lower compartment holds up to 40 (1-liter) liquid bottles or 12 (1 liter) liquid bags.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to match your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Testing | ||
| Dielectric Withstand | Achieve passing results through automated dielectric strength tester. | PASS |
| Earth and Enclosure Leakage Current | Must not exceed requirements listed in UL 61010-1 clause 6.3.1b (must not exceed .5mA normal condition and 3.5mA single fault condition). | PASS |
| Ground bond | Must not exceed 0.1 ohm and maintain ground continuity. | PASS |
| Power Input & Line Voltage | The power input of equipment at rated voltage and steady state current shall not exceed the marked rating by 10%. | PASS |
| System Functions | ||
| Main Power ON indicator | Main Power ON indicator at rear upper door is illuminated when Main Power Switch is set to the ON position. | PASS |
| Exhaust fans and blowers operation | Exhaust fans and blowers must operate continuously when the main power is set to the ON position. Opening or closing the doors shall not cause fans or blowers to turn off. | PASS |
| Input current | Input current must be within 11.4 - 14.25 Amps. | PASS |
| Over-temp alarm | Over-temp alarm must activate and displayed temperature flashes alternately with the error "Hi" when compartment temperature is more than 10°F above set point temperature. | PASS |
| Door lock | Door must remain locked when 40 pounds of force is applied. | PASS |
| Thermal Test | ||
| Temperature Limits (recessed mounted, normal condition) | Temperatures of easily touched surfaces and identified components must comply with UL 61010-1 clauses 10.1 and 10.2, UL 61010-2-010 clause 10.1, temperature limits under normal conditions. Maintain normal operation without faults occurring. | PASS |
| Single Fault Conditions | ||
| Cooling (single fault condition) | Pass dielectric strength test per UL 61010-1, section 6, clause 6.8. Cabinet outer surface must not exceed 105°C at 40°C ambient. Transformer, blower and exhaust fan windings must not exceed 150°C under single fault condition at 40°C ambient. Voltage measurement of cabinet outer surfaces must not exceed test voltages per UL 61010-1, section 6, clause 6.3.2a. No signs of molten metal, burning insulation, flaming particles, etc. No signs of charring, glowing, or flaming of tissue paper or cheesecloth. | PASS |
| Heating Devices (single fault condition) | Pass dielectric strength test per UL 61010-1, section 6, clause 6.8. Cabinet outer surface must not exceed 105°C at 40°C ambient. Transformer, blower and exhaust fan windings must not exceed 150°C under single fault condition at 40°C ambient. Voltage measurement of cabinet outer surfaces must not exceed test voltages per UL 61010-1, section 6, clause 6.3.2a. No signs of molten metal, burning insulation, flaming particles, etc. No signs of charring, glowing, or flaming of tissue paper or cheesecloth. | PASS |
| Protection against Hazards from Fluids | Pass dielectric strength test per UL 61010-1, section 6, clause 6.8. Voltage measurement of cabinet outer surfaces must not exceed test voltages per UL 61010-1, section 6, clause 6.3.2a. | PASS |
| Heating Performance (empty compartment) | Temperature reading of each thermocouple must not vary from set-point temperature by more than ± 3°F in upper compartment and ± 5°F in lower compartment. At a 160°F set-point temperature, the upper compartment display must reach set-point within 35 minutes and lower compartment display must be within 65 minutes. Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance (Full IV solution load in upper compartment and full blanket load in lower compartment) | Temperature reading of each thermocouple must not vary from set-point temperature by more than ± 3°F in upper compartment and ± 5°F in lower compartment. Upper and lower compartment controls temperature display must reach set-point within 12 hours. Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance (Full irrigation solution load in upper and lower compartments) | With a fully loaded compartment of Irrigation solution, bottles of solution shall not overbalance and fall off shelf when doors are opened. Temperature reading of each thermocouple must not vary from set-point temperature by more than ± 3°F in upper compartment and ± 5°F in lower compartment. Upper and lower compartment controls temperature display must reach set-point within 12 hours. Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| ETL/cETL Code Compliance | Meet UL 61010-1 Standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use. Meet CAN/CSA C22.2 61010-1 Standard for Safety Electrical Equipment for Measurement, Control and Laboratory Use. | PASS |
2. Sample size used for the test set and the data provenance
The document describes verification and validation activities performed on the physical device, not an algorithm using a dataset. Therefore, terms like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this device's testing. The "test set" in this case refers to the physical Amsco Warming Cabinet, 24" Wide Pass-thru model, itself undergoing various engineering and functional tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (warming cabinet) and the ground truth for its performance is established through objective engineering tests against established safety and performance standards (UL, CAN/CSA). There are no "experts" establishing ground truth in the sense of clinical interpretations or diagnoses.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements and evaluations against predefined quantitative and qualitative acceptance criteria (e.g., current limits, temperature ranges, successful operation of alarms). There is no ambiguity requiring adjudication by multiple readers or decision-makers.
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
Not applicable. This is a medical device (warming cabinet), not an AI algorithm for diagnostic imaging or similar applications where MRMC studies or AI assistance for human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical warming cabinet, not an algorithm. The "standalone" performance is the device operating as intended based on the tests described.
7. The type of ground truth used
The ground truth for this device is based on established engineering and safety standards (UL 61010-1, CAN/CSA C22.2 61010-1), which define acceptable performance limits for electrical safety, temperature control, and mechanical integrity.
8. The sample size for the training set
Not applicable. This is a medical device undergoing physical and functional testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm was used.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).