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.

Device Description

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 mid-size model consists of a single chamber unit and is available in (4) saleable configurations all with premium features (24" deep, glass door, electronic door lock, data recording and 120 or 230Vac with or without option mobile base). Optional pull-out wire baskets can be interchangeable with the existing wire shelf. Each of the two wire baskets have a 30L maximum capacity. The external measurements are 36-3/8"H x 27-1/8"D x 30"W (without mobile base) and the internal heat compartment is 22-3/4"H x 22-7/8"D x 24"W (7.2 cu ft).

AI/ML Overview

This document describes the acceptance criteria and the verification and validation study for the Amsco Warming Cabinet, Mid-size Model.

1. Table of acceptance criteria and the reported device performance

Test Description	Acceptance Criteria	Results
Electrical Testing	• Achieve passing results through automated dielectric strength tester• 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)• Ground bond must not exceed 0.1 ohm and maintain ground continuity.• The power input of equipment at rated voltage and steady state current shall not exceed the marked rating by 10%.	PASS
System Functions: Controls, Heating, Door Lock System Test	• 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• Input current must be within 5.9 - 7.12 Amps for 120Vac unit.• 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• Warming cabinet must communicate with laptop or personal-computer to transfer stored temperature data to the computer• Numeric code entered on keypad must unlock the door within 4 seconds.• Door must remain locked when 40 pounds of force is applied	PASS
Spillage	• 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 for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Heating Performance (Full IV solution load - upper and lower wire baskets)	• Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F.• 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 - upper and lower wire baskets)	• Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F• 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 - upper wire basket) (Full blanket load - bottom shelf)	• Temperature reading of each thermocouple must not vary from set-point temperature by more than ±3°F for temperature settings between 90-110°F and ±5°F for temperature settings between 110-160°F• Controls temperature display must reach set-point within 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Drop Test	• Pass dielectric strength test per UL 61010-1, section 6, clause 6.8• No damage that allows access to electrical live parts• No damage to the enclosure that could cause a safety hazard• No damage that could cause spread of fire• No damage to insulation of internal wiring	PASS
Stability Test	• No overbalance during test	PASS
Wire Basket Load and Force Test	• No catastrophic failure at 125 pounds.• No catastrophic failure at 105 pounds with the sliding of wire basket in a back and forward horizontal motion for at least 100 cycles.	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 sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific number of units used for each test. However, it details "verification and validation activities" conducted on the "Mid-size Single Compartment Warming Cabinet". The nature of these tests (electrical, system functions, heating performance, mechanical tests) suggests that the testing was performed on the device itself (product prototypes or final units) rather than on a dataset of external data. This would be considered prospective testing of the device hardware and software. The country of origin of the data is not specified, but the manufacturer (STERIS Corporation) is based in Mentor, OH, USA, implying the testing was likely conducted in the US or by a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (warming cabinet) validation, not an AI or diagnostic imaging study. Ground truth in this context is established by engineering specifications, safety standards (UL, CAN/CSA), and performance requirements for heating and mechanical integrity. There are no "experts" in the clinical sense establishing ground truth; rather, the device's performance is measured against predefined objective physical and electrical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, the acceptance criteria are objective physical and electrical measurements against established standards. There is no subjective interpretation or "adjudication" required in the typical sense of a clinical study or AI model evaluation.

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 not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI or algorithm-based device in the context of diagnostic or interpretive functions. The "software" mentioned is for control and data recording within the device's operational functions, not for independent diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on:

Engineering Specifications: Specific temperature ranges, electrical parameters, power draw.
Safety Standards: Compliance with UL 61010-1 and CAN/CSA C22.2 61010-1 for electrical safety.
Performance Requirements: Functional operation of fans, alarms, door locks, and heating profiles under various load conditions.
Mechanical Integrity Standards: Resistance to physical stress (drop test, load test).

These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set. The device operates based on predefined engineering and control logic.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for such a set.

Summary

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Image /page/0/Picture/0 description: The image shows the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol next to it. Above the word "STERIS" is the number "1.0769". Below the word "STERIS" is the date "JUN - 3 2011", and a graphic of several horizontal wavy lines.

510(k) Summary For Amsco Warming Cabinet Mid-size Model

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

Contact:

Robert F. Sullivan Senior Director, Regulatory Affairs

Telephone:	440 392 7695
Fax No:	440 357 9198

May 3, 2011 Summary Date:

STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600 T

May 3, 2011

Appendix 2, Page 1

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1. Device Name

Trade Name:	Amsco Warming Cabinet, Mid-size Model
Common/usual Name:	Warming Cabinet
Classification Name:	Warmer, Thermal, Infusion Fluid; UnclassifiedProduct Code LGZ

2. Predicate Device

Amsco Warming Cabinet (K092823)

3. Description of Device

The mid-size model consists of a single chamber unit and is available in (4) saleable configurations all with premium features (24" deep, glass door, electronic door lock, data recording and 120 or 230Vac with or without option mobile base). Optional pull-out wire baskets can be interchangeable with the existing wire shelf. Each of the two wire baskets have a 30L maximum capacity. The external measurements are 36-3/8"H x 27-1/8"D x 30"W (without mobile base) and the internal heat compartment is 22-3/4"H x 22-7/8"D x 24"W (7.2 cu ft).

4. Intended Use

ડ. Description of Safety and Substantial Equivalence

Substantial Equivalence

The Mid-size Amsco Warming Cabinet is identical in technology and intended use as the predicate Amsco Warming Cabinet models. A table comparing the proposed Amsco Warming Cabinet model to the predicate models is provided in Table 5-1.

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STERIS Response to FDA Request for Additional Information dated 4-15-2011

K110769 S001 - AMSCO WARMING CABINET -- MID-SIZE MODEL

Features	Technological CharacteristicsPREDICATEAmsco Warming Cabinet(K092823)	PROPOSEDAmsco Warming CabinetMid-size Model
Intended Use	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.	Identical
Heating System	Electric heater and fan blower (Convection heating)	Identical
Unit Configuration	Single/Double chamber	Single chamber
Unit Depth	18" or 24"	24"
Model	Freestanding, mobile base (24" dual chamber only), or Counter (single chamber only)	Freestanding or mobile base
Interior andExterior Surfaces	Stainless Steel, ABS Plastic and laminated galvanized steel	Identical
Installation	Free-Standing, Recessed, Mobile (24" dual chamber only), or Counter (single chamber only)	Free-Standing, Mobile, Recessed, or Under Counter
Door	Laminated steel exterior and Stainless Steel interior (Solid and Glass)	Laminated steel exterior and Stainless Steel interior (Glass)
Cabinet StorageCapacity andVolume	18" upper / single chamber - 3.2 cu ft - up to 24 (1-liter) bottles18" lower chamber - 8.5 cu ft - up to 72 (1-liter) bottles24" upper / single chamber - 4.3 cu ft - up to 30 (1-liter) bottles24" lower chamber - 11.6 cu ft -	7.2 cu ft - up to 60 (1-liter) bottles
Features	PREDICATEAmsco Warming Cabinet(K092823)	PROPOSEDAmsco Warming CabinetMid-size Model
Controls	Digital Push Button keypad /power switch / Digital LCDtemperature display / modeselection buttons / door ajarindicator / Over-temperature lightfor each compartment / Data portfor retrieval of storedtemperatures.	Identical components as thePredicate: Digital Push Buttonkeypad / power switch / DigitalLCD temperature display / modeselection buttons / door ajarindicator / Over-temperature lightfor compartment / Data port forretrieval of stored temperatures.
Software	Unit contains software	Identical - no changes were madeto the software
TemperatureSelection Range	90°F (32°C) to 160°F (71°C)	Identical
Temperature Lock	Temperature lock-out function toprevent unauthorized temperaturechanges.	Identical
Door Lock	All configurations will beequipped with either a manualmechanical door lock or optionalelectronic door lock system foreach compartment	All configurations will beequipped with an electronic doorlock system
Over TemperatureAlarm Point	Visual and audible alarm if unithas a chamber temperaturegreater than 10°F (5.5°C) aboveset temperature. In the event of anover temp condition, sensorsautomatically turns off theheater(s).	Identical
VoltageRequirements	110/120 Vac, 220/240 Vacnominal, 50/60 HZ	Identical

Table 5-1: Summary of the Proposed Device and Predicate Devices Technological Characteristics

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STERIS Response to FDA Request for Additional Information dated 4-15-2011 K110769 S001 - AMSCO WARMING CABINET - MID-SIZE MODEL

Safety and Effectiveness

Table 5-2 summarizes the verification and validation activities that were performed to ensure that modifications do not affect the safety or effectiveness of the Amsco Warming Cabinet.

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STERIS Response to FDA Request for Additional Information dated 4-15-2011 K110769 S001 - AMSCO WARMING CABINET - MID-SIZE MODEL

for Mid-size Single Compartment Warming Cabinet
Test Description	Acceptance Criteria	Results
Electrical Testing	• Achieve passing results thru automated dielectricstrength tester• Earth and Enclosure Leakage Current must notexceed requirements listed in UL 61010-1 clause6.3.1b (must not exceed .5mA normal condition and3.5mA single fault condition)• Ground bond must not exceed 0.1 ohm and maintainground continuity.• The power input of equipment at rated voltage andsteady state current shall not exceed the markedrating by 10%.	PASS
System Functions:Controls, Heating, DoorLock System Test	• Exhaust fans and blowers must operate continuouslywhen the main power is set to the ON position• Opening or closing the doors shall not cause fans orblowers to turn off• Input current must be within 5.9 - 7.12 Amps for120Vac unit.• Over-temp alarm must activate and displayedtemperature flashes alternately with the error "Hi"when compartment temperature is more than 10°Fabove set point temperature• Warming cabinet must communicate with laptop orpersonal-computer to transfer stored temperature datato the computer• Numeric code entered on keypad must unlock thedoor within 4 seconds.• Door must remain locked when 40 pounds of force isapplied	PASS
Spillage	• Pass dielectric strength test per UL 61010-1, section6, clause 6.8• Voltage measurement of cabinet outer surfaces mustnot exceed test voltages per UL 61010-1, section 6,clause 6.3.2a.	PASS
Heating Performance(empty compartment)	• Temperature reading of each thermocouple must notvary from set-point temperature by more than ±3°Ffor temperature settings between 90-110°F and ±5°Ffor temperature settings between 110-160°F.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Heating Performance(Full IV solution load -upper and lower wirebaskets)	• Temperature reading of each thermocouple must notvary from set-point temperature by more than ±3°Ffor temperature settings between 90-110°F.• Controls temperature display must reach set-pointwithin 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Test Description	Acceptance Criteria	Results
Heating Performance(Full irrigation solutionload - upper and lowerwire baskets)	• Temperature reading of each thermocouple must notvary from set-point temperature by more than ±3°Ffor temperature settings between 90-110°F and ±5°Ffor temperature settings between 110-160°F• Controls temperature display must reach set-pointwithin 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Heating Performance(Full irrigation solutionload - upper wirebasket)(Full blanket load -bottom shelf)	• Temperature reading of each thermocouple must notvary from set-point temperature by more than ±3°Ffor temperature settings between 90-110°F and ±5°Ffor temperature settings between 110-160°F• Controls temperature display must reach set-pointwithin 12 hours.• Normal system operation is maintained without over-temperature condition or faults occurring.	PASS
Drop Test	• Pass dielectric strength test per UL 61010-1,section6, clause 6.8• No damage that allows access to electrical live parts• No damage to the enclosure that could cause a safetyhazard• No damage that could cause spread of fire• No damage to insulation of internal wiring	PASS
Stability Test	• No overbalance during test	PASS
Wire Basket Load andForce Test	• No catastrophic failure at 125 pounds.• No catastrophic failure at 105 pounds with the slidingof wire basket in a back and forward horizontalmotion for at least 100 cycles.	PASS
ETL/cETL CodeCompliance	• Meet UL 61010-1 Standard for Safety ElectricalEquipment for Measurement, Control, andLaboratory Use.• Meet CAN/CSA C22.2 61010-1 Standard for SafetyElectrical Equipment for Measurement, Control andLaboratory Use.	PASS

Table 5-2: Summary of Verification and Validation Activities

for Mid-size Single Compartment Warming Cabinet

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STERIS Response to FDA Request for Additional Information dated 4-16-2011 K110769 S001 - AMSCO WARMING CABINET - MID-SIZE MODEL

Conclusion

Verification and validation testing demonstrate that the proposed Amsco Warming Cabinet, mid-size model, operates as intended and is as safe and effective as the predicate. The differences between the proposed and predicate device are limited to the described modifications of the device and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert F. Sullivan Senior Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

JAN 1 0 2017

Re: K110769

Trade/Device Name: Amsco Warming Cabinet, Mid-size Model Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: May 3, 2011 Received: May 4, 2011

Dear Mr. Sullivan:

This letter corrects our substantially equivalent letter of June 3, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of

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Page 2 - Mr. Robert F. Sullivan

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Amsco Warming Cabinet

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ld C. Chaym 6/2/11
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K110769

Page 1 of 1

Regulation Number and Section

§ 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).