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 upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles. The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria.

The document is a 510(k) premarket notification for a medical device called the "Amsco Warming Cabinet." It primarily discusses the substantial equivalence of this device to predicate devices and its intended use. While it includes a table comparing technological characteristics of the proposed device against predicate devices, this table focuses on features and specifications rather than acceptance criteria for performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide details related to sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

JAN 1 0 2017

Re: K092823

Trade/Device Name: Amsco Warming Cabinet Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: September 11, 2009 Received: September 14, 2009

Dear Mr. Sullivan:

This letter corrects our substantially equivalent letter of December 18, 2009.

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

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Page 2 - Mr. Robert F. Sullivan

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of 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:

The Ansco Warming Cabinet is designed to raise the temperature of blankets, lineus and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications

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)

Austin for Gz

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number: 692823

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STERIS.

DEC 1 8 2009

510(k) Summary For Amsco Warming Cabinet

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone: 440-392-7695 Fax No: 440-357-9198

Summary Date:

September 11, 2009

STERIS Corporation • 5960 Heisley Road • Mentor. OH 44060-1834 USA • 440-354-2600

September 11, 2009

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Device Name 1.

Trade Name:	Amsco Warming Cabinet
Common/usual Name:	Warming Cabinet
Classification Name:	Warmer, Irrigation Solution

2. Predicate Device

STERIS Amsco Warming Cabinet (Pre-Amendment) Enthermics EC-7701 Fluid Warming Cabinet, K993797, January 20, 2000

Warmer, Cabinet

3. Description of Device

The upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles.

The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.

4. Intended Use

ડ. Description of Safety and Substantial Equivalence

The Amsco Warming Cabinet is nearly identical to the two predicate devices in all material respects. A table comparing the technological characteristics of the proposed Amsco Warming Cabinet to the predicates is provided in Table 5-1.

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STERIS TRADITIONAL 510(k) PREMARKET SUBMISSION STERIS Amsco Warming Cabinet

Features	Technological Characteristics
	Amsco Warming Cabinet(IV Solution Capability)	Amsco Warming Cabinet(Pre-amendment)	EC-7701 Fluid WarmingCabinet (K993797)
Intended Use	The Amsco Warming Cabinetis designed to raise thetemperature of blankets, linensand sterile surgical irrigationsolutions and IV solutions toan acceptable level for varioussurgical, obstetrical,emergency, critical care andother healthcare applications.The Amsco Warming Cabinetis designed to hold acombination of flasks and/ordry goods.	Amsco Warming Cabinet is forheating flasked solutions,blankets and similar clinicalarticles.	The Enthermics MedicalSystems EC-7701 FluidWarming Cabinet isdesigned to safely storeand warm irrigation fluidsor injection fluids inaccordance with therecommended warmingtemperatures and storagetimes stated in the fluidmanufacturer's labeling.
HeatingSystem	Electric heater and fan blower(Convection heating)	Steam heat or Electric heaterblanket and fan blower(Convection heating)	Fully insulatedelectrothermal cable array(Convection heating)
UnitConfiguration	Single/Double	Single/Dual	Single
Unit Depth	18" or 24"	18" or 24"
Model	Wall or Counter	Wall or Counter	Wall
Interior andExteriorSurfaces	Stainless Steel, ABS Plasticand laminated galvanized steel	Stainless Steel	Stainless Steel
Installation	Free-Standing (mobile) orRecessed	Open-Mounted or Recessed	Free-standing (mobile) orRecessed
Door	Stainless Steel (Solid andGlass)	Stainless Steel	Stainless Steel (Glass)
CabinetStorageCapacity	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- up to 90 ( 1-liter) bottles	Dual Compartment Model -Two shelves15 flasks - 18" upper45 flasks - 18" lower20 flasks - 24" upper60 flasks - 24" lowerSingle Compartment Model -One shelf15 flasks - 18"20 flasks - 24"	The cabinet is equippedwith three (3) white,epoxy-coated wire baskets,each with a 24 litercapacity.
Features
CabinetVolume	Amsco Warming Cabinet(IV Solution Capability)18" upper chamber - 3.1 cu ft24" upper chamber - 4.2 cu ft18" lower chamber - 8.9 cu ft24" lower chamber - 12 cu ft	Amsco Warming Cabinet (Pre-amendment)18" upper chamber - 3.1 cu ft24" upper chamber - 4.2 cu ft18" lower chamber - 8.9 cu ft24" lower chamber - 12 cu ft	EC-7701 Fluid WarmingCabinet (K993797)
Controls	Digital Push Button keypad /power switch / Digital LCDtemperature display / modeselection buttons / door ajarindicator / Over-temperaturelight for each compartment /Data port for retrieval ofstored temperatures.	Thermostat / power switch /fuse with indicating light / colorcoded temperature selector	Electronic control consistsof 4 digit LED display,on/off key, increase anddecrease keys, integratedlock feature and a series ofprompt sequenceindicators.
Software	Unit contains software	Not Applicable	Not applicable
TemperatureSelectionRange	90°F (32°C) to 160°F (71°C)	95°F to 150°F (35°C to 65°C)	90°F (32°C) to 150°F(66°C)
TemperatureLock	Temperature lock-out functionto prevent unauthorizedtemperature changes.	Not Available	The device allows the userto "lock" the mode (IRR orINJ) and temperaturesetting controls.Available as an option
Door Lock	All configurations will beequipped with either a manualmechanical door lock oroptional electronic door locksystem for each compartment	Available by SSQ (SpecialSales Quote) only	Available as an option
OverTemperatureAlarm Point	Visual and audible alarm ifunit has a chambertemperature greater than 10°F(5.5°C) above set temperature.In the event of an over tempcondition, sensorsautomatically turns off theheater(s).	Visual alarm if unit has achamber temperature greaterthan 12°F above settemperature. In the event of anover temp condition, sensorsautomatically turns off theheater(s).	Visual and audible alarm ifunit has a chambertemperature greater than10°F (5.5°C) above settemperature. In the eventof an over temp condition,the heating system shutsdown.
VoltageRequirements	110/120 Vac, 220/240 Vacnominal, 50/60 HZ	Electric Model: 110/120 Vac,220/240 Vac nominal, 50/60HZSteam Model: 120 VAC singlephase	125 Vac, 60 HZ, 1 ph

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

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STERIS TRADITIONAL 610(k) PREMARKET SUBMISSION

STERIS Amsco Warming Cabinet

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).