The Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids in accordance with the recommended warming temperatures and storage time guidelines provided by the manufacturers of such products. The subject device is available with either single compartment or double compartment cabinets, all designed to ensure maximum storage capability. The 7000 series are made of 18 gauge stainless steel with the doors and shelves made of 20 gauge stainless steel. The 8000 series are of a similar design to the 7000 series, however the stainless steel doors have an inset double pane tempered glass to allow interior cabinet viewing. The small 9000 series are made of powder coated steel, and the doors have an inset Plexiglas also to allow interior cabinet viewing.

AI/ML Overview

Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/or injection fluids. The following details the acceptance criteria and the study proving the device meets these criteria as described in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Expected Specifications)	Reported Device Performance
Electrical Safety	Met by CSA International certification using CSA Standard(s) C22.2 No(s). 0, 0.4 as a guide and SPE-1000, UL1262, US Field Evaluation.
Temperature Control & Distribution
Accuracy of the temperature controller	Tested and met.
Even distribution of heat throughout the cabinet with limited temperature variance	Tested and met.
Multiple temperature readings within +/- 1.5ºC accepted variance	Tested and met.
Heating Performance
Quickness to reach desired temperature from a cold start	Tested and met.
Recovery time after repeated door openings to return to desired setting	Tested and met.
Time to achieve desired temperature when loaded to 3/4 capacity	Tested and met.

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

The document does not specify a distinct "test set" in terms of cases or patient data, as this is a device for warming medical items rather than diagnosing or treating patients. The testing involved the manufactured Blanket and Solution Warming Cabinets themselves.

Sample Size: The number of units tested is not explicitly stated but implies testing on at least one (or more, representative) unit of each model type to evaluate performance characteristics.
Data Provenance: The testing was conducted by Imperial Surgical Ltd., presumably at their manufacturing facility or a contracted testing lab, as part of their premarket notification process for the Canadian and US markets. The CSA International certification indicates testing conducted by a recognized third-party organization. This is prospective testing of the manufactured device.

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

This is not applicable to a non-clinical device performance study. "Ground truth" in this context refers to established engineering and safety standards (e.g., electrical safety standards, temperature accuracy specifications) rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable, as there was no expert adjudication of subjective results. The evaluation relied on objective measurements and adherence to predetermined technical specifications and safety standards.

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

This is not applicable. The device is a warming cabinet, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed.

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

This is not applicable. The device is a physical warming cabinet, not an algorithm or software. Its performance is inherent to its mechanical and electrical operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing comprised established engineering specifications, electrical safety standards (e.g., CSA Standard(s) C22.2 No(s). 0, 0.4, SPE-1000, UL1262), and the manufacturer's own design specifications for temperature accuracy and distribution (e.g., +/- 1.5ºC variance).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. The warming cabinet is a hardware device, not a machine learning model that requires training data.

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

This is not applicable, as there is no training set for this type of device.

Summary

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K112702

Image /page/0/Picture/2 description: The image shows a logo for Imperial Surgical. The logo features a stylized graphic above the text "IMPERIAL SURGICAL". The graphic appears to be an abstract design, possibly representing a medical or surgical concept. The text is in a bold, sans-serif font, emphasizing the company's name.

510(k) Summary For Imperial Surgical Ltd. BLANKET and SOLUTION WARMING CABINETS

September 14, 2011

Manufactured by: Contact Name: Address:

Tel.:

Fax:

Imperial Surgical Ltd. Suzy Bairos, Vice President 850 Halpern Ave. Dorval, Quebec Hab IGe 514-631-7988 Ext. 21 514-631-9083

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Image /page/1/Picture/1 description: The image shows a logo for Imperial Surgical. The logo is a square with a white mountain range at the top. Below the mountain range, the words "IMPERIAL SURGICAL" are stacked on top of each other in a bold, sans-serif font. Above the square are three black circles.

1. Device Name/Codes

Device Proprietary Name:Imperial Surgical Blanket and Solution Warming Cabinets

Warming Cabinets Common/Usual Name:

Warmer, Thermal, Infusion Fluid Classification Name: LGZ Classification Code:

2. Predicate Device

Steris Amsco Warming Cabinet (K092823, December 12, 2009) Enthermics EC-7701 Fluid Warming Cabinet, K993797, January 20, 2000

3. Description of Device

The subject device is available with either single compartment or double compartment cabinets, all designed to ensure maximum storage capability. The 7000 series are made of 18 gauge stainless steel with the doors and shelves made of 20 gauge stainless steel. The 8000 series are of a similar design to the 7000 series, however the stainless steel doors have an inset double pane tempered glass to allow interior cabinet viewing. The small 9000 series are made of powder coated steel, and the doors have an inset Plexiglas also to allow interior cabinet viewing.

4. Intended Use

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Image /page/2/Picture/1 description: The image shows a logo for Imperial Surgical. The logo is a square with a black and white pattern. The word "IMPERIAL" is written in large, bold letters at the bottom of the square. Below that, the word "SURGICAL" is written in smaller letters. There are three circles in the top left corner of the square, one black and two white.

5. Description of Safety and Substantial Equivalence

The Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are substantially equivalent to the two predicate devices in all material respects. Please refer to the table below comparing the technological characteristics of the proposed Imperial Surgical Blanket and Solution Warming Cabinets to the predicate devices.

Summary of the Proposed Device and Predicate Devices Technological Characteristics

Features	Imperial Surgical Ltd.Blanket and SolutionWarming Cabinets	Amsco Warming Cabinet(K092823)	EC-7701 Fluid WarmingCabinet (K993797)
Intended Use	The Imperial Surgical Ltd.Blanket and SolutionWarming Cabinets aredesigned to store and warmblankets, hospital linens,irrigation fluids and/orinjection fluids inaccordance with therecommended warmingtemperatures and storagetime guidelines provided bythe manufacturers of suchproducts	Amsco Warming Cabinet isfor heating flasked solutions,blankets and similar clinicalarticles.	The Enthermics MedicalSystems EC-7701 FluidWarming Cabinet isdesigned for safely store andwarm irrigation fluids orinjection fluids in accordancewith the recommendedwarming temperatures andstorage times stated in thefluid manufacturer'slabeling.
Heating System	Convection Electric heatingelement with circulating fan	Steam heat or Electric heaterblanket and fan blower(convection heating)	Fully insulatedelectrothermal cable array(Convection heating)Usually radiant heating
Unit Configuration	Single / dual	Single/Dual	Single
Unit Depth	22" or 28" for table top andfull size cabinets.16" depth on count topmodel.	18" or 24"	34″
Model	Wall or Counter	Wall or Counter	Wall
Interior and ExteriorSurfaces	Stainless Steel interior andexterior on table top and fullsize models.Counter top model madewith baked on powdercoated steel outer shell withStainless Steel interior.	Stainless Steel	Stainless Steel
Installation	Free standing or recessed	Open-Mounted or Recessed	Free-standing (mobile) orRecessed
Features	Imperial Surgical Ltd.Blanket and SolutionWarming Cabinets	Amsco Warming Cabinet(K092823)	EC-7701 Fluid WarmingCabinet (K993797)
Door	Stainless steel or doublepane Glass set in stainlesssteel frame on table top andfull size models.Counter top model hasPlexiglas mounted on toanodized aluminum doorframe.	Stainless Steel	Stainless Steel (Glass)
Cabinet Storage Capacity	Dual compartment and fullsize cabinets equipped with3 stainless steel perforatedshelvesTable top model equippedwith 1 stainless steelperforated shelf	Dual Compartment Model-Two shelves:15 flasks -18" upper45 flasks -18" lower20 flasks -24" upper60 flasks -24" lowerSingle Compartment Model-One Shelf15 flasks -18"20 Flasks - 24"	The cabinet is equipped withthree (3) white epoxy-coatedwire baskets, each with 24liter capacity.
Cabinet Volume	Dual compartment capacity18.1 cu ft overall (4.3 cu ftupper - 13.8 cu ft lower)Single compartment full sizecapacity 19.8 cu ftSingle compartmentshallow depth designcapacity 14.6 cu ftTable top model capacity7.5 cu ftTable top shallow designcapacity 5.2 cu ftCounter top version hascapacity of 2.0 cu ft (approx)	18" upper chamber - 3.1 cu ft24" upper chamber - 4.2 cu ft18" lower chamber - 8.9 cu ft24" lower chamber - 12 cu ft	Single compartment Apprx7.8 cu ft internal capacity
Controls	Electronic temp controllerwith LED display.Illuminated powerswitch/breaker (red)Amber neon indicator forElement onRed neon indicator fortrouble	Thermostat/powerswitch/fuse with indicatinglight/color codedtemperature selector.	Electronic control consists of4 digit LED display, on/offkeys, integrated lock featureand a series of promptsequence indicators.
Software	N/A	N/A	Not applicable
Features	Imperial Surgical Ltd.Blanket and SolutionWarming Cabinets	Amsco Warming Cabinet(K092823)	EC-7701 Fluid WarmingCabinet (K993797)
Temperature SelectionRange	Can be factory programmedfor Blankets:30℃ to 71℃ (86°F to 160°F)For Irrigation Fluids:30℃ to 66℃ (86°F to 150°F)For Injection Fluids:30℃ to 40℃ (86°F to 104°F)Must be specified at time ofordering.	95°F to 150°F (35°C to 65°C)	90°F to (32°C) to 150°F to(66°C)
Temperature Lock	Settings are factory set andlocked. The device can beunlocked in the field anduser can change settings ifthey wish to.	N/A	The device allows the user to"lock" the mode (IRR or INJ)and temperature settingcontrols.
Door Lock	Not available	Available by SSQ (SpecialSales Quote) only.	Available as an option
Over Temperature AlarmPoint	Visual alarm if chambertemperature exceeds 6℃above set temperature.Internal sensor shuts offheating elements when overtemperature occurs	Visual alarm if unit has achamber temperature greaterthan 12°F above settemperature. In the event ofan over temp condition,sensors automatically turnsoff the heather (s).	Visual and audible alarm ifunit has a chambertemperature greater than10°F (5.5°C) above settemperature. In the event fan over temp condition, theheating system shuts down.
Voltage Requirements	120VAC 60Hz	Electric Model: 110/120 Vac,220/240 Vac nominal, 50/60HZ. Steam Model: 120 Vacsingle phase.	125 Vac, 60 Hz, 1 ph

IMPERIAL SURGICAL LTD. 850 Halpem Ave.. Darval. Quebec, H9P 1G6 Canada Toll Free (800) 661-5432 • T.514.631.7988 • F.514.631.9083 • Web: www.surgmed.com

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Image /page/3/Picture/1 description: The image is a logo for Imperial Surgical. The logo features the words "IMPERIAL SURGICAL" in a stacked format, with "IMPERIAL" on top of "SURGICAL". Above the text, there is a triangular shape that resembles a mountain or a surgical drape. In the upper left corner, there are three small circles arranged horizontally.

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Image /page/4/Picture/1 description: The image is a logo for Imperial Surgical. The logo is a square with a white background. The top of the square has three circles in the upper left corner. The words "IMPERIAL SURGICAL" are stacked on top of each other in a bold, sans-serif font at the bottom of the square.

IMPERIAL SURGICAL LTD.

.....

350 Halpern Ave., Dorval, Quebec, H9P 1G6 Canada

· .

Toll Free (800) 661-5432 • T.514.631.7988 • F.514.631.9083 • Web: www.surgmed.com

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Image /page/5/Picture/1 description: The image is a logo for Imperial Surgical. The logo is a square with the words "IMPERIAL SURGICAL" stacked on top of each other in a bold, sans-serif font. Above the square are three circles, with the leftmost circle being filled in and the other two being empty. The background of the square is a mottled pattern.

6. Substantial Equivalent Assessment of non-clinical performance data.

The Imperial Surgical Ltd. Blanket and Solution Warming Cabinets have been tested to confirm they are safe and effective for their intended use. The following safety and functional tests have been performed:

Electrical safety is demonstrated as each unit is field certified by CSA International using CSA Standard(s) C22.2 No(s). 0,0.4 as a guide and SPE-1000, UL1262, US Field Evaluation.

Performance testing has been conducted to evaluate the following:

accuracy of the temperature controller ●
even distribution of heat throughout the cabinet with limited temperature variance, and . with multiple temperature readings within the accepted temperature variance of +/- 1.5ºC.
how quickly the cabinet will reach the desired temperature setting from a cold start. .
the recovery time required when the cabinet door is opened repeatedly for the . temperature to return to the desired setting.
time required for the cabinet to achieve the desired temperature setting loaded to 3/4 of ● its capacity (typical load expected during operation).

All tests met the expected specifications for the device. It is concluded that the electrical safety and performance testing conducted support the safety and effectiveness of the Imperial Surgical Ltd. Blanket and Solution Warming Cabinets.

7. Conclusion

Based on the information provided in this 510(k) premarket notification, the Imperial Surgical Ltd. Blanket and Solution Warming Cabinets are substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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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 figure 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-like figure.

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

Imperial Surgical Limited C/O Ms. Kathryn Ronalds Associate Director, Regulatory Affairs (Devices) CanReg Incorporation 4 Innovation Drive Dundas CANADA L9H 7P3

MAR 2 9 2012

Re: K112702

Trade/Device Name: Blanket and Solution Warming Cabinets Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LGZ Dated: March 21, 2012 Received: March 22, 2012

Dear Ms. Ronalds:

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.

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Page 2 - Ms. Ronalds

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 Part 801); 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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:

Blanket and Solution Warming Cabinets

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Indications for Use:

I reseription Use (Part 21 CFR 801 Subpart D)

AND/OR

رب ب-The-Counter Use (21 CFR 801 Subpart C)

. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Chym 3/28/12
(Division Sign Off)

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

510(k) Number: K112702

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).