IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 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. ### 4. Intended Use 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 {2}------------------------------------------------ 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.<br>Blanket and Solution<br>Warming Cabinets | Amsco Warming Cabinet<br>(K092823) | EC-7701 Fluid Warming<br>Cabinet (K993797) | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Imperial Surgical Ltd.<br>Blanket and Solution<br>Warming Cabinets are<br>designed to store and warm<br>blankets, hospital linens,<br>irrigation fluids and/or<br>injection fluids in<br>accordance with the<br>recommended warming<br>temperatures and storage<br>time guidelines provided by<br>the manufacturers of such<br>products | Amsco Warming Cabinet is<br>for heating flasked solutions,<br>blankets and similar clinical<br>articles. | The Enthermics Medical<br>Systems EC-7701 Fluid<br>Warming Cabinet is<br>designed for safely store and<br>warm irrigation fluids or<br>injection fluids in accordance<br>with the recommended<br>warming temperatures and<br>storage times stated in the<br>fluid manufacturer's<br>labeling. | | Heating System | Convection Electric heating<br>element with circulating fan | Steam heat or Electric heater<br>blanket and fan blower<br>(convection heating) | Fully insulated<br>electrothermal cable array<br>(Convection heating)<br>Usually radiant heating | | Unit Configuration | Single / dual | Single/Dual | Single | | Unit Depth | 22" or 28" for table top and<br>full size cabinets.<br>16" depth on count top<br>model. | 18" or 24" | 34″ | | Model | Wall or Counter | Wall or Counter | Wall | | Interior and Exterior<br>Surfaces | Stainless Steel interior and<br>exterior on table top and full<br>size models.<br>Counter top model made<br>with baked on powder<br>coated steel outer shell with<br>Stainless Steel interior. | Stainless Steel | Stainless Steel | | Installation | Free standing or recessed | Open-Mounted or Recessed | Free-standing (mobile) or<br>Recessed | | Features | Imperial Surgical Ltd.<br>Blanket and Solution<br>Warming Cabinets | Amsco Warming Cabinet<br>(K092823) | EC-7701 Fluid Warming<br>Cabinet (K993797) | | Door | Stainless steel or double<br>pane Glass set in stainless<br>steel frame on table top and<br>full size models.<br>Counter top model has<br>Plexiglas mounted on to<br>anodized aluminum door<br>frame. | Stainless Steel | Stainless Steel (Glass) | | Cabinet Storage Capacity | Dual compartment and full<br>size cabinets equipped with<br>3 stainless steel perforated<br>shelves<br>Table top model equipped<br>with 1 stainless steel<br>perforated shelf | Dual Compartment Model-<br>Two shelves:<br>15 flasks -18" upper<br>45 flasks -18" lower<br>20 flasks -24" upper<br>60 flasks -24" lower<br>Single Compartment Model-<br>One Shelf<br>15 flasks -18"<br>20 Flasks - 24" | The cabinet is equipped with<br>three (3) white epoxy-coated<br>wire baskets, each with 24<br>liter capacity. | | Cabinet Volume | Dual compartment capacity<br>18.1 cu ft overall (4.3 cu ft<br>upper - 13.8 cu ft lower)<br>Single compartment full size<br>capacity 19.8 cu ft<br>Single compartment<br>shallow depth design<br>capacity 14.6 cu ft<br>Table top model capacity<br>7.5 cu ft<br>Table top shallow design<br>capacity 5.2 cu ft<br>Counter top version has<br>capacity of 2.0 cu ft (approx) | 18" upper chamber - 3.1 cu ft<br>24" upper chamber - 4.2 cu ft<br>18" lower chamber - 8.9 cu ft<br>24" lower chamber - 12 cu ft | Single compartment Apprx<br>7.8 cu ft internal capacity | | Controls | Electronic temp controller<br>with LED display.<br>Illuminated power<br>switch/breaker (red)<br>Amber neon indicator for<br>Element on<br>Red neon indicator for<br>trouble | Thermostat/power<br>switch/fuse with indicating<br>light/color coded<br>temperature selector. | Electronic control consists of<br>4 digit LED display, on/off<br>keys, integrated lock feature<br>and a series of prompt<br>sequence indicators. | | Software | N/A | N/A | Not applicable | | Features | Imperial Surgical Ltd.<br>Blanket and Solution<br>Warming Cabinets | Amsco Warming Cabinet<br>(K092823) | EC-7701 Fluid Warming<br>Cabinet (K993797) | | Temperature Selection<br>Range | Can be factory programmed<br>for Blankets:<br>30℃ to 71℃ (86°F to 160°F)<br>For Irrigation Fluids:<br>30℃ to 66℃ (86°F to 150°F)<br>For Injection Fluids:<br>30℃ to 40℃ (86°F to 104°F)<br>Must be specified at time of<br>ordering. | 95°F to 150°F (35°C to 65°C) | 90°F to (32°C) to 150°F to<br>(66°C) | | Temperature Lock | Settings are factory set and<br>locked. The device can be<br>unlocked in the field and<br>user can change settings if<br>they wish to. | N/A | The device allows the user to<br>"lock" the mode (IRR or INJ)<br>and temperature setting<br>controls. | | Door Lock | Not available | Available by SSQ (Special<br>Sales Quote) only. | Available as an option | | Over Temperature Alarm<br>Point | Visual alarm if chamber<br>temperature exceeds 6℃<br>above set temperature.<br>Internal sensor shuts off<br>heating elements when over<br>temperature occurs | Visual alarm if unit has a<br>chamber temperature greater<br>than 12°F above set<br>temperature. In the event of<br>an over temp condition,<br>sensors automatically turns<br>off the heather (s). | Visual and audible alarm if<br>unit has a chamber<br>temperature greater than<br>10°F (5.5°C) above set<br>temperature. In the event f<br>an over temp condition, the<br>heating system shuts down. | | Voltage Requirements | 120VAC 60Hz | Electric Model: 110/120 Vac,<br>220/240 Vac nominal, 50/60<br>HZ. Steam Model: 120 Vac<br>single 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 {3}------------------------------------------------ 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. . {4}------------------------------------------------ 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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, lo 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 {8}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number (if known): Device Name: Blanket and Solution Warming Cabinets ・・・・ ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Indications for Use: 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. 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