(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 $\pm$ 3°F in upper compartment and $\pm$ 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 $\pm$ 3°F in upper compartment and $\pm$ 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 $\pm$ 3°F in upper compartment and $\pm$ 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.
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JUL 2 9 2011
KI11870
STERIS®
510(k) Summary For Amsco Warming Cabinet 24" Wide Pass-thru 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 |
June 30, 2011 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor. OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Trade Name: | Amsco Warming Cabinet, 24" Wide Pass-thru-Model |
|---|---|
| Common/usual Name: | Warming Cabinet |
| Classification: | Unclassified |
| Classification Name: | Warmer, Thermal, Infusion Fluid; Unclassified,Product Code LGZ |
Predicate Device 2.
Amsco Warming Cabinet (K092823)
Description of Device 3.
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.
4. 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.
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Description of Safety and Substantial Equivalence રાં
Substantial Equivalence
The 24" Wide Pass-thru Amsco Warming Cabinet is identical in technology and intended use to the predicate Amsco Warming Cabinet models. A table comparing the technological characteristics of the proposed Amsco Warming Cabinet to the predicate is provided in Table 8-1.
路站,同: 上海: 下:: 上一篇: 上一篇: 上一篇: 上一篇:
| Features | PREDICATE.Amsco Warming Cabinet.(K092823) | PROPOSEDAmsco Warming Cabinet.24" Wide Pass-thru Model |
|---|---|---|
| Intended Use | The Amsco Warming Cabinet isdesigned to raise the temperatureof blankets, linens and sterilesurgical irrigation solutions andIV solutions to an acceptablelevel for various surgical,obstetrical, emergency, criticalcare and other healthcareapplications. | Identical |
| Heating System | Electric heater and fan blower(Convection heating) | Identical |
| Unit Configuration | Single/Double chamber | Double chamber |
| Unit Depth | 18" or 24" | 18" |
| Model | Freestanding, mobile base (24"dual chamber only), or Counter(single chamber only) | Freestanding |
| Interior andExterior Surfaces | Stainless Steel, ABS Plastic andlaminated galvanized steel | Stainless Steel and laminatedgalvanized steel |
| Installation | Free-Standing, Recessed, Mobile(24" dual chamber only), orCounter (single chamber only) | Recessed only |
| Door | Laminated steel exterior andStainless Steel interior (Solid andGlass) | Stainless steel exterior andinterior (Solid only) |
| Features | PREDICATE:Amsco Warming Cabinet(K092823) | PROPOSED:Amsco Warming Cabinet24"-Wide-Pass-thru-Model |
| Cabinet StorageCapacity andVolume | 30" wide by 18" deep upper / single chamber - 3.2 cu ft - up to 24 (1-liter) bottles lower chamber - 8.5 cu ft - up to 72 (1-liter) bottles | Upper chamber - 2.1 cu ft - up to 20 (1-liter) bottlesLower chamber - 4.1 cu ft - up to 40 (1-liter) bottles |
| 30" wide by 24" deep upper / single chamber - 4.3 cu ft - up to 30 (1-liter) bottles lower chamber - 11.6 cu ft - up to 90 (1-liter) bottles | ||
| 30" wide by 18" deep OR Console upper chamber - 3.3 cu ft - up to 24 (1-liter) bottles lower chamber - 6.2 cu ft - up to 48 (1-liter) bottles | ||
| 24" wide by 18" deep OR Console upper chamber - 2.4 cu ft - up to 20 (1-liter) bottles lower chamber - 4.7 cu ft - up to 40 (1-liter) bottle | ||
| Controls | Digital Push Button keypad / power switch / Digital LCD temperature display / mode selection buttons / door ajar indicator / Over-temperature light for each compartment / Data port for retrieval of stored temperatures. | Identical |
| Software | Unit contains software | Identical - no changes were made to the software |
| TemperatureSelection Range | 90°F (32°C) to 160°F (71°C) | Identical |
| Temperature Lock | Temperature lock-out function to prevent unauthorized temperature changes. | Identical |
| Features | PREDICATEAmsco Warming Cabinet(K092823) | PROPOSEDAmsco Warming Cabinet24"-Wide-Pass-thru-Model |
| Door Lock | All configurations will beequipped with either a manualmechanical door lock or optionalelectronic door lock system foreach compartment | All configurations will beequipped with a manualmechanical door lock for eachdoor on each compartment |
| 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, the controlsautomatically turn off theheater(s). | Identical |
| VoltageRequirements | 110/120 Vac, 220/240 Vacnominal,50/60 HZ | 110/120 Vac, 50/60 HZ |
Table 8-1: Summary of the Proposed Device and Predicate Devices Technological Characteristics
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STERIS SPECIAL 510(k) – DEVICE MODIFICATION TO K092823
AMSCO WARMING CABINET – 24" WIDE PASS-THRU MODEL
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1
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STERIS SPECIAL 510(k) - DEVICE MODIFICATION TO K092823 AMSCO WARMING CABINET - 24" WIDE PASS-THRU MODEL
Safety and Effectiveness
Mechanical, electrical and heating performance testing demonstrate that the proposed Amsco Warming Cabinet, 24" Wide Pass-thru model, operates as intended and is as safe and effective as the predicate. Table 8-2 summarizes the verification and validation activities that were performed to ensure that rorifications do not affect the safety or effectiveness of the Amsco Warming Cabinet.
| Table 8-2: Summary of Verification and Validation Activities | |
|---|---|
| for 24" Wide Pass-thru Warming Cabinet |
| Test Description | Acceptance Criteria | Results |
|---|---|---|
| Electrical Testing | Dielectric Withstand• Achieve passing results thru automated dielectricstrength tester.Earth and Enclosure Leakage Current• Must not exceed requirements listed in UL 61010-1clause 6.3.1b (must not exceed .5mA normalcondition and 3.5mA single fault condition)Ground bond• Must not exceed 0.1 ohm and maintain groundcontinuity.Power Input & Line Voltage• The power input of equipment at rated voltage andsteady state current shall not exceed the markedrating by 10%. | PASS |
| Test Description | Acceptance Criteria | Results |
| System Functions | • Main Power ON indicator at rear upper door is - illuminated when Main Power Switch is set to the ON position.• 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 11.4 - 14.25 Amps.• 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• 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.Heating Devices• 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 |
| Test.Description | Acceptance Criteria | Results |
| Protection againstHazards from Fluids | - Pass dielectric strength test per-UL.61010-1, section.6, 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 $\pm$ 3°F inupper compartment and $\pm$ 5°F in lower compartment.- At a 160°F set-point temperature, the uppercompartment display must reach set-point within 35minutes and lower compartment display must bewithin 65 minutes.- Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance(Full IV solution load inupper compartment andfull blank load in lowercompartment) | - Temperature reading of each thermocouple must notvary from set-point temperature by more than $\pm$ 3°F inupper compartment and $\pm$ 5°F in lower compartment.- Upper and lower compartment controls temperaturedisplay must reach set-point within 12 hours.- Normal system operation is maintained without over-temperature condition or faults occurring. | PASS |
| Heating Performance(Full irrigation solutionload in upper and lowercompartments | - With a fully loaded compartment of Irrigationsolution, bottles of solution shall not overbalance andfall off shelf when doors are opened.- Temperature reading of each thermocouple must notvary from set-point temperature by more than $\pm$ 3°F inupper compartment and $\pm$ 5°F in lower compartment- Upper and lower compartment controls temperaturedisplay must reach set-point within 12 hours.- Normal system operation is maintained without over-temperature condition or faults occurring. | 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 |
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STERIS SPECIAL 510(k) – DEVICE MODIFICATION TO K092823
AMSCO WARMING CABINET – 24" WIDE PASS-THRU MODEL
{6}------------------------------------------------
STERIS SPECIAL 510(k) - DEVICE MODIFICATION TO K092823 AMSCO WARMING CABINET - 24" WIDE PASS-THRU MODEL
Conclusion
Verification and validation testing demonstrate that the proposed Amsco Warming Cabinet, 24" Wide Pass-thru 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. The proposed Amsco Warming Cabinet, 24" Wide Pass-thru model, is substantially equivalent to the predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three tail feathers.
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: K111870
Trade/Device Name: Amsco Warming Cabinet Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: June 30, 2011 Received: July 1, 2011
Dear Mr. Sullivan:
This letter corrects our substantially equivalent letter of July 29, 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 (OS) 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 yours,
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 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
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)
Ian Sti for Richard Chapman
(Division Sign-Off)
Division of Sign Only
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111876
Page 1 of 1
June 30, 2011
§ 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).