(77 days)
Not Found
No
The description focuses on basic warming and storage functions with standard electronic controls and data recording, with no mention of AI/ML terms or capabilities.
No
The device is a warming cabinet for blankets, linens, and solutions used in healthcare settings, not a device that directly treats a condition or disease.
No
The device is described as a warming cabinet for blankets, linens, and solutions, and its performance studies focus on heating and mechanical functions, not on diagnosing medical conditions.
No
The device description clearly outlines a physical warming cabinet with hardware components like a heating compartment, door lock, and optional mobile base. The performance studies also focus on hardware-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm blankets, linens, and solutions for patient care. This is a physical process applied to materials used in healthcare settings, not a diagnostic test performed on biological samples.
- Device Description: The description details a warming cabinet designed to store and heat items. It does not mention any components or functions related to analyzing biological specimens.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This warming cabinet does not fit that description.
N/A
Intended Use / 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.
Product codes
LGZ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and surgical outpatient center applications.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Electrical Testing
- Achieve passing results thru 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%.
Results: 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
Results: 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.
Results: 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.
Results: 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.
Results: 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.
Results: 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.
Results: 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
Results: PASS
Stability Test
- No overbalance during test
Results: 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.
Results: 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.
Results: PASS
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
1. Device Name
| Trade Name: | Amsco Warming Cabinet, Mid-size Model |
|---|---|
| Common/usual Name: | Warming Cabinet |
| Classification Name: | Warmer, Thermal, Infusion Fluid; Unclassified |
| Product Code LGZ |
2. Predicate Device
Amsco Warming Cabinet (K092823)
3. Description of Device
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).
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.
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.
2
STERIS Response to FDA Request for Additional Information dated 4-15-2011
K110769 S001 - AMSCO WARMING CABINET -- MID-SIZE MODEL
| Features | Technological Characteristics
PREDICATE
Amsco Warming Cabinet
(K092823) | PROPOSED
Amsco Warming Cabinet
Mid-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 and
Exterior 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 Storage
Capacity and
Volume | 18" upper / single chamber - 3.2 cu ft - up to 24 (1-liter) bottles
18" lower chamber - 8.5 cu ft - up to 72 (1-liter) bottles
24" upper / single chamber - 4.3 cu ft - up to 30 (1-liter) bottles
24" lower chamber - 11.6 cu ft - | 7.2 cu ft - up to 60 (1-liter) bottles |
| Features | PREDICATE
Amsco Warming Cabinet
(K092823) | PROPOSED
Amsco Warming Cabinet
Mid-size Model |
| 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 components as the
Predicate: Digital Push Button
keypad / power switch / Digital
LCD temperature display / mode
selection buttons / door ajar
indicator / Over-temperature light
for compartment / Data port for
retrieval of stored temperatures. |
| Software | Unit contains software | Identical - no changes were made
to the software |
| Temperature
Selection Range | 90°F (32°C) to 160°F (71°C) | Identical |
| Temperature Lock | Temperature lock-out function to
prevent unauthorized temperature
changes. | Identical |
| Door Lock | All configurations will be
equipped with either a manual
mechanical door lock or optional
electronic door lock system for
each compartment | All configurations will be
equipped with an electronic door
lock system |
| Over Temperature
Alarm Point | Visual and audible alarm if unit
has a chamber temperature
greater than 10°F (5.5°C) above
set temperature. In the event of an
over temp condition, sensors
automatically turns off the
heater(s). | Identical |
| Voltage
Requirements | 110/120 Vac, 220/240 Vac
nominal, 50/60 HZ | Identical |
Table 5-1: Summary of the Proposed Device and Predicate Devices Technological Characteristics
3
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.
4
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 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 | |
| Test Description | Acceptance Criteria | Results |
| 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, | |
| section6, 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 |
Table 5-2: Summary of Verification and Validation Activities
for Mid-size Single Compartment Warming Cabinet
5
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.
6
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
7
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
8
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)
ld C. Chaym 6/2/11
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K110769
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