(28 days)
Not Found
No
The description focuses on the mechanical and thermal performance of a warming cabinet and does not mention any AI or ML capabilities.
No
The device warms blankets, linens, and solutions for comfort and safety during medical procedures, rather than directly treating or diagnosing a medical condition.
No
The device is designed to warm blankets, linens, and solutions, not to diagnose medical conditions or provide information about a patient's health status.
No
The device description clearly describes a physical warming cabinet with doors, compartments, and heating elements, indicating it is a hardware device.
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 sterile solutions (surgical irrigation and IV solutions). This is a physical process applied to materials, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the physical structure and capacity for storing and warming these materials. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a warming cabinet used in a healthcare setting to prepare materials for patient care, not to perform diagnostic tests.
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 (comma separated list FDA assigned to the subject device)
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 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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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) | PROPOSED
Amsco Warming Cabinet.
24" Wide Pass-thru 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 | Double chamber |
| Unit Depth | 18" or 24" | 18" |
| Model | Freestanding, mobile base (24"
dual chamber only), or Counter
(single chamber only) | Freestanding |
| Interior and
Exterior Surfaces | Stainless Steel, ABS Plastic and
laminated galvanized steel | Stainless Steel and laminated
galvanized steel |
| Installation | Free-Standing, Recessed, Mobile
(24" dual chamber only), or
Counter (single chamber only) | Recessed only |
| Door | Laminated steel exterior and
Stainless Steel interior (Solid and
Glass) | Stainless steel exterior and
interior (Solid only) |
| Features | PREDICATE:
Amsco Warming Cabinet
(K092823) | PROPOSED:
Amsco Warming Cabinet
24"-Wide-Pass-thru-Model |
| Cabinet Storage
Capacity and
Volume | 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) bottles
Lower 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 |
| 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 |
| Features | PREDICATE
Amsco Warming Cabinet
(K092823) | PROPOSED
Amsco Warming Cabinet
24"-Wide-Pass-thru-Model |
| 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 a manual
mechanical door lock for each
door on each compartment |
| 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, the controls
automatically turn off the
heater(s). | Identical |
| Voltage
Requirements | 110/120 Vac, 220/240 Vac
nominal,
50/60 HZ | 110/120 Vac, 50/60 HZ |
Table 8-1: Summary of the Proposed Device and Predicate Devices Technological Characteristics
3
STERIS SPECIAL 510(k) – DEVICE MODIFICATION TO K092823
AMSCO WARMING CABINET – 24" WIDE PASS-THRU MODEL
1
1
4
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 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. | ||
| 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 | |
| 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 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 blank 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 |
5
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.
7
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
8
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
9
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