(166 days)
Not Found
No
The document describes a warming cabinet with standard temperature control and safety features, with no mention of AI or ML capabilities.
No
The device is described as a warming cabinet for irrigation solutions and blankets, not for directly treating a disease or condition in a patient.
No
The device is a warming cabinet for solutions and blankets, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical warming cabinet, which is a hardware device, not software.
Based on the provided information, the Getinge Series Warming Cabinet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for heating and storage of irrigation solutions and/or blankets used in patient care. This is a direct application to the patient or for items used on the patient, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces the use for warming solutions and blankets for patient care and explicitly states it's not for injectable fluids, blood, or blood products (which are often involved in IVD testing).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a warming cabinet used to prepare items for patient care, which falls under the category of medical devices used in a clinical setting, but not specifically for in vitro diagnosis.
N/A
Intended Use / Indications for Use
Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.
Product codes (comma separated list FDA assigned to the subject device)
LHC
Device Description
The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.
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
healthcare facilities, areas such as surgery, recovery, OB/GYN, ICU or ER.
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)
Performance testing was conducted to provide evidence that the Getinge Series Warming Cabinet performs as intended. Testing included empty chamber temperature profiles, heat up time with loads and testing of controls including overheat alarm conditions. Testing included 300 party tests to verify compliance to IEC 61010-1, 61010-2-010 and 61326-1 for electrical safety and EMC requirements. All tests were conducted on current production units. The results of the testing demonstrate that the Getinge Series Warming Cabinet performs as intended.
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.
AMSCO Warming Cabinet [K092823]
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
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Getinge Sourcing, LLC Barb Smith Sr. Regulatory Affairs Specialist 1777 East Henrietta Road Rochester, New York 14623
Re: K153713
Trade/Device Name: Getinge Series Warming Cabinet Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LHC Dated: December 21, 2015 Received: December 24, 2015
Dear Barb Smith:
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 Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR 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,
Susan Runno DDS, MA
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) K153713
Device Name
Getinge Series Warming Cabinet models 5524, 5618, 5624
Indications for Use (Describe)
Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Getinge Series Warming Cabinet
K153713
| Submitted by: | Getinge Sourcing LLC
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Barb Smith, RAC
Sr. Regulatory Affairs Specialist
Phone: (585) 214-6049
Fax: (585) 272-5299 |
| Date prepared: | June 7, 2016 |
| Proprietary Name: | Getinge Series Warming Cabinet |
| Common Name: | Warmer, Irrigation Solution |
| Device Classification: | Unclassified |
| Predicate Device: | AMSCO Warming Cabinet [K092823] |
Description of Device:
The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.
Intended Use:
The Getinge Series Warming Cabinet is intended for use by health care facilities for warm storage of irrigation solutions and blankets used for patient care.
Comparisons to Predicate Device:
Similarities between the Getinge Series Warming Cabinet and the identified predicate are:
- Intended use is similar: Intended for use by health care facilities to warm blankets and solutions used in patient care. Getinge models are not intended for the storage of injectable fluids.
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- Operating Principle is the same: Electric heater and fan blowing (convection ● heating).
- . Materials of construction are the same (stainless steel). There is no direct patient contact associated with this device.
- . Temperature Selection: Same: 32°C - 71°C (90°F - 160°F)
- . Both have over temperature alarms and temperature lockout functions
The primary difference between the Getinge Series Warming Cabinet and the predicate device (AMSCO Warming Cabinet) is that the Getinge Series Warming Cabinet is not labeled for the storage of injectable fluids.
| #
Features | Getinge Series Warming
Cabinet
[Subject Device] | AMSCO K092823
[Predicate Device] | Comparison | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 1
Intended Use | Designed for the warm
storage of the solutions and
blankets used for patient
care in Healthcare facilities. | 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 hold a
combination of flasks and/or
dry goods. | Same with
exception of IV
fluids | |
| 2
Heating System | Electric heater and fan
blowing (convection heating) | Electric heater and fan blowing
(convection heating) | same | |
| 3
Unit Configuration | Single/Double | Single/Double | same | |
| 4
Unit Depth | 18" or 24" | 18" or 24" | same | |
| 5
Model | Wall or Counter | Wall or Counter | same | |
| 6
Interior and
Exterior Surfaces | Stainless steel and glass | Stainless Steel, ABS Plastic
and laminated galvanized steel | Same and similar
materials | |
| 7
Installation | Free standing with pedestal
base, recessed, wall
mounted cabinet | Free Standing (mobile) or
recessed | Same with
exception of
mobile free
standing unit | |
| 8
Door | Tempered glass framed with
stainless steel | Stainless Steel (Solid and
Glass) | same | |
| 9
Cabinet Storage
Capacity | Model 5524 = 4.1 cu ft - up
to 30 ( 1 liter) bottles
Model 5618 upper chamber
= 2.9 cu ft - up to 18 (1 liter)
bottles | 18" upper/single = 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 = 4.3 cu ft - | Smaller capacity
in some models | |
| # | Features | Getinge Series Warming
Cabinet
[Subject Device] | AMSCO K092823
[Predicate Device] | Comparison |
| | | Model 5618 lower chamber
= 10.0 cu ft - up to 48 (1 liter) bottles | up to 30 (1 liter) bottles | |
| | | Model 5624 upper chamber
= 4.1 cu ft - up to 30 (1 liter) bottles | 24" lower chamber = 11.6 cu ft
- up to 90 (1 liter bottles) | |
| | | Model 5624 lower chamber
= 13.7 cu ft - up to 60 (1 liter) bottles | | |
| 10 | Cabinet Volume | Model 5524 = 4.1 cu ft | 18" upper chamber = 3.1 cu ft | Smaller cabinet
volume in some
models |
| | | Model 5618 upper chamber
= 2.9 cu ft | 24" upper chamber = 4.2.cu ft | |
| | | Model 5618 lower chamber
= 10.0 cu ft | 18" lower chamber = 8.9 cu ft
24" lower chamber = 12 cu ft | |
| | | Model 5624 upper chamber
= 4.1 cu ft | | |
| | | Model 5624 lower chamber
= 13.7 cu ft | | |
| 11 | Controls | Push button keypad controls
: control on/off/, temperature
set point, temperature
display in °F or °C,
temperature set point "lock
in"
LED display provides:
controls off, chamber
temperature, power loss,
temperature set point,
overheat, set point
lock/unlock, heater on,
Fahrenheit or Celsius.
An audible alarm indicates
overheat condition. | 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 | Same with
exception of data
port for retrieval
of stored
temperatures |
| 12 | Software | Unit contains software | Unit contains software | same |
| 13 | Temperature
Selection Range | 32°C (90°F) to 71°C (160°F) | 90°F (32°C) to 160°F (71°C) | same |
| 14 | Temperature Lock | Temperature lock-out
function to prevent
unauthorized temperature
changes. | Temperature lock-out function
to prevent unauthorized
temperature changes. | same |
| 15 | Door Lock | none | Manual mechanical door lock
or optional electronic door lock
system for each compartment | Door lock not
available on
subject device |
| 16 | Over Temperature
Alarm Point | In the event that chamber
temperature exceeds the
selected temperature by 4°C
(7°F) an "OH" (representing | Visual and audible alarm if unit
has a chamber temperature
greater than 10°F (5.5°C)
above set temperature. In the | Same alarm
functions.
Subject device
alarms at a lower |
| # | Features | Getinge Series Warming
Cabinet
[Subject Device] | AMSCO K092823
[Predicate Device] | Comparison |
| | | overheat) is displayed, an
alarm sounds and power to
the heaters is shut off. | event of an over temp
condition, sensors
automatically turns off the
heater(s). | overtemp
condition. |
| 17 | Voltage
Requirements | 110/220 Vac, 220/240 VAC
nominal, 50/60 HZ | 110/220 Vac, 220/240 VAC
nominal, 50/60 HZ | same |
Comparison Matrix Getinge Series Warming Cabinet to Predicate Device
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Summary of Performance Testing:
Performance testing was conducted to provide evidence that the Getinge Series Warming Cabinet performs as intended. Testing included empty chamber temperature profiles, heat up time with loads and testing of controls including overheat alarm conditions. Testing included 300 party tests to verify compliance to IEC 61010-1, 61010-2-010 and 61326-1 for electrical safety and EMC requirements. All tests were conducted on current production units. The results of the testing demonstrate that the Getinge Series Warming Cabinet performs as intended.
Clinical Data:
No clinical data is required for this device classification submission.
Conclusion:
The Getinge Series Warming Cabinet has the same intended use and technological characteristics as the predicate device. The Getinge Series Warming Cabinet has been tested and shown to meet the requirements of the product specification and intended use. Based on the information provided in this premarket notification, it can be concluded that the subject device is substantially equivalent to the predicate device.