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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Getinge Series Warming Cabinet. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study of acceptance criteria and performance as might be seen for more complex medical devices like those involving AI.

Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not fully applicable or are not explicitly detailed in this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria and reported device performance in the way a clinical trial or performance study for a high-risk device might. Instead, it summarizes "performance testing" and compares features to a predicate device.

However, based on the "Summary of Performance Testing" and the comparison table, we can infer some criteria and reported performance:

Acceptance Criteria (Inferred from testing and comparison)	Reported Device Performance (Summary)
Temperature Control & Performance
Empty chamber temperature profiles	Performed as intended (exact profiles not detailed)
Heat-up time with loads	Performed as intended (exact times not detailed)
Temperature Selection Range	32°C (90°F) to 71°C (160°F) - Matches predicate
Overheat Alarm Condition (Functional)	"OH" displayed, audible alarm, power to heaters shut off when chamber temp exceeds selected temp by 4°C (7°F)
Overheat Alarm Point (Threshold)	Alarms at 4°C (7°F) above set temperature (lower than predicate's 5.5°C/10°F threshold)
Temperature Lock-out Function	Present and functional (prevents unauthorized changes)
Electrical Safety and EMC
Compliance to IEC 61010-1	Verified
Compliance to IEC 61010-2-010	Verified
Compliance to IEC 61326-1	Verified

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document states, "All tests were conducted on current production units." It doesn't specify the number of units tested.
Data Provenance: The tests appear to be internal performance verification conducted by Getinge Sourcing LLC, based in Rochester, New York, USA. The testing is prospective for the purpose of this submission. It is not patient or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a warming cabinet, and its performance criteria are primarily engineering and safety standards, not clinical diagnostic accuracy. "Ground truth" in the clinical sense (e.g., confirmed disease diagnosis) is not relevant here. The "ground truth" for this device's performance would be derived from physical measurements and adherence to specified design parameters and referenced safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, often with disagreements that need resolution (e.g., in medical image analysis). For a warming cabinet's functional and safety testing, the "ground truth" is established by physical measurement equipment and compliance with engineering specifications, not by expert consensus on subjective interpretation.

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

This is not applicable. The Getinge Series Warming Cabinet is a physical device for heating and storing solutions/blankets, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI-assisted human reader improvement are entirely irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. As stated above, this is a warming cabinet, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing of this device is based on:

Engineering specifications and measurements: For temperature control, heat-up times, and adherence to design parameters.
Compliance with recognized standards: Such as IEC 61010-1, 61010-2-010, and 61326-1 for electrical safety and electromagnetic compatibility (EMC).
The measurements and verification against these standards serve as the "ground truth."

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/machine learning device.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153713

Device Name

Getinge Series Warming Cabinet models 5524, 5618, 5624

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

510(k) SUMMARY

Getinge Series Warming Cabinet

K153713

Submitted by:	Getinge Sourcing LLC1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Barb Smith, RACSr. Regulatory Affairs SpecialistPhone: (585) 214-6049Fax: (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:

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.

{4}------------------------------------------------

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 WarmingCabinet[Subject Device]	AMSCO K092823[Predicate Device]	Comparison
1Intended Use	Designed for the warmstorage of the solutions andblankets used for patientcare in Healthcare facilities.	Designed to raise thetemperature of blankets, linensand sterile surgical irrigationsolutions and IV solutions to anacceptable level for varioussurgical, obstetrical,emergency, critical care andother healthcare applications.The Amsco Warming Cabinetis designed to hold acombination of flasks and/ordry goods.	Same withexception of IVfluids
2Heating System	Electric heater and fanblowing (convection heating)	Electric heater and fan blowing(convection heating)	same
3Unit Configuration	Single/Double	Single/Double	same
4Unit Depth	18" or 24"	18" or 24"	same
5Model	Wall or Counter	Wall or Counter	same
6Interior andExterior Surfaces	Stainless steel and glass	Stainless Steel, ABS Plasticand laminated galvanized steel	Same and similarmaterials
7Installation	Free standing with pedestalbase, recessed, wallmounted cabinet	Free Standing (mobile) orrecessed	Same withexception ofmobile freestanding unit
8Door	Tempered glass framed withstainless steel	Stainless Steel (Solid andGlass)	same
9Cabinet StorageCapacity	Model 5524 = 4.1 cu ft - upto 30 ( 1 liter) bottlesModel 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) bottles18" lower chamber = 8.5 cu ft -up to 72 (1 liter) bottles24" upper/single = 4.3 cu ft -	Smaller capacityin some models
#	Features	Getinge Series WarmingCabinet[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 cabinetvolume in somemodels
		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 ft24" 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/, temperatureset point, temperaturedisplay in °F or °C,temperature set point "lockin"LED display provides:controls off, chambertemperature, power loss,temperature set point,overheat, set pointlock/unlock, heater on,Fahrenheit or Celsius.An audible alarm indicatesoverheat condition.	Digital push buttonkeypad/power switch/DigitalLCD temperature display/modeselection buttons/door ajarindicator/Over-temperaturelight for eachcompartment/Data port forretrieval of stored temperatures	Same withexception of dataport for retrievalof storedtemperatures
12	Software	Unit contains software	Unit contains software	same
13	TemperatureSelection 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-outfunction to preventunauthorized temperaturechanges.	Temperature lock-out functionto prevent unauthorizedtemperature changes.	same
15	Door Lock	none	Manual mechanical door lockor optional electronic door locksystem for each compartment	Door lock notavailable onsubject device
16	Over TemperatureAlarm Point	In the event that chambertemperature exceeds theselected temperature by 4°C(7°F) an "OH" (representing	Visual and audible alarm if unithas a chamber temperaturegreater than 10°F (5.5°C)above set temperature. In the	Same alarmfunctions.Subject devicealarms at a lower
#	Features	Getinge Series WarmingCabinet[Subject Device]	AMSCO K092823[Predicate Device]	Comparison
		overheat) is displayed, analarm sounds and power tothe heaters is shut off.	event of an over tempcondition, sensorsautomatically turns off theheater(s).	overtempcondition.
17	VoltageRequirements	110/220 Vac, 220/240 VACnominal, 50/60 HZ	110/220 Vac, 220/240 VACnominal, 50/60 HZ	same

Comparison Matrix Getinge Series Warming Cabinet to Predicate Device

{5}------------------------------------------------

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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.