Getinge Series Warming Cabinet

K153713 · Getinge Sourcing, LLC · LHC · Jun 7, 2016 · Physical Medicine

Device Facts

• Record ID: K153713
• Device Name: Getinge Series Warming Cabinet
• Applicant: Getinge Sourcing, LLC
• Product Code: LHC · Physical Medicine
• Decision Date: Jun 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

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.

Device Story

Getinge Series Warming Cabinet (models 5524, 5618, 5624) provides warm storage for irrigation solutions and blankets in clinical settings (surgery, recovery, OB/GYN, ICU, ER). Device uses electric heater and fan for convection heating; maintains temperatures between 32°C and 71°C (90°F - 160°F). Operated by healthcare facility staff via push-button keypad; LED display shows chamber temperature, power status, and set points. Includes over-temperature alarm and temperature lockout functions to prevent unauthorized changes. Device is not intended for storage of injectable fluids, blood, or blood products. Output is a temperature-controlled environment for patient care supplies; helps maintain optimal temperature for irrigation solutions and blankets to support patient comfort and clinical procedures.

Clinical Evidence

No clinical data required. Bench testing only: empty chamber temperature profiles, heat-up time with loads, and control functionality (overheat alarms). Electrical safety and EMC testing performed per IEC 61010-1, 61010-2-010, and 61326-1.

Technological Characteristics

Materials: stainless steel and tempered glass. Heating: electric heater with convection fan. Temperature range: 32°C-71°C. Configuration: wall or counter-mounted, single/double chamber. Controls: push-button keypad with LED display. Safety: over-temperature alarm (triggers at 4°C above set point) and temperature lockout. Power: 110/220 VAC, 50/60 Hz.

Indications for Use

Indicated for the heating and storage of irrigation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.

Regulatory Classification

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.

Predicate Devices

• AMSCO Warming Cabinet (K092823)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

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)

#### 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 [e-mail]

"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 LLC<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 |
|------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Barb Smith, RAC<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| 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.

{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.

| #<br>Features | Getinge Series Warming<br>Cabinet<br>[Subject Device] | AMSCO K092823<br>[Predicate Device] | Comparison | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 1<br>Intended Use | Designed for the warm<br>storage of the solutions and<br>blankets used for patient<br>care in Healthcare facilities. | Designed to raise the<br>temperature of blankets, linens<br>and sterile surgical irrigation<br>solutions and IV solutions to an<br>acceptable level for various<br>surgical, obstetrical,<br>emergency, critical care and<br>other healthcare applications.<br>The Amsco Warming Cabinet<br>is designed to hold a<br>combination of flasks and/or<br>dry goods. | Same with<br>exception of IV<br>fluids | |
| 2<br>Heating System | Electric heater and fan<br>blowing (convection heating) | Electric heater and fan blowing<br>(convection heating) | same | |
| 3<br>Unit Configuration | Single/Double | Single/Double | same | |
| 4<br>Unit Depth | 18" or 24" | 18" or 24" | same | |
| 5<br>Model | Wall or Counter | Wall or Counter | same | |
| 6<br>Interior and<br>Exterior Surfaces | Stainless steel and glass | Stainless Steel, ABS Plastic<br>and laminated galvanized steel | Same and similar<br>materials | |
| 7<br>Installation | Free standing with pedestal<br>base, recessed, wall<br>mounted cabinet | Free Standing (mobile) or<br>recessed | Same with<br>exception of<br>mobile free<br>standing unit | |
| 8<br>Door | Tempered glass framed with<br>stainless steel | Stainless Steel (Solid and<br>Glass) | same | |
| 9<br>Cabinet Storage<br>Capacity | Model 5524 = 4.1 cu ft - up<br>to 30 ( 1 liter) bottles<br><br>Model 5618 upper chamber<br>= 2.9 cu ft - up to 18 (1 liter)<br>bottles | 18" upper/single = 3.2 cu ft -<br>up to 24 (1 liter) bottles<br><br>18" lower chamber = 8.5 cu ft -<br>up to 72 (1 liter) bottles<br><br>24" upper/single = 4.3 cu ft - | Smaller capacity<br>in some models | |
| # | Features | Getinge Series Warming<br>Cabinet<br>[Subject Device] | AMSCO K092823<br>[Predicate Device] | Comparison |
| | | Model 5618 lower chamber<br>= 10.0 cu ft - up to 48 (1 liter) bottles | up to 30 (1 liter) bottles | |
| | | Model 5624 upper chamber<br>= 4.1 cu ft - up to 30 (1 liter) bottles | 24" lower chamber = 11.6 cu ft<br>- up to 90 (1 liter bottles) | |
| | | Model 5624 lower chamber<br>= 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<br>volume in some<br>models |
| | | Model 5618 upper chamber<br>= 2.9 cu ft | 24" upper chamber = 4.2.cu ft | |
| | | Model 5618 lower chamber<br>= 10.0 cu ft | 18" lower chamber = 8.9 cu ft<br>24" lower chamber = 12 cu ft | |
| | | Model 5624 upper chamber<br>= 4.1 cu ft | | |
| | | Model 5624 lower chamber<br>= 13.7 cu ft | | |
| 11 | Controls | Push button keypad controls<br>: control on/off/, temperature<br>set point, temperature<br>display in °F or °C,<br>temperature set point "lock<br>in"<br>LED display provides:<br>controls off, chamber<br>temperature, power loss,<br>temperature set point,<br>overheat, set point<br>lock/unlock, heater on,<br>Fahrenheit or Celsius.<br>An audible alarm indicates<br>overheat condition. | Digital push button<br>keypad/power switch/Digital<br>LCD temperature display/mode<br>selection buttons/door ajar<br>indicator/Over-temperature<br>light for each<br>compartment/Data port for<br>retrieval of stored temperatures | Same with<br>exception of data<br>port for retrieval<br>of stored<br>temperatures |
| 12 | Software | Unit contains software | Unit contains software | same |
| 13 | Temperature<br>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<br>function to prevent<br>unauthorized temperature<br>changes. | Temperature lock-out function<br>to prevent unauthorized<br>temperature changes. | same |
| 15 | Door Lock | none | Manual mechanical door lock<br>or optional electronic door lock<br>system for each compartment | Door lock not<br>available on<br>subject device |
| 16 | Over Temperature<br>Alarm Point | In the event that chamber<br>temperature exceeds the<br>selected temperature by 4°C<br>(7°F) an "OH" (representing | Visual and audible alarm if unit<br>has a chamber temperature<br>greater than 10°F (5.5°C)<br>above set temperature. In the | Same alarm<br>functions.<br>Subject device<br>alarms at a lower |
| # | Features | Getinge Series Warming<br>Cabinet<br>[Subject Device] | AMSCO K092823<br>[Predicate Device] | Comparison |
| | | overheat) is displayed, an<br>alarm sounds and power to<br>the heaters is shut off. | event of an over temp<br>condition, sensors<br>automatically turns off the<br>heater(s). | overtemp<br>condition. |
| 17 | Voltage<br>Requirements | 110/220 Vac, 220/240 VAC<br>nominal, 50/60 HZ | 110/220 Vac, 220/240 VAC<br>nominal, 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.