NATUS WARMETTE BLANKET AND DUAL CABINETS by NATUS NICOLET IRELAND LTD

The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (Irrigation and/or Injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.

Device Description

The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass.

A pull out shelf inside the top of the cabinet contains the heating element, fan, thermostat and temperature sensor. The electronics are located on the outside top of the cabinet and the power cable is connected at the back of the electronic cabinet.

Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning.

The Natus Warmette® Blanket Cabinet is factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). For the Natus Warmette® Dual Cabinet, the blanket and linen compartment is factory-set to 130°F (54°C) with a temperature range of 95° - 1769F (35° - 80°C); while the fluid compartment is factory-set to 110°F (43°C) with a temperature range of 970 - 122°F (36° - 50°C).

The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.

The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through the outlets. The temperature is regulated by the temperature regulator T1 to the set temperature.

Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 90F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting. It will be activated in case the fan stops or goes too slow.

AI/ML Overview

This document describes the Natus Warmette® Blanket and Dual Cabinets, which are medical warming cabinets. The provided text is a 510(k) Premarket Notification summary. It focuses on demonstrating substantial equivalence to a predicate device (Imperial Surgical Blanket and Solution Warming Cabinets) rather than presenting a study to prove the device meets acceptance criteria for an AI/ML context.

Therefore, most of the requested information regarding AI/ML device study parameters (e.g., sample sizes for test and training sets, expert adjudication, MRMC studies, ground truth establishment for AI, effect sizes, etc.) is not applicable to this document. This submission is for a physical medical device (warming cabinet), not a software or AI/ML device.

However, I can extract the closest information regarding "acceptance criteria" and "device performance" in the context of this product.

Acceptance Criteria and Device Performance (for a physical warming cabinet, not an AI/ML device)

The "acceptance criteria" for this device are implicitly derived from its functional specifications and comparison to the predicate device. The "study" proving it meets these is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Acceptance Criteria Category	Specific Acceptance Criteria (from text)	Reported Device Performance (from text, indicating compliance)
Intended Use	Designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids with recommended warming temperatures and storage time guidelines.	Same (Explicitly stated in comparison table, indicating the Natus Warmette® meets this intended use). Specifically: "The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items."
Heating System	Convection Electric heating element with circulating fan.	"The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through outlets. The temperature is regulated by the temperature regulator T1 to the set temperature." (This matches the convection electric heating system).
Temperature Control	Maintains factory-set temperatures within specified ranges; over-temperature protection.	Natus Warmette® Blanket Cabinet: Factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). Natus Warmette® Dual Cabinet: Blanket/Linen compartment factory-set to 130°F (54°C) with a range of 95° - 176°F (35° - 80°C); Fluid compartment factory-set to 110°F (43°C) with a range of 97° - 122°F (36° - 50°C). Over-temperature protection: "Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 9°F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting."
Electrical Safety	Must meet specified test requirements.	"Tests conducted on the cabinets consist of verification of the functional controls and calibration, electrical safety, and a physical inspection of each cabinet. Each cabinet must meet the specified test requirements per a formal, written test procedure." (Implies successful testing).
Functional Controls & Calibration	Must meet specified test requirements.	"Tests conducted on the cabinets consist of verification of the functional controls and calibration... Each cabinet must meet the specified test requirements per a formal, written test procedure." (Implies successful testing).
Physical Inspection	Must meet specified test requirements.	"Tests conducted on the cabinets consist of... a physical inspection of each cabinet. Each cabinet must meet the specified test requirements per a formal, written test procedure." (Implies successful testing).
Material / Construction	Stainless steel interior/exterior (predicate).	"Made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass." Also: "Made of high quality stainless steel. Polyurethane foam insulation for minimal heat leakage and optimal sound insulation." (Comparable to predicate).
Installation	Free standing (predicate).	"User manual specifies that cabinet is to be secured to the wall using the built in brackets at the top of the cabinet." (A difference noted, but not considered a disqualifier for substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance:

This is not an AI/ML device. The "test set" in this context refers to the manufacturing quality control and verification tests performed on the physical units.
The document states: "Each cabinet must meet the specified test requirements per a formal, written test procedure." This implies that every manufactured unit undergoes these tests as part of the quality assurance process.
Data Provenance: The tests are conducted internally by Natus Nicolet Ireland Limited, presumably at their manufacturing facility in Gort, County Galway, Ireland. The data would be specific to product verification and validation during manufacturing. It is retrospective in the sense that the results are documented after each unit is tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This concept is not relevant to this type of device. The "ground truth" for a warming cabinet is its measurable physical performance (temperature, electrical safety, functional operation) against engineering specifications.
The individuals involved would be qualified engineers, technicians, and quality assurance personnel responsible for manufacturing and testing medical devices, adhering to established procedures and standards (e.g., ISO 13485 for medical devices).

4. Adjudication Method for the Test Set:

Not applicable in the AI/ML sense. "Adjudication" here would simply be a pass/fail determination based on whether the measured performance during testing meets the defined specifications. Any discrepancies would lead to re-work, re-test, or rejection, not an expert consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is entirely irrelevant for a warming cabinet. MRMC studies are used for evaluating the performance of diagnostic imaging aids where human interpretation is involved.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable. There is no algorithm in the AI/ML sense. The device's operation is purely electro-mechanical with basic electronic controls for temperature regulation.

7. The Type of Ground Truth Used:

The "ground truth" (or objective performance benchmark) for this device is based on engineering specifications and established test procedures that verify the physical and functional characteristics, such as:
- Direct temperature measurements (e.g., using calibrated thermometers).
- Electrical safety measurements (e.g., leakage current, grounding integrity).
- Functional checks (e.g., fan operation, lamp indicators, control panel response).
- Comparison to the performance and characteristics of the predicate device (as shown in the comparison table).

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device. There is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. There is no "training set" or "ground truth" in the AI/ML context. The device's design and manufacturing rely on established engineering principles, material science, and quality control processes for physical products.

Summary

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Manufacturer's Name:

Natus Nicolet Ireland Limited IDA Business Park Gort, County Galway Ireland

Manager, Quality Assurance Natus Nicolet Ireland Limited

Official Correspondent:

Telephone Number: Fax Number:

Summary Date:

July 8, 2013

Michael Galvin

IDA Business Park

+353-(0)91-647451

+353-(0)91-630050

Gort, County Galway

Trade Names:

July 3, 2018

Ireland

Natus Warmette® Blanket Cabinet Natus Warmette® Dual Cabinet

Common or Usual Name: Warming Cabinets

Classification Name And Number:

Predicate Device:

Unclassified, Product Code: LGZ

K112702 Imperial Surgical Blanket and Solution Warming Cabinets

Device Description:

The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass.

Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning.

OCT 0 3 2013

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Tests conducted on the cabinets consist of verification of the functional controls and calibration, electrical safety, and a physical inspection of each cabinet. Each cabinet must meet the specified test requirements per a formal, written test procedure.

The Natus Nicolet Warmette® Blanket and Dual Cabinets are equivalent to the devices cleared under K112702, as is presented in the following table.

Intended Use:

Technological Characteristics:

Nonclinical Tests:

Substantial Equivalence:

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Comparison Table:

	Imperial Surgical Blanket and SolutionWarming Cabinets	Natus Warmette® Blanket andDual Cabinets
Predicate 510(k)number	K112702	New device
Intended Use	Designed to store and warm blankets, hospital linens, irrigation fluids and/or injection fluids with the recommended warning temperatures and storage time guidelines provided by the manufacturers of such products.	Same
Heating System	Convection Electric heating element with circulating fan	The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through outlets. The temperature is regulated by the temperature regulator T1 to the set temperature.
Unit Configuration	Single / dual	Same
Cabinet Dimensions(H x W x D) in inches	7000 & 8000 Series options:34 x 29 x 2034 x 29 x 2674 x 29 x 2274 x 29 x 289000 Series:15 x 23 x 19	Warmette® Blanket and DualCabinets:With adjustable feet (standard):71.25 - 73.25 x 26 x 25 With wheel kit (optional):72.5 x 26 x 25
Model	Wall or Counter	Wall
Interior and ExteriorSurfaces	Stainless Steel interior and exterior on table top and full size models. Counter top model made with baked on power coated steel outer shell with Stainless Steel interior.	Made of high quality stainless steel. Polyurethane foam insulation for minimal heat leakage and optimal sound insulation.
Installation	Free standing	User manual specifies that cabinet is to be secured to the wall using the built in brackets at the top of the cabinet.
Door	Stainless steel or double pane glass set in stainless steel frame on table top and full size models.Counter top model has Plexiglas mounted on to anodized aluminum door frame.	The door has double glazed safety glass.
	Imperial Surgical Blanket and SolutionWarming Cabinets	Natus Warmette® Blanket andDual Cabinets

Predicate 510(k)number	K112702	New device
Door Lock	No	Magnetic handle
Cabinet StorageCapacity	Dual compartment and full size cabinetsequipped with 3 stainless steel perforatedshelves.Table top model equipped with 1stainless steel perforated shelf.	Cabinets are equipped with railsfor shelves or baskets. TheNatus Warmette® BlanketCabinet can accommodate 4shelves. The Natus Warmette®Dual Cabinet (Blanket and Fluid)can accommodate 2 shelves inthe blanket compartment and 2shelves and 1 basket in the fluidcompartment.
Cabinet Volume	Single compartment shallow depth designcapacity 14.6 cu ftTable top model capacity 7.5 cu ftDual compartment capacity 18.1 cu ftoverall (4.3 cu ft upper - 13.8 cu ft lower)Table top shallow design capacity 5.2 cu ftCounter top version has capacity of 2.0cu ft (approx.).	For Natus Warmette® BlanketCabinet:Volume = 14.66 cu ftInside dimensions =55 x 22 x 21 in (H x W x D)For Natus Warmette® DualCabinet:Each compartment (Blanket orFluid):Volume = 5.65 cu ftInside dimensions =23 x 22 x 21 in (H x W x D)
Voltage Requirements	120V AC 60Hz	120V, 60Hz or 230V, 50Hz
Software	N/A	N/A
Controls	Electronic temperature controller withLED display. Illuminated power switch /breaker (red). Amber neon indicator forElement on. Red neon indicator fortrouble.	Electronic temperature controllerwith LED display. The ON/OFFswitch isolates the cabinetelectronics from mains power. Ared over-temperature lamp willbe lit to indicate a malfunction.
Temperature SelectionRange	Factory set:For Blankets: 86°F to 160°F (30° to 71°C)For Irrigation Fluids: 86°F to 150°F (30° to66°C)For Injection Fluids: 86°F to 104°F (30° to40°C)Must be specified at time of ordering.	Factory set:For Natus Warmette® BlanketCabinet:130°F (54°C); range 95° to 176°F(35° to 80°C)For Natus Warmette® DualCabinet:● Blanket compartment: 130°F(54°C); range 95° to 176°F(35° to 80°C)● Fluid compartment: 110°F(43°C); range 97° to 122°C(36° to 50°C)
	Imperial Surgical Blanket and SolutionWarming Cabinets	Natus Warmette® Blanket andDual Cabinets
Predicate 510(k)number	K112702	New device
Temperature resetting	Settings are factory set and locked. Thedevice can be unlocked in the field anduser can change settings if they wish to.	The user site's technician canchange the factory presettemperature setting to meet thesite's specific requirements.Temperature can be blocked at afixed value.
Over-Temperature AlarmPoint	Visual alarm if chamber exceeds 6°Cabove set temperature. Internal sensorshuts off heating elements when overtemperature occurs.	A capillary thermostat ensuresindependent over temperatureprevention.A bimetal thermostat isintegrated in the heating element.Additionally, the red over-temperature lamp will be lit toindicate a malfunction.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

October 3, 2013

Natus Nicolet Ireland Limited C/O Mr. Michael Galvin Manager, Quality Assurance IDA Business Park Gort, Country Galway IRELAND

Re: K132110

Trade/Device Name: Natus Warmette® Blanket and Dual Cabinets Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LGZ Dated: July 8, 2013 Received: July 9, 2013

Dear Mr. Galvin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revioused jour we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorsers) to 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.

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Page 2 - Mr. Galvin

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 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Natus Warmette® Blanket and Dual Cabinets

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ਮ (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)

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Richard C. Chapman 2013.10.03 15:56:47 -04'00'

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Regulation Number and Section

§ 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).