The VitalHeat™ is designed to Non-Invasively treat hypothermic patients by warming their body core. This is achieved by local application of negative pressure and thermal load (heat) to a distal appendage.

Device Description

The Dynatherm Medical, Inc. VitalHeat™ - Warming Mitt - Control Unit The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat tooknology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.

AI/ML Overview

The VitalHeat™ device is a thermal warming device intended to non-invasively treat hypothermic patients by rewarming their body core through the application of negative pressure and a thermal load to the hand.

Here's an analysis of its acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the comparative table with predicate devices rather than explicit acceptance criteria with specific performance values. However, the comparative table implicitly sets the performance expectations for the VitalHeat™ by aligning with or improving upon predicate devices.

Acceptance Criterion (Implicit)	VitalHeat™ Reported Performance
Intended Use	Patient Temperature Control and Maintain
Intended Environment of Use	Healthcare Facilities
Contraindications	Patients < 18 years, Peripheral Vascular Disease
Type of Technology	Sub Atmospheric Pressure/Water Paddle, Disposable Mitt
Pressure Device	Yes - Negative
Sub-Atmospheric Pressure (mmHg)	40 ± 5 mmHg
Electrical (AC)	Yes
Temperature Range	≤ 45 ° C
Application Site	Hand
Control Type	Micro - Logic
Size - Controller	16 x 6 x 6 In.
Weight	15.0 Lbs.
Mobility	Hand-Held, IV Pole MTG, Table Top
Water Tank	200 ml
Flow Rate	> 1000 ml/Min.
High Temperature Alarm	Yes
Water Level Alarm	Yes - Water Flow
Sub-Atmospheric Pressure Indicator	Yes
Alarms/Indicators	LED and Audible
Timer	Yes
Seal	Yes

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

The provided summary does not contain information about a test set sample size or data provenance (e.g., country of origin, retrospective or prospective data) for a clinical study. The submission relies on a comparison to predicate devices, electrical safety, EMC, and environmental testing.

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

No information is provided regarding experts used to establish a ground truth for a clinical test set. The submission is a 510(k) premarket notification, which often relies on comparison to predicate devices and bench testing rather than extensive clinical trials with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method, as no clinical test set with a need for ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information is provided to suggest that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The document focuses on the technical specifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The VitalHeat™ is a physical medical device, not an algorithm that performs diagnostic or analytical tasks requiring standalone performance evaluation. Therefore, no standalone algorithm-only performance study was conducted or is applicable.

7. Type of Ground Truth Used

Based on the provided information, the primary "ground truth" used for substantial equivalence is the performance and specifications of the legally marketed predicate devices (Aquarius Medical Corporation Thermo-STAT - K970367 and AcroTherm - K003368).

For the device's technical specifications, the ground truth would be established by bench testing and engineering measurements to confirm performance against design specifications (e.g., temperature range, pressure levels, flow rate, alarm functionality).

8. Sample Size for the Training Set

The device is a physical therapeutic device, not an AI/ML algorithm that requires a training set. Therefore, the concept of a "training set sample size" is not applicable to this submission.

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

As there is no training set for an AI/ML algorithm involved, this question is not applicable. The device's functionality and safety are established through adherence to engineering specifications and comparison to predicate devices.

Summary

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K040911

VitalHeat™

Premarket Notification 510(k) Section 2 - Certifications and Summaries

Dynatherm Medical, Inc. 819 Mitten Road, Suite 42 Burlingame, CA 94010 Non-Confidential Summary of Safety and Effectiveness Page 1 of 3

Dynatherm Medical, Inc.

Official Contact: Proprietary or Trade Name: Commom/Usual Name: Classification Name: Predicate Device:

Phone: (650) 777-4361 (650) 777-4370 Fax: Nathan Hamilton VitalHeat™ VitalHeat™ Thermal Regulating System Aquarius Medical Corporation Thermo-STAT - K970367 Aquarius Medical Corporation AcroTherm - K003368

Device Description:

The Dynatherm Medical, Inc. VitalHeat™

Warming Mitt �
Control Unit �

The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat tooknology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.

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2.1 Summary of Safety and Effectiveness

Indicated Used:

The VitalHeat™ designed to non-invasively treat hypothermic patients by rewarming their body core. This is The Vital loat - reseign application of negative pressure and thermal load (heat) to hand.

Dynatherm Medical, Inc. 819 Mitten Road, Suite 42 Burlingame, CA 94010 Non-Confidential Summary of Safety and Effectiveness Page 2 of 3

Patient Population:

The system is for use with patients experiencing cold who are 18 years of age and older.

Environments of Use:

The device is intended for use throughout healthcare facilities.

Contraindications:

The VitalHeat™ is contraindicated for patients under the age of 18 and for patients with peripheral vascular disease.

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VitalHeat™

Premarket Notification 510(k) Section 2 - Certifications and Summaries

2.1 Summary of Safety and Effectiveness - - - - - - - - - -

Page 3 of 3 510 (k) COMPARATIVE TABLE

COMPANY	DYNATHERM	AMC	AMC
PRODUCTS	VitalHeat™	ACROTHERMK003368	THERMO-STATK970367
Intended use	Patient TemperatureControl and Maintain	Patient TemperatureControl and Maintain	Patient TemperatureControl
IntendedEnvironment of use	HealthcareFacilities	HealthcareFacilities	PACU
Contraindications	Patients < 18 yearsPeripheral VascularDisease	Patients < 18 yearsPeripheral VascularDisease	Patients < 18 yearsPeripheral VascularDisease
Type	Sub AtmosphericPressure/Water PaddleDisposable Mitt	Sub AtmosphericPressure/WaterPerfusion Pad inCamber	Negative Pressure/Thermal Pad inChamber
Pressure Device	Yes - Neg.	Yes - Neg.	Yes - Neg.
Sub-AtmosphericPressure (mmHg)	$40 \pm 5$ mmHg	$40 \pm 5$ mmHg	$40 - 60$ mmHg
Electrical (AC)	Yes	Yes	No
Temperature Range	≤ 45 ° C	≤ 45 ° C	≤ 45 ° C
Application Site	Hand	Distal Limb	Distal Limb
Control Type	Micro - Logic	Micro - Logic	N/A
Size - Controller	16 x 6 x 6 In.	14 x 6 x 5 In.	N/A
Weight	15.0 Lbs.	9.30 Lbs.	N/A
Mobility	Hand-HeldIV Pole MTGTable Top	Hand-HeldIV Pole MTGTable Top	N/A
Water Tank	200 ml	400 - 500 ml	N/A
Flow Rate	> 1000 ml/Min.	< 500 ml/Min.	N/A
High Temperature Alarm	Yes	Yes	No
Water Level	Yes - Water Flow	Yes	N/A
Sub-Atmospheric	Yes	Yes	Yes
Pressure	LED and Audible	LED and Audible	LED Only
Timer	Yes	No	No
Seal	Yes	Yes	N/A

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Dynatherm Medical, Inc. c/o Mr. Nathan Hamilton 819 Mitten Road, Suite 42 Burlingame, CA 94010

Re: K040911

VitalHeat™ Regulation Number: 21 CFR 870.5906 Regulation Namber
Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 3, 2004 Received: June 7, 2004

Dear Mr. Hamilton:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 3 iQ(x) premaince is substantially equivvlent (for the indications
referenced above and have determined to levice is substantially enviveled in referenced above and have decembred the devices marketed in interstate
for use stated in the enclosure) to legally marketed previces marketed in interstate for use stated in the enclosure) to regally manced to dedical Device Amendments, or to
commerce prior to May 28, 1976, the enactment decitation of the Federal Food. Drue, commerce prior to May 28, 1976, the enaculines with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a proval application of the Act. and Cosmetic Act (Act) that a not require approval or a policols provisions of the Act. The
You may, therefore, market the device, subject to the general controls of listin You may, therefore, market the device, subject on the general scamal registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende roquilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mits entire) and states affecting your device can
may be subject to such additional controls. Existing major regulations affections may be subject to such additional controls: Existing may or esganto on on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addi be found in the Code of Federal Regalancies, as a vice in the Federal Register.

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Page 2 – Mr. Nathan Hamilton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a subscribe with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination that your areas by other Federal agencies. You must or any Federal statutes and regulations and united to: registration and listing (21)
comply with all the Act's requirements, including, but not assets as set comply with all the Act s requirements, moradias warmacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 80 ); gED Part 820); and if explicable, the el CFR Part 807); labeling (21 CFK Part 801); good manatowania (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 2017); 1000-105 forth in the quality systems (QS) regalation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Se product radiation control provisions (occions of the vironment of your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begill maketing your active quiralence of your device to a legally
premarket notification. The FDA finding of substantial equipales of your dev premarket notification. The FDA inding of substantial equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs in the may be and 11, 2011 1616 - Alles and see note the regulation enti If you desire specific advice for your ac tree on oak. Also, please note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note Yo contact the Office of Compliatics at (301) 591 1610 (21) Part 807.97). You may obtain
"Misbranding by reference to premarket notifications of Small "Misbranding by reference to premarket nonification of the Act from the Division of Small
other general information on your responsibilities under the Act the number (800) 63 other general information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the University by Manufacturers, Manufacturers, International and Consumer Fiserstants and and and and and himl

Sincerely yours,

Donna R Lochner

Image /page/4/Picture/5 description: The image contains what appears to be a signature. The signature is composed of a few curved lines and strokes, forming a unique and stylized mark. The lines are dark and bold, suggesting they were written with a pen or marker. The signature is positioned on a white background.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_K040911

Device Name:_VitalHeat™

Indications For Use:

The VitalHeat™ is designed to Non-Invasively treat hypothermic patients by warming The Vitalifeai - Is designed to Non-hivath local application of negative pressure and thermal load (heat) to a distal appendage.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Dana R. Vachner

Page 1 of 1_

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number: K040911

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).