VITALHEAT

K040911 · Dynatherm Medical, Inc. · DWJ · Jun 22, 2004 · Cardiovascular

Device Facts

• Record ID: K040911
• Device Name: VITALHEAT
• Applicant: Dynatherm Medical, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

VitalHeat™ is a thermal warming system for healthcare facilities to treat hypothermia. It consists of a control unit and a disposable warming mitt applied to a patient's hand. The device uses a combination of sub-atmospheric pressure (40 ± 5 mmHg) and a heating element (≤ 45 °C) to maximize heat transfer through the hand's vasculature. The system is operated by healthcare staff; it features micro-logic control, LED/audible alarms for high temperature and water flow, and a timer. By warming the blood in the hand, the device facilitates core rewarming. The compact design allows for full body access and does not impede standard patient care.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparative technical specifications.

Technological Characteristics

Thermal regulating system; sub-atmospheric pressure (40 ± 5 mmHg) and heating element (≤ 45 °C). Components: control unit and disposable mitt. Micro-logic control system. Electrical (AC) powered. Features high-temperature alarm, water flow monitoring, and timer. Dimensions: 16 x 6 x 6 inches; weight: 15.0 lbs. Mobility: hand-held, IV pole mountable, or table-top.

Indications for Use

Indicated for hypothermic patients 18 years of age and older. Contraindicated for patients under 18 years of age and patients with peripheral vascular disease.

Regulatory Classification

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.

Predicate Devices

• Aquarius Medical Corporation Thermo-STAT (K970367)
• Aquarius Medical Corporation AcroTherm (K003368)

Submission Summary (Full Text)

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K040911

VitalHeat™

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

2.1 Summary of Safety and Effectiveness | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

# 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: [phone] [phone] 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™ | ACROTHERM<br>K003368 | THERMO-STAT<br>K970367 |
| Intended use | Patient Temperature<br>Control and Maintain | Patient Temperature<br>Control and Maintain | Patient Temperature<br>Control |
| Intended<br>Environment of use | Healthcare<br>Facilities | Healthcare<br>Facilities | PACU |
| Contraindications | Patients < 18 years<br>Peripheral Vascular<br>Disease | Patients < 18 years<br>Peripheral Vascular<br>Disease | Patients < 18 years<br>Peripheral Vascular<br>Disease |
| Type | Sub Atmospheric<br>Pressure/Water Paddle<br>Disposable Mitt | Sub Atmospheric<br>Pressure/Water<br>Perfusion Pad in<br>Camber | Negative Pressure/<br>Thermal Pad in<br>Chamber |
| Pressure Device | Yes - Neg. | Yes - Neg. | Yes - Neg. |
| Sub-Atmospheric<br>Pressure (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-Held<br>IV Pole MTG<br>Table Top | Hand-Held<br>IV Pole MTG<br>Table 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

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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 [phone]. Also, please note Yo contact the Office of Compliatics at [phone] (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 [phone] 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