PRN THERMALCARE, MODEL 3000

K062794 · American Healthcare Products, Inc. · DWJ · Dec 7, 2006 · Cardiovascular

Device Facts

• Record ID: K062794
• Device Name: PRN THERMALCARE, MODEL 3000
• Applicant: American Healthcare Products, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 1bs./225k

Device Story

PRN ThermalCare Model 3000 is a thermal regulating system comprising a pressure-reducing mattress with integrated carbon fiber heating elements and a separate microprocessor-based control unit. Used in hospitals and surgical centers, the system is operated by physicians or clinicians to provide conductive warming to patients before, during, and after surgery. The control unit supplies low-voltage DC current to the mattress, maintaining preset temperatures between 36°C and 40°C. The device aids in preventing/treating hypothermia and reducing pressure sores. Clinicians monitor the system via visual/audible alarms. The device includes redundant independent systems for over-temperature detection to ensure patient safety.

Clinical Evidence

Bench testing only. Operational integrity testing demonstrated the device met performance and effectiveness parameters. Compliance with electrical safety standards (UL 2601-1, CSA C22.2 No. 60601-1, IEC 60601-2-35) was verified.

Technological Characteristics

Conductive heating system using carbon fiber heating elements. Microprocessor-based control unit provides low-voltage DC current. Pressure-reducing mattress design. Standards: UL 2601-1, CSA C22.2 No. 60601-1, IEC 60601-2-35. Features redundant independent over-temperature detection systems and visual/audible alarms.

Indications for Use

Indicated for pediatric and adult patients undergoing perioperative procedures to maintain normothermia and reduce pressure sore occurrence. Contraindicated for surgical procedures requiring patient hypothermia.

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

• Klimamed Thermal Mat & Controller 95 & 55 (K011859)
• The Bair Hugger® Model 750 Temperature Management System (K001149)
• Kimberly-Clark Patient Warming System Model 100 Control unit and Energy Transfer Pads (K033021)

Submission Summary (Full Text)

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7062794/

# SECTION III

DEC - 7 2006

# PREMARKET NOTIFICATION (510K) SUMMARY (Per 21 CFR 807.92)

Submitted by: American Healthcare Products, Inc. 3220 South Hanford Street Seattle, Wa. 98144 Phone: [phone] Fax: [phone]

Contact Person: Kent D. Ellis Quality and Compliance Phone: [phone] Fax: [phone] [e-mail] Date Prepared: January 2005

#### Device Name:

Trade Name:

Common Name: Classification Name: Product Code & Reg. No. PRN ThermalCare Patient Warming System: Model 3000 Hyperthermia System/Thermal Regulating System Thermal Regulating System DWJ, 21CFR 870.5900

### Substantially Equivalent:

The PRN ThermalCare Patient Warming System Model 3000 is substantially equivalent to the following devices:

| Klimamed Thermal<br>Mat & Controller 95<br>&55 | The Bair Hugger®<br>Model 750<br>Temperature<br>Management System | Kimberly-Clark Patient<br>Warming System<br>Model 100 Control unit and<br>Energy Transfer Pads |
|------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| KO11859 | KO01149 | K033021 |

Description of the Device: The PRN ThermalCare patient warming system, Model 3000 system includes a pressure reducing, thermal regulated mattress, which is placed beneath the patient, and a separate control unit. The mattress contains a carbon fiber heating element for which the control unit, when connected, supplies low voltage DC current, providing low level conductive heat (preset between 36°C and 40°C) to the patient.

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## Section III: Premarket Summary- continued

Indication for Use: By physicians in clinics and hospitals, the PRN ThermalCare Patient Warming System is intended to aid in maintaining the surgical patient's body temperature, before, during and after surgery. The heated pressure relieving surgical mattress is available in various lengths and is intended for use on operating tables, surgical and diagnostic surfaces in hospitals or surgical centers to prevent and treat hypothermia and to reduce the occurrence of pressure sores.

Patient Population: Pediatric and Adult.

Environment of Use: Hospitals and surgical centers operating rooms

Contraindications: Do not use during surgical procedures that require patient hypothermia during operation. Consult with patient physician or anesthesiologist to determine if anti-hypothermia treatment is desired

Comparison to Predicated Devices: See attached comparison: Table 1 The differences between PRN ThermalCare 3000 and the predicated devices are minimal: These predicated devices are all cxternal, thermal regulating systems that consist of a device that is placed in contact with the patient and a microprocessor -based control unit that provides physician determined temperature control.

Testing Safety and Effectiveness: Testing of the safety of PRN ThermalCare Patient Warming System Model 3000 were reviewed and found in accordance with the requirements in UL 2601-1, CSA C22.2 No. 60601-1 and IEC 60601-2-35 . The operational integrity testing conducted, demonstrated the device met the performance/effectiveness parameters.

Conclusion: Based upon the testing and comparison we believe the PRN ThermalCare Model 3000 to be substantially equivalent to predicated devices and that there is no new safety or effectiveness issues.

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| PRN ThermalCare<br>3000 Patient Warming<br>System | Klimamed<br>Thermal Mat &<br>Controller 95 &55 | The Bair<br>Hugger® Model<br>750<br>Temperature<br>Management<br>System | Kimberly-Clark<br>Patient Warming<br>System<br>Model 100 Control<br>unit and Energy<br>Transfer Pads | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 519(K) No. | | KO 11859 | K001149 | K033021 |
| Intended Use | Patient warming | Identical | Identical | Identical |
| Clinical areas<br>for Device Use | Hospital environment &<br>Surgical Centers | Identical | Identical | Identical |
| Patient<br>Population | Pediatric and adult | Identical | Identical | Identical |
| Device<br>Positioning | Control unit is placed on<br>hard surface, shelf, OR<br>pedestal, IV Pole<br>Pad is in external contact<br>with the Patient | Identical | Identical | Identical |
| Technology<br>Used | Conductive Heating<br>Carbon Fiber Heating | Similar:<br>Conductive Heating<br>Carbon Fiber | Different:<br>Convective<br>Heating<br>Forced air | Similar:<br>Conductive Heating<br>water |
| Over<br>temperature<br>detection | 2 completely<br>independent systems | Similar:<br>Independent<br>redundant safety<br>system | Similar:<br>Independent<br>electronic circuit.<br>Thermal cutoff<br>shuts heater off at<br>preset hi temp | Similar:<br>Temperature probe<br>connected to<br>control module.<br>Temp is controlled<br>by altering temp of<br>circulating water |
| Standards<br>Meet | UL 2601-1<br>IEC 60601-2-35<br>CSA 22.2 60601-1 | IEC 60601 &<br>60602 | UL 2601 & EN<br>60601 | IEC 601<br>EN60601<br>ISO 10993-1 |
| Alarms | Visual/Audible | identical | identical | identical |
| Control<br>circuitry | Microprocessor-based | identical | identical | identical |

Section III Table 1: Comparison to Predicated Devices

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American Healthcare Products, Inc. c/o Mr. Kent D. Ellis Quality and Compliance 3220 South Hanford Street Seattle, WA 98144

DEC - 7 2006

Re: K062794

PRN ThermalCare Patient Warming System Model 3000 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: November 17, 2006 Received: November 20, 2006

Dear: Mr. Ellis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Kent D. Ellis

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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# SECTION II

# STATEMENT: INDICATION FOR USE

510 (k) Number k062794

Device Name: PRN ThermalCare Patient Warming System Model: PRN ThermalCare 3000

Indications for Use: The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 1bs./225k

X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use Over the Counter Use (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K062794