INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1

K051419 · Inditherm Medical · DWJ · Apr 27, 2006 · Cardiovascular

Device Facts

• Record ID: K051419
• Device Name: INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1
• Applicant: Inditherm Medical
• Product Code: DWJ · Cardiovascular
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department; the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. In addition to providing warming and control, the mattress also provides pressure relief to help prevent pressure sores.

Device Story

System comprises precision temperature control unit and flexible warming mattress/blanket; warming surface composed of carbon polymer material; integrated pressure relief pad. Used in clinical settings (OR, ICU, recovery, etc.) by healthcare professionals. Device monitors and regulates temperature to assist patient in maintaining normothermia; provides pressure relief. Benefits include prevention of hypothermia and pressure sores.

Clinical Evidence

No clinical data provided. Device relies on bench testing and compliance with performance standards (BS EN 60601-1, BS EN 60601-2-35).

Technological Characteristics

Carbon polymer heating material; precision temperature control unit; integrated pressure relief pad. Complies with BS EN 60601-1 (General Safety) and BS EN 60601-2-35 (Particular requirements for heating blankets/pads).

Indications for Use

Indicated for patients in operating rooms, recovery rooms, anesthetic rooms, intensive care, medical/surgical floors, patient transport, and emergency departments requiring warming to maintain normal body temperature and pressure relief to prevent pressure sores.

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 and Controller (K011859)
• Klimamed Thermal Blanket and Controller (K031728)

Submission Summary (Full Text)

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Section 5: 510(k) Summary

K051419

даг 2 7 1905

## 510(k) Summary

21 CFR § 807.92

| Submitter: | Inditherm Medical<br>Houndhill Park<br>Bolton Road<br>Rotherham S63 7LG<br>United Kingdom |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nick Bettles, Division Director - Medical |
| Date Prepared: | 1 June, 2005 |
| Trade Name: | Inditherm Patient Warming System<br>Model numbers: MECU1, OTM1, OTM2, GTM1, PTM1, OTB, RB1 |
| Common Name: | Thermal Regulating System |
| Equivalence to: | Klimamed Thermal Mat and Controller (K011859)<br>Klimamed Thermal Blanket and Controller (K031728) |
| Description: | The Inditherm Patient Warming System consists of a precision<br>temperature control unit that controls and monitors the temperature of<br>a mattress or blanket composed of a carbon polymer material. A<br>pressure relief pad is integrated into the mattress, underneath the<br>flexible warming surface. |
| Intended Use: | Designed for use in the operating room, recovery room, anesthetic<br>room, intensive care, medical and surgical floors, patient transport<br>and emergency department; the Inditherm Patient Warming System<br>provides safe and controlled warming to assist patients to maintain<br>normal body temperature. In addition to providing warming and<br>control, the mattress also provides pressure relief to help prevent<br>pressure sores. |
| Technological<br>Characteristics: | Comparisons between the new and predicate devices shows that<br>technological characteristics (i.e. device design, materials,<br>components, and dimensions) and indications for use for the Inditherm<br>Patient Warming System are equivalent to the currently marketed<br>predicate devices. |

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## Non-Clinical Data:

The Inditherm Patient Warming System complies with the following performance standards:

| Standard | Description |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN 60601-1:1990 | Medical Electrical Equipment - Part 1:<br>General Requirements for Safety |
| BS EN 60601-2-35:1997 | Medical Electrical Equipment – Part 2:<br>Particular Requirements for the safety of<br>blankets, pads and mattresses, intended for<br>heating in medical use. |
| MDD: 93/42/EEC | Medical Device Directive (MDD) |

The Inditherm Patient Warming System has been in clinical use since Clinical Data: 1999 in Europe. No additional clinical testing was required.

The Inditherm Patient Warming System was found to be equivalent to Conclusion: technological characteristics and indications for use for the predicate device(s).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

P

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2005

Inditherm Medical c/o M.W. (Andy) Anderson, Ph.D. Senior Regulatory Project Director Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416

Re: K051419

Patient Warming Systems Model Numbers: MECU1, OTM1, OTM2, GTM1, PTM1, OTB. RB1 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: April 20, 2006 Received: April 21, 2006

Dear Dr. Anderson:

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

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Page 2 - M.W. (Andy) Anderson, Ph.D.

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 aft 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 eest onc 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 3 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 over), pro "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain 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,

Duna R. Vochmer

A 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 Statement

510(k) Number: K0501419

Inditherm Patient Warming System Device Name:

Indications for Use:

Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department, the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. The mattress includes a pressure-relieving pad.

Prescription Use X ( 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Lachner

Jivision Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devic

510(k) Number K05014