COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1

K061902 · Inditherm Medical · DWJ · Dec 8, 2006 · Cardiovascular

Device Facts

• Record ID: K061902
• Device Name: COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
• Applicant: Inditherm Medical
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.

Device Story

CosyTherm system provides controlled thermal support for neonates; consists of precision temperature control unit and carbon polymer mattress/blanket. Integrated pressure relief pad included in mattress. System operates via resistive carbon polymer technology to maintain infant body temperature. Used in NICU, SCBU, delivery suites, post-natal wards, and during transport. Healthcare providers monitor temperature settings to ensure safe warming. Benefits include maintenance of normothermia in newborns and pressure relief.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic emissions/immunity, and performance testing for temperature accuracy and thermal safety features.

Technological Characteristics

Resistive carbon polymer heating technology. System comprises a precision temperature control unit and a mattress/blanket with integrated pressure relief pad. Complies with electrical safety and electromagnetic compatibility standards.

Indications for Use

Indicated for newborn infants in NICU, SCBU, delivery suites, post-natal wards, and during transport to assist in maintaining normal body temperature.

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

• Inditherm Patient Warming System (K051419)

Submission Summary (Full Text)

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KOC1902

CosyTherm 510(k) Notification

5.

## 510(k) Summary (21CFR § 807.92)

DEC - 8 2006

## Submitted by: Inditherm Medical Houndhill Park Bolton Road Rotherham S63 7LG United Kingdom Contact: Nick Bettles, Division Director - Medical Establishment Registration Number: 3005246910 Date Prepared: June 30, 2006

Trade Name: Inditherm CosyTherm Neonatal Warming System Model numbers: NCM1, NCM2, NCB1, CCU1, CRU1

Common Name: Thermal Regulating System

Device Classification: Thermal Regulating System 21 CFR 870.5900

> Class: II

Product Code: DWJ

Classification Panel: Cardiovascular Therapeutic Devices

Equivalent Marketed Inditherm Patient Warming System (K051419) Device:

Device Description: The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.

Intended Use: Designed for use in the neonatal intensive care unit

Confidential

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CosyTherm 510(k) Notification (NICU), Special Care Baby Unit (SCBU), delivery suite and post-natal wards, the CosyTherm system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad. Contrast to Predicate: The predicate device is sized for and intended for use in adult and pediatric populations in the operating room, anaesthetic room, intensive care, emergency department, on medical and surgical wards and for patient transport. Technological The CosyTherm system uses the same technology as the Characteristics: predicate device; resistive carbon polymer technology. The CosyTherm predicate device has similar intended uses and has similar features which include: principle of operation, indications for use, safety standards compliance, thermal safety features, EMI compatibility and configurations Non-Clinical Testing: Inditherm conducted testing against recognized standards for electrical safety and electromagnetic emissions and immunity. Performance testing was also conducted to assure adequate temperature accuracy and stability as well as the proper functioning of thermal safety features. All test results verify the device meets or exceeds predetermined specifications. Clinical Testing: None submitted Summary: Based on Performance Testing results and specifications, the CosyTherm system is substantially cquivalent to the Inditherm Patient Warming System.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 8 2006

Inditherm Medical c/o Andy Anderson 5353 Wayzata Blvd. Suite 505 Minneapolis, MN 55416

Re: K061902

Trade/Device Name: Cosytherm Neonatal Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: II Product Code: DWJ Dated: November 16, 2006 Received: November 17, 2006

Dear Mr. 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 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 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

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## Page 2 - Mr. Anderson

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.

07 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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CosyTherm 510(k) Notification

## - Kob1902 Indication For Use Statement 4.

Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.

Prescription Use _ X (21 CFR 801 Subpart D)

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

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

ffige of Device Evaluation (ODE) Concurrence of

(Division Sign-Off)
Division of Cardiovascular Devices

OR

**510(k) Number** K061902

Confidential

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