PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

K033040 · International Hospital Supply Co. · FMT · Dec 17, 2003 · General Hospital

Device Facts

• Record ID: K033040
• Device Name: PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
• Applicant: International Hospital Supply Co.
• Product Code: FMT · General Hospital
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care. Federal law restricts this device to sale or use by or upon the order of a licensed health care practitioner. Its use is restricted to health care facilities and only by persons with specific training and experience in the use of the device.

Device Story

PHOENIX Infant Radiant Warmer provides thermal support to infants; utilizes infrared heating element positioned over patient; maintains body temperature at caregiver-determined levels. Used in neonatal/infant care areas of healthcare facilities; operated by trained personnel. Device output is controlled radiant heat; assists in preventing hypothermia in neonates. Clinical decision-making involves monitoring infant temperature and adjusting heat output accordingly.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Infrared heating element; radiant heat source; intended for neonatal/infant care environments. Class II device (Product Code: FMT).

Indications for Use

Indicated for infants requiring thermal support in neonatal and infant care areas of healthcare facilities. Restricted to use by trained healthcare professionals upon order of a licensed practitioner.

Regulatory Classification

Identification

The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

Special Controls

*Classification.* Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer; (2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and (3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

International Hospital Supply Company C/O Mr. Dagmar Maser Business Support International Amstel 320-1 Amsterdam Netherlands 1017AP

Re: K033040

Trade/Device Name: PHOENIX Infant Radiant Warmer, Model 100NWS Regulation Number: 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: April 28, 2003 Received: September 29, 2003

Dear Mr. Maser:

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. Maser

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/dsma/dsmamain.html

Sincerely yours,

Cls

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K033040

Device Name

PHOENIX Infant Radiant Warmer

## INDICATIONS FOR USE

The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care.

Federal law restricts this device to sale or use by or upon the order of a licensed health care practitioner. Its use is restricted to health care facilities and only by persons with specific training and experience in the use of the device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lalveux Cincerite

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K033040

Prescription Use ✓

OR

Over-The-Counter Use

(Per CFR 801 109)

(Optional Format 1-2-96)