SUNFLOWER WARNER

K120937 · Atom Medical Corporation · FMT · Jul 6, 2012 · General Hospital

Device Facts

• Record ID: K120937
• Device Name: SUNFLOWER WARNER
• Applicant: Atom Medical Corporation
• Product Code: FMT · General Hospital
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.

Device Story

Sunflower Radiant Warmer is an open-type incubator for newborns and premature neonates; used in hospital/institutional settings for thermoregulation, skin temperature monitoring, and Apgar timing. Device utilizes an electric radiant heater (canopy) to provide heat; operates in Manual or Servo modes. In Servo mode, device uses a skin temperature probe (thermistor) to automatically adjust heater output based on infant's skin temperature. Device features include CPR timer, set temperature range 34.0–38.0°C, and various alarms (High Temperature, Probe failure, Power failure, System failure). Clinicians monitor infant status via display and alarms; output assists in maintaining stable body temperature for neonates. Device is provided in eight mechanical variants with identical heat source technology.

Clinical Evidence

Bench testing only. Testing included alarm verification, skin temperature accuracy, temperature control, mattress temperature distribution, pre-warming mode, and power switch stress testing. Device met all pass/fail criteria and cited international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-21).

Technological Characteristics

Radiant infant warmer; electric heater source; thermistor-based skin temperature sensing. Modes: Manual and Servo (automatic control). Power: 120V, 60Hz, 700VA. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-21. Dimensions vary by configuration; weight 20-89 kg.

Indications for Use

Indicated for thermoregulation, skin temperature monitoring, and Apgar timing of newborn and premature neonates in hospital or institutional settings.

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.

Predicate Devices

• Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer (K003335)

Submission Summary (Full Text)

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6 2012 JUL

| Atom Medical Corporation<br>3-18-15, Hongo, Bunkyo-ku<br>Tokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632<br>Fax - 011-81-3-3812-3199 |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Sunflower Radiant Warmer |
| Common/Usual Name: | Infant Radiant Warmer |
| Classification Name/Code: | Product Code: FMT, Regulation: 880.5130 Name: warmer,<br>infant radiant |
| Device: | Sunflower Radiant Warmer |
| Predicate Device: | Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer<br>K003335 |

#### Device Description:

The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.

#### Indications for Use:

The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.

Environment of Use: Hospital or institutional

#### Summary of Substantial Equivalence

The Sunflower Radiant Warmer was compared to the predicate Hill-Rom Air-Shields (Draeger) -Resuscitaire Radiant Warmer K003335

Indications for Use - The Sunflower Radiant Warmer is intended for thermoregulation and skin temperature monitoring of newborn infants. The sunflower Radiant Warmer has the same intended use as the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 except it does not provide resuscitation functions.

Patient Population - The Sunflower Radiant Warmer is indicated for newborns and premature neonates as is the predicate.

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## 510(k) Summary Page 2 of 3 7/3/2012

Environment for use – The Sunflower Radiant Warmer has the identical environments for use as the predicate (hospital/institutional)

Prescriptive - The Sunflower Radiant Warmer is prescriptive as is the predicate.

Design and Technology - The Sunflower Radiant Warmer has equivalent design and features as the predicate and has the identical technology to the predicate with regard to radiant heating.

Performance and Specifications - The Sunflower Radiant Warmer has equivalent specifications of performance as the predicate with regard to radiant heating.

Compliance with standards - The Sunflower Radiant Warmer and predicate device declare compliance with IEC 60601-1, IEC 60601-1-2. Additionally the Sunflower Radiant Warmer complies with IEC 60601-2-21.

| | Sunflower Radiant Warmer | Hill-Rom Air-Shields (Draeger)-<br>Resuscitaire Radiant Warmer K003335 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Attributes | | |
| Indications for Use | The Sunflower Warmer is intended<br>for thermoregulation, skin<br>temperature monitoring, and Apgar<br>timing of newborn infants. | The Resuscitaire® Radiant Warmer is<br>intended for thermoregulation, skin<br>temperature monitoring, Apgar timing, and<br>resuscitation of newborn infants. |
| Patient Population | Newborn and Premature Neonates | Newborn Infants |
| Environment of Use | Hospital or institutional | Hospital or institutional |
| Prescriptive | Yes | Yes |
| Patient Connection | Yes via temperature probe | Yes via temperature probe |
| Technology | Electric heater | Electric heater |
| Technical specifications | | |
| Dimensions | Equivalent, see Section 11 for detailed<br>dimensions for the various configurations | Equivalent |
| Weight | 20-89 kg depending on variant | 100-127 kg depending on variant |
| Power | 120V±10%, 60Hz, 700VA | 120V, 50-60Hz, 750 W |
| Performance | | |
| Heater Capacity | 500W | Similar based on power consumption |
| Alarms | Baby Check | Check patient |
| | Set temperature | Baby temperature |
| | High Temperature | High temperature |
| | Probe Short or open circuit / No probe | Probe Short or open circuit / No probe |
| | Power failure | Power failure |
| | System failure | |
| Set Temperature<br>Range | 34.0~38.0°C (in 0.1°C increments) | 34-38° C |
| Skin Temperature<br>Display | 30.0~42.0°C Accuracy: ±0.3°C | 18-43° C +/- 0.2° C |

#### Device Comparison

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## 510(k) Summary Page 3 of 3 7/3/2012

| | Sunflower Radiant Warmer | Hill-Rom Air-Shields (Draeger)-<br>Resuscitaire Radiant Warmer K003335 |
|--------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------|
| Technical specifications | | |
| Skin Temperature<br>sensing | Thermistor | Thermistor |
| Heater output setting<br>range | 0~100% (in 5% increments) | 0-100%, 10% increments |
| Modes | Manual, Servo (automatic based on skin<br>temperature probe) | Manual, Servo (automatic based on skin<br>temperature probe) |
| Environmental | | |
| Operating | 18 to 30°C<br>RH 30 to 75% (non-condensing) | 15°C to 35°C |
| Storage | 0°C to 50°C<br>RH 30-75% (non-condensing) | -20°C to 55°C |

#### Conclusion

The Atom Sunflower Warmer is substantially equivalent to the predicate Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

## Performance Testing

We have performed bench tests which included the list below and found that the Sunflower warmer met all pass /fail criteria, cited standards requirements and was found to be equivalent in comparison to the predicate.

- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility Requirements and . Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- IEC 60601-2-21: 2009 Medical Electrical Equipment Part 2-21: Particular requirements . for the basic safety and essential performance of infant radiant warmers
- . Alarm testing
- . Skin Temperature Accuracy testing
- Temperature Control Testing .
- . Mattress temperature Distribution Testing
- . Pre-warming mode
- Testing has been performed to insure power switch does not malfunction under heat . stress.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Atom Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K120937

Trade/Device Name: Sunflower Radiant Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: June 11, 2012 Received: June 13, 2012

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

6 2012 JUL

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# Page 2- Mr. Dryden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications_for Use Statement

Page 1 of 1

510(k) Number: K120937

Sunflower Radiant Warmer Device Name:

Indications for Use:

The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.

Prescription Use X (Part 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)

Ril
(Division Sign-Off)
7/6/2012

Division of Anesthesiology General Hospital Infection Control, Dental Dental Dental De neess

510(k) Number: K120937