INFA WARMER I

K102227 · Atom Medical Corporation · FMT · Jan 21, 2011 · General Hospital

Device Facts

• Record ID: K102227
• Device Name: INFA WARMER I
• Applicant: Atom Medical Corporation
• Product Code: FMT · General Hospital
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Infa Warmer i 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 Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,

Device Story

Infa Warmer i is an open-type radiant infant warmer; consists of canopy with heater, mattress platform, control panel, and stand. Inputs: skin temperature via sensor attached to infant; optional SpO2/pulse monitoring. Operation: servo-control mode (automatic heater adjustment based on skin temperature setpoint 34°C–38°C) or manual mode (0–100% heater output). Used in neonatal nurseries/surgery; operated by clinicians. Provides thermal regulation to prevent hypothermia; supports resuscitation/oxygen therapy via integrated space for external gas blenders/resuscitators (functionally independent). Output: thermal energy to infant; visual monitoring of temperature/SpO2. Benefits: maintains stable body temperature for neonates.

Clinical Evidence

Bench testing only. Device verified against IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21 standards. Biocompatibility evaluated per ISO 10993-1 using materials identical to the predicate device. Software validation was conducted.

Technological Characteristics

Radiant warming heater; servo-control and manual control modes. Components: canopy, mattress platform, pole, control panel. Connectivity: optional SpO2 module. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-21 (infant radiant warmers), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for newborns and premature neonates requiring thermal support, including pre/post-operative intensive care, neonatal hypothermia management, observation, examination, and prevention of temperature drop post-delivery.

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

• V-505 Infa Warmer (K060461)

Submission Summary (Full Text)

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K102227

### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR \$807.92.

# Sponsor Information:

Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku 113-0033 Tokyo Japan

JAN 2 1 201

Date Summary Prepared: July 30, 2010

## Contact Person:

Mr. Tsuyoshi Sugino Atom Medical Corporation Regulatory Affairs Department Manager TEL [phone] FAX [phone] E-mail [e-mail]

#### Device Name:

Trade Name(s): Infa Warmer i (Atom Infant Warmer Model 103) Classification Name: Infant Radiant Warmer Classification Regulation: 880.5130 Panel: General Hospital Product Code: FMT

## Predicate Device Information:

Device Name: V-505 Infa Warmer 510(k) Reference: K060461 Manufacturer: Atom Medical Corporation

#### Device Description:

Infa Warmer i (Atom Infant Warmer Model 103) consists of a canopy, a warming heater (heater), a pole, a control panel, a mattress, a mattress platform, baby guards and a stand with casters. This product has 3 types (Type Name: HE, MS, ST) according to the following specification.

HE: (1)With mattress platform, stand can go up and down

MS: (2)With mattress platform, stand cannot go up and down

ST: (3)Without mattress platform

A warming heater is installed in the canopy.

Skin temperature sensors are connected to front panel of the pole.

This product has 2 types of function modes; one is "servo control model" (called as "skin temperature control mode") and another is manual control mode.

In "servo control mode", skin temperature can be set from 34°C to 38°C

In "bel to control mode", heater output of the warming heater can be set from 0 to 100% (in 5% increments).

When the product is functioned in "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature.

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When the product is functioned in "manual control mode", heater output of the warming heater is controlled manually according to measured baby's skin temperature. The mattress platform can be tilted.

The mattress platform can be tilted.
The skin temperature sensors and X-ray cassette tray

The skin temperature sensors and X-ray cassette tray are accessories.

The X-ray cassette tray is optional accessory, and it can be installed under the mattress platform. These accessories are available separately as replacements.

SpO2 module is component of this product, and it is optional whether they are attached initially or not. If it is not attached initially, it can be attached later, and SpO2/pulse monitoring can be available. The component can be supplied individually.

This product has a space inside the pole, and gas powered resuscitator or oxygen/air gas blender whose sizes are within the space, can be installed in the space, so that resuscitation or oxygen therapy can be done immediately for any new born baby who needs such the treatments. When the resuscitator or the blender is installed in this space, it is completely separated from this product, and it does not have any connections with this product regarding function, operation and power source. Therefore, this product operates normally without the resuscitator or the blender. Also, this product operates normally, even if the resuscitator or the blender is out of order.

### Intended Use:

The Infa Warmer i 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 Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,

### Comparison to Predicate Device:

Main differences between Infa Warmer i and Atom V-505 are as follows.

The functions of oxygen delivery and suction are installed in Atom V-505 but are not installed in the Infa Warmer i.

The technological characteristics of the Infa Warmer i as compared to the predicate products, the V-505 Infa Warmer. is equivalent in the following areas and do not compromise the safety or efficacy of the device.

-Intended use

- Feature

- Appearance
- Temperature Modes

- Components and those function

## Testing and Conclusions:

Infa Warmer i is electrical medical device. Therefore, tests based on IEC60601-1-2 and IEC60601-2-21 standards were carried out for Infa Warmer i, and it was verified that Infa Warmer i is met to requirements of IEC60601-1, IEC60601-1-2 and IEC60601-2-21.

Biocompatibility was evaluated based on ISO10993-1. Infants-contacting narts of the Infa Warmer i are not unprecedented and are generally used for various type of medical devices. And

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also the materials are identical to those used for the 510(k)-cleared predicate device. Thus the biological safety can be evaluated to have been assured.

Validation has been conducted on the device software.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

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

Mr. Tsuyoshi Sugino Regulatory Affairs Manager Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku 113-0033 Tokyo JAPAN

JAN 2 1 201

Re: K102227

Trade/Device Name: Infa Warmer i (Atom Infant Warmer Model 103) Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: January 17, 2011 Received: January 18, 2011

Dear Mr. Sugino:

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.

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Page 2- Mr. Sugino

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 reportung (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/Centers.offices/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.html 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,

Jums f. Rofot

fes

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

510(k) Number (if known):

Device Name: Infa Warmer i (Atom Infant Warmer Model 103)

## Indications for Use:

The Infa Warmer i 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 Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

for RICHARD
CHAPMAN

Juston Sign ്വാന്‍ട്രിഗ്രം(പ്രുമംഗീ)
Division of Anesthesionogy, General Hospital
Division of Anesthesion Devices Division of Anoothool, Dental Devices

510(k) Number: K102227

.