INCU I

K102279 · Atom Medical Corporation · FMZ · Dec 29, 2010 · General Hospital

Device Facts

• Record ID: K102279
• Device Name: INCU I
• Applicant: Atom Medical Corporation
• Product Code: FMZ · General Hospital
• Decision Date: Dec 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.

Device Story

Incu i is a neonatal incubator comprising a hood, main body, mattress platform, and control panel. It monitors air conditions via oxygen, humidity, and temperature sensors. Operates in two modes: 'servo control' (skin temperature control via probe attached to infant) and 'manual control' (air temperature control via hood sensor). Optional modules include SpO2 monitoring, oxygen density control, weight monitoring, and humidification. Used in newborn nurseries and neonatal surgery units by clinical staff. Provides controlled thermal environment to prevent hypothermia and support intensive care. Healthcare providers adjust settings via control panel; output includes real-time temperature, oxygen, and pulse oximetry data to guide clinical interventions and maintain infant stability.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including verification of compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19 standards. Biocompatibility was evaluated per ISO 10993-1 using materials identical to those in the predicate device. Software validation was also conducted.

Technological Characteristics

Neonatal incubator with hood, mattress platform, and conditioning chamber. Sensing: temperature, humidity, oxygen, and skin temperature probes. Energy: electrical. Connectivity: optional SpO2 and oxygen controller modules. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-19 (incubator safety), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for newborns and premature neonates requiring temperature control for hypothermia, observation, examination, prevention of post-delivery body temperature drop, and pre/post-operative intensive care in neonatal surgery.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• V-2200 Infant Incubator (K061856)
• Caleo (K003067)

Submission Summary (Full Text)

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K102279

# Section 5 - 510(k) Summary

This document is provided in the following pages.

:

DEC 2 9 2010

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K 102279

# DEC 2 9 2010

#### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 8807.92.

# Sponsor Information:

Atom Medical Corporation 3-18-15. Hongo. Bunkvo-ku 113-0033 Tokyo Japan

#### 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): Incu i (Atom Infant Incubator Model 101) Classification Name: Neonatal Incubator Classification Regulation: 880.5400 Panel: General Hospital Product Code: FMZ

#### Predicate Device Information: ·

Device Name: V-2200 Infant Incubator 510(k) Reference: K061856 Manufacturer: Atom Medical Corporation

Device Name: Caleo 510(k) Reference: K003067 Manufacturer: DRAGER MEDIZINTECHNIK GMBH

#### Device Description:

Incu i (Atom Infant Incubator Model 101) consists of a hood, a main body, a control panel and a stand with casters. A hood consists of a canopy and access doors (Snap-open access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body.

This product has 2 types of function modes; one is skin temperature control mode and another is air temperature control mode.

The skin temperature control mode is called "servo control mode" also, and the air temperature control mode is called "manual control mode" also.

In "servo control mode", skin temperature can be set from 34°C to 38°C (including override).

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In "manual control mode", air temperature inside the hood can be set from 23°C to 39°C (including override).

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.

In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature.

The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories; "Skin temperature probe (sensor)", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements.

"SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not.

If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can be gone up and down.

# Intended Use:

The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.

# Comparison to Predicate Device:

There are not main differences between Incu i and Atom V-2200.

The technological characteristics of the incu i as compared to the predicate products, the Atom V-2200 and Caleo, are 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:

Incu i is electrical medical device. Therefore, tests based on IEC60601-1, IEC60601-1-2 and IEC60601-2-19 standards were carried out for Incu i, and it was verified that Incu i is met to requirements of IEC60601-1, IEC60601-1-2 and IEC60601-2-19.

Biocompatibility was evaluated based on ISO10993-1. Infants-contacting parts of the Incu i are not unprecedented and are generally used for various type of medical devices. And also, the

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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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Image /page/4/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 stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

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

DEC 2 9 2010

Re: K102279

Trade/Device Name: Incu i (Atom Infant Incubator 101) Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: December 20, 2010 Received: December 21, 2010

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

Enclosure .

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-fire number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

James J. Roberto
fos

Anthony 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

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Indications for Use

DEC 2 9 2010

510(k) Number (if known): K(02279

Device Name: Incu i (Atom Infant Incubator 101)

# Indications for Use:

The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature.

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)

Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number. K102279