NEO-SERVO I

K102710 · Atom Medical Corporation · FMZ · Dec 22, 2010 · General Hospital

Device Facts

• Record ID: K102710
• Device Name: NEO-SERVO I
• Applicant: Atom Medical Corporation
• Product Code: FMZ · General Hospital
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.

Device Story

Neo-Servo i Atom Infant Incubator Model 102 provides controlled thermal environment for neonates; consists of hood, main body, control panel, optional stand. Operates in two modes: Manual (air temperature control) and Servo (skin temperature control). Sensors monitor air and skin temperature; heater in conditioning chamber circulates air via fan to maintain set temperature. Optional features include humidity chamber and x-ray cassette tray. Used in hospitals, delivery suites, and NICUs by clinicians. Output includes temperature/humidity monitoring and alarm notifications (high temperature, skin temperature, humidity, system failure). Device maintains stable environment to prevent hypothermia and support post-operative care.

Clinical Evidence

Bench testing only. Device performance verified against recognized standards: IEC 60601-1 (General safety), IEC 60601-1-2 (Electromagnetic compatibility), and IEC 60601-2-19 (Particular requirements for baby incubators).

Technological Characteristics

Closed-type incubator; manual and servo control modes. Sensing: skin temperature probe, air temperature/humidity sensors. Heating: electric heater with fan-forced air circulation. Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-19. Dimensions: 100(D) x 60(W) x 138-158(H) cm. Power: AC 120V.

Indications for Use

Indicated for newborns and premature neonates (≤ 10 kg) requiring temperature control, observation, or intensive care in hospital settings, delivery suites, or NICUs.

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

• Atom V-2200 Infant Incubator (K061856)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 - 510(k) Summary

# Neo-Servo i

DEC 2 2 2010

510(k) Summary Page 1 of 4 17-Sept-10

#### Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku Tel - 011-81-3-3815-3632

Tokyo, Japan 113-0033

| Tokyo, Japan 113-0033 | Fax – 011-81-3-3812-3199 |
|----------------------------|----------------------------------------------|
| Official Contact: | Tsuyoshi Sugino – Regulatory Affairs Manager |
| Proprietary or Trade Name: | Neo-Servo i Atom Infant Incubator Model 102 |
| Common/Usual Name: | Neonatal Incubator |
| Classification Name/Code: | FMZ – neonatal incubator<br>CFR 880.5400 |
| Device: | Neo-Servo i Atom Infant Incubator Model 102 |
| Predicate Devices: | Atom Model V-2200 – K061856 |

#### Device Description:

The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).

The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.

There are 2 functional modes:

- Skin temperature control mode referred to as "Servo Control Mode" 1.
- Air temperature control mode referred to as "Manual Control Mode" 2.

#### Indications for Use:

The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.

Environment of Use: Hospitals, delivery suites, NICU

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# 510(k) Summary Page 2 of 4
17-Sept-10

·

# Summary of substantial equivalence

| | Proposed | Predicate |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neo-Servo i | K061856 |
| | Atom Infant Incubator Model 102 | Atom V-2200 Infant Incubator |
| Indications for Use | The Neo-Servo i Incubator Model 102<br>is a closed-type incubator for newborns<br>and premature neonates. It is mainly<br>intended for temperature control in<br>neonatal hypothermia, observation and<br>examination in newborn nurseries,<br>prevention of body temperature drop<br>shortly after delivery, and pre-operative<br>and post-operative intensive care in<br>neonatal surgery. The incubator is<br>provided with a function to control the<br>infant's skin temperature. | The V-2200 infant incubator is intended<br>to keep premature neonates or infants in<br>a warm environment which is covered<br>by a hood and isolated from ambient air<br>and of which internal air temperature<br>and humidity, are controlled. |
| Environment of use | Hospital, delivery suites, NICU<br>Not for transport | Hospital, delivery suites, NICU<br>Not for transport |
| Patient Population | Infant and neonates ≤ 10 kg | Infant and neonates ≤ 10 kg |
| Features and Performance Characteristics | | |
| Overall dimensions | With HL stand<br>100(D) x 60(W) x 138-158(H) cm<br>Mattress - 65(W) x 36.5(D) x 2(T) cm<br>Adjustable height of 86 - 106 cm from<br>the floor to the mattress top | With HL stand<br>109 (D) x 61(W) x 133-153(H) cm<br>Mattress - 74(W) x 36(D) x 2(T) cm |
| Weight | 90 kg | 107.5 kg |
| Major components | Hood<br>Main body<br>Control unit | Hood<br>Main body<br>Control unit |
| Power | AC 120V | AC 120 V |
| Operating conditions | Ambient - 20-30 °C<br>RH - 30-75% | Ambient - 20-30 °C<br>RH - 30-75% |
| Storing conditions | Ambient - 0-50 °C<br>RH - 30-75% | Ambient - 0-50 °C<br>RH - 30-75% |
| Maximum load capacity | IV Pole ~ 10 kg<br>Drawer ~ 3kg | IV Pole ~ 5kg<br>Drawer ~ 5kg<br>MF Rail ~ 10kg |
| | Proposed | Predicate |
| | Neo-Servo i | K061856 |
| | Atom Infant Incubator Model 102 | Atom V-2200 Infant Incubator |
| Features and Performance Characteristics (continued) | | |
| Accessories / optional<br>components | Skin Temperature Probe<br>Electrostatic Air filter<br>Access port covers<br>X-ray cassette tray (optional)<br>Humidifier chamber (optional) | Skin Temperature Probe<br>Electrostatic Air filter<br>Access port covers<br>X-ray cassette tray (optional)<br>Humidifier chamber (optional)<br>Optional only on V-2200<br>Pulse oximeter<br>Oxygen sensor |
| Control modes | Manual and Servo | Manual and Servo |
| Skin Temperature Setting<br>Range | Servo<br>34 - 37.5 °C<br>(override mode 37.6 - 38.0 °C) | Servo<br>34 - 37.5 °C<br>(override mode 37.6 - 38.0 °C) |
| Incubator air temperature | 23 - 39 °C (including override) | 23 - 39 °C (including override) |
| Display range | Skin - 30.0 - 42 °C<br>Accuracy - ± 0.3 °C<br>Air - 20.0 - 42.0°C<br>Accuracy - ± 0.3 °C | Skin - 30.0 - 42 °C<br>Accuracy - ± 0.3 °C<br>Air - 20.0 - 42.0°C<br>Accuracy - ± 0.3 °C |
| Heater output | 0 - 100% in 10 increments | 0 - 100% in 10 increments |
| Warm-up time | ≤ 60 min @ 25°C | ≤ 60 min @ 25°C |
| Alarms | High temperature<br>Set temperature<br>Skin temperature | High temperature<br>Set temperature<br>Skin temperature |
| Humidity | In Servo mode | In Servo mode |
| Humidity setting range | 40 - 95% RH | 40 - 95% RH |
| Humidity display | 15 - 99% RH | 15 - 99% RH |
| Continuous humidity | ~ 8 hours | ~ 8 hrs |
| Alarms | Humidity sensor<br>Low water level<br>No water<br>Humidity chamber off<br>Set humidity | Humidity sensor<br>No water<br>Humidity chamber off<br>Set humidity |
| Oxygen supply | Maximum concentration ≥ 65% @ 10<br>Lpm | Maximum concentration ≥ 65% @ 10<br>Lpm |
| Environment CO2<br>concentration in the hood | < 0.4% at center of mattress at 750<br>ml/min | < 0.4% at center of mattress at 750<br>ml/min |
| Oxygen supply | Maximum concentration ≥ 65% @ 10<br>Lpm | Maximum concentration ≥ 65% @ 10<br>Lpm |
| Other alarms | Fan<br>System failure | Fan<br>System failure<br>Power failure |
| Other functions | Not offered<br>Not offered | SpO2 monitoring (optional)<br>Oxygen (FiO2) control (optional) |
| Mattress | Tilting | Titling |
| X-ray cassette | Optional | Optional |
| Performance testing | | |
| Performance testing has been<br>performed per the following<br>standards | IEC 60601-1 (1995) – Medical<br>Electrical Equipment - Part 1: General<br>Requirements for Safety, 1988;<br>Amendment 2<br><br>IEC 60601-1-2 : 2001- Medical<br>Electrical Equipment - Part 1-2: General<br>requirements for Safety-Collateral<br>standard: Electromagnetic compatibility<br>Requirements and tests (Edition 3)<br><br>IEC 60061-2-19 (1996) - Amendment 1<br>- Medical Electrical Equipment - Part 2:<br>Particular Requirements for Safety of<br>Baby Incubators. | IEC 60601-1 (1995) – Medical<br>Electrical Equipment - Part 1: General<br>Requirements for Safety, 1988;<br>Amendment 2<br><br>IEC 60601-1-2 : 2001-- Medical<br>Electrical Equipment - Part 1-2: General<br>requirements for Safety-Collateral<br>standard: Electromagnetic compatibility<br>Requirements and tests (Edition 3)<br><br>IEC 60061-2-19 (1996) - Amendment 1<br>- Medical Electrical Equipment - Part 2:<br>Particular Requirements for Safety of<br>Baby Incubators. |

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Premarket Notification 510(k)
Section 5 – 510(k) Summary

# 510(k) Summary

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## Premarket Notification 510(k) Section 5 – 510(k) Summary

## 510(k) Summary Page 4 of 4 17-Sept-10

# Substantial Equivalence Rationale

The Neo-Servo i Atom Infant Incubator Model 102 is viewed as substantially equivalent to the predicate device because:

### Indications -

- Identical to predicate Atom V-2200 Infant incubator K061856 .
### Technology -

- Identical technology and design Atom V-2200 Infant incubator K061856 .
### Materials -

- The materials in patient contact are identical to the predicate K061856 .
### Environment of Use -

- Identical to predicate Atom V-2200 Infant incubator K061856 .
### Performance Testing -

Performance testing has been performed according to recognized standards and the proposed device met and passed all testing criteria.

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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 Dryden Promedic. Incorporated 24301 Woodstage Drive Bonita Springs, Florida 34134

DEC 2 2 2000

Re: K102710

Trade/Device Name: Neo-Servo I Atom Infant Incubator Model 102 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: November 22, 2010 Received: November 23, 2010

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. . . . . . . . . .

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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 (OS) 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,

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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K102710 DEC 2 2 2010

#### Indications for Use Statement

Page 1 of 1

510(k) Number:

(To be assigned)

Device Name:

Neo-Servo i Atom Infant Incubator Model 102

Indications for Use:

The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.

Environment of use - Hospitals, delivery suites, NICU

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

Red C. 12/20/10

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anest Devises Division of Anool, Dental Devices

510(k) Number: