ATOM TRANSCAPSULE V-707

K123937 · Atom Medical Corporation · FPL · May 23, 2013 · General Hospital

Device Facts

• Record ID: K123937
• Device Name: ATOM TRANSCAPSULE V-707
• Applicant: Atom Medical Corporation
• Product Code: FPL · General Hospital
• Decision Date: May 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. Environment of use -- Hospitals, delivery suites, NICU, and transport

Device Story

Atom Transcapsule V-707 is a closed-type neonatal transport incubator; used in hospitals, NICUs, and during transport. Device provides controlled thermal environment for infants; input includes air temperature and optional skin temperature probe. Electrically powered heat source maintains incubator air temperature (23.0-38.0°C); system displays air and skin temperatures. External power pack with integrated battery provides DC power during transport. Device features audible/visual alarms for high temperature, set point, power failure, fan, system failure, and low voltage. Clinicians monitor infant status via control panel; output facilitates thermal regulation and monitoring of neonates during transit. Benefits include stable thermal environment for vulnerable infants.

Clinical Evidence

Bench testing only. Performance testing verified compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-20 standards. No clinical data presented.

Technological Characteristics

Electrically heated closed-type incubator; temperature control based on air temperature. Range: 23.0-38.0°C (air), 30.0-42.0°C (skin). Power: 100-240 VAC or external DC power pack with battery backup. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20.

Indications for Use

Indicated for transport of low birth weight infants and neonates, including premature infants.

Regulatory Classification

Identification

A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Predicate Devices

• Air-Shields (Draeger) TI500 Isolette (K941106)

Submission Summary (Full Text)

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# 123937

# MAY 2 3 2013

#### 510(k) Summary Page 1 of 4 つつ、あるの ...

| /<br>3-May-<br>1<br>イ | |
|-----------------------|--|
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| Atom Medical Corporation | |
|----------------------------|----------------------------------------------------|
| 3-18-15, Hongo, Bunkyo-ku | Tel - 011-81-3-3815-3632 |
| Tokyo, Japan 113-0033 | Fax - 011-81-3-3812-3199 |
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Atom Transcapsule V-707 |
| Common/Usual Name: | Neonatal Transport Incubator |
| Classification Name/Code: | FPL - neonatal transport incubator<br>CFR 880.5410 |
| Device: | Atom Transcapsule V-707 |
| Predicate Devices: | Air-Shields (Draeger) TI500 Isolette - K941106 |

#### Device Description:

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport.

The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃.

The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission.

The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack.

The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V).

The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.

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## 510(k) Summary Page 2 of 4 23-May-13

# Indications for Use:

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.

Environment of Use: Hospitals, delivery suites, NICU, and transport

#### Comparison to Predicate

| | Proposed<br>Transcapsule V-707 | Predicate<br>K941106<br>Air-Shields (Draeger) T1500 Isolette<br>Infant Incubator |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Indications for Use | The Atom Transcapsule V-707 is a<br>closed-type transport incubator for<br>neonatal and premature infants intended<br>to transport low birth weight infants and<br>neonates. | Specific indications as submitted to the<br>FDA are unknown. Intended use is<br>equivalent |
| Environment of use | Hospitals, delivery suites, NICU, and<br>transport | Hospital, NICU |
| Patient Population | Infant and neonates | Premature infants |
| Technology | Electrically heated and controlled on air<br>temperature | Electrically heated and controlled on air<br>temperature |
| Features and Performance Characteristics | | |
| Overall dimensions | Main Body:<br>95(W) X 44(D) X 42(H) cm<br>Power Pack:<br>29(W) X 17.5(D) X 25(H) cm<br>Alternate Power Pack:<br>35(W) X 20(D) X 33(H) cm<br>Mattress - 55(W) x 28(D) x 2.5(H) cm | 52.7(W) X 95.9(L) X 50.8(H)<br>Mattress - 74(W) x 36(D) x 2(T) cm |
| Weight | Main Body and Power Pack<br>approximately 32kg | 49kg |
| Major components | Hood<br>Main body<br>Power Pack | Hood<br>Main body |
| Power | 100-240 VAC<br>47-63 Hz or 47-440Hz<br>220 or 280VA max<br>11.0- 14V DC 10A | 110/120 V, 50/60/400 Hz - 220/240 V,<br>50/60/400 Hz<br>11-13/26-30 VDC 200W |
| Operating conditions | Temperature: 10-30 °C<br>RH - 30-75% | Temperature: Not specified<br>RH - 0-95% |

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# 510(k) Summary

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| | Proposed<br>Transcapsule V-707 | Predicate<br>K941106<br>Air-Shields (Draeger) T1500 Isolette<br>Infant Incubator |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum load capacity | IV Pole ~ 3 kg | Not specified |
| Features and Performance Characteristics (continued) | | |
| Accessories / optional<br>components | Skin Temperature Probe<br>Access port covers<br>Infant Fixing Band<br>IV Pole | Skin Temperature Probe<br>Accessory Shelf<br>IV Pole<br>Infant restraint straps<br>High Hood, Pressure Regulator and<br>flowmeter<br>Humidity Pad |
| Control modes | Automatic based on incubator air<br>temperature | Automatic based on incubator air<br>temperature |
| Skin Temperature<br>Measurement Range | 30.0 and 42.0℃ in 0.1℃ increments<br>with an accuracy of +/-0.3°C | Not specified |
| Incubator air temperature<br>setting range | 23.0 to 38.0℃ in 0.1℃ increments | 22 - 38°C |
| Display range | Skin - 30.0 - 42 °C in 0.1°C increments,<br>Accuracy - ± 0.3 °C<br>Air - 20.0 - 42.0 °C<br>Accuracy - ± 1.0 °C | Skin - Not specified<br>Air - Not specified |
| Heater output | 0 - 100% in 10 increments | Not specified |
| Warm-up time | Approximately 40 min @ 25℃ | ≤ 60 min @ 25°C |
| Alarms | High temperature<br>Set point<br>Skin Temperature Probe Fault | High temperature<br>Heater temperature<br>Skin temperature probe fault |
| Humidity | N/A | Passive |
| Oxygen supply | ≥ 60% @ 10 Lpm | 21% to 58% minimum |
| Environment CO₂<br>concentration in the hood | < 0.5% 10cm above center of mattress<br>at 750 ml/min | Not specified |
| Other alarms | Fan<br>System failure<br>Power failure<br>Low voltage | Fan<br>System failure<br>Power failure |

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## 510(k) Summary Page 4 of 4 23-May-13

| | Proposed<br>Transcapsule V-707 | Predicate<br>K941106<br>Air-Shields (Draeger) T1500 Isolette<br>Infant Incubator |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Safety and Performance testing | | |
| Performance testing has been<br>performed per the following<br>standards | IEC 60601-1 (1988) - Medical<br>Electrical Equipment - Part 1: General<br>Requirements for Safety+Al<br>+A2Amendment 2<br><br>IEC 60601-1-2 : 2007- Medical<br>Electrical Equipment - Part 1-2:<br>General requirements for Safety-<br>Collateral standard: Electromagnetic<br>compatibility Requirements and tests<br>(Edition 3)<br><br>IEC 60061-2-20 (1996) - Amendment<br>1 - Medical Electrical Equipment - Part<br>2: Particular Requirements for the<br>Basic Safety and Essential Performance<br>of Infant Transport Incubators | Not specified |

#### Substantial Equivalence Rationale

The Atom Transcapsule V-707 is viewed as substantially equivalent to the predicate device because:

#### Indications -

- Based on marketing literature equivalent .
#### Technology -

- Identical technology and design .
#### Materials -

- . The materials in patient contact are identical to previously cleared Atom Medical Devices
#### Environment of Use -

- Similar to predicate ~ Air-Shields (Draeger) T1500 Isolette K941106 .
#### Nonclinical Performance Testing -

Performance testing has been performed to verify requirements have been met and in accordance . with FDA recognized standards. The proposed device met and passed all testing criteria.

# Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

Public Health Service

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

May 23, 2013

Atom Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS, FL 34134

Re: K123937

Trade/Device Name: Atom Medical Transcapsule V-707 Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: April 15, 2013 Received: April 16, 2013

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

DAGRID

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, 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:

### K123937 :

Device Name:

Atom Medical Transcapsule V-707

Indications for Use:

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.

Environment of use -- Hospitals, delivery suites, NICU, and transport

Prescription Use XX (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)

Sajjad H Syed

Digitally signed by Sajjad H. Syed DN: c=US, o=U.S. Government, ou=HH5, ou=FDA, ou=People, cn=Sajjad H. Syed, 0.9.2342.19200300.100.1.1=2000601 742 Date: 2013.05.23 09:32:23 -04'00'

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

**510(k) Number:** K123957