LMT NOMAG IC 1,5

K033565 · Lmt Lammers Medical Technology GmbH · FPL · Nov 21, 2003 · General Hospital

Device Facts

• Record ID: K033565
• Device Name: LMT NOMAG IC 1,5
• Applicant: Lmt Lammers Medical Technology GmbH
• Product Code: FPL · General Hospital
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

LMT nomag IC 1,5 is an infant incubator system for temporary use during MR-imaging in clinical environments and in combination with a suitable trolley for intra hospital transport. LMT nomag IC 1,5 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches). LMT nomag IC 1,5 is suitable for MR scanner of field strengths up to 1.5T.

Device Story

LMT nomag IC 1,5 is a neonatal incubator designed for use within MR imaging environments and for intra-hospital transport. Device provides a microclimate of controlled air temperature and humidity for premature and sick infants. System includes a trolley for transport and power supply. Incubator operates in air control mode using closed-loop control for temperature and humidity; humidification achieved via vaporization of distilled water. Device is MR-compatible for scanners up to 1.5T. Healthcare providers use the device to maintain infant body temperature during diagnostic imaging, preventing hypothermia. Benefits include continuous warming therapy during scanning, reducing risks associated with patient transport and temperature fluctuations. Performance is monitored by clinicians to ensure stable microclimate conditions.

Clinical Evidence

Evidence includes bench testing and patient testing. MR compatibility evaluated using phantoms and patient subjects across 1.5T scanners (Siemens, GE, Philips). Primary endpoints included Signal to Noise Ratio (SNR) and imaging artifacts (geometric distortion, ghosting, uniformity). Results showed 0-2% decrease in SNR, considered acceptable. No adverse effects on imaging or incubator function reported.

Technological Characteristics

Neonatal incubator; air control mode; closed-loop temperature and humidity control; humidification via distilled water vaporization. MR-compatible design for 1.5T scanners. Compliant with IEC 60601-2-20, IEC 60601-1, and ISO 10993 standards.

Indications for Use

Indicated for premature and sick infants up to 4.5 kg body weight and 55 cm length requiring a controlled thermal and humidity environment during MR imaging (up to 1.5T) and intra-hospital transport.

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

• Hill-Rom Air-Shields TI 500 (K001019)

Submission Summary (Full Text)

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K033565

NOV 2 1 2003

Sec. 3 510(k) Summary
LMT nomag IC 1,5

| Applicant | LMT Lammers Medical Technology GmbH<br>Bessemerstr. 7<br>23562 Luebeck<br>Germany |
|-------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Michael Bohnen<br>Tel: [phone]<br>Fax. [phone]<br>Email: [e-mail] |
| Common Device Name | Neonatal Transport Incubator |
| Device Panel: | General Hospital |
| Product Code | FPL |
| Regulation No. | 880.5410 |
| Class | 2 |
| Propietary Name | LMT nomag IC 1,5 |
| Performance Standard: | IEC 60601-2-20<br>IEC 60601-1<br>ISO 10993 |
| Legally marketed device | Hill-Rom Air-Shields TI 500 K#001019 |

510(k) Submission LMT nomag IC 1,5

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Sec. 3 510(k) Summary LMT nomag IC 1,5

# Intended Use of the LMT Nomag IC 1,5

LMT nomag IC 1,5 is an infant incubator system for temporary use during MRimaging in clinical environments and in combination with a suitable trolley for intra hospital transport.

LMT nomag IC 1,5 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).

LMT nomaq IC 1,5 is suitable for MR scanner of field strengths up to 1,5T.

# Function of the Device

The LMT Nomag IC 1,5 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapv. It provides a microclimate of air temperature and humidity suiting the infants needs. The incubator has a trolley for intra clinical transport providing power.

The incubator runs in air control mode and has closed loop control for both air temperature and humiditication works hygienically via vaporizing of distilled water.

### Design and Specifications

The basic incubator performance of the LMT nomaq IC 1,5 is defined by the IEC particular standard and thus similar to commercially available incubators. The technologies used for providing incubator functions are similar to legally marketed devices.

### Testing under MR influence

The MR compatibility has been proven in patient and bench testing.

The images were evaluated regarding Signal to Noise Ratio (SNR) and artefacts like geometric distortion, ghosting and uniformity. The decrease in imaging quality (i.e. loss of SNR) was 0 to 2% for most sequences. This value is considered acceptable compared to the benefits of continuous warming therapy throughout scanning.

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Image /page/2/Picture/1 description: The image shows three black dots followed by the letters "LMT" in bold black font. The dots are evenly spaced and aligned horizontally. The letters "LMT" are also aligned horizontally and are larger than the dots. The letter "M" is stylized with a sharp angle at the top.

The compatibility with MR scanners of different manufacturers (Siemens, GE, Philips all 1,5T) have been tested according to an established protocol using phantoms.

# SE Statement

The LMT Nomag IC 1,5 incubator is substantially equivalent to the legally marketed device with respect to the incubator functions. It is compliant with international harmonized standards for incubators by the IEC. The behaviour of the incubator under the special environmental conditions during MR imaging have been tested and have shown no adverse effects in neither direction. The incubator performance was not influenced in any way by the scanner and the imaging has not shown significant artefacts caused by the incubator. Other functions of the scanner were also not influenced by the incubator. The testing did not rise new risks or questions associated with the use of a MR compatible incubator.

The LMT Nomag IC 1,5 1,5T works as safe and effective as the legally marketed device.

V.V. BoC

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thomas Michael Bohnen Manager R&D LMT Lammers Medical Technology GmbH, Germany

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 1 2003

LMT Lammers Medical Technology GMBH C/O Ms. Susan A. Gill Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K033565

Trade/Device Name: LMT nomag IC 1,5 Regulation Number: 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: November 6, 2003 Received: November 12, 2003

# . Dear Ms. Gill:

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.

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

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Ching-Liu, Ph.D.

Chiu Lin, Ph.D. 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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Page 1_ of 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

LMT nomag IC 1,5 is an infant incubator system for temporary use during MR-imaging in clinical environments and in combination with a suitable trolley for intra hospital transport.

LMT nomag IC 1,5 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).

LMT nomag IC 1,5 is suitable for MR scanner of field strengths up to 1.5T.

Pituca Cuconte

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)