(9 days)
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.
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.
The acceptance criteria and study proving the device meets them can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Imaging Quality) | Reported Device Performance (LMT nomag IC 1,5) |
|---|---|
| Decrease in Signal to Noise Ratio (SNR) | 0 to 2% for most sequences |
| Image Artefacts (geometric distortion, ghosting, uniformity) | "no significant artefacts caused by the incubator" |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical count of patients or phantom images. The document mentions "patient and bench testing" and "tested according to an established protocol using phantoms." It also states compatibility was tested with "MR scanners of different manufacturers (Siemens, GE, Philips all 1.5T)." This implies a small, targeted test set to evaluate MR compatibility.
- Data Provenance: The testing appears to be conducted by the manufacturer, LMT Lammers Medical Technology GmbH, in Germany. The nature of "patient testing" isn't further elaborated, so it's unclear if this was retrospective or prospective. Phantom studies are inherently prospective.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The evaluation of imaging quality ("images were evaluated regarding Signal to Noise Ratio (SNR) and artefacts like geometric distortion, ghosting and uniformity") would typically be performed by trained radiologists or MR physicists, but this is not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The study focused on the impact of the incinerator on image quality, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
This device is a neonatal transport incubator, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the physical device's impact on MR imaging.
7. Type of Ground Truth Used:
The ground truth for the imaging quality assessment appears to be based on expert evaluation of image quality metrics (SNR, artefacts) relative to expected baseline MR image quality without the incubator. The document implicitly uses the concept of "acceptable" performance based on expert judgment in the context of the benefits of continuous warming therapy.
8. Sample Size for the Training Set:
Not applicable. This device is hardware, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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NOV 2 1 2003
Sec. 3 510(k) Summary
LMT nomag IC 1,5
| Applicant | LMT Lammers Medical Technology GmbHBessemerstr. 723562 LuebeckGermany |
|---|---|
| Contact Person: | Thomas Michael BohnenTel: +49-451-58098-14Fax. +49-451-58098-15Email: bohnen@lammersmedical.com |
| 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 60601-2-20IEC 60601-1ISO 10993 |
| Legally marketed device | Hill-Rom Air-Shields TI 500 K#001019 |
510(k) Submission LMT nomag IC 1,5
03-00-510k_Summary-V04.doc
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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.
03-00-510k Summary-V04.doc
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Sec. 3 510(k) Summary LMT nomag IC 1,5
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
03-00-510k Summary-V04.doc
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a triple-stranded design.
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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)
§ 880.5410 Neonatal transport incubator.
(a)
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.(b)
Classification. Class II (performance standards).