(11 days)
K#033565
Not Found
No
The description focuses on environmental control (temperature, humidity) and MR compatibility, with no mention of AI/ML terms or functions.
Yes
The device is an infant incubator that provides a controlled environment of warmth and humidity, which constitutes warming therapy for premature and sick infants.
No.
The device is an infant incubator system designed to maintain a controlled environment for infants during MR imaging; it does not diagnose medical conditions.
No
The device description clearly outlines a physical incubator system with hardware components for temperature and humidity control, a trolley for transport, and compatibility testing with MR scanners. It is not solely software.
Based on the provided information, the LMT nomag IC 3.0 MR-incubator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of the LMT nomag IC 3.0 clearly state its purpose is to provide a controlled environment for infants during MR imaging and transport. It does not involve the analysis of biological specimens.
- The device's function is to support the patient's physiological needs (warmth and humidity) during a medical imaging procedure. This is a life support or patient care function, not a diagnostic test performed on a sample.
The information provided focuses on the device's compatibility with MR imaging and its ability to maintain a suitable environment for the infant, which aligns with the characteristics of a medical device used for patient support and care, not an IVD.
N/A
Intended Use / Indications for Use
The LMT nomag IC 3.0 is an infant incubator system for temporary use during MR-imaging in clinical environments and provided with a suitable trolley for intra hospital transport.
The LMT nomag IC 3.0 MR-incubator 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).
The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.0T.
Product codes (comma separated list FDA assigned to the subject device)
FPL
Device Description
The LMT Nomag IC 3.0 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapy. 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 humidity. Humidification works hygienically via vaporizing of distilled water.
The basic incubator performance of the LMT nomag IC 3.0 is defined by the IEC particular standard and the design changes over the nomag IC 1.5. do not affect these performance figures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR-imaging
Anatomical Site
Not Found
Indicated Patient Age Range
infant (premature babies and sick infants)
Intended User / Care Setting
Not Found / clinical environments, intra hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The compatibility to MR scanners with 3T field strength has been proven in extensive bench testing.
Image evaluation was performed to the same standards as with the nomag IC 1.5.
The compatibility with MR scanners of different manufacturers (Siemens, Philips, GE 1.5T and 3T) have been tested according to an established protocol using phantoms.
During this testing the behaviour of the incubator has 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#033565
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Sec. 5 510(k) Summary LMT nomag IC 3.0
Image /page/0/Picture/1 description: The image shows the text "K062952 (p. 1 of 3)" written in black ink at the top. Below this text is a logo consisting of five black dots followed by the letters "LMT" in a bold, sans-serif font. The letters are also black, and the overall image has a high contrast.
JUL 3 1 2006
Preparation Date: Feb, 17th 2006
Applicant LMT Lammers Medical Technology GmbH Osterweide 8 23568 Luebeck Germany
Establishment Registration No. 3004083324
| Contact Person: | Thomas Michael Bohnen
Tel: +49-451-58098-0
Fax: +49-451-58098-15
Email: bohnen@lammersmedical.com |
| ----------------- | ------------------------------------------------------------------------------------------------------------ |
|---|
Common Device Name Neonatal Transport Incubator
Device Panel: General Hospital
Product Code FPL (Incubator, Neonatal Transport) Regulation No. 880.5410
Class
Propietary Name LMT nomag IC 3.0 REF: LMT-0100004-A
-
Performance Standard: IEC 60601-2-20: 1996 IEC 60601-1 (Ed.2): 1995 ISO 10993: 1997
2 -
Legally marketed device LMT nomag IC 1.5 K#033565
Reason for 510(k): extended indications for use
1
Sec. 5 510(k) Summary LMT nomag IC 3.0
Image /page/1/Picture/1 description: The image shows the text "K462452 (0.2043)" at the top. Below this text are four black dots in a horizontal row, followed by the letters "LMT" in a bold, sans-serif font. The letters are aligned horizontally and appear to be part of a logo or identifier.
Intended Use of the LMT nomag IC 3.0
The LMT nomag IC 3.0 is an infant incubator system for temporary use during MR-imaging in clinical environments and provided with a suitable trolley for intra hospital transport.
The LMT nomag IC 3.0 MR-incubator 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).
The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.0T.
Function of the Device
The LMT Nomag IC 3.0 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapy. 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 humidity. Humidification works hygienically via vaporizing of distilled water.
Design and Specifications
The basic incubator performance of the LMT nomag IC 3.0 is defined by the IEC particular standard and the design changes over the nomag IC 1.5. do not affect these performance figures.
Testing under MR influence
The compatibility to MR scanners with 3T field strength has been proven in extensive bench testing.
lmage evaluation was performed to the same standards as with the nomag IC 1.5.
2
Sec. 5 510(k) Summary LMT nomaq IC 3.0
Image /page/2/Picture/1 description: The image shows the text "Kψ62φ52 (P.3ΩΔ3)" written in black ink at the top. Below this text is a row of three black dots followed by the letters "LMT" in a bold, sans-serif font. The letters are also black, and the overall image has a simple, clean appearance.
The compatibility with MR scanners of different manufacturers (Siemens, Philips, GE 1.5T and 3T) have been tested according to an established protocol using phantoms.
During this testing the behaviour of the incubator has 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.
SE Statement
The LMT Nomag IC 3.0 incubator is substantially equivalent to the legally marketed device. It is compliant with international harmonized standards for incubators by the IEC.
The testing did not rise new risks or questions associated with the use of a MR compatible incubator.
The LMT Nomag IC 3.0 works as safe and effective as the legally marketed device.
V.N.BoC
Thomas Michael Bohnen RA LMT Lammers Medical Technology GmbH, Germany
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JUL 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LMT Lammers Medical Technology GmbH C/O Mr. Jeffrey D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K062052
Trade/Device Name: LMT Nomag IC 3.0 Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: June 19, 2006 Received: July 20, 2006
Dear Mr. Rongero:
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 affècting 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.
4
Page 2 - Mr. Rongero
.
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 (240) 276-0115. 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/cdrlv/industrv/support/index.html.
Sincerely vours,
Chiu Lin, 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
5
Indications for Use
510(k) Number (if known):
______________________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
The LMT nomag IC 3.0 MR-incubator is an infant incubator system for temporary use during MR-imaging in clinical environments provided with a suitable trolley for intra hospital transport.
The LMT nomag IC 3.0 MR-incubator 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).
The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.0T.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
His C. Murphy & Elizabeth M. Petton (Widow of John)
1789
sthesiblogy, General Hospi
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