(233 days)
Not Found
No
The summary describes a transport incubator for infants during MRI procedures, focusing on maintaining a controlled environment and MRI compatibility. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device's intended use is to maintain a warm and controlled environment during transport and MRI procedures for pre-term, term newborns, and small infants, which is a supportive function rather than a therapeutic intervention.
No
The device is an MRI Transport Incubator designed to maintain a warm and controlled environment for infants during transport and MRI procedures. Its function is to facilitate the diagnostic exam, not to perform the diagnosis itself.
No
The device description clearly outlines multiple hardware components including an incubator, trolley, and backup power supply. While there is mention of software testing, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SREE MRI Transport Incubator is a medical device designed to provide a warm and controlled environment for infants during transport and MRI procedures. It is a piece of equipment used to support the patient, not to analyze biological samples.
- Intended Use: The intended use clearly states its purpose is to maintain a warm and controlled environment during transport and the MRI procedure. It does not mention any analysis of biological samples.
- Device Description: The description details the physical components and how the device functions to transport and house the infant during the MRI. There is no mention of sample collection or analysis.
Therefore, the SREE MRI Transport Incubator falls under the category of a medical device used for patient support and transport, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.
The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
Product codes (comma separated list FDA assigned to the subject device)
FPL
Device Description
The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply.
The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment.
The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry.
A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
pre-term, term newborns and small infants up to 1 month of age
Intended User / Care Setting
Not Found
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)
Performance Testing:
Bench testing as per IEC 60601 and other applicable standards with respect to mechanical, software, biocompatibility, disinfection/cleaning validations and MRI testing. All tests complied.
Device Performance Validation:
Additional bench validation testing was performed to demonstrate that the SREE MRI incubator system met the predetermined acceptance criteria not covered under the recognized IEC standards. Validation testing included:
- Software validation according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Finite Element Analysis
- Cleaning and Disinfection Validation
MRI Testing:
MRI safety testing performed to rule out Bo displacement, Bo induced torque and RF induced heating per proven ASTM standards was successful. MRI compatibility was proven with phantom and human testing. Phantom and human testing accomplished with the MRI incubator showed no appreciable deviation of incubator behavior of MRI image quality. Phantom signal-noise-ratio and image uniformity with and without the incubator were within a few percent and deemed acceptable considering the benefits of continuous warming therapy throughout the MR exam. Compatibility with different field strengths (1.5T, 3.0T) and manufacturers (GE, Siemens etc) were verified on phantoms using established quality assurance protocols.
Incubator behavior within the MRI suite was verified to show no adverse effects in either direction. Incubator performance was unaffected during the MRI exam and the MRI image quality was preserved. Other MRI scanner functions were not influenced by the incubator presence.
Clinical Tests:
Not Applicable
Conclusions:
Testing of the SREE MRI Transport Incubator system did not raise new risks, questions or resulted in any new potential hazards. SREE MRI transport incubator system is therefore considered to be substantially equivalent to the legally marketed transport incubators: LMT's Nomag IC 1.5T and 3.0T (K033565, K062052).
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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, representing health and well-being. The figure is positioned within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the top portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Advanced Imaging Research, Inc. dba SREE MEDICAL SYSTEMS Ravi Srinivasan President P.O. Box 603220 Cleveland. Ohio 44103
Re: K161918
Trade/Device Name: SREE MRI Transport Incubator Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: Class II Product Code: FPL Dated: July 12, 2016 Received: July 13, 2016
Dear Ravi Srinivasan:
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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161918
Device Name
SREE MRI Transport Incubator
Indications for Use (Describe)
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.
The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K161918 510(K) SUMMARY
Manufacturer's Name:
ADVANCED IMAGING RESEARCH, INC. DBA SREE MEDICAL SYSTEMS
| Corresponding Official: | Ravi Srinivasan, President |
|---|---|
| Telephone Number: | 216-426-1461 |
| Fax: | 216-426-1180 |
| E-mail: | ravi@sreemedical.com |
| Preparation Date: | March 1, 2017 |
| Trade Name: | SREE MRI Transport Incubator |
| Common or Usual Name: | Incubator, Neonatal Transport |
| Regulation Name: | Incubator, Neonatal Transport |
| Regulation Number: | 21 CFR 880.5410 |
| Product Code: | FPL |
| Device Class: | Class II |
| Primary Predicate Device: | K062052 LMT Nomag IC 3.0 |
| Secondary Predicate Device: | K033565 LMT Nomag IC 1.5 |
Device Description
The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply.
The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment.
The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry.
A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.
4
Intended Use
Intended use is to provide a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a MRI with either 1.5T or 3.0T magnet field strengths. The SREE MRI Transport Incubator is intended to accommodate pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (approx. 21.7").
The SREE MRI Transport Incubator is intended for temporary, intra-hospital patient use and on a MRI scanner up to and including three tesla magnet field strengths.
Indications for Use
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.
The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
Substantial Equivalence Discussion
The intended use, operating principles, patient population and environment of use of the SREE MRI Transport Incubator are substantially equivalent to LMT Nomag IC 1.5, 3.0 (K033565, K062052)
Specifications pertaining to general safety of medical equipment, electromagnetic compatibility, risk management, medical device software and basic performance specifications particular to transport incubators are defined by harmonized international ISO, IEC standards recognized by the FDA and therefore similar to commercially available transport incubators. Design and manufacturing technology used for providing incubator functions are similar to legally marketed predicate devices. In general, the SREE MRI Transport Incubator technical characteristics are similar to the predicate devices:
| | LMT Nomag IC 1.5, 3.0
(K033565, K062052) | SREE MRI Transport Incubator
(K161918) | Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indications for use | K033565 -
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 | Indications for use are for pre-term,
term newborns and small infants
requiring a diagnostic MRI exam
and need to be moved from their
warm and controlled intensive care
units to the MRI scanner.
Indications for use are to maintain a
warm and controlled environment
during inter-departmental transport
and during the MRI procedure.
The SREE MRI Transport | See Discussion of
differences |
| | 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.
K062052 -
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.Ot | Incubator provides a warm and
controlled environment during
inter-departmental transport and
during the diagnostic exam on a
scanner with either 1.5T or 3T
magnet field strengths. The SREE
MRI Transport Incubator
accommodates pre- and term
newborns and infants up to 1 month
of age and 4.5Kg whole body
weight or 55cm whole body length
(21.7"). | |
| Incubator
Dimensions
Weight | 72"L x 14" W x 11" H
95 lbs | 48" L x 16"W x 12" H
68 lbs | Substantially
Equivalent
Substantially
Equivalent |
| Patient
Compartment | 3 feet long | Same | N/A |
| Incubator Hood | Clear polycarbonate, Double Wall | Same | N/A |
| Incubator Housing | Urethane and polycarbonate | Same | N/A |
| Hand Ports | Four ports, two on each lateral side | Five ports, two on each lateral side and
one on top | Substantially
Equivalent |
| Doors | Three doors (left, right, superior) | Same | N/A |
| Tubing Port Holes | Four | Same | N/A |
| Coil Port Holes | Two | Same | N/A |
| Temperature Sensors | Resistance temperature detector
(RTD) | Same | N/A |
| Incubator Operation
Air | Air Temperature Regulation, 28-
39°C in 0.1°C increments | Same | N/A |
| Humidity | Humidity monitoring 10-99%
±5% rH and | Humidity monitoring only between 5-
95% ±5% without regulation. | See Discussion of
Differences |
| | regulation 30-70%rH in 1% increment | | |
| Skin Temperature | Monitoring only - Option | We offer MR safe, fiber-optic skin sensors (2) to monitor patient skin temperature | Substantially Equivalent |
| Incubator Mechanical Design | Unibody construction with 3 compartments | Unibody construction with 2 compartments | Substantially Equivalent |
| Incubator Display | Unibody construction with 3 compartments | Remote, on trolley on a swivel base for wide angle viewing by MRI techs in the console room | Substantially Equivalent |
| Incubator Display | 7" non interactive screen | Interactive 10.4" touch screen LCD display | Substantially Equivalent |
| Trolley | Aluminum with brakes on all wheels | Same | N/A |
| Trolley – Tank Holding Capacity | 4 USA E style tanks next to one another on the trolley | 4 USA E style tanks, two on the head side and two on the foot side of the trolley | Substantially Equivalent |
| UPS | Battery backup for 2 hours | Same | N/A |
| UPS Details | Custom UPS with audio, visual signals | UL/CE approved, medical grade UPS with audio and visual signals | Substantially Equivalent |
| Battery AH | Three 12VDC, 38AH used | Four 12VDC, 38AH used | Substantially Equivalent |
| Alarms | Audio and visual | Same | N/A |
| ISO/IEC Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 14971, ISO 62304, IEC 60601-1-8, ISO 10993 | Same | N/A |
| Performance Incubator | Warm up time 45 minutes, with holding temperature of Set ±1.5°C | Warmup time of 45 minutes, with holding temperature of Set ±1.0°C | Substantially Equivalent |
| Biocompatibility | Short-term use