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").

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.

AI/ML Overview

The provided documentation describes the SREE MRI Transport Incubator, a medical device. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily in the form of compliance with recognized standards and comparative equivalence to predicate devices, rather than specific quantitative performance targets with tolerance limits for all parameters. However, I can extract the explicit performance metrics mentioned.

Acceptance Criteria / Performance Metric	Reported Device Performance
Compliance with IEC 60601-1 (Safety - Medical Equipment)	Comply
Compliance with IEC 60601-1-2 (Essential Performance - EMC)	Comply
Compliance with IEC 60601-2-20 (Essential Performance - Transport Incubator)	Comply
Compliance with IEC 60601-1 Sec 14 (Software)	Comply
Compliance with ISO 10993 (Biocompatibility)	Comply
Compliance with AAMI TIR-12 (Disinfection Validation)	Comply
Compliance with AAMI TIR-12 (Cleaning Validation)	Comply
B0 Displacement per ASTM F2052-15 (MRI Testing)	Comply
B0 Induced Torque per ASTM F2213-06 (MRI Testing)	Comply
RF Induced Heating per ASTM F2182-11a (MRI Testing)	Comply
MRI Phantom QA (SREE QA Protocol)	Comply (within a few percent deviation)
MRI Incubator Temperature Stability Tests (SREE Installation Testing Protocol)	Comply
Incubator Warm-up time	45 minutes
Incubator holding temperature stability	Set ±1.0°C
Compatibility with 1.5T MRI field strength	Achieved
Compatibility with 3.0T MRI field strength	Achieved
MRI image quality with incubator presence (phantom & human testing)	Preserved (no appreciable deviation)
Incubator performance during MRI exam	Unaffected
Influence on other MRI scanner functions	Not influenced

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set used in performance testing. It mentions "phantom and human testing" for MRI compatibility but does not provide details on the number of phantoms or human subjects.

The data provenance is from bench testing and, for MRI compatibility, involves "phantom and human testing." The country of origin for the data is not explicitly stated, but the company is US-based (Cleveland, Ohio). The testing described is prospective in nature, as it was performed to demonstrate device compliance and performance for the premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described appears to be primarily technical and engineering-focused, relying on standardized test methods (ASTM, IEC, ISO) and internal SREE QA protocols, rather than expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided or applicable as the testing described doesn't involve subjective assessments requiring expert adjudication. The compliance is determined against objective standards and technical protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a transport incubator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The device is a physical medical device (an incubator) with integrated software for control, not an AI diagnostic algorithm. Software validation was performed according to FDA guidance, which focuses on the reliability and safety of the software controlling the device, not its diagnostic accuracy in a standalone AI capacity.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

Standardized Test Methods: Adherence to established international and national standards (IEC, ISO, ASTM). These standards define objective criteria and measurement methods.
Engineering Specifications: Internal SREE QA protocols for incubator temperature stability and MRI QA, indicating comparison to predefined engineering targets.
Comparative Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices (LMT Nomag IC 1.5, 3.0). This implies that the device's performance is "ground-truthed" by its ability to perform comparably to devices already deemed safe and effective.

8. The Sample Size for the Training Set

This information is not applicable. The SREE MRI Transport Incubator is a hardware device with controlling software, not an AI-driven system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle processes, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this device.

Summary

{0}------------------------------------------------

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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.

{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

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 infantincubator system for temporaryuse during mr-imaging in clinicalenvironments and in combinationwith a suitable trolley for intrahospital transport.LMT Nomag IC 1.5 provides acontrolled environment of warmthand humidity for premature babiesand sick infants up to a bodyweight of 4.5 kg (10 lbs) and a	Indications for use are for pre-term,term newborns and small infantsrequiring a diagnostic MRI examand need to be moved from theirwarm and controlled intensive careunits to the MRI scanner.Indications for use are to maintain awarm and controlled environmentduring inter-departmental transportand during the MRI procedure.The SREE MRI Transport	See Discussion ofdifferences
	maximum body length of 55 cm(21.7 inches).LMT Nomag IC 1.5 is suitable formr scanner of field strengths up to1.5t.K062052 -The LMT Nomag ic 3.0 mr-incubator is an infant incubatorsystem for temporary use duringmr-imaging in clinicalenvironments provided with asuitable trolley for intra hospitaltransport.The LMT Nomag IC 3.0 mr-incubator provides a controlledenvironment of warmth andhumidity for premature babies andsick infants up to a body weight of4.5 kg (10 lbs) and a maximumbody length of 55 cm (21.7 inches)the LMT Nomag IC 3.0 is suitablefor use with mr scanners of fieldstrengths up to 3.Ot	Incubator provides a warm andcontrolled environment duringinter-departmental transport andduring the diagnostic exam on ascanner with either 1.5T or 3Tmagnet field strengths. The SREEMRI Transport Incubatoraccommodates pre- and termnewborns and infants up to 1 monthof age and 4.5Kg whole bodyweight or 55cm whole body length(21.7").
IncubatorDimensionsWeight	72"L x 14" W x 11" H95 lbs	48" L x 16"W x 12" H68 lbs	SubstantiallyEquivalentSubstantiallyEquivalent
PatientCompartment	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 andone on top	SubstantiallyEquivalent
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 OperationAir	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 ofDifferences
	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 <2hrs; widely used plastics (polycarbonate and urethanes with Polane T plus paint) for transport incubators and imaging predicate devices	Same	N/A
Electrical Safety	Per IEC 60601-1 for class II medical equipment	Same	N/A
Thermal Safety	Satisfy IEC 60601-1 surface temperature tests	Same	N/A
Radiation Safety	Satisfy IEC 60601-1 surface temperature tests	Same	N/A
MRI Compatibility	model for use with 1.5T (K033565)	Single model for use with 1.5T and 3.0T	Substantially Equivalent

{5}------------------------------------------------

{6}------------------------------------------------

Discussion of Differences

The indications for use statements are similar. The minor differences include the single incubator system for 1.5T and 3.0T magnetic field strengths and clarification of the intended patient population to be consistent with the labeling. These changes are supported by the performance testing provided and do not introduce any new or different risks.

{7}------------------------------------------------

The design used for providing incubator functions is similar to predicate devices. SREE MRI transport incubator provides a warm and controlled environment for infants dependent on warming therapy during interdepartmental transport and MRI procedure.

Incubator air temperature and humidity are continually monitored. Air temperature regulation is accomplished with continuous feedback from sensors whereas skin temperature is monitored continuously. Humidity regulation found in the predicate devices, is not present in the SREE MRI Transport Incubator. Supplying humidity regulation can lead to condensation of the incubator walls affecting the MRI diagnosis and possible contamination from algae growth in the humidifier supply chain affecting patient safety. Therefore, the benefit of providing low level humidity regulation during the 1 hour MRI exam is outweighed by the risks of obscuring MRI images and possibility of algae growth based contamination.

The incubator has a trolley that supports inter-departmental transport with backup power consisting of an UL/CE approved, medical grade uninterrupted power supply and batteries with flame rated enclosures. Incubator, trolley and backup power supply components and associated electronic circuitry are enclosed in housings made of aluminum or plastic. Polycarbonate, polyurethane plastic materials used are flame rated and have a high impact and tensile strength similar to, LMT's transport incubators (K033565, K062052).

The differences between the predicate devices and the SREE MRI Transport Incubator do not raise new or different questions of safety or effectiveness.

Performance Testing

We have performed the following safety/essential performance bench testing as per to IEC 60601 and other applicable standards with respect to mechanical, software, biocompatibility, disinfection/cleaning validations and MRI testing.

Safety and EssentialPerformance Testing	Testing Standards/Comparative Testing	Test results
Safety - Medical Equipment	IEC 60601-1	Comply
Essential Performance - EMC	IEC 60601-1-2	Comply
Essential Performance - TransportIncubator	IEC 60601-2-20	Comply
Software	IEC 60601-1 Sec 14	Comply
Biocompatibility	ISO 10993	Comply
Disinfection Validation	AAMI TIR-12	Comply
Cleaning Validation	AAMI TIR-12	Comply
MRI Testing	B0 Displacement per ASTM F2052-15Bo Induced Torque per ASTM F2213-06RF Induced Heating per ASTM F2182-11aMRI Phantom QA (SREE QA Protocol)MRI Incubator Temperature Stability Tests(SREE Installation Testing Protocol)	Comply

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 the following:

{8}------------------------------------------------

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. Compaibility 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).

Regulation Number and Section

§ 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).