SREE MRI Transport Incubator

K161918 · Advanced Imaging Research Dba Sree Medical Systems · FPL · Mar 3, 2017 · General Hospital

Device Facts

• Record ID: K161918
• Device Name: SREE MRI Transport Incubator
• Applicant: Advanced Imaging Research Dba Sree Medical Systems
• Product Code: FPL · General Hospital
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

System comprises MRI incubator, non-magnetic trolley, and backup power supply (UPS/battery). Incubator provides warm, controlled environment for neonates during inter-departmental transport and MRI scanning (1.5T/3T). Patient positioned head-first on curved table with mattress/straps. Trolley features transfer table for movement between trolley and MRI gantry. Backup power supply attaches to trolley rails. Device uses RTD sensors for air temperature regulation (28-39°C) and fiber-optic sensors for skin temperature monitoring. Operated by clinical staff in hospital settings. Output includes real-time temperature data on 10.4" touch screen display. Benefits include continuous thermal support, reducing risks associated with removing infants from controlled environments during diagnostic imaging.

Clinical Evidence

No clinical data. Bench testing only. Includes safety/performance testing per IEC 60601-1, 60601-1-2, 60601-2-20, ISO 10993, and MRI compatibility per ASTM F2052-15, F2213-06, and F2182-11a. Phantom and human testing verified MRI image quality and incubator temperature stability.

Technological Characteristics

Unibody construction; polycarbonate/polyurethane housing; aluminum trolley. RTD sensors for air temperature; fiber-optic sensors for skin temperature. 10.4" touch screen LCD. Powered by medical-grade UPS/battery. MR-conditional. Sterilization/cleaning per AAMI TIR-12. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 14971, ISO 62304, ISO 10993.

Indications for Use

Indicated for pre-term, term newborns and small infants (up to 1 month, 4.5kg, 55cm) requiring diagnostic MRI exams and transport from intensive care units to MRI scanners. Maintains warm, controlled environment during transport and MRI procedures (1.5T or 3T).

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

• LMT Nomag IC 3.0 (K062052)
• LMT Nomag IC 1.5 (K033565)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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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

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# 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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## 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: | [e-mail] |
| 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.

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# 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<br>(K033565, K062052) | SREE MRI Transport Incubator<br>(K161918) | Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indications for use | K033565 -<br>LMT Nomag IC 1.5 is an infant<br>incubator system for temporary<br>use during mr-imaging in clinical<br>environments and in combination<br>with a suitable trolley for intra<br>hospital transport.<br><br>LMT Nomag IC 1.5 provides a<br>controlled environment of warmth<br>and humidity for premature babies<br>and sick infants up to a body<br>weight of 4.5 kg (10 lbs) and a | Indications for use are for pre-term,<br>term newborns and small infants<br>requiring a diagnostic MRI exam<br>and need to be moved from their<br>warm and controlled intensive care<br>units to the MRI scanner.<br><br>Indications for use are to maintain a<br>warm and controlled environment<br>during inter-departmental transport<br>and during the MRI procedure.<br><br>The SREE MRI Transport | See Discussion of<br>differences |
| | maximum body length of 55 cm<br>(21.7 inches).<br>LMT Nomag IC 1.5 is suitable for<br>mr scanner of field strengths up to<br>1.5t.<br>K062052 -<br>The LMT Nomag ic 3.0 mr-<br>incubator is an infant incubator<br>system for temporary use during<br>mr-imaging in clinical<br>environments provided with a<br>suitable trolley for intra hospital<br>transport.<br>The LMT Nomag IC 3.0 mr-<br>incubator provides a controlled<br>environment of warmth and<br>humidity for premature babies and<br>sick infants up to a body weight of<br>4.5 kg (10 lbs) and a maximum<br>body length of 55 cm (21.7 inches)<br>the LMT Nomag IC 3.0 is suitable<br>for use with mr scanners of field<br>strengths up to 3.Ot | Incubator provides a warm and<br>controlled environment during<br>inter-departmental transport and<br>during the diagnostic exam on a<br>scanner with either 1.5T or 3T<br>magnet field strengths. The SREE<br>MRI Transport Incubator<br>accommodates pre- and term<br>newborns and infants up to 1 month<br>of age and 4.5Kg whole body<br>weight or 55cm whole body length<br>(21.7"). | |
| Incubator<br>Dimensions<br>Weight | 72"L x 14" W x 11" H<br><br>95 lbs | 48" L x 16"W x 12" H<br><br>68 lbs | Substantially<br>Equivalent<br>Substantially<br>Equivalent |
| Patient<br>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<br>one on top | Substantially<br>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<br>(RTD) | Same | N/A |
| Incubator Operation<br>Air | Air Temperature Regulation, 28-<br>39°C in 0.1°C increments | Same | N/A |
| Humidity | Humidity monitoring 10-99%<br>±5% rH and | Humidity monitoring only between 5-<br>95% ±5% without regulation. | See Discussion of<br>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 <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 |

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## 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.

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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 Essential<br>Performance Testing | Testing Standards/Comparative Testing | Test results |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Safety - Medical Equipment | IEC 60601-1 | Comply |
| Essential Performance - EMC | IEC 60601-1-2 | Comply |
| Essential Performance - Transport<br>Incubator | 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 F2052-15<br>Bo Induced Torque per ASTM F2213-06<br>RF Induced Heating per ASTM F2182-11a<br>MRI Phantom QA (SREE QA Protocol)<br>MRI Incubator Temperature Stability Tests<br>(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:

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- 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).