TECOTHERM NEO (T NEO)

K140078 · Inspiration Healthcare, Ltd. · DWJ · Nov 14, 2014 · Cardiovascular

Device Facts

• Record ID: K140078
• Device Name: TECOTHERM NEO (T NEO)
• Applicant: Inspiration Healthcare, Ltd.
• Product Code: DWJ · Cardiovascular
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer.

Device Story

TECOTHERM NEO is a thermal regulating system for neonates and pediatric patients (up to 50 kg). It uses a water-based fluid circulating through a polyurethane mattress or wrap to provide conductive heating or cooling. The system includes a cold/heat generating unit, interconnecting hoses, and accessories. It accepts input from calibrated patient temperature probes (YSI 400 series compatible). A microcomputer-based Operational System and Controlling System manage the closed-loop circuit, maintaining set temperatures within +/- 0.3 °C. The device features a user menu for treatment mode selection and monitoring. It provides alarms for temperature deviations, probe faults, and fluid flow issues. The system is designed for clinical use to manage patient temperature, potentially benefiting patients by providing precise thermal therapy. It is smaller and has lower power/fluid requirements than adult-focused predicate devices.

Clinical Evidence

Bench testing verified biocompatibility, durability under transport conditions, and functional performance. Clinical evidence is supported by the Europe-wide TOBY trial (referenced via URL), demonstrating the effectiveness of the therapy type.

Technological Characteristics

Thermal regulating system using circulating water-based fluid. Components: polyurethane mattress/wrap, microcomputer-based control system. Connectivity: data output available. Power: 100-130V/200-250V. Accuracy: +/- 0.3 °C. Patient input: 2 probes (core/surface), YSI 400 series compatible. Closed-loop control. Dimensions: 310mm x 375mm x 190/215mm. Weight: 7.2 kg (filled).

Indications for Use

Indicated for pediatric patients (up to 50 kg) requiring temperature control and monitoring via conductive heat transfer.

Regulatory Classification

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Predicate Devices

• Criticool (K083662)
• Arctic Sun (K071341)
• Allon Version 5 (K024128)

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

November 14, 2014

Inspiration Healthcare Limited Wayne Iddon Regulatory Affairs Manager Gildor House, West Street Earl Shilton, Leicester LE9 7EJ United Kingdom

Re: K140078

Trade/Device Name: TECOTHERM NEO Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: October 13, 2014 Received: October 16, 2014

Dear Mr. Wayne Iddon:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

M.A. Hillebrand

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Abbreviated 510(k) T NEO

## 004 Indications for Use Statement

K140078 510k number if known:

Device Name:

TECOTHERM NEO

Indications for Use:

The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

| Submitter: | Inspiration Healthcare Limited<br>Gildor House<br>West Street<br>Earl Shilton<br>Leicester<br>LE9 7EJ United Kingdom<br>(t) [phone]<br>(f) [phone]<br>(m) [phone]<br>(e) [e-mail]<br>(w) www.inspiration-healthcare.co.uk |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Neil Campbell |
| Date of preparation | 2013-03 |
| Name of Device: | TECOTHERM NEO |
| Common Name: | Whole Body Cooling System |
| Classification Name: | Thermal regulating system<br>21CFR870.5900<br>Product Code DWJ |

#### Predicate Devices

| K083662 | Criticool (Primary) |
|---------|---------------------|
| K071341 | Arctic Sun |
| K024128 | Allon Version 5 |

#### Device Description

The TECOTHERM NEO is designed for controlled cold & heat treatment procedures and application of specific cold and heat doses to neonate and babies. The system applies cold and heat to total body, body parts and areas depending on therapy target by means of mattresses and/wrap.

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The main application is Total Body Treatment of Children up to body mass of 50 kg.

TECOTHERM NEO consists of a unique cold & heat generating device, applied parts like mattresses/wrap, interconnecting hoses (tubing set), accessories. Applied parts are connected to the device via hoses by self- sealing quickdisconnect couplings.

The patient is provided with cold or heat according to the therapy target in a fully controlled way by a circulating fluid. This physiologic safe water- based fluid is cooled or warmed in the device and flows through the mattress or wrap continuously supplying the patient with therapeutically prescribed doses.

Patient temperatures are measured with approved calibrated probes connected to the TECOTHERM NEO device. Temperature data is permanently communicated to the device Operational System.

Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points and operating at set point temperatures accurately with max. deviation of +/-0.3 °C, monitoring the treatment, and alarming when exceeding or falling below temperature limits are performances of TECOTHERM NEO.

TECOTHERM NEO is a system with built-in physiologic closed loop circuit PCLC. TECOTHERM NEO is electronically divided into an Operational System and a Controlling System. Both sub systems are micro computer (uC) based. Both uC communicate permanently to ensure safe and proper operation according to therapy needs.

A comfortable user MENU will guide the operator to the treatment modes, advise how to proceed the treatment and how to manage treatment details.

#### Indications for Use

The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer.

#### Comparative Analysis

Enhanced safety by smart design: In comparison to the predicate devices, TECOTHERM NEO has

- -Lowest wattage
- Lowest maximum fluid temperature -
- -Lowest liquid reservoir
- -Lowest fluid flow rate

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This is made possible, because the device is designed especially for neonate and pediatric patients. In any fault condition, there is much less chance of hazardous situations – the machine really fits to the needs for the specific treatment and is not "oversized" as it is the case with devices designed for cooling adults.

Listed below are the major attributes of the TECOTHERM NEO compared to the predicate devices listed: Criticool, ArcticSun and Allon 2001 version 5

| Specification | Criticool<br>(primary) | Arctic Sun | Allon<br>Version 5 | TECOTHERM<br>NEO |
|-------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| FDA<br>Notification | K083662 | K071341 | K024128 | This application |
| Control<br>Modes | Automatic | Automatic,<br>manual,<br>Purge, Stop | Automatic | Automatic,<br>Manual,<br>Full treatment<br>program |
| Heater<br>Capability | 500 W | 750 W | 500 W | 340 W |
| Circulating<br>Fluid | Tap Water | Distilled /<br>Sterile Water | Tap Water | TECOmed Fluid<br>(water based) |
| Reservoir<br>Capacity | 6 liters | 5 liters | 6 liters | 0.25 liters |
| Heat<br>Exchanger | Garment | Jell Pads | Garment | Polyurethane<br>mattress / wrap |
| Fluid Flow<br>Rate | 1...1.2 l/min | 0.5...0.8 l/min | 1...1.2 l/min | 0.3 l/min<br>0.5 l/min (max) |
| Patient Probe<br>Type | YSI 400<br>Series<br>compatible | YSI 400<br>Series<br>compatible | YSI 400<br>Series<br>compatible | YSI 400 Series<br>compatible |
| Patient<br>Temperature<br>Input | 2 - Core and<br>Surface | 2 | 2 - Core<br>and Surface | 2 - Core and<br>Surface |
| Patient<br>Temperature<br>Display<br>Range | 18.5...43.9<br>°C<br>(65.3...111.0<br>°F)<br>in 0.1 °C/F<br>increments | 10...44 °C<br>(50...111.2<br>°F)<br>In 0.1 °C/F<br>increments | 18.5...43.9<br>°C<br>(65.3...111.0<br>°F)<br>in 0.1 °C/F<br>increments | 10...45 °C<br>(50...113 °F)<br>trusted range:<br>29...39 °C<br>(84.2...102.2 °F)<br>in 0.1 °C/F<br>increments |
| Patient<br>Measurement<br>Accuracy | +/- 0.3 °C<br>(0.4 °F) | +/- 0.4 °C<br>@ 10...32 °C<br>+/- 0.2 °C<br>@ 32...38 °C<br>+/-0.4 °C<br>@ 38...44 °C | +/- 0.3 °C<br>(0.4 °F) | +/- 0.3 °C<br>(0.4 °F)<br>29...39 °C<br>(84.2...102.2 °F)<br>+/- 0.2 °C<br>@ 33.5 °C |
| Specification | Criticool<br>(primary) | Arctic Sun | Allon<br>Version 5 | TECOTHERM<br>NEO |
| Patient<br>Temperature<br>Control<br>Range –<br>Automatic<br>Mode | 30...40 °C<br>(86...104 °F)<br>in 0.1 °C/F<br>increments | 32...38.5 °C<br>(89.6...101 °F)<br>in 0.1° C/F<br>increments | 30...40 °C<br>(86...104 °F) in 0.1<br>°C/F<br>increments | 32...38 °C<br>(89.6...100.4 °F)<br>in 0.1 °C/F<br>increments |
| Fluid<br>Temperature<br>Display<br>Range | 9...44 °C<br>(48.2...111.2 °F) in 0.1<br>°C/F<br>increments | 3...45 °C<br>(37.4...113.0 °F) in 0.1<br>°C/F<br>increments | 9...44 °C<br>(48.2...111.2 °F) in 0.1<br>°C/F<br>increments | 11 °C to 40 °C<br>(51.8...104 °F)<br>in 0.1 °C steps<br>(resolution) |
| Fluid /<br>Mattress<br>Temperature<br>Control<br>Range –<br>Manual Mode | N/A | 4...42 °C<br>(39.2...107.6 °F) in 0.1<br>°C/F<br>increments | N/A | 12...39 °C<br>(53.6...102.2 °F) |
| Maximum<br>Fluid<br>Temperature<br>(Automatic<br>Mode) | 40.8 °C<br>(105.4 °F) | 42 °C<br>(107.6 °F) | 40.8 °C<br>(105.4 °F) | 39 °C<br>(102.2 °F) |
| Minimum<br>Fluid<br>Temperature | 13 °C<br>(55.4 °F) | 4 °C<br>(39.2 °F) | 13 °C<br>(55.4 °F) | 12 °C<br>(53.6 °F) |
| Mains Input | 230/115<br>VAC, 500 W,<br>50/60 Hz,<br>6.3 A | 115 VAC,<br>60 Hz,<br>11.0A<br>(nominal)<br>230 VAC,<br>50 Hz,<br>5.5 A | 230/115<br>VAC,<br>500 W,<br>50/60 Hz,<br>6.3 A | 100...130 V and<br>200...250 V,<br>50...60 Hz,<br>max. 350 W, |
| Leakage<br>Current | < 150 μΑ | < 300 μΑ | < 150 μΑ | < 200 μΑ<br>(@ 115V)<br>< 400 μΑ<br>(@ 230V) |
| Circuit<br>Breaker | 2 x 6.3 A<br>fuse | 12.0 A | 2 x 6.3 A<br>fuse | 2 x 250 VAC,<br>S 4A H (@<br>100...130 V)<br>S 2.5 A H (@<br>200...250 V) |
| Data Output | Yes | Yes | Yes | Yes |
| Relative<br>Humidity | 10...100% | 5...70% | 10...100% | 10...75%, non-<br>condensing |
| Specification | Criticool<br>(primary) | Arctic Sun | Allon<br>Version 5 | TECOTHERM<br>NEO |
| (Operating<br>Range) | | | | |
| Relative<br>Humidity<br>(Storage<br>Range) | 10...100% | 5...95%<br>non-<br>condensing | 10...100% | 5...90%<br>non-condensing |
| Temperature<br>(Operating<br>Range) | 10...40 °C<br>(50...104 °F) | 10...27 °C<br>(50...80 °F) | 10...40 °C<br>(50...104 °F) | 5...27 °C<br>(41...80.6 °F) |
| Temperature<br>(Storage<br>Range) | -40...70 °C<br>(40...158 °F) | -30...50 °C<br>(20...120 °F) | -40...70 °C<br>(40...158 °F) | 5...40 °C<br>(41...104 °F)<br>(filled with fluid)<br>-5...60°C<br>(23...140 °C)<br>(without fluid) |
| Height<br>(without<br>handle) | 24.4 inches<br>(620 mm) | 30 inches<br>(760 mm) | 24.4 inches<br>(620 mm) | 7.6 / 8.6 inches<br>190 / 215 mm |
| Length | 24.6 inches<br>(625 mm) | 22 inches<br>(560 mm) | 24.6 inches | 12.4 inches<br>310 mm |
| Width | 10.23 inches<br>(260 mm) | 12.5 inches<br>(320 mm) | 10.23<br>inches<br>(260 mm) | 15 inches<br>375 mm |
| Weight (filled) | 86 lbs<br>(39 kg) | 116 lbs<br>(53 kg) | 86 lbs<br>(39 kg) | 15.8 lbs<br>7.2 kg |
| ALARMS | | | | |
| High Fluid<br>Temperature | 42 °C<br>(107.6 °F) | 42.5 / 44 °C<br>(108.5 / 111.2 °F) | 42 °C<br>(107.6 °F) | 41 °C<br>(105.8 °F) |
| Low Fluid<br>Temperature | 10 °C<br>(50 °F) | 3.5 °C<br>(38.3 °F) | 10 °C<br>(50 °F) | 10 °C<br>(50 °F) |
| System<br>Patient<br>Temperature<br>High Alarm | 38.5 °C<br>(101.3 °F) or<br>2 °C (3.6 °F)<br>above set<br>point | 39.5 °C<br>(103.1 °F) | 38.5 °C<br>(101.3 °F) or<br>2 °C (3.6 °F)<br>above set<br>point | Patient<br>temperature +/-<br>0.5 °C from<br>target<br>temperature |
| System<br>Patient<br>Temperature<br>Low Alarm | 35.5 °C<br>(95.9 °F) or<br>0.5 °C<br>(0.9 °F)<br>below set<br>point | 31.0 °C<br>(87.8 °F) | 35.5 °C<br>(95.9 °F) or<br>0.5 °C<br>(0.9 °F)<br>below set<br>point | Patient<br>temperature +/-<br>0.5 °C from<br>target<br>temperature |
| Adjustable<br>Patient | N/A | 10.1...44 °C<br>(50.1...111.2 | N/A | N/A |
| Specification | Criticool<br>(primary) | Arctic Sun | Allon<br>Version 5 | TECOTHERM<br>NEO |
| Temperature<br>High Alarm | | °F) | | |
| Adjustable<br>Patient<br>Temperature<br>Low Alarm | N/A | 10.041.9<br>°C<br>(50107.5<br>°F) | N/A | N/A |
| Patient Probe<br>Fault Alarm<br>(short or<br>open) | Yes | Yes | Yes | Yes |
| Fluid Flow<br>Alarm | Yes | Yes | Yes | Yes |
| Fluid<br>Temperature<br>High Alarm | 42.0 °C<br>(107.6 °F) | 43.0 / 44 °C<br>(109.4 °F /<br>111.2 °F) | 42.0 °C<br>(107.6 °F) | 41.0 °C<br>(105.8 °F) |
| Fluid<br>Temperature<br>Low Alarm | 10 °C<br>(50 °F) | 3.0 °C<br>(37.4 °F) | 10 °C<br>(50 °F) | 10 °C<br>(50 °F) |
| Reservoir<br>Low Alarm | Yes | Yes | Yes | Yes |
| System Self<br>Test Alarm on<br>Power Up | Yes | Yes | Yes | Yes |

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The Tecotherm Neo has the same intended use as the predicates (albeit only for pediatrics) and similar technological characteristics that do not raise new types of questions of safety and effectiveness and is therefore substantially equivalent to the predicate devices.

## Performance Testing

The Tecotherm Neo device was introduced into the European market in 2010.

Materials were tested and proven for biocompatibility.

The design of the device has been verified and validated both through testing and actual experience throughout Europe.

The system was tested and proven for durability under transport conditions by an independent third party. Subsequent functional and performance testing was performed and showed no deterioration in the device integrity.

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Reports of the above are confidential but were included with this submission as requested. The testing and European experience provided data that demonstrated substantial equivalence to the predicates.

The therapy type has been proven in the Europe wide Toby trial. This report can be viewed using the following URL:

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0038504 .

### Conclusion

The data from using the device show the high performance level regarding safety and effectiveness. The device is substantially equivalent to the predicate devices.