(305 days)
No
The description focuses on a closed-loop temperature control system using microcomputers, without mentioning AI or ML algorithms for decision-making or data analysis beyond basic control and monitoring.
Yes
The device is described as a "temperature management system for pediatric patients, indicated for controlling and monitoring patient's temperature through conductive heat transfer." It "applies cold and heat to total body, body parts and areas depending on therapy target" and provides "therapeutically prescribed doses" of cold or heat. This indicates its use for therapeutic purposes.
No
This device is a temperature management system that controls and monitors a patient's temperature through conductive heat transfer, applying cold or heat. While it monitors temperature, its primary function is therapeutic (temperature control), not diagnostic.
No
The device description clearly outlines hardware components such as a cold & heat generating device, applied parts (mattresses/wrap), interconnecting hoses, and patient temperature probes. It also describes a circulating fluid system and electronic subsystems (Operational System and Controlling System) that are microcomputer-based, indicating a physical device with integrated software, not a software-only device.
Based on the provided information, the TECOTHERM NEO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to control and monitor patient temperature through conductive heat transfer. This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The device description details a system that circulates a fluid to apply cold or heat to the patient's body via mattresses or wraps. It measures patient temperature using probes connected to the device. This is a physical intervention and monitoring of a physiological parameter.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. IVDs are specifically designed for testing samples in vitro.
The TECOTHERM NEO is a therapeutic and monitoring device used for temperature management in pediatric patients.
N/A
Intended Use / 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.
Product codes
DWJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
total body, body parts and areas
Indicated Patient Age Range
pediatric patients, neonate and babies, Children up to body mass of 50 kg.
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:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5900 Thermal regulating system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
510(k) Summary
| Submitter: | Inspiration Healthcare Limited
Gildor House
West Street
Earl Shilton
Leicester
LE9 7EJ United Kingdom
(t) +44(0)1455 840555
(f) +44(0)1455 841464
(m) +44(0)7812 976247
(e) neil.campbell@inspiration-healthcare.co.uk
(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
21CFR870.5900
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.
4
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
5
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
(primary) | Arctic Sun | Allon
Version 5 | TECOTHERM
NEO |
|-------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| FDA
Notification | K083662 | K071341 | K024128 | This application |
| Control
Modes | Automatic | Automatic,
manual,
Purge, Stop | Automatic | Automatic,
Manual,
Full treatment
program |
| Heater
Capability | 500 W | 750 W | 500 W | 340 W |
| Circulating
Fluid | Tap Water | Distilled /
Sterile Water | Tap Water | TECOmed Fluid
(water based) |
| Reservoir
Capacity | 6 liters | 5 liters | 6 liters | 0.25 liters |
| Heat
Exchanger | Garment | Jell Pads | Garment | Polyurethane
mattress / wrap |
| Fluid Flow
Rate | 1...1.2 l/min | 0.5...0.8 l/min | 1...1.2 l/min | 0.3 l/min
0.5 l/min (max) |
| Patient Probe
Type | YSI 400
Series
compatible | YSI 400
Series
compatible | YSI 400
Series
compatible | YSI 400 Series
compatible |
| Patient
Temperature
Input | 2 - Core and
Surface | 2 | 2 - Core
and Surface | 2 - Core and
Surface |
| Patient
Temperature
Display
Range | 18.5...43.9
°C
(65.3...111.0
°F)
in 0.1 °C/F
increments | 10...44 °C
(50...111.2
°F)
In 0.1 °C/F
increments | 18.5...43.9
°C
(65.3...111.0
°F)
in 0.1 °C/F
increments | 10...45 °C
(50...113 °F)
trusted range:
29...39 °C
(84.2...102.2 °F)
in 0.1 °C/F
increments |
| Patient
Measurement
Accuracy | +/- 0.3 °C
(0.4 °F) | +/- 0.4 °C
@ 10...32 °C
+/- 0.2 °C
@ 32...38 °C
+/-0.4 °C
@ 38...44 °C | +/- 0.3 °C
(0.4 °F) | +/- 0.3 °C
(0.4 °F)
29...39 °C
(84.2...102.2 °F)
+/- 0.2 °C
@ 33.5 °C |
| Specification | Criticool
(primary) | Arctic Sun | Allon
Version 5 | TECOTHERM
NEO |
| Patient
Temperature
Control
Range –
Automatic
Mode | 30...40 °C
(86...104 °F)
in 0.1 °C/F
increments | 32...38.5 °C
(89.6...101 °F)
in 0.1° C/F
increments | 30...40 °C
(86...104 °F) in 0.1
°C/F
increments | 32...38 °C
(89.6...100.4 °F)
in 0.1 °C/F
increments |
| Fluid
Temperature
Display
Range | 9...44 °C
(48.2...111.2 °F) in 0.1
°C/F
increments | 3...45 °C
(37.4...113.0 °F) in 0.1
°C/F
increments | 9...44 °C
(48.2...111.2 °F) in 0.1
°C/F
increments | 11 °C to 40 °C
(51.8...104 °F)
in 0.1 °C steps
(resolution) |
| Fluid /
Mattress
Temperature
Control
Range –
Manual Mode | N/A | 4...42 °C
(39.2...107.6 °F) in 0.1
°C/F
increments | N/A | 12...39 °C
(53.6...102.2 °F) |
| Maximum
Fluid
Temperature
(Automatic
Mode) | 40.8 °C
(105.4 °F) | 42 °C
(107.6 °F) | 40.8 °C
(105.4 °F) | 39 °C
(102.2 °F) |
| Minimum
Fluid
Temperature | 13 °C
(55.4 °F) | 4 °C
(39.2 °F) | 13 °C
(55.4 °F) | 12 °C
(53.6 °F) |
| Mains Input | 230/115
VAC, 500 W,
50/60 Hz,
6.3 A | 115 VAC,
60 Hz,
11.0A
(nominal)
230 VAC,
50 Hz,
5.5 A | 230/115
VAC,
500 W,
50/60 Hz,
6.3 A | 100...130 V and
200...250 V,
50...60 Hz,
max. 350 W, |
| Leakage
Current |