(145 days)
No
The description details standard electronic signal processing and a permanently installed software program for temperature readout. There is no mention of AI, ML, or any learning algorithms.
No
The device is described as a continuous monitor of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. It alerts when temperature exceeds or falls below pre-selected levels. While it aids in patient monitoring, it does not directly treat or cure any condition, which is the primary characteristic of a therapeutic device.
No
Explanation: The device is described as a continuous monitoring system for skin temperature, alerting personnel when temperatures fall outside pre-selected levels. While it measures a physiological parameter, its primary function is monitoring and alerting, not diagnosing a specific disease or condition. The "Intended Use" focuses on monitoring during surgical procedures, recovery, intensive care, and general patient monitoring, which are surveillance activities rather than diagnostic. The "Device Description" confirms it measures and displays temperature.
No
The device description explicitly details hardware components including a thermistor probe, "Pen", "finger", Interface Module, and cables, indicating it is not solely software.
Based on the provided information, the Abreu BTT 700 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the continuous monitoring of skin temperature during surgical procedures, recovery, intensive care, and general patient monitoring. This is a direct measurement of a physiological parameter on the patient's body.
- Device Description: The device measures skin temperature using a thermistor probe applied to the skin. It processes and displays this measurement.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Abreu BTT 700 System does not perform any analysis on such specimens. It directly measures a physical property of the patient's skin.
Therefore, the Abreu BTT 700 System falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
Product codes
FLL
Device Description
The Abreu BTT 700 is a device used to measure the temperature of the skin by means of a thermistor coupled with an electronic signal amplification, conditioning, and display unit. As part of its basic design, the thermistor probe is an integral part of a non-disposable "Pen" (covered by a condom), and a disposable "finger." The components of the Abreu BTT 700 consist of a "pen", a disposable "finger", an Interface Module, and a USB A to USB mini cable. The Abreu BTT 700's Interface Module incorporates an onboard computer processing unit which is controlled by a permanently installed software program. Electronic signals received from the thermistor are processed in the Interface Module. With the aid of a computer assisted program, the output is a digital and analog temperature readout. The digital readout is in Celsius and Fahrenheit. The digital analog display is a 270° circular dial illustrating 16-40°C in tenths of a degree
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Adults and children (including adults, geriatric, and pediatric)
Intended User / Care Setting
Doctors and Health Care Professionals, surgical procedures, recovery room, intensive care, and general patient monitoring.
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)
Laboratory and clinical testing has verified electrical safety, . electromagnetic compatibility, and accuracy in the clinical environment. Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric with results showing performance equivalent to or better than the predicate. There were no adverse events.
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
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
510(K) Summary, K100843
BRAIN TUNNELGENIX TECHNOLOGIES CORP 3000 Park Avenue Bridgeport CT 06604 319-545-7377 Contact: Joseph Roger Titone, President Date prepared: June 5, 2010
AUG 1 7 2010
Trade Name: Abreu BTT 700 Skin Temperature System 1. Common Name: Thermometer, Electronic, Clinical
- Classification Name: FLL Clinical Electronic Thermometer 2. Class of device: Class II.
-
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : YSI Precision 4000 Thermometer, submitted by Yellow Springs Instrument, Inc. K910718
- Description of device: The Abreu BTT 700 is a device used to measure the 4. temperature of the skin by means of a thermistor coupled with an electronic signal amplification, conditioning, and display unit. As part of its basic design, the thermistor probe is an integral part of a non-disposable "Pen" (covered by a condom), and a disposable "finger." The components of the Abreu BTT 700 consist of a "pen", a disposable "finger", an Interface Module, and a USB A to USB mini cable. The Abreu BTT 700's Interface Module incorporates an onboard computer processing unit which is controlled by a permanently installed software program. Electronic signals received from the thermistor are processed in the Interface Module. With the aid of a computer assisted program, the output is a digital and analog temperature readout. The digital readout is in Celsius and Fahrenheit. The digital analog display is a 270° circular dial illustrating 16-40°C in tenths of a degree
- Intended use: The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
- Technological characteristics: The Abreu BTT 700 is substantially equivalent to the YSI Precision 4000 Thermometer, submitted by Yellow Springs Instrument, Inc. K910718, in that it provides the following characteristics:-
- Same thermistor detectors used in the design
- -Physical characteristics are essentially the same
- -Material composition is essentially the same
- -Same basic indications for use
- Technological characteristics: The Abreu BTT 700 is substantially equivalent to the YSI Precision 4000 Thermometer, submitted by Yellow Springs Instrument, Inc. K910718, in that it provides the following characteristics:-
- Intended use: The Abreu BTT 700 System is intended for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
- -Same presentation of temperature data.
1
| Comparison Table | ||
|---|---|---|
| Characteristic | YS14000 K910718 | Abreu BTT 700 |
| Indication for Use | Skin Temperature Measurement | SAME |
| Ambient Operating | ||
| Temperature Range | 0 to 50° C | SAME |
| Temperature Display | ||
| Range | 25 to 45° C | SAME |
| Accuracy | +/- 0.3° C Between 25 to 35° C | |
| +/- 0.2° C Between 35 to 37° C | ||
| +/- 0.1° C Between 37 to 39° C | ||
| +/- 0.2° C Between 39 to 41° C | ||
| +/- 0.3° C Between 41 to 45° C | SAME | |
| Resolution | 0.1° C | SAME |
| Display | LCD | Computer Monitor |
| Probes | Various | Abreu BTT 700 Temperature |
| pen with disposable coverlet | ||
| or BTT Forehead Finger Sensor | ||
| Technology | Precision PTC Thermistor 2250 | |
| ohms., enclosed in metal capsule | Precision PTC Thermistor 10 K | |
| instead of a 2250 ohm thermistor | ||
| in order to reduce the size of the | ||
| contact area of the sensing probe | ||
| isolated with medical grade | ||
| acrylic | ||
| Probe Power | 30 microwatts or less | SAME |
| Target Population | Adults and children | SAME |
| Conditions of Use | Doctors and Health Care Professionals | SAME |
| Alarm Settings | Independent HI and LO (low) alarm | |
| settings, user adjustable, flash and | ||
| audio alerts | SAME | |
| Computer Connection | Not available | USB |
| Error indications | No probe | |
| Under Range | ||
| Over Range | SAME with the addition of a | |
| Shorted Probe detector | ||
| Self Check Function | Every temperature scan includes | |
| reading the value of an internal | ||
| precision resistance (37.1° C) | ||
| checking conversion process | SAME | |
| Power Source | Internal battery | USB port, 5 volts @ 175 ma. |
- Performance: Laboratory and clinical testing has verified electrical safety, 7. . electromagnetic compatibility, and accuracy in the clinical environment. Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric with results showing performance equivalent to or better than the predicate. There were no adverse events.
- . ;
Conclusion and Summary: The comparison of technological characteristics, test results, and the indications for use leads to the conclusion that there are no new issues of safety or effectiveness leading to the conclusion of substantial equivalence with the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Brain Tunnelgenix Technologies Corporation C/O Mr. Daniel Kamm Kamm & Associates 8870 Ravello Court Naples, Florida 34114
AUG 1 7 2010
Re: K100843
Trade/Device Name: Abreu BTT 700 System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 28, 2010 Received: August 4, 2010
Dear Mr. Kamm:
.
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.
3
Page 2- Mr. Kamm
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 forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Wh .for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
1/10843
510(k) Number (if known): K100843
Device Name: Abreu BTT 700 System
Indications For Use:
The instrument is for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.
Prescription Use X (Part 21 CFR 801 Subpart D) - AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nid C. Chagn
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antool, Dental Devices 100843 Page 1 of 1 510(k) Number: