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.

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

AI/ML Overview

The provided text describes a 510(k) submission for the Abreu BTT 700 Skin Temperature System, claiming substantial equivalence to the YSI Precision 4000 Thermometer. The focus is on technical characteristics and performance, not a multi-reader multi-case comparative effectiveness study or a standalone AI algorithm performance study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the predicate device's specifications, as the Abreu BTT 700 aims for "substantial equivalence." The "Comparison Table" directly addresses this.

Characteristic	Acceptance Criteria (from YS14000 K910718)	Reported Device Performance (Abreu BTT 700)	Meets Criteria?
Indication for Use	Skin Temperature Measurement	SAME (continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring; alerts when temperature exceeds or falls below pre-selected levels)	Yes
Ambient Operating Temperature Range	0 to 50° C	SAME	Yes
Temperature Display Range	25 to 45° C	SAME	Yes
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	Yes
Resolution	0.1° C	SAME	Yes
Probe Power	30 microwatts or less	SAME	Yes
Target Population	Adults and children	SAME	Yes
Conditions of Use	Doctors and Health Care Professionals	SAME	Yes
Alarm Settings	Independent HI and LO alarm settings, user adjustable, flash and audio alerts	SAME	Yes
Error indications	No probe, Under Range, Over Range	SAME with the addition of a Shorted Probe detector	Improved
Self Check Function	Every temperature scan includes reading the value of an internal precision resistance (37.1° C) checking conversion process	SAME	Yes

Note on Differences:

Display: Predicate uses LCD, new device uses Computer Monitor. This is a change in presentation but not a performance metric for accuracy.
Probes: Predicate uses various, new device uses "Abreu BTT 700 Temperature pen with disposable coverlet or BTT Forehead Finger Sensor." This is a design difference, but the performance (accuracy) is claimed to be equivalent.
Technology: Predicate uses Precision PTC Thermistor 2250 ohms. New device uses Precision PTC Thermistor 10 K to reduce probe size, isolated with medical grade acrylic. This is a design difference to achieve the same performance.
Computer Connection: Predicate not available, new device has USB. A new feature, but not a performance metric for temperature accuracy.
Power Source: Predicate uses internal battery, new device uses USB port, 5 volts @ 175 ma. A design difference.

The claim of substantial equivalence hinges on the "Performance: Laboratory and clinical testing has verified ... 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."

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

The document states: "Clinical testing was performed on subjects of different age groups: adults, geriatric, and pediatric." However, the exact sample size for the clinical test set is not provided in the given text.

The data provenance is implied to be clinical testing of the Abreu BTT 700, making it prospective for this device. The country of origin is not explicitly stated.

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 appears to be objective measurements against a standard, not requiring expert ground truth in the subjective medical interpretation sense. For a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or a controlled temperature environment, not expert interpretation.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of device accuracy testing for a thermometer. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations where expert consensus is needed to establish ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MPMC comparative effectiveness study was done or mentioned. This device is a clinical electronic thermometer measuring skin temperature, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable to a clinical thermometer in the sense of an AI algorithm. The device itself (Abreu BTT 700) performs the measurement and displays it. Its "standalone" performance is its accuracy and reliability in measuring temperature, which was verified through "Laboratory and clinical testing."

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth would have been established by a highly accurate reference temperature source/method during laboratory testing, and potentially comparison against the predicate device or another established accurate method during clinical testing. It is not "expert consensus," "pathology," or "outcomes data" in this context.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware-based thermometer with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The permanently installed software program likely performs signal processing and display functions based on fixed algorithms, not learned parameters.

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

This information is not applicable and not provided for the reasons stated in point 8.

Summary

{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.
1. 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

-Same presentation of temperature data.

{1}------------------------------------------------

Comparison Table
Characteristic	YS14000 K910718	Abreu BTT 700
Indication for Use	Skin Temperature Measurement	SAME
Ambient OperatingTemperature Range	0 to 50° C	SAME
Temperature DisplayRange	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 Temperaturepen with disposable coverletor BTT Forehead Finger Sensor
Technology	Precision PTC Thermistor 2250ohms., enclosed in metal capsule	Precision PTC Thermistor 10 Kinstead of a 2250 ohm thermistorin order to reduce the size of thecontact area of the sensing probeisolated with medical gradeacrylic
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) alarmsettings, user adjustable, flash andaudio alerts	SAME
Computer Connection	Not available	USB
Error indications	No probeUnder RangeOver Range	SAME with the addition of aShorted Probe detector
Self Check Function	Every temperature scan includesreading the value of an internalprecision 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:

Regulation Number and Section

§ 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.