ABREU, MODEL 700

{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. - 3. 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 5. 6. - -Same presentation of temperature data. {1}------------------------------------------------ | Comparison Table | | | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | YS14000 K910718 | Abreu BTT 700 | | Indication for Use | Skin Temperature Measurement | SAME | | Ambient Operating<br>Temperature Range | 0 to 50° C | SAME | | Temperature Display<br>Range | 25 to 45° C | SAME | | Accuracy | +/- 0.3° C Between 25 to 35° C<br>+/- 0.2° C Between 35 to 37° C<br>+/- 0.1° C Between 37 to 39° C<br>+/- 0.2° C Between 39 to 41° C<br>+/- 0.3° C Between 41 to 45° C | SAME | | Resolution | 0.1° C | SAME | | Display | LCD | Computer Monitor | | Probes | Various | Abreu BTT 700 Temperature<br>pen with disposable coverlet<br>or BTT Forehead Finger Sensor | | Technology | Precision PTC Thermistor 2250<br>ohms., enclosed in metal capsule | Precision PTC Thermistor 10 K<br>instead of a 2250 ohm thermistor<br>in order to reduce the size of the<br>contact area of the sensing probe<br>isolated with medical grade<br>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<br>settings, user adjustable, flash and<br>audio alerts | SAME | | Computer Connection | Not available | USB | | Error indications | No probe<br>Under Range<br>Over Range | SAME with the addition of a<br>Shorted Probe detector | | Self Check Function | Every temperature scan includes<br>reading the value of an internal<br>precision resistance (37.1° C)<br>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. 8. . ; 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: