BCI MINI-TORR PLUS, MODEL 6004

{0}------------------------------------------------ 3/25/99 Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '9', '8', '4', '6', '1', and '8'. The handwriting style appears cursive, with some characters connected to each other. ## Summary of Safety and Effectiveness | Submitter: | BCI International, Inc. | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | N7 W22025 Johnson Road<br>Waukesha, WI 53186 | | Telephone: | (414) 542-3100 | | Contact: | VP Regulatory Affairs | | Prepared: | December 7, 1998 | | Proprietary Name: | BCI Mini-Torr Plus (model 6004) with new<br>neonate NIBP mode | | Common/Classification Name: | Noninvasive blood pressure measurement system | | Predicate Devices: | BCI 6004 NIBP Monitor (K970801)<br>BCI 6004 Monitor with Temperature Option,<br>510(k) pending (K983796)<br>BCI 6200 Vital Signs Monitor (K953415) | ## New Device Description: The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic thermometer, and printer has been updated to include a new neonatal NIBP mode which uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), display of patient NIBP mode via an LED, system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication. ## Intended Use: The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer {1}------------------------------------------------ are available. The device will provide fast, reliable NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions. ## Performance Data: The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done previously to ensure that the BCI 6004 monitor would perform within the environment(s) for which it is to be marketed (510[k] pending, K983796). As only software has changed, further environmental testing was not necessary. The previous testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices and electronic thermometers. Electromagnetic compatability (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BCI 6004 monitor was in compliance with the guidelines and standards referenced in the reviewer's guides and that it performed within its specifications and functional requirements. Additional safety testing of the new neonatal NIBP mode was performed in accordance with IEC601-2-30: 1995. The monitor passes all of these tests and met all requirements of the standard. Comparison testing of the 6004 with the new neonate NIBP mode and the predicate 6004 was done to show that the performance of the NIBP adult mode, oximetry, and electronic thermometry parameters of the two devices are the same (systolic, and mean arterial pressures, NIBP heart rate, SpO2, oximetry heart rate, and temperature). Using simulators, measurements were made by both devices. The tests were run with simulator settings spanning the 6004's entire specification range. The difference between measurements made by both devices (predicate - new) was calculated. The average difference between readings were 1.29 mmHg for adult mode systolic pressure, 0.71 mmHg for adult mode diastolic pressure, 0.93 mmHg for adult mode MAP, 0.43 bpm for heart rate measured with the adult mode NIBP parameter, 0.04% for SpO2, 0 bpm for heart rate measured with the oximetry parameter, and -0.05 °F for oral and rectal temperature. All measurements were within the specified tolerances of the monitors and simulators. These data support substantial equivalence of the adult mode NIBP, oximetry, and electronic thermometry parameters of the new 6004 monitor to the predicate 6004 monitor. {2}------------------------------------------------ Finally, clinical testing of the BCI 6004 NIBP monitor with new neonatal NIBP mode demonstrated compliance to the ANSI/AAMI SP10-1992 standard (American National Standard for Electronic or automated sphygmomanometers ) and ANSI/AAMI/ISO SP10A-1996 Amendment to ANSI/AAMI SP10-1992. The SP-10 testing was conducted after receiving Institutional Review Board (IRB) approvals at two local hospitals on neonates ranging in size from 0.52 to 8.60 kilograms. Measurements of systolic, diastolic, and mean arterial blood pressures made by the 6004 monitor's algorithm were compared to measurements made from an arterial line pressure transducer. The means of these differences are: -0.4 mmHg for systolic pressures, -0.2 mmHg for diastolic pressures, and -0.6 mmHg for mean arterial pressures. These fall within the ±5 mmHg limit imposed by the SP-10 standard. The standard deviations of these differences are: 7.6 mmHg for systolic pressures, 5.3 mmHg for diastolic pressures, and 5.1 mmHg for mean arterial pressures. These fall within the 8 mmHg limit imposed by the SP-10 standard. Further testing demonstrated that the clinical software used for data acquisition and the final software for the monitor obtain the same measurements when tested using simulators. The testing described above indicate that there is no functional difference between the operation of the 6004 NIBP monitor with new neonatal NIBP mode and the predicate 6004 NIBP monitor for adult mode NIBP, oximetry, and electronic thermometry measurements. Also, the clinical data provide information on the accuracy of the new neonatal NIBP function. On the basis of these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s). This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Respectfully. Donald Alexander Donald Alexander VP Regulatory Affairs {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 5 1999 Mr. Donald J. Alexander BCI International N7 W22025 Johnson Road Waukesha, WI 53186 Re: K984618 BCI Mini-Torr Plus Monitor, Model 6004 with Neonatal NIBP Mode Regulatory Class: II (two) 74 DXN Product Code: December 22, 1998 Dated: December 29, 1998 Received: Dear Mr. Alexander: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Mr. Donald J. Alexander This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 510(k) Number: K984618 Device Name: BCI Mini-Torr Plus Monitor, Model 6004, NIBP monitor with optional oximeter, electronic thermometer, and printer Indications For Use: The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers, and provides oral or rectal temperature information for neonate through adult patients. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) of litted Shanker (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_k984 Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)