(253 days)
No
The summary describes a standard vital signs monitor using established technologies for NIBP and SpO2 measurement, with no mention of AI or ML. The performance testing focuses on accuracy against standards and predicate devices, not on training or validation of AI/ML models.
No.
This device is a monitor designed for diagnostic purposes, providing measurements of blood pressure and oxygen saturation. It does not actively treat or alleviate a medical condition.
Yes
Explanation: The device is intended for spot checking or monitoring of a patient's blood pressures and pulse rate, with optional SpO2. These measurements are used to assess a patient's physiological state, which is a diagnostic function.
No
The device description clearly states it is a "portable NIBP monitor" and describes physical components like a "small table top non-invasive blood pressure monitor with a desk top charger," "NIBP cuff hose connection," "SpO2 probe interface," "optional internal printer," "LED display," and a "function keypad area." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as a portable monitor for measuring blood pressure and pulse rate (and optionally SpO2). These are physiological measurements taken directly from the patient's body.
- Device Description: The device description details a monitor with connections for blood pressure cuffs and SpO2 probes. These are external sensors applied to the patient.
- Lack of In Vitro Testing: The performance studies described involve testing the device's accuracy against standards and other monitoring devices using human subjects and simulators. There is no mention of testing biological samples (like blood, urine, or tissue) outside of the body, which is the hallmark of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures physiological parameters directly from the patient, not from a biological sample tested in vitro.
N/A
Intended Use / Indications for Use
The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) 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 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.
Product codes
74 DXN
Device Description
The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device will provide fast, reliable measurements on patients ranging from children (pediatric) 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.
Intended User / Care Setting
The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
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 Data: The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that it would perform within the environment(s) for which it is to be marketed. The testing was performed in accordance with the guidelines and standards found in the reviewers guide for respiratory devices. This testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements.
SpO2 & HR: Performance testing between the new 6004 with the LOX board oximeter option and the predicate 6100 was done to show that the performance of the two devices is the same (SpO2 & HR). The SpO2 simulator was the Biotek Index (K933519). All the SpO2 results were within one count (max) of the simulator and each other. The same was true of heart rate until 240 bpm was run. Both devices were within 0 to 3 counts of each other and the simulator. The result was still with in the device specification of +/- 2% ((a) 240 -> 4.8 counts). A deep desaturation test was run on the LOX board oximeter using the Capnocheck Plus (9004) as the host at the VA Medical Center in Milwaukee under an approved IRB. The LOX values were compared to an OSM-3 co-oximeter. Over the SpO2 range of 70% - 100% the standard deviation was 2.0 (spec = +/- 2%). Over the SpO2 range of 50% - 4.8 counts).
NIBP: Performance testing for the NIBP function was composed of two sections. The first part was testing to the ANSI/AAMI SP10-1992 standard (American National Standard for Electronic or automated sphygmomanometers) & ANSI/AAMI/ISO SP10A-1996 Amendment to ANSI/AAMI SP10-1992. This test was to determine the accuracy of the NIBP technology using the MicroNIBP module. The next test showed that the 6004 monitor with the same hardware design, electronics and software as the MicroNIBP performed the same. The MicroNIBP design was moved into the 6004 design because of space and cost constraints. The SP-10 testing was conducted under an approved IRB at the VA Medical Center in Milwaukee and at BCI International. When the MicroNIBP measurements are compared to the average of the manual readings the mean difference is -1.8 mmHg on systolic pressures and -2.6 mmHg on diastolic pressures. This meets the SP-10 requirement for a maximum mean difference of +/- 5 mmHg. The standard deviation of the difference between the MicroNIBP values and the average manual values was 7.1 mmHg for systolic pressures and 7.6 mmHg for diastolic pressures. This falls within the 8 mmHg limit imposed by the SP-10 standard. The next test showed that the MicroNIBP and the 6004 NIBP monitor will give the same NIBP readings. Using the Dynatech Nevada CuffLink NIBP Analyzer as the NIBP simulator a series of readings where taken over the specification range. The CuffLink repeatability specification is +/-1% of the selected target value. The test was run for heart rates from 30 bpm to 200 bpm (over the spec) and a pressure range (SYS/DIA) of 60/30 to 250/200 mmHg. Three readings were taken at each setting for both devices. An average of the three readings was calculated for both devices. Then the difference between devices was calculated. The average difference of all the readings were 1.0 for SYS, 1.1 for DIA, 1.1 for MAP and 0 for HR. This shows that the MicroNIBP and the 6004 NIBP monitor operate the same. The 6004 passed all the tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2:
Over the SpO2 range of 70% - 100% the standard deviation was 2.0 (spec = +/- 2%).
Over the SpO2 range of 50% -
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a series of characters that appear to be handwritten. The characters are 'KY 10801'. The characters are written in a dark ink or marker on a white background. The writing style is somewhat stylized, with some characters appearing slightly slanted or curved.
Image /page/0/Picture/1 description: The image shows the logo for BCI International. The logo consists of a circle on the left side, which is made up of vertical lines. To the right of the circle is the text "BCI" in large, bold letters, with the word "INTERNATIONAL" underneath in smaller letters.
Summary of Safety and Effectiveness
NOV 1 2 1997
| Submitter: | BCI International, Inc. |
|---|---|
| Address: | W238 N1650 Rockwood Drive |
| Waukesha, WI 53188 |
Telephone: Contact:
Prepared:
Proprietary Name: Common/Classification Name:
Predicate Devices:
(414) 542-3100 VP Regulatory Affairs
March 3, 1997
BCI 6004 NIBP Monitor Noninvasive blood pressure measurement svstem BCI 6100 Vital Signs Monitor
New Device Description:
The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.
Intended Use:
The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpQ and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) 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 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.
1
Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that it would perform within the environment(s) for which it is to be marketed. The testing was performed in accordance with the guidelines and standards found in the reviewers guide for respiratory devices. This testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements.
SpO2 & HR
Performance testing between the new 6004 with the LOX board oximeter option and the predicate 6100 was done to show that the performance of the two devices is the same (SpO2 & HR).
The SpO2 simulator was the Biotek Index (K933519). All the SpO2 results were within one count (max) of the simulator and each other. The same was true of heart rate until 240 bpm was run. Both devices were within 0 to 3 counts of each other and the simulator. The result was still with in the device specification of +/- 2% ((a) 240 -> 4.8 counts).
A deep desaturation test was run on the LOX board oximeter using the Capnocheck Plus (9004) as the host at the VA Medical Center in Milwaukee under an approved IRB. The LOX values were compared to an OSM-3 co-oximeter. Over the SpO2 range of 70% - 100% the standard deviation was 2.0 (spec = +/- 2%). Over the SpO2 range of 50% - 4.8 counts).
NIBP
Performance testing for the NIBP function was composed of two sections. The first part was testing to the ANSI/AAMI SP10-1992 standard (American National Standard for Electronic or automated sphygmomanometers ) & ANSI/AAMI/ISO SP10A-1996 Amendment to ANSI/AAMI SP10-1992. This test was to determine the accuracy of the NIBP technology using the MicroNIBP module. The next test showed that the 6004 monitor with the same hardware design, electronics and software as the MicroNIBP performed the same. The MicroNIBP design was moved into the 6004 design because of space and cost constraints.
The SP-10 testing was conducted under an approved IRB at the VA Medical Center in Milwaukee and at BCI International. When the MicroNIBP measurements are compared to the average of the manual readings the mean difference is -1.8 mmHg on systolic pressures and -2.6 mmHg on diastolic pressures. This meets the SP-10 requirement for a maximum mean difference of +/- 5 mmHg. The standard deviation of the difference between the MicroNIBP values and the average manual values was 7.1 mmHg for systolic pressures and 7.6 mmHg for diastolic
2
pressures. This falls within the 8 mmHg limit imposed by the SP-10 standard. The next test showed that the MicroNIBP and the 6004 NIBP monitor will give the same NIBP readings. Using the Dynatech Nevada CuffLink NIBP Analyzer as the NIBP simulator a series of readings where taken over the specification range. The CuffLink repeatability specification is +/-1% of the selected target value. The test was run for heart rates from 30 bpm to 200 bpm (over the spec) and a pressure range (SYS/DIA) of 60/30 to 250/200 mmHg. Three readings were taken at each setting for both devices. An average of the three readings was calculated for both devices. Then the difference between devices was calculated. The average difference of all the readings were 1.0 for SYS, 1.1 for DIA, 1.1 for MAP and 0 for HR. This shows that the MicroNIBP and the 6004 NIBP monitor operate the same.
The 6004 passed all the tests.
On the basis of these results and the above-referenced testing it is our determination that the device is safe, effective, and performs as well as or better than 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 Alexand
Donald Alexander VP Regulatory Affairs
3
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 1 2 1997
NOV 1 2 1997
Mr. Donald J. Alexander VP_Requlatory Affairs BCI International, Inc. W238 N1650 Rockwood Drive Waukesha, Wisconsin 53188-1199
K970801 Re : BCI Model 6004 NIBP Monitor Regulatory Class: II (Two) Product Code: 74 DXN Dated: September 22, 1997 Received: September 23, 1997
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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions.
Failure to comply with the GMP regulation may result in requlatory 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 requlations.
4
Page 2 - Mr. Donald J. Alexander
This letter will allow you to begin marketing your device as Inis lecter will arow you over are notification. The FDA finding described in your 310 k; premaries nevice to a legally marketed or substancial equivalence 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 regulation (21 CFR Part 801 and additionally 809.10 for in xirro diagnostic devices), please contact the Office of Compliance at Glaghosere devices), promoty, for questions on the promotion and (501) 391 1010. Thanksice, please contact the Office of auvertioning of your as (301) - Also, please note the regulation compilance at (301) by reference to premarket notification" (21 CFR 807.97). Other general information on your (2) CFR 807.977 - Ocher the Act may be obtained from the Division respondibilities and its toll-free number (800) i 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callshan
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
Monitor
Indications For Use
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name: BCI 6004 NIBP Monitor
Indications For Use:
870 : 1130 -
Intended Use
11- 12
The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children
(pediatric) to adults when using the appropriate BCI blood pressure cult. The rate on all patients from neonate to 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.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kira L. Campere
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
OR
510(k) Number K970801
Prescription Use (Per 21 CFR 801.109)
Over-The Counter Use