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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the BCI 6004 NIBP Monitor, extracted from the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Accuracy (70% - 100% saturation range): Standard deviation of 2.0% or less compared to a co-oximeter.	Standard deviation = 2.0%.
SpO2 Accuracy (50% - < 70% saturation range): Standard deviation of 3.0% or less compared to a co-oximeter.	Standard deviation = 2.7%.
SpO2 Simulator Accuracy: Within +/- 1 count (max) compared to a simulator.	All SpO2 results were within one count (max) of the simulator.
Heart Rate Simulator Accuracy (up to 240 bpm): Within +/- 2% of the simulator.	Both devices were within 0 to 3 counts of each other and the simulator, within the +/- 2% device specification.
NIBP Systolic Pressure Accuracy (mean difference): +/- 5 mmHg maximum compared to manual readings (per ANSI/AAMI SP10-1992).	Mean difference = -1.8 mmHg.
NIBP Diastolic Pressure Accuracy (mean difference): +/- 5 mmHg maximum compared to manual readings (per ANSI/AAMI SP10-1992).	Mean difference = -2.6 mmHg.
NIBP Systolic Pressure Accuracy (standard deviation of difference): 8 mmHg limit compared to manual readings (per ANSI/AAMI SP10-1992).	Standard deviation = 7.1 mmHg.
NIBP Diastolic Pressure Accuracy (standard deviation of difference): 8 mmHg limit compared to manual readings (per ANSI/AAMI SP10-1992).	Standard deviation = 7.6 mmHg.
NIBP Simulator Repeatability (CuffLink): Average difference for SYS, DIA, MAP, and HR close to zero across a specified range.	Average difference: SYS=1.0, DIA=1.1, MAP=1.1, HR=0.

Study Details

2. Sample sizes for the test set and data provenance:

SpO2 "deep desaturation test": The number of subjects is not explicitly stated. The study for this was conducted at the VA Medical Center in Milwaukee. This appears to be a prospective clinical study given the IRB approval.
NIBP testing (to ANSI/AAMI SP10-1992): The number of subjects is not explicitly stated. The study was conducted at the VA Medical Center in Milwaukee and at BCI International. This appears to be a prospective clinical study given the IRB approval.
Simulator Tests (SpO2 & NIBP): These tests involve devices and simulators, not human subjects. The number of readings taken at each setting for NIBP was three.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

SpO2 "deep desaturation test": The ground truth was established by an OSM-3 co-oximeter. No human experts are mentioned as directly establishing the ground truth for SpO2 values in this context.
NIBP testing (to ANSI/AAMI SP10-1992): The ground truth was established by "manual readings" which implies a human operator taking blood pressure measurements. The number and qualifications of these individuals (e.g., healthcare professionals) are not specified.

4. Adjudication method for the test set:

SpO2: No explicit adjudication method is mentioned for the SpO2 deep desaturation test. The LOX values were compared directly to the OSM-3 co-oximeter.
NIBP: For the ANSI/AAMI SP10-1992 standard, the MicroNIBP measurements were compared to the average of the manual readings. This implies that multiple manual readings were taken and averaged to form the ground truth, but no further details on adjudication (e.g., if there were discrepancies between manual readers) are provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The studies focused on device-to-device and device-to-standard comparisons.

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

Yes, the studies described are standalone performance evaluations of the BCI 6004 monitor itself against simulators, predicate devices, and established standards. While human interaction is involved in operating the device and taking manual readings for NIBP, the performance metrics reported are for the device's output.

7. The type of ground truth used:

SpO2: The ground truth for SpO2 in the deep desaturation test was based on an OSM-3 co-oximeter, which is a laboratory instrument, not expert consensus or pathology. For simulator tests, the ground truth was the Biotek Index SpO2 simulator.
NIBP: The ground truth for NIBP was the average of manual readings performed by unspecifed individuals, and for simulator tests, the Dynatech Nevada CuffLink NIBP Analyzer.

8. The sample size for the training set:

This information is not provided. The document describes performance testing of a finished device, not the development or training of an AI model.

9. How the ground truth for the training set was established:

This information is not applicable as details about a training set or AI model development are not discussed. The document focuses on demonstrating the performance of the BCI 6004 NIBP Monitor, which is a traditional medical device, against established standards and predicate devices.

Summary

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Summary of Safety and Effectiveness

NOV 1 2 1997

Submitter:	BCI International, Inc.
Address:	W238 N1650 Rockwood DriveWaukesha, 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:

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.

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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% - < 70% the standard deviation was 2.7 (spec = +/- 3%). R squared = 0.97 (measure of how true the regression line is, one being perfect).

A test was run in-house comparing the 6004 with the LOX board to the 9004 with a LOX board to show that the device will give the same reading even if the host is different. Another monitor, the BCI 9000 Capnograph with Oximeter was also run at the same time. (BCI 9000 K873856). Again 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. All of the devices were within 0 to 3 counts of each other and the simulator. The result was still with in the device specification of +/- 2% ((d) 240 -> 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

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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

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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.

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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

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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

510(k) Number K970801

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

Regulation Number and Section

§ 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).