The 6004 NIBP monitor is a low cost 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 SpO3, optional oral/rectal temperature, and/or inter. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO3 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.

Device Description

The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional pulse oximeter, electronic thermometer and printer has been updated to include an additional Nellcor pulse oximeter option which uses the same technology as existing legally marketed devices. The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter.

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), 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BCI MiniTorr Plus NIBP monitor (model 6004) with the new Nellcor pulse oximetry option, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific thresholds for accuracy or precision. Instead, it relies on demonstrating equivalence to legally marketed predicate devices. The performance data focuses on establishing that the new device performs "the same" as or "as well as" the predicate devices for each measured parameter.

Parameter/Component	Acceptance Criteria (Implied)	Reported Device Performance
NIBP Monitor	Performance is the same as the predicate BCI 6004 NIBP monitor.	Comparison testing showed performance of NIBP parameters (systolic, diastolic, mean arterial pressures, NIBP heart rate) are the same as the predicate BCI 6004.
Electronic Thermometry	Performance is the same as the predicate BCI 6004 NIBP monitor.	Comparison testing showed performance of electronic thermometry parameters (oral, rectal temperature) are the same as the predicate BCI 6004.
Nellcor Pulse Oximetry	Performance is the same as the predicate Nellcor N-595 Pulse Oximeter.	Comparison testing showed performance of SpO2 measurements are the same as the predicate Nellcor N-595.
Overall Software Validation	Device modifications operate as intended and do not compromise overall monitor performance.	A full software validation test was completed, demonstrating that modifications operate as intended and do not compromise performance.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2: 2001.	EMC testing demonstrated compliance with IEC 60601-1-2: 2001.
Nellcor MP506 Pulse Oximetry Board	Performs to its specifications.	Bench-top performance testing by Nellcor using proprietary simulators showed the MP506 board performs to its specifications when contained in the BCI 6004.

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

The document does not explicitly state the sample sizes used for the comparison testing (e.g., number of patients/measurements). It mentions "Comparison testing" was done for both the NIBP/thermometry and SpO2 components.

Sample Size: Not specified for any of the comparison tests.
Data Provenance: Not explicitly stated, but the nature of comparison testing suggests controlled, possibly internal, studies rather than broad multi-country clinical trials. The bench-top testing was done by Nellcor using their proprietary simulators. Whether the comparison tests involved human subjects or entirely bench testing is not clear from the text. The term "patient's" is used in the intended use, implying human subject testing would be relevant for performance claims.

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 studies described are comparison tests against predicate devices or bench-top tests against proprietary simulators and specifications, not studies establishing a new ground truth based on expert review of data from the device itself.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the comparison and bench testing, an adjudication method in the context of expert review (like 2+1 or 3+1) is unlikely to have been applied as the ground truth was either a predicate device's output or a simulator's defined output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study was not conducted. This device is a monitoring device, not an AI diagnostic tool requiring human interpretation. The study focuses on the device's measurement accuracy and equivalence to predicate devices, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance evaluation was done through:

Comparison testing: The new device was directly compared against predicate devices (BCI 6004 NIBP monitor for NIBP/temperature; Nellcor N-595 for SpO2) to show equivalent performance. This implies the new device's readings were compared directly to the predicate's readings without human intervention influencing the measurement itself.
Bench-top performance testing by Nellcor: This involved using "proprietary simulators" to ensure the Nellcor MP506 pulse oximetry board performed to its specifications, which is a standalone assessment.
Software validation test: This confirmed the modifications operated as intended, an intrinsic evaluation of the device's internal workings.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was:

Predicate Device Performance: For NIBP, heart rate, and temperature, the predicate BCI 6004 NIBP monitor was used as the reference. For SpO2, the predicate Nellcor N-595 Pulse Oximeter was used as the reference.
Manufacturer Specifications/Simulator Output: For the Nellcor MP506 pulse oximetry board, Nellcor's "proprietary simulators" and their associated "specifications" served as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an updated version of an existing monitor with an added module. There is no mention of machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality relies on established physiological measurement principles and validated software, not on trained algorithms.

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

This information is not applicable as there is no training set involved in the development or validation of this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text 'K031742' written in a handwritten style, angled diagonally from the bottom left to the upper right. To the right of this text is a logo that includes a circular graphic with vertical lines, followed by the letters 'BCI' in a bold, sans-serif font. The logo appears to be a company or brand identifier.

AUG 1 8 2003

Summary of Safety and Effectiveness

Submitter:	BCI, Inc.
Address:	N7 W22025 Johnson Road Waukesha, WI 53186
Telephone:	(262) 542-3100
Contact:	VP Regulatory Affairs
Prepared:	May 16, 2003
Proprietary Name:	BCI® MiniTorr Plus® NIBP monitor (model 6004) with new Nellcor pulse oximetry option.
Common/Classification Name:	Non-invasive blood pressure monitor/pulse oximeter
Predicate Devices:	BCI® 6004 NIBP monitor (K984618, K983796, K970801)
	Nellcor® Oximax N-550 Pulse Oximeter (K021090)
	Nellcor® N-595 Pulse Oximeter (K012891)

New Device Description:

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

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 6004 NIBP monitor is a low cost 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, optional oral/rectal temperature, and/or integral printer. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO2 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.

Performance Data:

The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that the BCI 6004 monitor would perform within the environment(s) for which it is to be marketed. Testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices. Electromagnetic compatibility testing to IEC 60601-1-2: 2001 has been completed and demonstrated that the BCI 6004 monitor was in compliance.

Comparison testing of the new 6004 with Nellcor pulse oximetry option and the predicate 6004 was done to show that the performance of the NIBP and electronic thermometry parameters of the two devices are the same (systolic, and mean arterial pressures, NIBP heart rate, oral and rectal temperature). Comparison testing of the new 6004 with Nellcor pulse oximetry option and the Nellcor® N-595 Pulse Oximeter (K012891) was done to show that the performance of the SpO2 measurements made by the two devices is the same.

Bench-top performance testing of the BCI 6004 NIBP monitor were performed by Nellcor using their proprietary simulators. They show that their MP506 pulse oximetry board when contained in the BCI 6004 monitor performs to its specifications.

A full software validation test of the BCI 6004 NIBP monitor with new Nellcor pulse oximetry option was completed. These tests showed that the device modifications operate as

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle made of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font. There is a small dot to the right of the letter "I". The logo is black and white.

intended and that the changes made do not compromise the overall performance of the monitor.

The testing described above indicate that there is no functional difference between the operation of the new 6004 NIBP monitor with Nellcor pulse oximetry option and the original 6004 NIBP monitor or Nellcor N-595 Pulse Oximeter. 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 D. Alyward

Donald Alexander VP Regulatory Affairs

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The bird is facing towards the right. Encircling the bird symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged along the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2003

Mr. Donald Alexander Vice President of Regulatory Affairs BCI, Incorporated N7 W22025 Johnson Road Waukesha, Wisconsin 53186-1856

Re: K031742

Trade/Device Name: BCI 6004 NIBP Monitor with Nellcor Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II (Two) Product Code: DQA, DXN Dated: May 23, 2003 Received: June 4, 2003

Dear Mr. Alexander:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

{4}------------------------------------------------

Page 2 - Mr. Alexander

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Susan Russoni

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications For Use

510(k) Number (if known): KO31742

Device Name: BCI 6004 NIBP Monitor with Nellcor Pulse Oximeter.

Indications For Use:

Intended Use

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K031242
----------------	---------

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

UUUU 7

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).