(75 days)
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.
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.
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.
§ 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).