FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The NBM-200MP is a portable Hemoglobin and oximetry monitor. It non-invasively monitors and displays Hemoglobin (Hb), estimated Hematocrit (Hct), functional saturation of arterial oxygen hemoglobin (SpO2), temporary occluded blood oxygen saturation (SoO2), pulse rate (PR) and plethysmogram waveform.

For oximetry (SpO2/SoO2), the NBM-200MP permits continuous patient monitoring with adjustable alarm limits, as well as visible and audible alarm signals. SoO2 is intended for use in low perfusion conditions and under any conditions that will cause poor signal quality.

The NBM-200MP periodically displays Hemoglobin (Hb) and estimated Hematocrit (Hct) values and it can also be used for spot measurements. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (i.e. 11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in clinical and non-clinical settings (e.g. hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers).

Device Description

OrSense NBM-200MP device is a pulse oximetry and hemoglobin monitoring device, measuring SpO2, pulse rate, hemoglobin and estimated Hematocrit. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions for oximetry (SoO2) and for Hb measurements. The sensor probe pneumatic cuff is placed around a finger and briefly inflates and deflates; the resulting changes in blood optical behavior within the finger are measured and analyzed to provide accurate measurements of SoO2 during low-perfusion conditions and Hemoglobin values at predetermined time intervals. The monitor should not be used under any circumstances as a substitute for an approved lab blood analyzer.

AI/ML Overview

This document describes the NBM-200MP Pulse Oximetry and Hemoglobin Monitor. Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Hemoglobin (Hb) Accuracy	The device aims to provide accurate Hb measurements over a range of 7 to 17 g/dl (derived from the collected range of 6.5 to 17.1 g/dl). While explicit acceptance criteria (e.g., specific bias or SD thresholds) are not stated, the overall goal is "accuracy" and "substantial equivalence" to predicate devices. The "Draft Guidance for Industry and FDA Staff- Pulse Oximeters-Premarket Notification Submissions [510(k)s], 19 July 2007" likely informs these criteria for similar devices. Implied (from common regulatory expectations for medical devices):

Low bias (mean difference)
Small standard deviation of the difference
Acceptable Root Mean Square Error (RMSE)
Narrow 95% Limits of Agreement (LoA) | Overall results in the Hb study:
Mean difference (bias) of -0.13 g/dl
Standard deviation of the difference: 0.96 g/dl
Root mean square error (RMSE): 0.97 g/dL
95% limits of agreement: [-2.01, 1.76 g/dl]
Reproducibility SD of the NBM is 0.5 g/dl; the CV is 4.2%.
Measurement range: The device demonstrated accuracy over the range of 6.5 to 17.1 g/dl, and the specified measurement range of the device is 7 to 17 g/dl. |
| SpO2 Accuracy (Pulse Mode) | Conformance to ISO9919:(2005) Standard for Medical Electrical Equipment-Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use.
Implied (from regulatory expectations and previous submission K091564):
Acceptable error (rms)
High correlation with reference
Low bias | Results (K091564 study):
Based on 388 pairs of data points
Error (rms) obtained was 2.5%
0.95 correlation
0.2% bias |
| SoO2 Accuracy (Occlusion Mode) | Conformance to ISO9919:(2005) Standard for Medical Electrical Equipment-Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use.
Implied (from regulatory expectations and previous submission K091564):
Acceptable error (rms)
High correlation with reference
Low bias | Results (K091564 study):
Based on 438 data pairs
Error (rms) was 2.2%
0.96 correlation
0.05% bias |
| Repeatability and Reproducibility (Hb) | Implied: Low variability (SD and CV) to ensure consistent measurements over time and across different operators/devices. | Reproducibility SD of the NBM is 0.5 g/dl; the CV is 4.2%. |
| Safety (Cuff inflation/deflation) | Compliance with IEC 60601-2-30 (1999) standard for automatic non-invasive blood pressure monitoring equipment and demonstration of safe device duty cycle.
Implied: No adverse events related to cuff use. | Analyzed by comparison of device duty cycle to predicate, compliance with IEC 60601-2-30, and clinical testing.
No adverse events or subject discontinuation related to the use of the NBM-200MP were reported during the multi-center studies (which included cuff use). |
| General Safety and Performance Standards | Compliance with:
ISO9919:(2005)
IEC/EN-60601-1 (1990 + amendments)
IEC/EN 60601-1-2 (2001)
IEC/EN 32604:2006 (Software)
ISO14971:2007 (Risk Management)
Extensive safety, performance testing, and validation.
Implied: Device meets all functional specifications. | All tests passed and demonstrated substantial equivalence with predicates and compliance with the relevant standards.
Final testing included various performance tests and software validation tests, Biocompatibility, Bench Performance Testing (Simulator testing), Safety testing, Environmental testing, and Clinical testing. |
| Adverse Events | Implied: No significant adverse events related to the device. | No adverse events or subject discontinuation related to the use of the NBM-200MP were reported during the multi-center studies for Hb.
No adverse events were reported for the oximetry study. |

Study Information

The document describes clinical studies supporting the NBM-200MP device, particularly for Hemoglobin (Hb) accuracy and reproducibility, and refers to a previous submission (K091564) for SpO2/SoO2 accuracy.

Sample Size Used for the Test Set and Data Provenance:
- Hb Accuracy Studies (NBM-200MP):
  - Total Subjects: 359 (Site 1) + 212 (Site 2) + 100 (Site 3) = 671 subjects
  - Provenance: Retrospective comparison to routine Hb measurements. The studies were conducted at three sites in Israel (Assaf Harofeh Medical Center, Rabin Medical Center, Chaim Sheba Medical Center).
- Hb Reproducibility Study:
  - Total Subjects: 33 subjects
  - Provenance: Retrospective data from Site 3 (Sheba MC) in Israel.
- Hb Continuous Trending / Hemodilution Study:
  - Total Subjects: 27 volunteers for variability; 12 of these for hemodilution.
  - Provenance: Supplemental study performed at one site in the U.S. (Zabloki Veterans Affairs Medical Center).
- SpO2 and SoO2 Accuracy Studies (K091564 submission):
  - Total Subjects: 10 healthy individuals.
  - Provenance: Clinical study of induced hypoxia. Country of origin not explicitly stated in this document for the K091564 study, but given the company is Israeli, it's likely Israel or a comparable medical research environment.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The ground truth for Hb measurements was established using automated blood analyzers (Coulter LH750 or Radiometer OSM3). These are laboratory instruments, not human experts. Therefore, the concept of "number of experts" is not directly applicable here.
- The ground truth for SpO2 and SoO2 was established by reference measurements of blood SaO2 by a cooximeter. Again, this is an instrument, not human experts.
Adjudication Method for the Test Set:
- The document does not describe any human expert adjudication process for the clinical study results. The ground truth was based on objective laboratory measurements from automated analyzers and cooximeters.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an automated measurement tool, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the clinical studies presented for the NBM-200MP are standalone performance studies (algorithm only). The device directly measures and displays Hb, Hct, SpO2, SoO2, and pulse rate. Its performance is compared against established reference methods, not against human interpretation or with human-in-the-loop assistance for its core function.
Type of Ground Truth Used:
- Hemoglobin (Hb): Laboratory reference standard from automated blood analyzers.
  - For Israeli sites: Coulter LH750 using venous whole blood samples.
  - For U.S. site (supplemental study): Radiometer OSM3.
- SpO2 and SoO2: Reference measurements of blood SaO2 by a cooximeter (for the K091564 study).
Sample Size for the Training Set:
- The document does not explicitly state the sample size for a training set. This is common for devices using established biophysical principles and algorithms, where detailed "training set" information, as understood in machine learning, might not be separately presented in a 510(k) summary. The development and internal validation would have been performed on various datasets before the final clinical validation studies.
How the Ground Truth for the Training Set Was Established:
- As the training set size is not provided, the method for establishing its ground truth is also not described in this 510(k) summary. However, implicitly, any internal development and validation would have used similar reference standards (laboratory measurements for Hb and cooximetry for SaO2) to establish ground truth for algorithm development.

Summary

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).