BK190322 Summary
BK190322-Summary OrSense 510(k)
510(K) SUMMARY NBM-200 PULSE OXIMETER AND HEMOGLOBIN MONITOR
510(k) Number BK190322
Submitter's Name: OrSense Ltd. 17 Ha'Mefalsim St., Kiryat Arie, Petah Tikva, 49514 Israel Tel. + 972-3-7404900 Fax. +972-3-7404909 E-mail: Aharon.weinstein@orsense.com
Contact Persons:
Kristin Davenport Covington & Burling LLP One CityCenter 850 Tenth Street, NW Washington, DC 20001-4956 Tel. 202-662-5286 Fax: 202-778-5286 E-mail: Kdavenport@cov.com
Aharon Weinstein VP Research OrSense Ltd. 17 ha'Mefalsim St. Petah Tikva, 49514 ISRAEL Tel. +972-3-7404900 Fax. +972-3-7404909 Email: Aharon.weinstein@orsense.com
Date Prepared:
February 11, 2019
Trade Name:
NBM-200 Pulse Oximeter and Hemoglobin Monitor
Device Common Name: Pulse Oximeter
Regulation Number:
21 CFR § 864.7500
Regulation Name:
Whole blood hemoglobin assays
Product Code:
QGU
Predicate Device: HemoCue Hb 301 system (BK060048) manufactured by HemoCue Inc.
Page 5-1
OrSense 510(k)
Device Description:
The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate. These parameters can be displayed periodically for patient monitoring.
The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result. The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.
Intended Use / Indication for Use:
The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring.
The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (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 non-critical clinical and non-clinical settings, e.g., non-critical settings in hospitals, hospital-type facilities, blood donation settings, mobile environments, clinics, physician offices and ambulatory surgery centers. In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units.
Page 5-2
OrSense 510(k)
Technological Characteristics The NBM-200 includes a portable monitor and a cable-connected finger sensor with inflatable cuffs employing pneumatic tissue manipulation and an optical measuring system. The sensor consists of a multi-wavelength light source, a photodetector and a radial finger cuff for temporarily controlled tissue pressure. The measurement process is based on successive occlusion and release cycles and on the occlusion spectroscopy algorithm for the calculation of blood parameters.
Test Data The NBM-200 device has been subjected to extensive testing before its release to ensure that it complies with the desired specifications and safety and performance standards. The tests included testing of its electrical functionality and safety, EMC, software and functionality under various environmental conditions. Additional testing ensured that the device meets its performance specifications for oximetry (SpO2 and pulse rate) measurements with an adequate safety profile.
Page 5-3
OrSense 510(k)
Clinical Data
A clinical study was performed in order to validate the performance of OrSense's NBM-200 Pulse Oximeter and Hemoglobin Monitor device in a blood donation environment.
The study evaluated healthy volunteers who were active donors or candidates for donation of blood or aphaeresis products, and compared hemoglobin (Hb) values obtained by 3 methods: The NBM-200 system; HemoCue Hb 301 device based on finger sticks with capillary blood that is FDA-cleared (BK060048) for use in blood banks; and Sysmex XE-2100 laboratory blood analyzer using venous blood samples that is cleared by FDA (K992875). The NBM-200 was used in Hb parameter mode for the performance testing.
Data from 355 subjects at 3 sites were available for the comparison analyses required, 134 females and 221 males. Hemoglobin values ranged between 8.5 and 17.1g/dL. The precision study included 14 donors in the repeatability part and 18 in the reproducibility part. In addition to the accuracy evaluation, the comparison study compared the anemia detection by the NBM and HemoCue against the lab determination. Subjects are deferred from donating blood if anemic, with anemia defined as a hemoglobin level less than 12.5 g/dL for females or less than 13 g/dL for males.
Main results:
· The overall accuracy of the NBM-200 is -0.029g/dL ± 0.99g/dL and the overall relative accuracy is -0.0478% ± 7.59%.
· The overall accuracy of the HemoCue is 0.481g/dL ± 0.631g/dL and the relative accuracy is 3.46% ± 4.62%.
· NBM device has a higher repeatability with a smaller CV than that of the HemoCue (2.2% vs. 4.6%).
· NBM between device, operator and finger reproducibility CVs for each subject are all less than 3.66%
· The deferral rate by the lab method is 28.45%, by the NBM is 27.89% and by the HemoCue is 21.13%. However, among the 99 subjects deferred by NBM, 28 were Page 5-4
OrSense 510(k)
eligible donors by the lab method and among the 75 subjects deferred by HemoCue, only 6 were eligible by the lab method.
· Sensitivity of the NBM-200 in anemia detection, compared against the diagnosis of the lab, is 70.3% while that of HemoCue is 68.32%.
· Specificity of the NBM-200 in anemia detection, compared against the diagnosis of the lab, is 88.98% versus that of HemoCue which is 97.64%.
· No adverse events or subject discontinuation were reported during the study.
Table 1 shows a comparison of the sensitivity of the NBM-200 and HemoCue in the detection of anemic subjects (diagnosed by lab) for males, females and overall. A "positive" anemia result is defined as detection of anemia and deferral from blood donation, while a "negative result" means no anemia and eligibility for donation.
Table 1: Sensitivity (anemia detected by Lab)
Males (n=39)
NBM-200
Positive Negative
Total
Positive 18 5 23
HemoCue Negative 5 11 16
Total 23 16 39
Females (n=62)
NBM-200
Positive Negative
Total
Positive 39 7 46
HemoCue Negative 9 7 16
Total 48 14 62
Overall (n=101)
NBM-200
Positive Negative
Total
Positive 57 12 69
HemoCue Negative 14 18 32
Page 5-5
Total 71 30 101
OrSense 510(k)
Table 2 shows a comparison of the specificity of the NBM-200 and HemoCue in the detection of non-anemic subjects for males, females and overall.
Table 2: Specificity (anemia not detected by Lab)
Males (n=182)
NBM-200
Positive Negative
Total
Positive 0 5 5
HemoCue Negative 12 165 177
Total 12 170 182
Females (n=72)
NBM-200
Positive Negative
Total
Positive 0 1 1
HemoCue Negative 16 55 71
Total 16 56 72
Overall (n=254)
NBM-200
Positive Negative
Total
Positive 0 6 6
HemoCue Negative 28 220 248
Total 28 226 254
Page 5-6
OrSense 510(k)
Table 3 shows a comparison of the detection of subjects as deferred or eligible for donation by the NBM-200 and HemoCue in the repeatability study.
Table 3: Deferrals (anemia detection) in the repeatability study
NBM200
HemoCue301
Gender
# of replicates Mean Hb [g/dL] Eligible Deferred # of replicates* Mean Hb [g/dL] Eligible Deferred
Female
6
14.15
6
0
6
14.92
6
0
Male
6
14.57
6
0
6
14.93
6
0
Female
6
9.60
0
6
6
10.37
0
6
Female
6
12.58
5
1
6
12.55
3
3
Female
6
12.62
5
1
6
14.10
6
0
Male
6
14.12
6
0
6
16.27
6
0
Male
6
14.23
6
0
6
13.87
6
0
Male
6
12.97
3
3
6
14.03
6
0
Female
6
13.57
6
0
6
12.28
2
4
Female
6
12.53
3
3
6
13.25
6
0
Female
6
12.60
3
3
6
11.95
1
5
Female
6
12.72
5
1
6
12.60
4
2
Male
6
14.47
6
0
6
13.77
5
1
Female
6
13.88
6
0
6
13.08
6
0
*conducted with separate finger-prick for each test/replicate
Page 5-7
OrSense 510(k)
Table 4 shows the NBM-200's detection of subjects as deferred or eligible for donation in the reproducibility study.
Table 4: Deferrals (anemia detection) in the reproducibility study
NBM200 Gender Site
# of replicates Mean Hb [g/dL] Eligible Deferred
Female Site 1
16
12.91
15
1
Female Site 1
15
13.75
15
0
Male Site 1
16
13.85
16
0
Female Site 1
16
12.98
16
0
Male Site 1
16
15.25
16
0
Female Site 1
15
11.99
0
15
Male Site 1
16
12.84
9
7
Male Site 1
16
14.43
16
0
Female Site 2
11
13.91
11
0
Male Site 2
10
15.41
10
0
Female Site 2
12
12.75
9
3
Female Site 2
11
13.26
11
0
Female Site 2
15
13.11
15
0
Male Site 2
16
14.00
16
0
Male Site 2
13
15.29
13
0
Male Site 2
16
13.91
16
0
Female Site 2
16
13.24
16
0
Female Site 2
16
14.38
16
0
The following clinical data were relied upon for the previous NBM-200 clearance (K142209), and previously submitted to FDA in K091564 and K124041.
1. Study for assessment of Oximetry accuracy as submitted for K091564. 2. Studies for assessment of hemoglobin accuracy and precision as submitted for
K124041.
Page 5-8
OrSense 510(k)
Substantial Equivalence The proposed NBM-200 has the same intended use as the predicate HemoCue Hb 301, i.e., providing hemoglobin values, including in blood donation settings. In both the NBM-200 and the predicate Hb 301 the measurement of hemoglobin is based on spectroscopy, i.e., transmission of light through the blood and detection of attenuated intensity. The NBM-200 and the predicate Hb 301 rely on different technologies to isolate the effect of blood from other tissue components: the NBM manipulates the blood volume via occlusion, while the HemoCue device uses blood extracted into a cuvette. The proposed NBM-200 is technologically identical to the reference NBM-200 cleared by CDRH (K142209), except for minor software updates. Due to the differences in technological characteristics between the proposed NBM-200 and the predicate Hb 301, OrSense provided clinical data to compare the devices' performance. The data show that the different technological characteristics do not raise different questions of safety or effectiveness, and that the proposed NBM-200 is at least as safe and effective as the predicate Hb301. As a result, the NBM-200 Pulse Oximeter and Hemoglobin Monitor device is substantially equivalent to the 510(k)-cleared HemoCue Hb 301 system (BK060048) manufactured by HemoCue Inc.
Page 5-9