The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform.

Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions.

It may be used on adult patients in the hospital or clinical environments.

The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.

The NBM-200MP is NOT intended for home use.

Device Description

OrSense NBM-200MP device is a pulse oximetry device, measuring SpO2 and Pulse Rate. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions. A pneumatic cuff placed around a finger temporarily inflates and deflates; the resulting changes in blood behavior within the occluded finger are measured and analyzed to provide accurate measurements of blood oxygen saturation during low-perfusion conditions.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the NBM-200MP Pulse Oximetry device, focusing on its accuracy for blood oxygen saturation (SpO2) and temporary occluded arterial blood oxygen saturation (SoO2).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for pulse oximeters are typically defined by regulatory standards, such as ISO9919:(2005), which specifies accuracy requirements. While the document states that the study was performed in compliance with ISO9919:(2005), it doesn't explicitly list the numerical acceptance criteria from the standard. However, it does provide the measured performance in terms of Root Mean Square (RMS) accuracy, correlation, and bias.

Parameter	Acceptance Criteria (from ISO9919:2005 implied)	Reported Device Performance (NBM-200MP)
SpO2 Accuracy (RMS) - Pulse Mode	(Implied by compliance with ISO9919:2005)	2.5%
SpO2 Correlation - Pulse Mode	(Implied by compliance with ISO9919:2005)	0.95
SpO2 Bias - Pulse Mode	(Implied by compliance with ISO9919:2005)	0.2%
SoO2 Accuracy (RMS) - Occlusion Mode	(Implied by compliance with ISO9919:2005)	2.2%
SoO2 Correlation - Occlusion Mode	(Implied by compliance with ISO9919:2005)	0.96
SoO2 Bias - Occlusion Mode	(Implied by compliance with ISO9919:2005)	0.05%
Safety (Adverse Events)	No device-related adverse events	No adverse events reported
Skin integrity (cuff mechanism)	No marks, significant differences in color/shape	No marks, or any significant differences

Study Proving Device Meets Acceptance Criteria:

The document describes two clinical studies:

Hypoxia Study: This study validated SpO2 and SoO2 accuracy against a reference co-oximeter.
Safety Study: This study evaluated the safety of the inflation/deflation mechanism in an Intensive Care Unit (ICU) environment.

2. Sample Size and Data Provenance for the Test Set

Hypoxia Study (Accuracy Validation):
- Sample Size: 10 healthy individuals.
- Data Points: 388 pairs of data points for pulse mode, 438 data pairs for occlusion mode.
- Data Provenance: Not explicitly stated, but the study was performed to validate accuracy, implying it served as the primary test set for performance. The use of "consenting healthy individuals" suggests a prospective controlled study. Country of origin is not specified.
Safety Study (Cuff Mechanism):
- Sample Size: 32 patients.
- Data Provenance: Conducted in an Intensive Care Unit (ICU) environment. The patient profiles (pneumonia, pancreatitis, GI Bleeding, etc.) indicate a prospective clinical observation in a hospital setting. Country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Hypoxia Study: The "reference measurements of blood SaO2 by a cooximeter" are considered the ground truth. A co-oximeter is a laboratory device, and its operation and results are typically interpreted by trained medical laboratory professionals, but the exact number and qualifications of experts interpreting the co-oximeter data are not specified in the document.
Safety Study: The ground truth for safety was established by "investigators observ[ing] the fingers" for changes. The number and specific qualifications of these investigators are not specified, beyond being based in an ICU environment, implying medical professionals.

4. Adjudication Method for the Test Set

Hypoxia Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the co-oximeter readings or the comparison. The co-oximeter is likely considered the gold standard, so its readings would be directly used.
Safety Study: The investigators "observed the fingers." The method for ensuring consistent evaluation among multiple observers (if there were more than one) or an explicit adjudication process is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance was reported. This device is a measurement device (a pulse oximeter) rather than an image interpretation or diagnostic aid that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done for the NBM-200MP device. The reported accuracy, correlation, and bias for both pulse mode and occlusion mode (SpO2 and SoO2) represent the algorithm's performance independent of human intervention in the measurement process, aside from initial sensor placement.

7. Type of Ground Truth Used

Hypoxia Study: The ground truth for SpO2 and SoO2 accuracy was established using reference measurements of blood SaO2 by a co-oximeter. This is considered a highly accurate, objective, and quantitative physiological measurement.
Safety Study: The ground truth for safety was based on clinical observation of patient outcomes (skin integrity) by investigators.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As this is a 510(k) submission for a non-AI device relying primarily on established physiological principles and signal processing, the concept of a "training set" in the machine learning sense might not be explicitly relevant or documented in the same way. The device's algorithms were likely developed and validated using engineering principles, bench testing, and pilot studies, but specific "training set" sizes are not mentioned.

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

Since no specific "training set" is mentioned in the context of machine learning, the method for establishing its ground truth is not provided. Device development typically involves a variety of engineering and pre-clinical testing, where ground truth would be established through calibrated instruments, known physiological models, or expert evaluation to refine the device's algorithms and hardware before formal clinical validation.

Summary

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MAR 1 9 2010

510(K) SUMMARY

NBM-200MP PULSE OXIMETRY DEVICE

510(k) Number K (09/56 Y

OrSense Ltd. Applicant's Name: 5 Golda Meir St. Weizmann Science Park Nes Ziona Israel 70400 Tel: +972-8-9465142 Fax: +972-8-9465502 Email: orsense@orsense.com

Ahava Stein/ Ofer Hornick Contact Person: A. Stein - Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 e-mail: ahava@asteinrac.com or ofer@asteinrac.com

March 2010 Date Prepared:

NBM-200MP pulse oximeter Trade Name:

Device Common or Usual Names: Pulse Oximeter

Classification Name: CFR Classification section 870.2700 (Product code DQA)

Classification: Class II medical Device

The NBM-200MP Pulse Oximeter device is substantially Predicate Device: equivalent to a combination of the following predicate devices:

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SET Rad-8 Pulse Oximeter (K053269) manufactured by Masimo corp. SET Rad-8 is a pulse oximeter device, similar to the NBM-200MP pulse oximeter device.
CRIT-SCAN (K910077) manufactured by In-Line Diagnostics. CRIT-SCAN is a non-invasive hematocrit measuring device, using a pneumatic cuff technology for periodic inflation and deflation around a finger. Similarly, the NBM-200MP pulse oximeter device is also using a pneumatic cuff technology for temporary inflation and deflation around a finger.
BMEYE NEXFIN HD (K072049) manufactured by BMEYE B.V. (The Netherlands). BMEYE NEXFIN_HD is a non-invasive monitor that enables the continuous assessment of a patient's cardiovascular function and blood pressure, using a pneumatic cuff technology which exerts continuously changing external pressure around a finger. Similarly, the NBM-200MP pulse oximeter device is also using a pneumatic cuff technology for temporary inflation and deflation around a finger.
OrSense NBM-200MP device is a pulse oximetry device, Device Description: measuring SpO2 and Pulse Rate. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions. A pneumatic cuff placed around a finger temporarily inflates and deflates; the resulting changes in blood behavior within the occluded finger are measured and analyzed to provide accurate measurements of blood oxygen saturation during low-perfusion conditions.

Intended Use / Indication for Use:

The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and

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continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform.

Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions. It may be used on adult patients in the hospital or clinical environments.

The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.

The NBM-200MP is NOT intended for home use.

ContraIndications:

Patients with significant deformity, swelling, irritation, . degenerative changes or edema of the fingers or hand

Patients with localized infection, ulceration or skin . lesions involving the fingers
Placing the sensor on a finger that has restricted blood . flow e.g. tourniquet or pressure cuff

Performance Standards:

This 510(k) submission was written in accordance with the FDA's "Draft Guidance for Industry and FDA Staff- Pulse Oximeters-Premarket Notification Submissions [510(k)s], 19 July 2007. The design of the NBM-200MP device conforms to the following voluntary standards:

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ISO9919:(2005) Standard: Medical Electrical Equipment- Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use
IEC/EN-60601-1: Medical Electrical Equipment; Part 1: . General Requirements for Safety. Second edition (1990), including amendments #1(1993), #2(1995) and #13(1996).
IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: Collateral Standard: Electromagnetic Compatibility-Requirements and Tests (2001)

The NBM-200MP device has been subjected to extensive safety, performance testing, and validation before device release. Final testing of the NBM-200MP device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards. Tests included Biocompatibility, Bench Performance testing (Simulator testing), Safety testing, Environmental testing, and Clinical Testing.

The safety of the cuff inflation/deflation mechanism, with regard to potential skin ischemia under low blood pressure conditions, was analyzed by comparison of the device duty cycle to a predicate device, by compliance with the relevant sections of a standard for automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30 (1999) standard), and by clinical testing as reported below.

All tests passed and demonstrated substantial equivalence with predicates and compliance with the relevant standards.

Test Data:

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Clinical Data Summary:

The following clinical data was submitted:

A clinical study of induced hypoxia in consenting healthy individuals was performed to validate SpO2 and SoO2 accuracy in comparison to reference measurements of blood SaO2 by a cooximeter. The study was performed in compliance with the requirements of ISO9919:(2005) Standard. The device was tested on 10 healthy individuals.

Results: In the NBM-200MP pulse mode, based on 388 pairs of data points, the accuracy (rms) obtained was 2.5%, with 0.95 correlation and 0.2% bias.

In the occlusion mode there were 438 data pairs, with 2.2% error, 0.96 correlation and 0.05% bias.

No adverse events were reported.

To evaluate the safety of the inflation/deflation mechanism, the device was clinically tested in an Intensive Care Unit environment. The device was tested on 32 patients in a general ICU (including patients with pneumonia, pancreatitis, GI Bleeding, cervical trauma, diabetes, sepsis and septic shock, post surgery, with cancer, receiving blood transfusion, respiratory failure, liver failure, and arrhythmias). The OrSense device was attached to patients and operated in continuous cyclic occlusion mode for varying durations, from 3 to 24 hours. The tested patients included patients receiving high Noradrenalin doses, low oxygenation states, and low blood pressures. The range of blood pressure ranged from severe hypotension to hypertension.

The investigators observed the fingers (on which cuffs were placed and inflated/deflated during monitoring) for any changes

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Results: No device-related adverse events were reported. There were no reports of marks, or any significant differences in color/shape, on the fingers. This, even in those patients with markedly reduced perfusion states, and after the longest durations of operation.

Substantial Equivalence:

The NBM-200MP pulse oximeter device is similar to currently distributed pulse oximeter devices intended for measurement and monitoring of SpO2 and Pulse Rate.

Conclusions:

The conclusions drawn from the above Performance Testing and comparison to predicate devices is that the NBM-200MP pulse oximetry device is substantially equivalent in safety and efficacy to the predicate devices listed above.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Ahava Stein Regulatory Affairs Consulting OrSense Limited 20 Hata'as Street Kfar Saba Israel 44425

MAR 1 9 2010

Re: K091564

Trade/Device Name: NBM-200MP Pulse Oximetry Device Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 7, 2010 Received: March 11, 2010

Dear Mr. Stein:

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 mav, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Mr. Stein

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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm 1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NBM-200MP Pulse Oximetry device :

Indications for Use:

Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions.

It may be used on adult patients in the hospital or clinical environments.

The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.

The NBM-200MP is NOT intended for home use.

Prescription Use (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Arhalik

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

510(k) Number: K091564

Page 4-2

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).