Pulse oximeter NBM-200

K142209 · Orsense, Ltd. · DQA · Jan 16, 2015 · Cardiovascular

Device Facts

• Record ID: K142209
• Device Name: Pulse oximeter NBM-200
• Applicant: Orsense, Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications 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, 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.

Device Story

Portable monitor for non-invasive spot-checking of hemoglobin, hematocrit, SpO2, and pulse rate; utilizes occlusion spectroscopy technology. System includes reusable ring-shaped finger sensor probe with multi-wavelength optical system and inflatable pneumatic cuff. Cuff briefly occludes finger blood flow; device analyzes resulting optical behavior changes to calculate blood parameters. Operated by trained medical personnel in non-critical settings (clinics, physician offices, ambulatory surgery centers). Output displayed on monitor screen for clinician review; assists in patient assessment. No alarms included. Benefits include non-invasive, periodic monitoring without continuous clinical oversight.

Clinical Evidence

No clinical data generated for the modified device. Bench performance testing (simulator testing) conducted to verify accuracy specifications for SpO2 and pulse rate. Safety, environmental, and biocompatibility testing performed per IEC 62304 and IEC 60601 standards.

Technological Characteristics

Portable desktop monitor with reusable ring-shaped finger sensor. Employs occlusion spectroscopy via multi-wavelength optical system and pneumatic tissue manipulation. Connectivity: optional rechargeable battery. Software: IEC 62304 compliant. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult patients in non-critical clinical and non-clinical settings for non-invasive spot-checking and periodic monitoring of hemoglobin, estimated hematocrit (for normal Hb values 11-17 g/dl), SpO2, and pulse rate.

Regulatory Classification

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.

Predicate Devices

• NBM 200MP Pulse Oximeter and Hemoglobin Monitor (K124041)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

OrSense Ltd. c/o Mr. Mark Heller Consultant Goodwin Procter LLP 901 New York Avenue. N.W. Washington, D.C. 20001

Re: K142209

Trade/Device Name: NBM-200 Pulse Oximeter and Hemoglobin Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, GLY Dated: December 17, 2014 Received: December 18, 2014

Dear Mr. Heller:

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. 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. Heller

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The text is black and appears to be the name of a person with their medical degree. The font is a decorative script, giving the name a formal and elegant appearance. The background is plain and white.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OrSense 510(k)

#### INDICATIONS FOR USE

510(k) Number (if known): K142209

NBM-200 Pulse Oximetry and Hemoglobin Monitor device Device Name:

#### Indications 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, 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.

Prescription Use V OR Over-The-Counter Use (Per 21 C.F.R. 801 Subpart D) C)

(Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(K) SUMMARY

# NBM-200 PULSE OXIMETRY DEVICE

510(k) Number K142209_

| Applicant's Name: | OrSense Ltd. |
|-------------------|------------------------------|
| | 17 Ha'Mefalsim St., |
| | Kiryat Arie, |
| | Petah Tikva, 49514 |
| | Israel 4900302 |
| Tel. | [phone] |
| Fax. | [phone] |
| E-mail: | [e-mail] |

| Contact Person: | Mark A. Heller<br>Kristin Davenport<br>Goodwin Procter LLP<br>901 New York Avenue, N.W.<br>Washington D.C. 20001<br>USA<br>Tel. [phone]<br>Fax. [phone]<br>e-mail: [e-mail] or<br>[e-mail] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

- Date Prepared: August 7, 2014
Trade Name: NBM-200 Pulse Oximeter and Hemoglobin Monitor

Device Common or Usual Names: Pulse Oximeter

Classification Name: Oximeter

| Classification: | 21 CFR § 870.2700 (Product Code DQA) |
|-----------------|--------------------------------------|
| | 21 CFR § 864.7500 (Product code GLY) |

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## Predicate Device:

The NBM-200 Pulse Oximeter and Hemoglobin Monitor device is substantially equivalent to the FDA cleared NBM 200MP Pulse Oximeter and Hemoglobin Monitor (K124041) manufactured by OrSense Ltd.

## 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.

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 hospital-type facilities, 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.

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## Technological Characteristics

The NBM-200 is a portable, non-invasive, Hemoglobin and oximetry monitor for spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate. These parameters can be displayed periodically for patient monitoring.

The device is a modification to the cleared NBM-200MP device (K124041). The modified device has the same intended use as the predicate, with the new device's use being limited to non-critical settings, and the two devices use the same technology, main board, finger sensor and algorithm for the calculation of blood parameters. Like the predicate device, the NBM-200 non-invasively spot checks and displays Hemoglobin (Hb) and estimated Hematocrit (Hct) values. The modified device does not measure the NBM-200MP's temporary occluded blood oxygen saturation (SoO2) and plethysmogram waveform. The NBM-200 includes a spot SpO2 and pulse rate measurement, with an optional periodic monitoring function, instead of continuous monitoring of these parameters. The new device's indication and labeling limit use of the device to non-critical care settings. The NBM-200 does not incorporate any alarms, reflecting the device's use in non-critical care environments. The new device has different dimensional specifications of the monitor and display screen, and includes an optional rechargeable battery. The patient/user interface was modified, and software changes were made to accommodate the user interface changes (the algorithm, including the calculation for the parameters, did not change).

#### Test Data:

The NBM-200 device has been subjected to extensive validation, safety and performance testing before release to ensure that it complies with industry and safety standards. Final testing of the NBM-200 device included safety, environmental and biocompatibility testing according to international industry standards (IEC 62304 and IEC 60601 parts 1 and 1-2), and software validation tests that were designed to ensure that the device meets all its functional specifications.

Bench performance tests were conducted (simulator testing) to ensure that the device meets its accuracy specifications for oximetry (SpO2 and pulse rate).

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The NBM-200 sensor probe is identical to that of the NBM-200MP device and its safety was extensively tested in the context of the NBM-200MP submission to FDA.

# Clinical Data:

Clinical data for the predicate NBM 200-MP were submitted for the K124041 clearance and no clinical data were generated for the modified device.

# Substantial Equivalence:

The NBM-200 pulse oximeter device is substantially equivalent to the NBM 200-MP pulse oximeter and hemoglobin monitor (K124041).