NEXFIN MODEL 2

K101123 · Bmeye B.V. · DXN · Oct 28, 2010 · Cardiovascular

Device Facts

• Record ID: K101123
• Device Name: NEXFIN MODEL 2
• Applicant: Bmeye B.V.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The CC Nexfin monitor does not feature (physiological) alarms. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting

Device Story

CC Nexfin is a non-invasive hemodynamic monitor; utilizes Peňáz-Wesseling method for continuous blood pressure (systolic, diastolic, mean) and heart rate; derives cardiac output from blood pressure waveform; integrates Masimo Rainbow SET technology for SpO2 and SpHb measurement via pulse-CO oximetry sensors. Used in hospitals/clinical settings by physicians or trained personnel. Device lacks physiological alarms; output functions as spot-checks. Healthcare providers use data for hemodynamic assessment; requires calibration with thermodilution or reference cardiac output estimation for optimal accuracy. Benefits include non-invasive, continuous hemodynamic monitoring without arterial line placement.

Clinical Evidence

Clinical testing performed for NBP functionality (via Nexfin Model 1 predicate). Bench testing conducted for cardiac output functionality. Masimo performed hardware and software implementation verification testing for SpO2 and SpHb functions. No specific clinical performance metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Non-invasive hemodynamic monitor. Blood pressure/cardiac output via Peňáz-Wesseling method. SpO2/SpHb via Masimo Rainbow SET pulse-CO oximetry. Standalone monitor. No physiological alarms. Software-based processing for hemodynamic parameter derivation.

Indications for Use

Indicated for adult patients requiring non-invasive, continuous measurement of blood pressure, hemodynamic parameters, SpO2, and SpHb. Pulse-oximetry component indicated for motion/no-motion conditions and well/poorly perfused patients. Not for continuous monitoring due to lack of physiological alarms; data should be treated as spot-checks.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Nexfin Model 1 (K072049)
• Masimo Radical 7 (K080238)

Submission Summary (Full Text)

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K101/123

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## 510(k) Summary (per 21 CFR 807.92)

| Name of<br>Submitter: | BMEYE B.V.<br>Academic Medical Center, Suite K2-245<br>Meibergdreef 9. 1105 AZ Amsterdam, The Netherlands |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | OCT 28 2010<br>Mr J Grijpma<br>BMEYE BV<br>T: [phone],<br>F: [phone],<br>E: [e-mail] |
| Date Prepared: | February 26, 2009 |
| Trade Names: | Nexfin Model 2, Trade name CC Nexfin |
| Classification | Class II |
| Classification<br>Name | CFR 870.1130, System, measurement, blood pressure, non-invasive, DXN<br>CFR 870.2770, Plethysmograph, impedance, DSB<br>CFR 870.2700, Oximeter, DQA |
| Predicate: | The Nexfin Model 2 is substantially equivalent to the Nexfin Model 1 (K072049)<br>and the Masimo Radical 7 (K080238) |
| Device<br>description · | The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor that<br>enables the continuous assessment of a patient's hemodynamic function based on<br>the scientific method of Peňáz - Wesseling.<br><br>The device measures continuous non-invasive blood pressure (Systolic, Diastolic<br>and Mean) and heart rate as well as a Cardiac Output (CO), which is derived,<br>non-invasively, from the blood pressure waveform. The monitor also calculates<br>derived hemodynamic parameters. The operation of the blood pressure and<br>cardiac output measurement is identical to the operation in Nexfin Model 1<br>(K072049).<br><br>The CC Nexfin enables in addition the simultaneous measurement of SpO2 and<br>SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in<br>combination with Masimo oximetry sensors. (K090238) |
| Intended Use: | The BMEYE CC Nexfin is intended to, non-invasively and continuously,<br>measure blood pressure, hemodynamic parameters, functional saturation of<br>arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult<br>patients. The CC Nexfin monitor should be calibrated with a thermodilution<br>measurement, or other accurate reference estimation of cardiac output, to ensure<br>optimal accuracy of cardiac output. The CC Nexfin monitor does not feature<br>(physiological) alarms. The device is intended for use by physicians or other<br>properly trained medical personnel in a hospital or other appropriate clinical<br>setting |
| Technology | The device employs identical technology for blood pressure and cardiac output<br>measurement as was implemented in the predicate device (Nexfin Model 1), and<br>uses the Masimo Rainbow SET technology for the measurement of SpHb and<br>SpO2. |
| Functional/<br>Safety Testing: | The CC Nexfin has successfully undergone safety testing as well as functional<br>testing to demonstrate equivalence to its predicate devices. The following quality |

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assurance measures were applied to the device:

- -Risk Analysis
- -Requirements Review
- -Design reviews
- -Code Inspections
- Verification and Validation -
- Bench Testing (for Cardiac Output functionality in Nexfin Model 1) -
- Clinical Testing (for NBP functionality, in Nexfin Model 1) ﺳﮯ
- H/W and S/W Implementation Verification Testing of the SpO2 and SpHb l functions by Masimo

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K161123

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- Biocompatibility Testing -
- Safety Testing -

Conclusion: The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

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

BMEYE B.V. c/o Mr. William Greenrose Official Correspondent & Regulatory Consultant for BMEYE B.V. Oserve America, Inc. 220 River Road Claremont, NH 03743-5647

OCT 2 8 2010

Re: K101123 Trade/Device Name: CC Nexfin Regulation Number: 21 CFR 870.1130 -- Regulation-Name .- Non-invasive-blood-pressure-measurement-system-Regulatory Class: Class II (two) Product Code: DXN DSB DOA Dated: April 16, 2010 Received: April 22, 2010

Dear Mr. Greenrose:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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. William Greenrose

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/CDRHOffices/ucm115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

8 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K10/ /23

QCI 2 8 2010

Device Name: Nexfin Model 2 (trade name CC Nexfin)

Indications For Use:

The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, function of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfin is indicated for use during both no motion and motion conditions and for patients who are well or poorly perfused. The CC Nexfin monitor does not feature (physiological) alarms, therefore the continuous availability of pulse-oximetry data should be treated as a series of spot-checks rather than continuous monitoring. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

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Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.A. West

510(k) Number K101123

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