CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS

K072049 · Bmeye B.V. · DXN · Nov 29, 2007 · Cardiovascular

Device Facts

• Record ID: K072049
• Device Name: CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS
• Applicant: Bmeye B.V.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BMEYE NEXFIN_HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

Device Story

NEXFIN_HD is a non-invasive cardiovascular monitor utilizing Peňáz-Wesseling method; measures continuous blood pressure (systolic, diastolic, mean) and heart rate; derives cardiac output and hemodynamic parameters from blood pressure waveform. Used in hospitals/clinical settings by physicians or trained personnel. Provides real-time hemodynamic data to assist clinicians in cardiovascular assessment and decision-making; benefits patients by enabling continuous monitoring without invasive arterial lines.

Clinical Evidence

Clinical testing performed for non-invasive blood pressure (NBP) functionality. Bench testing performed for cardiac output functionality. Device demonstrated safety and effectiveness equivalent to predicate.

Technological Characteristics

Non-invasive hemodynamic monitor; utilizes Peňáz-Wesseling method for blood pressure measurement; derives cardiac output from blood pressure waveform. Class II device. Subject to biocompatibility, safety, and functional testing.

Indications for Use

Indicated for continuous, non-invasive measurement of blood pressure and hemodynamic parameters in adult patients in hospital or clinical settings. Requires calibration via thermodilution or other accurate cardiac output reference.

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

• Finometer (K023723)

Submission Summary (Full Text)

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K072049

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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>Meiberg Dreef 9. 1105 AZ Amsterdam, The Netherlands | | NOV 2 9 2007 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Contact Person: | Jacqueline Emery, BSEE<br>CliniQuest, Inc., 74 Pleasant St., Westford, MA 01886, USA<br>Tel: [phone]/ Fax: [phone]/ [e-mail] | | |
| Date Prepared: | June 25, 2007 | | |
| Trade Names: | NEXFIN_HD™ Continuous Non-Invasive Hemodynamic Monitor | | |
| Classification | Class II | | |
| Classification<br>Name | - CFR 870.1130, System, measurement, blood pressure, non-invasive, DXN<br>- CFR 870.2770, Plethysmograph, impedance, DSB | | |
| Predicate: | The NEXFIN_HD is substantially equivalent to the Finometer (K023723). | | |
| Device<br>description | The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that<br>enables the continuous assessment of a patient's cardiovascular function based<br>on the scientific method of Peňáz - Wesseling.<br><br>The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic,<br>Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is<br>derived, non-invasively, from the blood pressure waveform. The monitor also<br>calculates derived hemodynamic parameters. | | |
| Intended Use: | The BMEYE NEXFIN_HD is intended to, non-invasively and continuously,<br>measure blood pressure and hemodynamic parameters in adult patients. The<br>NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or<br>other accurate reference determination of cardiac output, to ensure optimal<br>accuracy. The device is intended for use by physicians or other properly trained<br>medical personnel in a hospital or other appropriate clinical setting. | | |
| Technology | The device employs the same functional technology as its predicate device. | | |
| Functional/<br>Safety Testing: | The NEXFIN_HD has successfully undergone safety testing as well as functional<br>testing to demonstrating equivalence to its predicate devices. The following<br>quality assurance measures were applied to the device:<br>- Risk Analysis<br>- Requirements Review<br>- Design reviews<br>- Code Inspections<br>- Verification and Validation<br>- Bench Testing (for Cardiac Output functionality)<br>- Clinical Testing (for NBP functionality)<br>- Biocompatibility Testing<br>- Safety Testing | | |
| Conclusion: | The results of this testing demonstrates that the device is safe and effective and<br>substantially equivalent to its predicate device. | | |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes extending from its head, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

NOV 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BMEYE B. V c/o Ms. Jacqueline Emery, BSEE, Principal Cliniquest, Inc. 74 Pleasant St. Westford, MA 01886

Re: K072049

Trade Name: NEXFIN_HD Continuous Non-Invasive Hemodynamic Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Codes: DXN, DSB Date: November 20, 2007 Received: November 21, 2007

Dear Ms. Emery:

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.

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

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

B. Kommerfor

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

K072049 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: NEXFIN_HD Non-Invasive Hemodynamic Monitor

Indications for Use:

The BMEYE NEXFIN_HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate dinical setting.

Melliam Bednard

William Bednarsk Chief Executive Officer BMEYE B.V.

OCTOBER 4, 2007
Date

Prescription Use Part 2 ICFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumme

(Division Sign-Of Division of Cardlovascular Devices 510ík) Number