(127 days)
No
The document describes a device based on a scientific method (Peňáz - Wesseling) and waveform analysis, with no mention of AI, ML, or related concepts.
No.
The device is for measurement and monitoring of physiological parameters, not for actively treating or preventing a disease or condition.
No
The device measures parameters like blood pressure and cardiac output but is not described as providing a diagnosis or identifying a medical condition. Its purpose is to monitor, not diagnose.
No
The device description explicitly states it is a "non-invasive monitor" that "measures continuous non-invasive blood pressure" and "heart rate," indicating it includes hardware components for data acquisition. The performance studies also mention "Bench Testing" and "Biocompatibility Testing," which are typically associated with hardware devices.
Based on the provided information, the BMEYE NEXFIN_HD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- NEXFIN_HD Function: The description clearly states that the NEXFIN_HD is a non-invasive monitor that measures blood pressure and hemodynamic parameters directly from the patient. It does not involve the collection or analysis of specimens taken from the body.
Therefore, the NEXFIN_HD falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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 clinical setting.
Product codes
DXN, DSB
Device Description
The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that enables the continuous assessment of a patient's cardiovascular function based on the scientific method of Peňáz - Wesseling.
The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The NEXFIN_HD has successfully undergone safety testing as well as functional testing to demonstrating equivalence to its predicate devices. The following quality assurance measures were applied to the device:
- Risk Analysis
- Requirements Review
- Design reviews
- Code Inspections
- Verification and Validation
- Bench Testing (for Cardiac Output functionality)
- Clinical Testing (for NBP functionality)
- Biocompatibility Testing
- Safety Testing
The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Finometer (K023723)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
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510(K) SUMMARY (per 21 CFR 807.92)
| Name of
Submitter: | BMEYE B.V.
Academic Medical Center, Suite K2-245
Meiberg Dreef 9. 1105 AZ Amsterdam, The Netherlands | | NOV 2 9 2007 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Contact Person: | Jacqueline Emery, BSEE
CliniQuest, Inc., 74 Pleasant St., Westford, MA 01886, USA
Tel: 978-692-0630/ Fax: 978-692-2609/ jacqueline.emery@cliniquest.net | | |
| Date Prepared: | June 25, 2007 | | |
| Trade Names: | NEXFIN_HD™ Continuous Non-Invasive Hemodynamic Monitor | | |
| Classification | Class II | | |
| Classification
Name | - CFR 870.1130, System, measurement, blood pressure, non-invasive, DXN
- CFR 870.2770, Plethysmograph, impedance, DSB | | |
| Predicate: | The NEXFIN_HD is substantially equivalent to the Finometer (K023723). | | |
| Device
description | The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that
enables the continuous assessment of a patient's cardiovascular function based
on the scientific method of Peňáz - Wesseling.
The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic,
Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is
derived, non-invasively, from the blood pressure waveform. The monitor also
calculates derived hemodynamic parameters. | | |
| 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. | | |
| Technology | The device employs the same functional technology as its predicate device. | | |
| Functional/
Safety Testing: | The NEXFIN_HD has successfully undergone safety testing as well as functional
testing to demonstrating equivalence to its predicate devices. The following
quality assurance measures were applied to the device:
- Risk Analysis
- Requirements Review
- Design reviews
- Code Inspections
- Verification and Validation
- Bench Testing (for Cardiac Output functionality)
- Clinical Testing (for NBP functionality)
- 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. | | |
,一
. .
1
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.
2
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
3
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