(189 days)
No
The document describes a device based on established scientific methods (Peňáz - Wesseling) and relies on signal processing and derived parameters from measured physiological signals (blood pressure, heart rate, SpO2, SpHb). There is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML in the provided text.
No
The document describes the device as a non-invasive monitor that measures vital signs and hemodynamic parameters. There is no indication that the device is intended to treat a disease or condition.
Yes
The device is described as measuring and monitoring various physiological parameters (blood pressure, hemodynamic parameters, SpO2, SpHb) to assess a patient's functional state, which is a characteristic function of a diagnostic device.
No
The device description explicitly states it is a "non-invasive monitor" and mentions the use of "Masimo oximetry sensors," indicating the presence of hardware components beyond just software. The performance studies also include "H/W and S/W Implementation Verification Testing."
Based on the provided information, the BMEYE CC Nexfin is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- BMEYE CC Nexfin Function: The description clearly states that the BMEYE CC Nexfin is a non-invasive monitor that measures physiological parameters directly from the patient's body (blood pressure, heart rate, SpO2, SpHb). It does not analyze specimens taken from the body.
Therefore, the BMEYE CC Nexfin falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes
DXN, DSB, DQA
Device Description
The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Penaz - Wesseling.
The device 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. The operation of the blood pressure and cardiac output measurement is identical to the operation in Nexfin Model 1 (K072049).
The CC Nexfin enables in addition the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in combination with Masimo oximetry sensors. (K090238)
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)
Functional/Safety Testing: The CC Nexfin has successfully undergone safety testing as well as functional testing to demonstrate 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 in Nexfin Model 1) -
- Clinical Testing (for NBP functionality, in Nexfin Model 1)
- H/W and S/W Implementation Verification Testing of the SpO2 and SpHb l functions by Masimo
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
K101/123
1/2
510(k) Summary (per 21 CFR 807.92)
| Name of
Submitter: | BMEYE B.V.
Academic Medical Center, Suite K2-245
Meibergdreef 9. 1105 AZ Amsterdam, The Netherlands |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | OCT 28 2010
Mr J Grijpma
BMEYE BV
T: +31 20 5665838,
F: +31 20 6976424,
E: john.grijpma@bmeye.com |
| Date Prepared: | February 26, 2009 |
| Trade Names: | Nexfin Model 2, Trade name CC Nexfin |
| Classification | Class II |
| Classification
Name | CFR 870.1130, System, measurement, blood pressure, non-invasive, DXN
CFR 870.2770, Plethysmograph, impedance, DSB
CFR 870.2700, Oximeter, DQA |
| Predicate: | The Nexfin Model 2 is substantially equivalent to the Nexfin Model 1 (K072049)
and the Masimo Radical 7 (K080238) |
| Device
description · | The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor that
enables the continuous assessment of a patient's hemodynamic function based on
the scientific method of Peňáz - Wesseling.
The device 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. The operation of the blood pressure and
cardiac output measurement is identical to the operation in Nexfin Model 1
(K072049).
The CC Nexfin enables in addition the simultaneous measurement of SpO2 and
SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in
combination with Masimo oximetry sensors. (K090238) |
| 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 |
| Technology | The device employs identical technology for blood pressure and cardiac output
measurement as was implemented in the predicate device (Nexfin Model 1), and
uses the Masimo Rainbow SET technology for the measurement of SpHb and
SpO2. |
| Functional/
Safety Testing: | The CC Nexfin has successfully undergone safety testing as well as functional
testing to demonstrate equivalence to its predicate devices. The following quality |
13
:
1
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
2/2
14
- 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.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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.
ر جي جي جي جي جي جي جي جي جي جي جي ويورو ويورو ويورو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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
(.71