(259 days)
Not Found
No
The summary describes standard non-invasive physiological monitoring techniques (Peňáz - Wesseling method, pulse-oximetry) and does not mention AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for measurement and monitoring of physiological parameters, not for treating a disease or condition.
Yes
The device measures various physiological parameters such as blood pressure, hemodynamic parameters, SpO2, and SpHb, which are used to assess a patient's condition. While it doesn't feature physiological alarms, the continuous availability of data, even treated as spot-checks, provides information about the patient's health status, fitting the definition of a diagnostic device that provides information for diagnosis.
No
The device description explicitly states it is a "non-invasive monitor" and mentions "H/W and S/W Implementation Verification Testing," indicating the presence of hardware components.
Based on the provided text, the BMEYE CC Nexfin is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- 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 (blood pressure, heart rate, cardiac output, SpO2, SpHb). It does not involve the analysis of samples 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 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 device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Product codes (comma separated list FDA assigned to the subject device)
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 CC Nexfin also enables the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The operation of the blood pressure, cardiac output, SpO2 and SpHb measurement are identical to the operation in the predicate (K101123).
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 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 H/W and S/W Implementation Verification Testing of the SpO2 and SpHb functions by Masimo 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 5 - 510(k) Summary
APR 2 2 2013
510(k) Summary (per 21 CFR 807.92)
| Name of Submitter: | BMEYE BV
Hoogoorddreef 60
1101 BE Amsterdam
the Netherlands |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mr. J van Goudoever,
BMEYE BV
Tel + 31 20 7512410
Fax + 31 20 7512419 |
| Date Prepared | August 1, 2012 |
| 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 | Nexfin Model 2, K101123 |
| 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 CC Nexfin also
enables the simultaneous measurement of SpO2 and SpHb using a pulse-
CO oximetry sensor. The operation of the blood pressure, cardiac output,
SpO2 and SpHb measurement are identical to the operation in the
predicate (K101123). |
| 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 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 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 compared to the predicate
(K101123) for blood pressure and cardiac output measurement and the
measurement of SpHb and SpO2 using the Masimo Rainbow SET
technology. |
NEXFIN MODEL 2, Traditional 510(k) Filing BMEYE BV - August 2012 .
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Commission of the count
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1
K122381
| 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 H/W and S/W Implementation Verification Testing of the SpO2 and
SpHb 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. |
:
Comments of the country
.
NEXFIN MODEL 2, Traditional 510(k) Filing BMEYE BV - August 2012 Page | : | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Page 19 of 664
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a single staff entwined by a serpent.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2013
Edward Lifesciences BMEYE c/o Mr. Jeroen van Goudoever Hoogoorddreeef 60 1101 BE Amsterdam The Netherlands
Re: K122381
Trade/Device Name: Nexfin Model 2 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN, DSB, DQA Dated: April 3, 2013 Received: April 08, 2013
Dear Mr. van Goudoever:
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.
3
Page 2 – Mr. Jeroen van Goudoever
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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
OwenParis -S
for 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):
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, functional saturation 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 device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Prescription Use _ V AND/OR Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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)
Owen P. Faris -S
2013.04.22
16:04:32 -04'00'