(189 days)
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 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.
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)
The provided document focuses on the 510(k) summary for the Nexfin Model 2 (trade name CC Nexfin) and primarily discusses its substantial equivalence to predicate devices, safety testing, and intended use. It does not contain details about specific acceptance criteria, a standalone study proving performance, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies for this particular device.
The document mentions functional and clinical testing for the predicate device (Nexfin Model 1) for Cardiac Output and NBP functionality, but it does not present the specific results or acceptance criteria for those tests. It merely states that the CC Nexfin has successfully undergone safety and functional testing.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of the available information:
1. Acceptance Criteria and Reported Device Performance
The document states that the CC Nexfin has "successfully undergone safety testing as well as functional testing to demonstrate equivalence to its predicate devices." However, it does not provide a table of specific acceptance criteria or reported device performance metrics for these tests. The conclusion is a general statement that "The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document.
The document mentions "Clinical Testing (for NBP functionality, in Nexfin Model 1)" but does not specify the sample size or data provenance for this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not provided in the document.
4. Adjudication Method for the Test Set
Not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study is not mentioned. The document focuses on showing substantial equivalence to predicate devices through functional and safety testing, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document implies standalone testing for the device's functional aspects, stating "Functional Testing" and "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" as part of the quality assurance measures. However, no specific details about the standalone performance metrics, experimental setup, or results are provided for the CC Nexfin.
7. The Type of Ground Truth Used
For the predicate device, "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" and "Clinical Testing (for NBP functionality, in Nexfin Model 1)" are mentioned. This suggests that reference measurements (likely from other established devices or clinical procedures) were used as ground truth for these functionalities. For the SpO2 and SpHb functions, it states "H/W and S/W Implementation Verification Testing of the SpO2 and SpHb functions by Masimo," implying validation against Masimo's established standards or reference methods. The document does not explicitly state the specific type of ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set
Not applicable. This device is a hemodynamic monitor, not an AI/machine learning device that would typically have a "training set" in the conventional sense of algorithm development. The document describes it as employing "identical technology for blood pressure and cardiac output measurement as was implemented in the predicate device (Nexfin Model 1)" and using "the Masimo Rainbow SET technology for the measurement of SpHb and SpO2."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.
In summary, the provided text serves as a 510(k) summary for regulatory clearance, focusing on substantial equivalence and general safety/effectiveness. It does not contain the detailed study information sought for acceptance criteria, performance metrics, and study design elements like sample sizes, expert qualifications, or adjudication methods.
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K101/123
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510(k) Summary (per 21 CFR 807.92)
| Name ofSubmitter: | BMEYE B.V.Academic Medical Center, Suite K2-245Meibergdreef 9. 1105 AZ Amsterdam, The Netherlands |
|---|---|
| Contact Person: | OCT 28 2010Mr J GrijpmaBMEYE BVT: +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 |
| ClassificationName | CFR 870.1130, System, measurement, blood pressure, non-invasive, DXNCFR 870.2770, Plethysmograph, impedance, DSBCFR 870.2700, Oximeter, DQA |
| Predicate: | The Nexfin Model 2 is substantially equivalent to the Nexfin Model 1 (K072049)and the Masimo Radical 7 (K080238) |
| Devicedescription · | The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor thatenables the continuous assessment of a patient's hemodynamic function based onthe scientific method of Peňáz - Wesseling.The device measures continuous non-invasive blood pressure (Systolic, Diastolicand Mean) and heart rate as well as a Cardiac Output (CO), which is derived,non-invasively, from the blood pressure waveform. The monitor also calculatesderived hemodynamic parameters. The operation of the blood pressure andcardiac output measurement is identical to the operation in Nexfin Model 1(K072049).The CC Nexfin enables in addition the simultaneous measurement of SpO2 andSpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used incombination 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 ofarterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adultpatients. The CC Nexfin monitor should be calibrated with a thermodilutionmeasurement, or other accurate reference estimation of cardiac output, to ensureoptimal accuracy of cardiac output. The CC Nexfin monitor does not feature(physiological) alarms. The device is intended for use by physicians or otherproperly trained medical personnel in a hospital or other appropriate clinicalsetting |
| Technology | The device employs identical technology for blood pressure and cardiac outputmeasurement as was implemented in the predicate device (Nexfin Model 1), anduses the Masimo Rainbow SET technology for the measurement of SpHb andSpO2. |
| Functional/Safety Testing: | The CC Nexfin has successfully undergone safety testing as well as functionaltesting 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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- 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 (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
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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.
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
§ 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).