(127 days)
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.
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.
The provided text is a 510(k) summary for the NEXFIN_HD Continuous Non-Invasive Hemodynamic Monitor. It focuses on establishing substantial equivalence to a predicate device (Finometer K023723) through functional and safety testing, rather than an AI-based performance study with specific acceptance criteria and ground truth for an algorithm.
Therefore, many of the requested categories for a study proving device acceptance criteria in an AI context are not applicable or cannot be extracted from this document, as the device described is a hardware medical device with embedded functional technology, not an AI/ML algorithm.
Here's an attempt to address the request based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in numerical thresholds for performance metrics for the NEXFIN_HD versus a reference or ground truth. Instead, the "acceptance criteria" are implied by the successful completion of various tests to demonstrate safety, effectiveness, and substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Device employs the same functional technology as its predicate device. |
| Safety Testing Passed | Successfully undergone safety testing. |
| Functional Testing Passed | Successfully undergone functional testing (for Cardiac Output functionality). |
| Clinical Testing for NBP functionality Passed | Successfully undergone clinical testing (for NBP functionality). |
| Risk Analysis Conducted | Risk Analysis applied. |
| Requirements Review Conducted | Requirements Review applied. |
| Design Reviews Conducted | Design reviews applied. |
| Code Inspections Conducted | Code Inspections applied. |
| Verification and Validation Conducted | Verification and Validation applied. |
| Biocompatibility Testing Passed | Biocompatibility Testing applied. |
| Conclusion of Safety and Effectiveness and Substantial Equivalence | Results of testing demonstrate the device is safe and effective and substantially equivalent to its predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document mentions "Clinical Testing (for NBP functionality)" but does not specify the sample size used for this clinical testing.
- Data Provenance: Not specified. It's likely prospective for clinical testing, but the location is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable as this is a functional/measurement device, not an AI-driven diagnostic or interpretative device where expert-established ground truth would be relevant in the way this question implies. Ground truth for blood pressure and hemodynamic parameters would typically come from other validated medical devices or established physiological measurements (e.g., thermodilution for cardiac output, invasive arterial line for blood pressure).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a functional medical device as described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a measurement tool, not an AI-assisted diagnostic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of an AI algorithm. The device itself is a standalone monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document states: "The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy." This strongly suggests that a gold standard for Cardiac Output (like thermodilution) was used as a reference (ground truth) during testing or for calibration. For Blood Pressure (NBP), it would typically be compared against another validated NBP device or an invasive arterial line.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.
9. How the ground truth for the training set was established:
Not applicable.
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510(K) SUMMARY (per 21 CFR 807.92)
| Name ofSubmitter: | BMEYE B.V.Academic Medical Center, Suite K2-245Meiberg Dreef 9. 1105 AZ Amsterdam, The Netherlands | NOV 2 9 2007 | |
|---|---|---|---|
| Contact Person: | Jacqueline Emery, BSEECliniQuest, Inc., 74 Pleasant St., Westford, MA 01886, USATel: 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 | ||
| ClassificationName | - 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). | ||
| Devicedescription | The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor thatenables the continuous assessment of a patient's cardiovascular function basedon 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 isderived, non-invasively, from the blood pressure waveform. The monitor alsocalculates 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. TheNEXFIN_HD monitor should be calibrated with a thermodilution measurement, orother accurate reference determination of cardiac output, to ensure optimalaccuracy. The device is intended for use by physicians or other properly trainedmedical 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 functionaltesting to demonstrating equivalence to its predicate devices. The followingquality 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 andsubstantially 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 (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
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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
§ 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).