(39 days)
The CNAP Monitor 500 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals, clinical institutions, medical practices and outpatient settings. The device displays the blood pressure waveform and generates trends, beat numerics and alarms for the parameters blood pressure and pulse rate. The CNAP Monitor 500 is to be used for adults and pediatric patients from the age of 4 year and is to be operated by physicians and other medical professional staff.
The CNAP™ Monitor 500 is a device for continuous non-invasive blood pressure monitoring. The device measures continuous and oscillometric blood pressure as well as pulse rate. CNAP is a joint solution, where absolute blood pressure values are coming from an integrated OEM oscillometric blood pressure device and beat-to-beat changes as well as waveform are measured with the CNAP finger sensor. Finger-BP is automatically calibrated to absolute NIBP-values. Immediately after a NIBP, the CNAP computer puts systolic and diastolic finger BP on the same level as NIBP values. NIBP calibrations can be obtained ipsilateral as well as contralateral to the CNAP-cuff.
The CNAP Monitor 500 device is a non-invasive continuous blood pressure monitoring system. The provided text indicates that the device underwent functional and clinical performance testing to demonstrate equivalence to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "Bench Testing (for continuous blood pressure measurement functionality)" and "Clinical Performance Testing (for oscillometric NIBP measurement functionality)" were conducted. However, it does not provide specific numerical acceptance criteria or detailed results for either of these tests. It only states that the device "has successfully undergone safety testing as well as functional testing to demonstrate equivalence to its predicate device." and "The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device."
Without specific numerical criteria or performance metrics, a table cannot be accurately generated.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical Performance Testing (for oscillometric NIBP measurement functionality)" but does not specify the sample size used for this test set or the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed or described in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study:
The document discusses "Bench Testing (for continuous blood pressure measurement functionality)" and "Clinical Performance Testing (for oscillometric NIBP measurement functionality)," which suggest standalone performance evaluations. However, specific details about these studies and their outcomes (beyond general success and equivalence) are not provided. The device itself is an algorithm-driven monitor, implyiung its standalone performance is what was evaluated against the predicate.
7. Type of Ground Truth Used:
While the document states that clinical performance testing was done for oscillometric NIBP measurement, it does not explicitly define the "ground truth" used for these tests. For NIBP, the ground truth would typically be a more invasive or highly accurate reference measurement (e.g., intra-arterial blood pressure), but this is not specified. The phrasing "equivalence to its predicate device" implies the predicate device's measurements served as a reference point for comparison.
8. Sample Size for the Training Set:
The concept of a "training set" is usually associated with machine learning or AI model development. While the CNAP Monitor 500 uses algorithms (e.g., for beat-to-beat changes and waveform measurement, and automatic calibration), the document does not provide any information about a training set size or the development of such algorithms. It's possible the algorithms were developed and validated internally without a formally described "training set" in the context of this 510(k) summary.
9. How Ground Truth for the Training Set Was Established:
As no training set is described, the method for establishing its ground truth is also not mentioned.
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0CT 1 7 2008
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CNSystems CNAP Monitor 500 Traditional 510(k) Filing
510(k) Summary (per 21 CFR 807.92)
| Name of Submitter: | CNSystems Medizintechnik AGReininghausstrasse 13, A-8020 Graz, Austria |
|---|---|
| Contact Person: | Andreas SumperReininghausstrasse 13, A-8020 Graz, AustriaPhone: +43 (0)316 7234560, Fax: +43 (0)316 723456-2,email: andreas.sumper@cnsystems.at |
| Date prepared: | February 18, 2008 |
| Trade names: | Non-invasive continuous blood pressure monitoring systemCNAP Monitor 500i, 500ac |
| Classification: | Class II |
| Classification name: | 21 CFR 870.1130, System, measurement, blood pressure, non-invasive, DXN |
| Predicate: | The CNAP Monitor 500 is substantially equivalent to the Task ForceMonitor 3040 (K014063) and ZOLL. M-Series NIBP Option(K032363) |
| Device description: | The CNAP™ Monitor 500 is a device for continuous non-invasiveblood pressure monitoring. The device measures continuous andoscillometric blood pressure as well as pulse rate.CNAP is a joint solution, where absolute blood pressure values arecoming from an integrated OEM oscillometric blood pressure deviceand beat-to-beat changes as well as waveform are measured withthe CNAP finger sensor. Finger-BP is automatically calibrated toabsolute NIBP-values. Immediately after a NIBP, the CNAPcomputer puts systolic and diastolic finger BP on the same level asNIBP values. NIBP calibrations can be obtained ipsilateral as well ascontralateral to the CNAP-cuff. |
| Intended use: | The CNAP Monitor 500 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals,clinical institutions, medical practices and outpatient settings.The device displays the blood pressure waveform and generatestrends, beat-to-beat numerics and alarms for the parameters bloodpressure and pulse rate. The CNAP Monitor 500 is to be used foradults and pediatric patients from the age of 4 year and is to beoperated by physicians and other medical professional staff. |
| Technology: | The device employs the same functional technology as its predicatedevice. |
| Functional/SafetyTesting: | The CNAP Monitor 500 has successfully undergone safety testing aswell as functional testing to demonstrate equivalence to itspredicate device. The following quality assurance measures wereapplied to the device:- Risk Analysis- Requirements Review- Code inspections- Verification and Validation- Bench Testing (for continuous blood pressure measurementfunctionality)- Clinical Performance Testing (for oscillometric NIBPmeasurement functionality)- Biocompatibility Testing- Safety Testing (CB Test Protocol) |
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| Conclusion : | . The results of this testing demonstrates that the device is safe and |
| effective and substantially equivalent to its predicate device..assessarages appears and CARARANAAA U.S. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L. L |
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DNSysterns
The Crown & Heart Company
CNSystems CNAP Monitor 500 Traditional 510(k) Filing
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
TUV SUD American Inc. c/o Mr. Norbert Stuiber Third Party Reviewer 1775 Old Highway 8 NW, Ste. 104 New Brighton, MN 55112-1891
Re: K082599
Trade/Device Name: CNAP Monitor 500i, 500at Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 26, 2008 Received: October 3, 2008
Dear Mr. Stuiber:
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. 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
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Page 2 - Mr. Norbert Stuiber
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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,
Duma R. Vachner
A 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): Ko 82G99
Device Name: CNAP Monitor 500i, 500at
Indications For Use:
The CNAP Monitor 500 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals, clinical institutions, medical practices and outpatient settings. The device displays the blood pressure waveform and generates trends, beat numerics and alarms for the parameters blood pressure and pulse rate. The CNAP Monitor 500 is to be used for adults and pediatric patients from the age of 4 year and is to be operated by physicians and other medical professional staff.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Dana R. Joiner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
Page 1 of
§ 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).