← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K082599 # NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT (K082599) _Cnsystem Medizintechnik AG · DXN · Oct 17, 2008 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K082599 ## Device Facts - **Applicant:** Cnsystem Medizintechnik AG - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Oct 17, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric, 3rd-Party Reviewed ## 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-to-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. ## Device Story The CNAP Monitor 500 provides continuous non-invasive blood pressure (BP) and pulse rate monitoring. It utilizes a dual-input approach: an integrated OEM oscillometric BP module for absolute BP values and a finger sensor for beat-to-beat waveform and change detection. The system automatically calibrates the finger-derived BP to the absolute oscillometric values, aligning systolic and diastolic finger BP with NIBP measurements. Used in hospitals, clinics, and outpatient settings by physicians and medical staff, the device displays real-time waveforms, trends, and numeric data, and triggers alarms. This continuous monitoring allows clinicians to observe hemodynamic changes between intermittent NIBP measurements, potentially improving patient management through timely detection of BP fluctuations. ## Clinical Evidence Clinical performance testing was conducted specifically for the oscillometric NIBP measurement functionality. The device also underwent bench testing for continuous blood pressure measurement functionality, alongside risk analysis, code inspections, and biocompatibility/safety testing to demonstrate equivalence. ## Technological Characteristics System integrates an OEM oscillometric BP module and a finger sensor for photoplethysmographic waveform analysis. Provides continuous BP and pulse rate monitoring. Connectivity includes waveform display and alarm generation. Software includes verification and validation protocols. Biocompatibility and safety testing (CB Test Protocol) performed. ## Regulatory 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. ## Predicate Devices - Task Force Monitor 3040 ([K014063](/device/K014063.md)) - ZOLL M-Series NIBP Option ([K032363](/device/K032363.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 0CT 1 7 2008 Image /page/0/Picture/2 description: The image shows a logo for CV Systems, "The Brain & Heart Company". The logo features a stylized chess piece, specifically a queen, positioned above and to the right of the company name. The text is in a simple, sans-serif font, and the overall design is clean and professional. CNSystems CNAP Monitor 500 Traditional 510(k) Filing ## 510(k) Summary (per 21 CFR 807.92) | Name of Submitter: | CNSystems Medizintechnik AG
Reininghausstrasse 13, A-8020 Graz, Austria | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Andreas Sumper
Reininghausstrasse 13, A-8020 Graz, Austria
Phone: +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 system
CNAP 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 Force
Monitor 3040 (K014063) and ZOLL. M-Series NIBP Option
(k032363) | | Device description: | 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. | | 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 generates
trends, beat-to-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. | | Technology: | The device employs the same functional technology as its predicate
device. | | Functional/Safety
Testing: | The CNAP Monitor 500 has successfully undergone safety testing as
well as functional testing to demonstrate equivalence to its
predicate device. The following quality assurance measures were
applied to the device:
- Risk Analysis
- Requirements Review
- Code inspections
- Verification and Validation
- Bench Testing (for continuous blood pressure measurement
functionality)
- Clinical Performance Testing (for oscillometric NIBP
measurement functionality)
- Biocompatibility Testing
- Safety Testing (CB Test Protocol) | | | ALLEALERS AND LEASE LASS CARACTER COLLECTION CALL CARALASALAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | | 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 | {1}------------------------------------------------ ![Image of text block from image] DNSysterns *The Crown & Heart Company* CNSystems CNAP Monitor 500 Traditional 510(k) Filing {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image. 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K082599](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K082599) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com