(42 days)
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
The Nuvon Vitals Charting System is a software only system that permits the display of data from biomedical, patient care devices, and ancillary hospital systems (e.g.: laboratory and hospital admission, discharge and transfer systems). The system can be used to review and validate the data for transfer to existing hospital information technology and electronic medical record systems. Additionally, the system can be used for patient surveillance to evaluate trends in patient data.
The Nuvon Vitals Charting System is a software-only system designed to display data from various biomedical, patient care devices, and hospital information systems. It's intended for use by clinicians as a diagnostic aid for patient information display and surveillance, but not as a replacement for direct viewing of monitored devices or for direct patient monitoring.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Unit Testing: Functions verified for valid operation per requirements and design. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." |
| Integration and System Testing: Functions operate within the scope of the larger VEGA System. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." | |
| Non-Functional Performance | Performance/Non-functional testing: Support for multiple simultaneous users and demonstration of key functional performance over time to illustrate scalability without appreciable degradation. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." |
| Overall Equivalence | Substantial Equivalence to predicate devices (VISICU ARGUS, K012171 and Airstrip Remote Patient Monitoring Viewing System, K121871) in intended uses, indications, technological characteristics, and principles of operation. Minor technological differences raise no new issues of safety or effectiveness. | "The Nuvon Vitals Charting System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Nuvon Vitals Charting System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Nuvon Vitals Charting System meets its specifications and intended use, and thus is substantially equivalent performance to the VISICU ARGUS System and the Airstrip Patient Monitoring System." |
2. Sample size used for the test set and the data provenance
The provided text does not specify a numerical sample size for any test sets used.
The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or a ground truth established by experts for the test set. The validation seems to rely on the system's ability to accurately display data consistent with expected performance and its functional requirements.
4. Adjudication method for the test set
The document does not describe any adjudication method like 2+1, 3+1 for establishing ground truth, as ground truth is not explicitly mentioned in the context of expert review.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported. This device is described as a "display system" and "diagnostic aid," not an AI algorithm intended to assist human readers in interpretation or diagnosis in the way an imaging AI might. There's no mention of AI assistance for "human readers" or an "effect size" of such assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone software system (algorithm only in a sense that it's a software displaying data), but the "standalone performance" referred to in AI/ML contexts (where an algorithm makes a diagnostic decision without human input) is not applicable here. The system's function is to display data, and its performance centers on accurate data transfer and display, not on making independent diagnostic decisions. The stated intended use is as a "diagnostic aid," with clinicians using it, not as a replacement for direct viewing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" in the strict sense of a reference standard established by experts or confirmed by pathology/outcomes data is not explicitly used or described in the context of device performance validation. The validation focused on whether the system "displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance" and "meets its specifications and intended use." This implies that the "truth" for this system is the accurate representation of the data generated by the source biomedical devices, validated against the expected output based on functional requirements and system integration.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI model training. This device is described as a charting and display system, not a system that uses machine learning in a way that requires a distinct training and test set in the typical AI/ML validation paradigm.
9. How the ground truth for the training set was established
As no training set or machine learning components are mentioned, the concept of establishing ground truth for a training set is not applicable to this submission.
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510(k) SUMMARY
K130234 p1/3
Nuvon Vitals Charting System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
4801 South Broad Street, Suite 120 Building 100 Innovation Center Philadelphia, PA 19112 1-484-319-7345 Phone: Facsimile: Contact Person: John R. Zaleski
Date Prepared: Thursday, January 17, 2013
Name of Device and Name/Address of Sponsor
Nuvon Vitals Charting System Nuvon, Inc. 4801 South Broad Street, Suite 120 Philadelphia, PA 19112
Common or Usual Name
Physiological and biomedical device data retrieval and display system and rules engine and standard industry format (e.g .: XML, HL7) translator.
Classification Name/Product Code/CFR Reference
Monitor, Physiological, Patient (Without Arrhythmia Detection)
Product Code: MWI
CRF Reference: 870.2300
Predicate Device(s)
VISICU ARGUS, K012171
Airstrip Remote Patient Monitoring Viewing System, K121871
Intended Use / Indications for Use
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location
MAR 1 3 2013
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and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Technological Characteristics
The Nuvon Vitals Charting System is a software only system that permits the display of data from biomedical, patient care devices, and ancillary hospital systems (e.g.: laboratory and hospital admission, discharge and transfer systems). The system can be used to review and validate the data for transfer to existing hospital information technology and electronic medical record systems. Additionally, the system can be used for patient surveillance to evaluate trends in patient data.
Performance Data
Validation and verification of the Nuvon Vitals Charting System performance focused on the following areas:
- unit testing, in which functions are verified for valid function and operate per requirements . and design;
- integration and system testing, in which functions operate within the scope of the larger system, in this case, the operation of Nuvon Vitals Charting with respect to the overall VEGA System;
- performance or non-functional testing, in which the operation of the product to support multiple simultaneous users and demonstrate key functional performance over time so as to illustrate it can scale to meet multiple user operation without appreciable degradation in performance. Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance.
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Substantial Equivalence
The Nuvon Vitals Charting System is substantially equivalent to the VISICU ARGUS System and the Airstrip Patient Monitoring System. The Nuvon Vitals Charting System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Nuvon Vitals Charting System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Nuvon Vitals Charting System meets its specifications and intended use, and thus is substantially equivalent performance to the VISICU ARGUS System and the Airstrip Patient Monitoring System. Thus, the Nuvon Vitals Charting System is substantially equivalent.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Nuvon, Inc. c/o Mr. Jonathan Kahan Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, D.C. 20004
Re: K130234
Trade/Device Name: Nuvons Vital Charting System Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: January 30, 2013 Received: January 30, 2013
Dear Mr. Kahan:
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.
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Page 2 - Mr. Jonathan Kahan
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,
for 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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K130234
Indications for Use Statement
510(k) Number (if known):
. Device Name: Nuvon Vitals Charting System
Indications for Use:
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Prescription Use X AND/OR (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use_ (21 C.F.R. 807 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
2013.03.13
14:26:24 -04'00'
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).