(42 days)
No
The description focuses on data display, review, validation, and trending, with no mention of AI/ML terms or capabilities. The performance studies are focused on data display accuracy and system integration, not algorithmic performance.
No
The device is described as an accessory system intended to display patient information and surveillance data, for use by clinicians as a diagnostic aid, and specifically states it is "not intended for monitoring purposes" or to control biomedical devices. It does not provide any treatment or therapeutic function.
Yes
The "Intended Use / Indications for Use" states that the system is intended for use by clinicians as a diagnostic aid, which classifies it as a diagnostic device.
Yes
The device description explicitly states that the Nuvon Vitals Charting System is a "software only system".
Based on the provided information, the Nuvon Vitals Charting System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Nuvon Vitals Charting System Function: The description clearly states that the system is a software-only system that displays data from biomedical devices, patient care devices, and ancillary hospital systems. It is used for displaying patient information, surveillance, reviewing and validating data, and evaluating trends.
- No Sample Analysis: There is no mention of the system analyzing samples taken from the human body. Its function is to display and manage data already generated by other devices and systems.
Therefore, the Nuvon Vitals Charting System falls outside the scope of an In Vitro Diagnostic device.
N/A
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 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.
Product codes
MWI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians / point of care location and at a remote supplementary care location
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
2
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
5
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'