(42 days)
No
The description focuses on data capture, storage, and remote access with pre-defined limits for alerts. There is no mention of AI/ML for analysis, interpretation, or prediction.
No
Explanation: The device is explicitly stated to be a "monitoring tool" and "not intended for diagnosis or as a substitute for medical care." It facilitates remote access to vital sign measurements but does not provide any direct therapeutic benefit or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for diagnosis or as a substitute for medical care".
No
The device description explicitly states that the system includes a "RemoteNurse™ Patient Station –which is a computer with a touch sensitive screen". This is a hardware component, not solely software.
Based on the provided information, the RemoteNurse™ Patient Monitoring system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RemoteNurse™ Function: The RemoteNurse™ system's primary function is to collect and transmit vital sign measurements from commercially available medical devices designed for home use. These measurements are taken in vivo (on the living patient), not from specimens in vitro (outside the body).
- Intended Use: The intended use explicitly states it is a "monitoring tool" and "is not intended for diagnosis or as a substitute for medical care." While it uses data from devices that might be used in conjunction with IVDs (like a Glucose Meter or PT/INR), the RemoteNurse™ system itself is not performing the in vitro analysis. It's acting as a data aggregator and transmission system.
Therefore, the RemoteNurse™ Patient Monitoring system falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, and is intended for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.
The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.
Clinical judgment and experience are required to check and interpret the information delivered.
Typical devices that may be connected to RemoteNurse™ Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.
Product codes
DXH
Device Description
The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, for the purpose of providing caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.
The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.
Clinical judgment and experience are required to check and interpret the information delivered.
The RemoteNurse™ Patient Monitoring system consists of
- (1) RemoteNurse™ Patient Station – which is a computer with a touch sensitive screen- for capturing patient's vital signs from devices manufactured by others, The RemoteNurse™ Patient Station provides a user interface for displaying reminder information as well as prompting for patient responses to pre-defined questions.
- (2) RemoteNurse™ software application for capturing, storing and forwarding patient's vital signs to a secure website via either a standard telephone lines or LAN/WAN.
- (3) RemoteAccess™ software application to allow caregiver to review patient's vital signs on the secure website, RemoteAccess™ software application allows for pre-defining limits above or below which it emails and/or pages the caregiver.
- (4) Processor software application to manage the interface between RemoteNurse™ software application and the website.
Typical devices that may be connected to RemoteNurse™ Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR.
Also, digital camera may be connected to RemoteNurse™ Patient Station.
The unit supports up to 8 devices in the same time.
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
Prescribed by a licensed physician. Intended for use to provide caregivers remote access to vital sign measurements of patients at home.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
510(k) Summary As Required by 21 section 807.92 ( c )
WEBVMC, LLC 1-Submitter Name:
904 Center Street. Conyers, GA 30012 USA 2-Address:
(770) 602-3189 3-Phone:
(678) 413-2033 4-Fax:
5-Contact Person: Scott Sheppard, President
6-Date summary prepared: April 5", 2004
7-Device Trade or Proprietary Name: RemoteNurse™ Patient Monitoring system
8-Device Common or usual name: Remote Patient Monitoring System
Remote Patient Monitoring System 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following devices:
11-Description of the Device:
The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, for the purpose of providing caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.
The device is contraindicated for palients with uncompensated heart failure, patients at high risk of life threatening archythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to selfadministrate it.
Clinical judgment and experience are required to check and interpret the information delivered.
The RemoteNurse™ Patient Monitoring system consists of
- (1) RemoteNurse™ Patient Station –which is a computer with a touch sensitive screen- for capturing patient's vital signs from devices manufactured by others, The RemoteNurse™ Patient Station provides a user interface for displaying reminder information as well as prompting for patient responses to pre-defined questions.
- (2) RemoteNurse™ software application for capturing, storing and forwarding patient's vital signs to a secure website via either a standard telephone lines or LAN/WAN.
- (3) RemoteAccess™ software application to allow caregiver to review patient's vital signs on the secure website, RemoteAccess™ software application allows for pre-defining limits above or below which it emails and/or pages the caregiver.
- (4) Processor software application to manage the interface between RemoteNurse™ software application and the website.
Typical devices that may be connected to RemoteNurse™ Patient Station are:
Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR.
Also, digital camera may be connected to RemoteNurse™ Patient Station.
The unit supports up to 8 devices in the same time.
PAGE EI REVISED
1
12-Intended use of the device: .
The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed prysician The device "Remotenuited, and is intended for use to provide caregivers remote access to vital sign when time-chical care is not required on commercially are list in the cation of consisted for home
measurements of patients at home, as captured on commercially are interess measurements of patients at nome, as capta con contine clairy of it is not intended for diagnosis or as a use, and transmitted to a dolding to and it is not intended to provide real time data.
The device is contraindicated for patients with uncompensated head failure, perients at high risk of life i he device is contrainticated for patients with uncomponsations, or patients requiring direct medical threatening armychmiss, patients with recent myceardial who are willing and capable to setadministrate it
Clinical judgment and experience are required to check and interpret the information delivered.
Typical devices that may be connected to RemoteNurse™ Patient Station are: rypical devices that may be collinouse in raight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Blood Fressure Monitor, Chaoooo Rioto RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate devices cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent in other Fredical devices in commercial distribution. Also, Engivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.
REFER TO MAIN SUBMISSION FOR COMPLETE DETAILS
| FDA file reference number | 510k # K022274 & K030222 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Similar |
| Target population | Similar |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not applicable |
| Biocompatibility | Not applicable |
| Mechanical safety | Similar |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
PAGE E2
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2004
WEBVMC, LLC c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K041308
K041308
Trade Name: WEBVMC RemoteNurse™ Patient Monitoring System Regulation Number: 21 CFR 870.2920 Regulation Name: Electrocardiograph telephone transmitter and receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 11, 2004 Received: June 15, 2004
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the we nave fevice wed your Scotton 910(x) presidentially equivalent (for device referenced above and have and oure) to legally marketed predicate devices the indications for use stated in the May 28, 1976, the enactment date of the marketed in micerstate commerce process that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not re with the provisions of the reason in plication (PMA). You may, therefore, market the approval of a promance applicons of the Act. The Act. The general controls ucvice, subject to the general connects for annual registration, listing of devices, provisions of the Free rectice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is elaboried (.see hadditional controls. Existing major regulations (FMA), it may be subject to sach additions on the Code of Federal Regulations, Title 21, Parts arrecting your de 755 v. FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does Hease be auvised that FDA 5 issuesermination that your device complies with other not mean that PDA has made a acteral statutes and regulations administered by other requirements of the Act of any I odelaretines and is requirements, including, but not Federal agencies: 1 vu must compry mark 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation Inanufacturing practice isquirements the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
(Secubits 531-542 of the Net), 21 Crain eting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your JTV(K) promative notification edicate 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 IT you desire specific ad not 10. Journaliance at (301) 594-4646. Also, please note the 801), picase contact are Office of Softence to premarket notification2 (21CFR Part regulation entition, "Misolanan's of the general information on your responsibilities under the 007.77) you may obtain. "Other gension of Small Manufacturers, International and Act may be obtained from the Driver umber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R. Ogden
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):
Device Name: WEBVMC RemoteNurse™ Patient Monitoring system
Indications For Use:
The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a I he device Remotendrse licensed physician when time-chical call to hot requested at home, as captured on caregivers remote access to that signed for home use, and transmitted to a commercially available medical devices books or diagnosis or as a subsitiate for medical care, and it is not intended to provide real time data.
meoical care, and it is not intonobe to propensated heart failure, patients at high ) ite usince is contrainceded for public to with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.
patients who are while one include are required to check and interpret the information delivered.
Typical devices that may be connected to RemoteNurse™ Patient Station are: Typical Gevices that may be comments of the state, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K041308 |
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