REMOTENURSE PATIENT MONITORING SYSTEM
Device Facts
| Record ID | K041308 |
|---|---|
| Device Name | REMOTENURSE PATIENT MONITORING SYSTEM |
| Applicant | Webvmc, LLC |
| Product Code | DXH · Cardiovascular |
| Decision Date | Jun 28, 2004 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2920 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
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, 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.
Device Story
RemoteNurse™ Patient Monitoring system; home-based monitoring tool. Input: vital sign data from external medical devices (BP monitor, glucose meter, weight scale, pulse oximeter, peak flow, ECG, PT/INR, digital camera). System components: Patient Station (touch-screen computer) for data capture/patient prompts; RemoteNurse™ software for storage/forwarding via phone/LAN/WAN; RemoteAccess™ software for caregiver review on secure website; Processor software for interface management. Caregiver sets limits; system emails/pages if exceeded. Used by patients at home; operated by patient; reviewed by physician/caregiver. Clinical judgment required for interpretation. Benefits: remote access to patient data for non-time-critical care.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
System consists of a touch-screen computer (Patient Station) and software applications. Connectivity via standard telephone lines or LAN/WAN. Supports up to 8 external medical devices simultaneously. Software manages data capture, storage, forwarding, and web-based review. No specific materials or sterilization methods applicable as it is a monitoring system interface.
Indications for Use
Indicated for patients at home requiring remote vital sign monitoring. Contraindicated for patients with uncompensated heart failure, high risk of life-threatening arrhythmias, recent myocardial infarctions, or those requiring direct medical supervision or emergency intervention. Intended for patients willing and capable of self-administration.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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## 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:
- 1- K030222 by American Telecare, Inc
- 2- K022274 by Neptec Design Group Ltd
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
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## 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 |
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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.
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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
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## 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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