MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
Device Facts
| Record ID | K993169 |
|---|---|
| Device Name | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A |
| Applicant | Hewlett-Packard Co. |
| Product Code | DRG · Cardiovascular |
| Decision Date | Dec 20, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
Indications for Use
The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider.
Device Story
System for daily home collection/transmission of weight, blood pressure, and ECG data; includes scale, blood pressure unit, and ECG rhythm recorder. Patient-operated at home; data transmitted wirelessly to home Hub; Hub relays data via standard modem over telephone lines to secure database. Healthcare professionals access data via secure log-on; monitor trends; follow up on unexpected changes via phone. System server decodes data; provides security. No real-time alarms; clinical judgment required for interpretation. Benefits include remote monitoring for chronic cardiac conditions and post-surgical management.
Clinical Evidence
Bench testing only. Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15.
Technological Characteristics
System includes home Hub (receiver, processor, memory, modem, auto-dialer) and peripheral units (scale, BP monitor, ECG recorder). Connectivity via standard residential telephone lines. Electrical safety per IEC 60601-1. Data transmission is automated.
Indications for Use
Indicated for home patients capable of self-administration, upon prescription, to collect/transmit weight, blood pressure (including pulse), and non-diagnostic ECG rhythm strips. Used for management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post-cardiovascular surgery, post-myocardial infarction, and other post-cardiac events. Contraindicated for uncompensated heart failure, high risk of life-threatening arrhythmias, recent myocardial infarction, or patients requiring direct medical supervision/emergency intervention.
Regulatory Classification
Identification
A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
DEC 20 1939
Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters. The characters are 'K993169'. The characters appear to be written with a dark ink or marker on a white background.
# 510(k) Summary
# HP Model 3810A Hewlett Packard Company Prepared June 15, 1999
Product Name: Current Trade Name: Model 3810A Hewlett Packard Company Manufacturer: 3500 Deer Creek Road
Palo Alto, California 94043
- Generic Name: Telemedicine System
Classification Name: DXN
Submitted by: Hewlett-Packard Company,Healthcare Solutions Group, Customer Services Division , New Clinical Ventures
| Contact Person: | Sheila W. Pickering Ph.D. |
|-----------------|-----------------------------|
| | 2081 Longden Circle |
| | Los Altos, California 94024 |
| | Telephone/Fax 650 969 6114 |
### A. Legally Marketed Predicate Device
The HP device is substantially equivalent to the following predicate devices.
### Table 1 Predicate Devices
| Ref.<br># | Sponsor | Predicate Device | 510(k) Number |
|-----------|-------------------|------------------------------|---------------|
| 1 | Acme Medical | Digital Scale | K790130 |
| 2 | Instromedix | Lifesigns System | K964408 |
| 3 | American Telecare | Personal Telemedicine System | K952882 |
{1}------------------------------------------------
### B. Device Description
The Hewlett-Packard (HP) Model 3810A telemedicine device provides a system for daily collection of weight, blood pressure and ECG used in the management of home care patients.
The main flow of information originates in the home where a patient uses a blood pressure unit, a scale and an ECG rhythm recorder on a daily schedule. Each of the units automatically reports their data wirelessly to a home Hub, which in turn relays the data using a standard modem over the telephone to a secure database. Health care professionals (such as physicians, nurses, and case managers) having approval for access use a secure log-on procedure to gain access to their patient's data. The provider follows up on any unexpected or undesired changes in the patient's data trends with a phone call.
The home Hub incorporates a receiver, an embedded processor with memory, a standard modem and an automatic dial up module. It is designed so that its operation does not interfere with normal use of the phone including an answering machine. Its connections are identical to those of an answering machine, consisting of a standard wall power plug and a daisy chain phone connection. The installation and use of the home Hub poses no significant risk to the patient or other people within the patient's home.
The data forwarded through the home Hub arrives though a standard modem contained in the HP system server. This server is separate from the Telemedicine PC in the clinic and is programmed to decode the data from the home units. The system design provides for data security.
### C. Indications for use and Intended Use
Intended Use: The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider. Indications for Use: The Model 3810A is indicated for patients at home, who are capable and willing self-administrate this device, upon prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered. Contraindications: The device is not intended as a substitute for medical care. 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.
{2}------------------------------------------------
# D. Substantial Equivalence
The following tables show the basis for substantial equivalence
| | Predicate Devices | | Submission Device |
|-------------------|----------------------------------------|----------------------------------------|----------------------------------------|
| Product Name | Instromedix LifeSigns | American Telecare PTS | Model 3810A |
| Intended Use | Telemedicine system | Telemedicine system | Telemedicine system |
| Transmission | Residential telephone<br>lines | Residential telephone<br>lines | Residential telephone<br>lines |
| Intended<br>Users | Home users and health<br>care provider | Home users and health<br>care provider | Home users and health<br>care provider |
| Site of Use | Home; clinic | Home, clinic | Home, clinic |
| Measurements | Blood pressure, ECG | Blood pressure | Weight, blood pressure,<br>ECG |
| Software | Patient database | Patient database | Patient database |
# Substantial Equivalence Comparison Table
## E. Performance Data
The M3810A patient units- the M3813A Scale Unit, the M3815A Blood Pressure Unit, and the M3816A Rhythm Strip Recorder Unit- have been tested for electrical safety and has received a certificate of compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling a bird or a series of abstract shapes, possibly representing human profiles or a stylized caduceus, a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
Hewlett-Packard Co. Sheila W. Pickering, Ph.D. c/o Sheila W. Pickering, Ph.D. 2081 Longden Circle Los Altos, CA 94024
K993169 Re : Modification of: Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: September 21, 1999 Received: September 22, 1999
Dear Dr. Pickering:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
#### Page 2 - Sheila W. Pickering, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
/ Vark Telth
Witten, Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Dec-16-99 06:06A
P . 03
#### FDA Submission Cover Sheet
510(k) Number (if known): Not applicable K993169
Device Name: Hewlett Packard Model M3810A
Intended Use: The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider.
Indications for Use: The Model 3810A is indicated for patients at home, who are capable and willing selfadministrate this device, upon prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered.
Contraindications: The device is not intended as a substitute for medical care. The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arthythmias, patients with recent history of myocardial infarctions, or patients requiring direct medical supervision or emergency intervention.
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE re needed)
| IF NEEDED | |
|--------------------------------------------------------|--|
| Concurrence Of CDRH, Office Of Device Evaluation (ODE) | |
| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
| (Per 21 CFR 801) | | | |
**
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K973169 |
|---------------|---------|
|---------------|---------|
