PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A

K992478 · Hewlett-Packard, Healthcare Solutions Group · DXN · Oct 15, 1999 · Cardiovascular

Device Facts

• Record ID: K992478
• Device Name: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
• Applicant: Hewlett-Packard, Healthcare Solutions Group
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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 nondiagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider.

Device Story

System collects daily weight, blood pressure, and ECG data from home patients. Components include scale, blood pressure unit, and rhythm strip recorder. Data transmits wirelessly to home Hub; Hub relays data via standard modem over telephone lines to secure server. Healthcare professionals access data via secure log-on to monitor trends. Device provides no real-time alarms; clinical judgment required for interpretation. Benefits include remote patient monitoring for management of home care patients. System design ensures data security; operation does not interfere with telephone usage.

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 comprises M3813A Scale, M3815A Blood Pressure Unit, and M3816A Rhythm Strip Recorder. Home Hub includes receiver, embedded processor, memory, and modem. Connectivity via standard telephone lines. Electrical safety per IEC 60601-1; FCC Part 15 compliance. 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 to healthcare providers. Contraindicated for patients with uncompensated heart failure, high risk of life-threatening arrhythmias, recent myocardial infarction, or those requiring direct medical supervision/emergency intervention.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Digital Scale (K790130)
• Lifesigns System (K964408)
• Personal Telemedicine System (K952882)

Submission Summary (Full Text)

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# 510(k) Summary

| OCT 1 5 1999 | HP Model 3810A |
|-------------------------|---------------------------------|
| Hewlett Packard Company | |
| Prepared June 15, 1999 | |
| Product Name: | Current Trade Name: Model 3810A |
| Manufacturer: | Hewlett Packard Company |
| | 3500 Deer Creek Road |

Palo Alto, California 94043

- Telemedicine System Generic Name:
Classification Name: DXN

Submitted by: Hewlett-Packard Company,Healthcare Solutions Group, Customer Services Division , New Clinical Ventures

| Contact Person: | Sheila W. Pickering Ph.D.<br>2081 Longden Circle<br>Los Altos, California 94024<br>Telephone/Fax [phone] |
|-----------------|---------------------------------------------------------------------------------------------------------------|
|-----------------|---------------------------------------------------------------------------------------------------------------|

#### A. Legally Marketed Predicate Device

The HP device is substantially equivalent to the following 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 |

#### Table 1 Predicate Devices

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# 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 thythm 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 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.

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# 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Sheila W. Pickering, Ph.D. Requlatory Affairs Consultant Hewlett-Packard, Healthcare Solutions Group 2081 Longden Circle Los Altos, CA 94024

Re: K992478 Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Codes: DXN, DPS, FRW Dated: July 23, 1999 Received: July 26, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory 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.

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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 leqally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

# 510(k) Number (if known) K9924

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 nondiagnostic 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 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.

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| Concurrence Of CDRH, Office Of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | ✓ | OR | Over-The-Counter Use |
|------------------|---|----|------------------------------------------|
| (Per 21CFR 801) | | | |
| | | | (Division Sign-Off) |
| | | | Division of Cardiovascular, Respiratory, |
| | | | and Neurological Devices |
| | | | 510(k) Number K992478 |