(81 days)
Not Found
No
The description focuses on data collection and transmission via standard technology (modem, telephone lines). There is no mention of AI or ML for data analysis, interpretation, or decision-making. The summary explicitly states that "Clinical judgement and experience are required to check and interpret the information delivered."
No.
The device is described as collecting and transmitting medical information, such as weight, blood pressure, and non-diagnostic ECG, from the patient to a healthcare provider for monitoring purposes. It does not provide any direct therapeutic intervention or treatment.
No
Explanation: The Intended Use section explicitly states that the device collects and transmits "non-diagnostic ECG" and that "Clinical judgement and experience are required to check and interpret the information delivered," indicating it is not a diagnostic device itself.
No
The device description explicitly details multiple hardware components including a home Hub with a receiver, embedded processor, memory, modem, and automatic dial-up module, as well as a system server with a modem. It also mentions patient units (scale, blood pressure unit, ECG rhythm recorder) that wirelessly report data to the Hub. This is clearly a system with significant hardware components, not a software-only device.
Based on the provided information, the Model 3810A device is not an In Vitro Diagnostic (IVD).
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.
- Model 3810A Function: The Model 3810A collects and transmits medical information like weight, blood pressure, and non-diagnostic ECG. These are measurements taken directly from the patient's body or related to their physical state, not tests performed on samples in vitro (outside the body).
- Intended Use and Indications: The intended use and indications clearly describe the device as a means to collect and transmit medical information from the patient at home to a healthcare professional. There is no mention of analyzing biological samples.
- Device Description: The device description details the components (scale, blood pressure unit, ECG recorder) that interact directly with the patient, not with biological samples.
Therefore, the Model 3810A falls under the category of a medical device that collects physiological data, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
DXN, DPS, FRW
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.
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
Home users and health care provider / Home; clinic
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 992478. The numbers are written in a cursive style, with some of the digits connected to each other.
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.
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.
| Ref.
| 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
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 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.
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 | ||
| lines | Residential telephone | ||
| lines | Residential telephone | ||
| lines | |||
| Intended | |||
| Users | Home users and health | ||
| care provider | Home users and health | ||
| care provider | Home users and health | ||
| care provider | |||
| Site of Use | Home; clinic | Home, clinic | Home, clinic |
| Measurements | Blood pressure, ECG | Blood pressure | Weight, blood pressure, |
| 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with a human profile incorporated into the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
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 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 (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,
Thomas J. Callahan, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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 |