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 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.

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.

AI/ML Overview

This document, a 510(k) submission for the HP Model 3810A Telemedicine System, primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices and ensuring electrical safety standards are met. It does not contain information regarding detailed acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.

Therefore, I cannot populate the requested table and sections regarding clinical performance, sample sizes, ground truth, experts, adjudication, or MRMC studies from the provided text.

The "Performance Data" section (E. Performance Data) only mentions electrical safety testing:

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.

This indicates that the primary "acceptance criteria" presented in this document relate to electrical safety and regulatory compliance, not clinical performance of the telemedicine system's ability to accurately manage patient data or improve outcomes.

Here's a breakdown of what can be extracted or inferred based on the document's content, and what cannot:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Safety/Regulatory): Compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15.
- Reported Device Performance (Safety/Regulatory): "received a certificate of compliance."
- Clinical Performance Acceptance Criteria: Not specified in the provided text.
- Clinical Performance Reported Performance: Not specified in the provided text.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- For electrical safety: Not specified (generally not applicable for safety compliance testing in the same way it would be for clinical performance).
- For clinical performance: Not specified. No clinical test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified, as no clinical performance test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified, as no clinical performance test set is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned. The device is a "telemedicine system" for data collection and transmission, not an AI-based diagnostic tool for interpretation by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study for an algorithm is mentioned. The device's function is described as collecting and transmitting data, with "Clinical judgement and experience are required to check and interpret the information delivered." This explicitly states a human-in-the-loop is required for interpretation, implying no standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified, as no clinical performance study is described.
The sample size for the training set:
- Not applicable/Not specified. The document does not describe an AI/ML algorithm requiring a training set for clinical performance.
How the ground truth for the training set was established:
- Not applicable/Not specified.

In summary, this 510(k) submission demonstrates the device's safety and regulatory compliance based on testing to electrical standards. It does not provide an analysis of clinical performance or effectiveness studies involving patients or healthcare professionals interpreting data, as these types of studies were likely not required for this particular type of device (a data collection and transmission system, not a diagnostic interpretation tool). The submission focuses on substantial equivalence to predicate devices for its intended use, which is facilitating data transmission.

Summary

{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.#	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.

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 telephonelines	Residential telephonelines	Residential telephonelines
IntendedUsers	Home users and healthcare provider	Home users and healthcare provider	Home users and healthcare 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

{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

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
---------------	---------

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).