THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)

K023749 · Philips Medical Systems · DRG · Nov 19, 2002 · Cardiovascular

Device Facts

• Record ID: K023749
• Device Name: THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
• Applicant: Philips Medical Systems
• Product Code: DRG · Cardiovascular
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The M3810A Philips TeleMonitoring System with M3812B TeleStation is intended to be used upon prescription by a licensed physcian 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 healthcare professional at the authorized provider. Apart from the convenience features added for enhanced interaction, and blood glucose meter data transmission, that is the same intended use as previously cleared for the M3810A Interactive Health System

Device Story

System collects patient physiological data (weight, blood pressure, pulse, non-diagnostic ECG) and subjective responses via automated interactions; includes glucose meter download capability. Data transmitted automatically over residential telephone lines from home to healthcare provider. Device used by patients for daily self-measurement; healthcare professionals review transmitted data to support clinical management of cardiac conditions. No real-time alarms; clinical judgment required for interpretation. Benefits include remote monitoring of chronic conditions and post-event recovery.

Clinical Evidence

Bench testing only. Verification and validation activities included laboratory studies for biocompatibility, electrical safety, EMC, and radio telemetry, alongside user evaluations for consumer accuracy. Acceptance criteria were based on specifications cleared for the predicate device.

Technological Characteristics

Physiological signal transmitter and receiver system. Components include M3810A TeleMonitoring System and M3812B TeleStation. Connectivity via residential telephone lines. Features include automated data collection for weight, blood pressure, pulse, non-diagnostic ECG, and glucose meter data. No specific software algorithm architecture or material standards provided.

Indications for Use

Indicated for home patients capable of self-administration, prescribed by healthcare providers, 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. No real-time alarms.

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

• Modification of Physiological Signal Transmitter & Receiver (K993169)

Submission Summary (Full Text)

{0}------------------------------------------------

Confidential

## Special 510(k) Modification

K023749

# NOV 1 9 2002

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 C.F.R. §807.92.

| The submitter of this<br>premarket notification<br>is: | J. P. Ouellette<br>Quality Program Manager<br>Cardiac and Monitoring Solutions<br>New Clinical Ventures Division/eCare MS 0024<br>Philips Medical Systems<br>3000 Minuteman Road<br>Andover MA 01810-1099<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------|
| Date of summary | October 25, 2002 | | |
| Device name | The M3810A Philips TeleMonitoring System with M3812B TeleStation | | |
| Common name | Physiological Transmitter and Receiver | | |
| Classification names | Regulation Number | ProCode | Classification Name |
| | 870.2910 | DRG | Physiological Signal<br>Transmitters And<br>Receivers |
| | 870.1130 | DXN | Non-invasive Blood<br>Pressure<br>Measurement System |
| | 870.2340 | DPS | Electrograph |
| | 870.2720 | FRW | Patient Scale |
| Predicate Devices | The modified device is substantially equivalent to the previously cleared<br>Modification of Physiological Signal Transmitter & Receiver pursuant to<br>K993169 (September 22, 1999). | | |
| Modifications | The primary modification is a change to add the functionality of glucose<br>meter downloads and subjective questions (automated interactions). | | |
| Intended Use | The modified device has the same intended use as the legally marketed<br>predicate devices. The M3810A Philips TeleMonitoring System with<br>M312B TeleStation is intended to be used upon prescription by a licensed<br>physcian or authorized healthcare provider by patients as a means to<br>automatically collect and transmit medical information, such as weight,<br>blood pressure, and non-diagnostic ECG, over normal residential telephone<br>lines, between a patient, typically at home, and a healthcare professional at | | |

Philips Medical Systems

Page 54 of 87

{1}------------------------------------------------

| Confidential | Special 510(k) Modification |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the authorized provider. Apart from the convenience features added for<br>enhanced interaction, and blood glucose meter data transmission, that is the<br>same intended use as previously cleared for the M3810A Interactive Health<br>System |
| Technological<br>characteristics | The modified device has the same technological characteristics as the<br>legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to establish the<br>performance and reliability characteristics of the modified device.<br>Testing involved safety testing from the risk analysis, including laboratory<br>studies for biocompatibility electrical safety testing, EMC testing and radio<br>telemetry testing and user evaluations for consumer accuracy. Acceptance<br>criteria were based on the specifications cleared for the predicate device and<br>test results showed substantial equivalence. |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with three lines representing its wings and head. 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

Philips Medical Systems c/o Mr. J.P. Ouellette, M.S. Quality Program Manager 3000 Minuteman Road Andover, MA 01810

#### Re: K023749

Trade Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: November 6, 2002 Received: November 8, 2002

#### Dear Mr. Ouellette:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

## Page .2 - Mr. J.P. Ouellette, M.S.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic . product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely vours.

Ana Alumku fo
Brant D. Zuckerman, M.D.

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

Enclosure

{4}------------------------------------------------

### Special 510(k): Device Modification

#### 3.1 ODE Indications Statement

#### Indications for Use Statement

510(k) Number (if known)

Device Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation

## Indications for Use:

The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the 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 judgment and experience are required to check and interpret the information delivered.

PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K023749
DOF 11/18

Philips Medical Systems

Page 13 of 87