THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

K041674 · Philips Medical Systems · DQA · Jul 19, 2004 · Cardiovascular

Device Facts

• Record ID: K041674
• Device Name: THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
• Applicant: Philips Medical Systems
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 which is the same intended use as previously cleared for the M3810A Interactive Health System

Device Story

The M3810A Philips TeleMonitoring System with M3814A SpO2 unit is a home-use telemonitoring system. Patients collect physiological data—weight, blood pressure, pulse rate, and non-diagnostic ECG—typically once daily. The device transmits this data automatically over standard residential telephone lines to a remote healthcare provider. The system does not provide real-time alarms; healthcare professionals interpret the transmitted data to support clinical decision-making. The device enables remote patient monitoring, allowing providers to track patient health status outside of clinical settings.

Clinical Evidence

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

Technological Characteristics

The device is a telemonitoring system for physiological signal transmission. It includes an M3814A SpO2 transmitter and receiver. Connectivity is via standard residential telephone lines. The system is designed for home use. Technological characteristics are substantially equivalent to the predicate device.

Indications for Use

Indicated for patients at home, capable and willing to self-administer, upon prescription, to collect and transmit weight, blood pressure (including pulse rate), and non-diagnostic ECG rhythm strips to a healthcare provider via telephone lines. Not for real-time alarms.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Physiological Signal Transmitter & Receiver (K992478)

Submission Summary (Full Text)

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### <041674 Confidential Special 510(k) Modification JUL 1 9 2004 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 J. P. Quellette Quality and Regulatory Manager premarket notification Cardiac and Monitoring Solutions is: New Clinical Ventures Division/eCare MS 0024 Philips Medical Systems 3000 Minuteman Road Andover MA 01810-1099 Tel: [phone] Fax: [phone] e-mail: [e-mail] May 28, 2004 Date of summary Device name The M3810A Philips TeleMonitoring System with M3814A SpO2 Physiological Transmitter and Receiver Common name Classification names Regulation Number ProCode Classification Name 870.2910 Physiological Signal DRG Transmitters And Receivers Non-invasive Blood 870.1130 DXN Pressure Measurement System 870.2340 DPS Electrograph 870.2720 FRW Patient Scale 870.2700 Oximeter DQA 862.1345 CGA Glucose test system Predicate Devices The modified device is substantially equivalent to the previously cleared Physiological Signal Transmitter & Receiver pursuant to K992478 (October 15, 1999). Modifications The primary modification is a change to add the functionality of pulse oximetry Intended Use The modified device has the same intended use as the legally marketed predicate devices. The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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, Philips Medical Systems Page 60 of 73

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| ﺭﻳﺎ<br>} | 1<br>- ﺗ | ! |
|----------|----------|---|
|----------|----------|---|

| Confidential | Special 510(k) Modification |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | blood pressure, and non-diagnostic ECG, over normal residential telephone<br>lines, between a patient, typically at home, and a healthcare professional at<br>the authorized provider which is the same intended use as previously<br>cleared for the M3810A Interactive Health 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. Acceptance criteria were based on the specifications<br>cleared for the predicate device and test results showed substantial<br>equivalence. |

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2004

Mr. J.P. Ouellette Quality & Regulatory Manager Philips Medical Systems 3000 Minuteman Road MS 0024 Andover, MA 01810-1099

Re: K041674

K041074
Trade Name: The M3810A Philips TeleMonitoring System with M3814A SpO2 Unit Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: June 17, 2004 Received: June 21, 2004

Dear Mr. Ouellette:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected it = = = = = = = = = = = = = = = = = = = = = = = = = = = indications felerenced above and nave acterines ally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegains and date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are exames with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costiete Hot (110) that be nevice, subject to the general controls provisions of the Act. The r ou may, disterere, maniel and include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (600 a00 rols. 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.

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Page 2 – Mr. J.P. Ouellette

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Neil R.P. Ophen +N

Dr. R. Zohman, MD

Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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 M3814A SpO2 unit

## Indications for Use:

The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Neil R. Qyle
(Division Sign-Off)
Division of Cardiovascular Devices
for 802

510(k) Number k041674

Prescription Use YES (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use NO

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Philips Medical Systems

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