(30 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and transmission, not analysis or interpretation by the device itself. Clinical judgment is required for interpretation.
Yes
The device is intended for the management of various medical conditions, such as congestive heart failure and hypertension, by collecting and transmitting medical information to a healthcare provider. While it doesn't provide real-time alarms or diagnostic interpretations, its intended use for disease management aligns with the definition of a therapeutic device.
No
The document explicitly states that the device collects and transmits "non-diagnostic ECG" and emphasizes that "Clinical judgment and experience are required to check and interpret the information delivered," meaning the device itself does not provide a diagnosis.
No
The device description explicitly mentions the "eDevice BridgeD130 is an external wireless communication device that transmits data to the backend clinical server," indicating a hardware component beyond just software. The performance studies also mention electrical safety testing, EMC testing, mechanical durability, and radio telemetry testing, which are associated with hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The M3810A Philips TeleMonitoring System collects and transmits physiological measurements (weight, blood pressure, non-diagnostic ECG) directly from the patient's body or from devices connected to the patient (like a blood pressure cuff or scale). It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring and transmitting patient data for clinical interpretation, not for performing diagnostic tests on biological samples.
- Lack of Mention of Samples: The text does not mention the collection or analysis of any biological samples.
Therefore, the device falls under the category of a remote patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 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 or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 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 or cellular connectivity 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, DPS, FRW, DQA, CGA
Device Description
The M3810A Philips Telemonitoring System with eDevice BridgeD130 is a system that allows patients to collect and transmit medical information such as weight, blood pressure, and non-diagnostic ECG. The system includes the eDevice BridgeD130, which is a wireless communication option to transmit data to the backend clinical server.
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
licensed physician or authorized healthcare provider; patients at home; health care professional at the authorized provider
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved level tests, functionality/performance tests, software and safety testing from hazard/risk analysis. Completed electrical safety testing, EMC testing, mechanical durability, safety (operator and patient), temperature/humidity and radio telemetry testing and user evaluations for consumer accuracy demonstrated compliance with applicable standards. Acceptance criteria were based on the specification cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the M3810A Philips Telemonitoring System with the addition of a cellular connectivity device meets all reliability requirements and performance claims and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Section 510 (K) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807-92(c).
The submitter of this pre-market notification is: Carlos O. Acosta Philips Lifeline 111 Lawrence Street. Framingham, MA 01702-8156 Tel: 508-988-1366 Fax: 508-988-1015 Email: carlos.acosta1@philips.com
DEC 1 2010
Alternate contact: David R. Jones Philips Home Monitoring 111 Lawrence Street, Framingham, MA 01702-8156 Tel: 508-988-1658 Fax: 508-988-1015 Email: david.r.jones@philips.com
| Date of summary | Thursday, October 28, 2010 |
|---|---|
| Device name | The M3810A Philips Telemonitoring System with eDevice |
| BridgeD130 |
Common name Physiological Transmitter and Receiver.
Classification names are as follows:
| Classification Name | Regulation
Number | ProCode |
|-------------------------------------------------|----------------------|---------|
| Physiological Signal Transmitters and Receivers | 870.2910 | DRG |
| Non-invasive Blood Pressure | 870.1130 | DXN |
| Electrograph | 870.2340 | DPS |
| Patient scale | 870.2720 | FRW |
| Oximeter | 870.2700 | DQA |
| Glucose Test System | 862.1345 | CGA |
Predicate Devices
The modified device is substantially equivalent to the previously cleared Modification of Physiological Signal Transmitter & Receiver pursuant to K993169 (September 22, 1999).
Confidential
Page 55 of 75
1
K103214 P2/2
HILIPS
Modifications The addition of the eDevice BridgeD130 wireless communication option to transmit data to the backend clinical server. This device is substantially equivalent to the previous cleared Honeywell HomMedtGenesis DM Remote Patient Care Monitor K101242, the difference between the two devices is that the eDevice BridgeD130 is an external communication device and the Honeywell HomMedtGenesis DM Remote Patient Care Monitor is an internal communication module.
Intended Use The subject device has the same intended use and indications for use as the legally marketed predicate devices with the addition of wireless communication option:
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 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 or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Technological The modify device has the same fundamental technological characteristics characteristics as the legally marketed predicate device.
Performance data Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved level tests, functionality/performance tests, software and safety testing from hazard/risk analysis. Completed electrical safety testing, EMC testing, mechanical durability, safety (operator and patient), temperature/humidity and radio telemetry testing and user evaluations for consumer accuracy demonstrated compliance with applicable standards. Acceptance criteria were based on the specification cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the M3810A Philips Telemonitoring System with the addition of a cellular connectivity device meets all reliability requirements and performance claims and supports a determination of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 2010
Lifeline Systems, Inc. Philips Medical Systems North America, Co. c/o Mr. Carlos O. Acosta Sr. Quality Assurance & Regulatory Manager 111 Lawrence Street, Framingham, MA 01702-8156
Re: K103214
Trade/Device Name: M3810A Philips Telemonitoring System with eDevice BridgeD130 Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DRG Dated: October 28, 2010 Received: November 1, 2010
Dear Mr. Acosta:
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 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. Carlos O. Acosta
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PHILIPS
3.2 Indications for Use KI03214 510 (k) Number (if known):
DEC 1 2010
Device Name: M3810A Philips Telemonitoring System with eDevice BridgeD130
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 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 or cellular connectivity 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.
Prescription Use: YES AND/OR over-the-counter Use: NO (Part 21 CFFR 801 Subpart D) (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
- W.
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103214
Confidential
Page 26 of 75