Who is the manufacturer of MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921?

Philips Medical Systems filed the 510(k) submission for MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 (K071564).

What is the FDA product code for MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921?

BL Management Remote Care Management System (K051470).

Who can help prepare an FDA 510(k) submission like MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921

K071564 · Philips Medical Systems · DRG · Aug 31, 2007 · Cardiovascular

Device Facts

Record ID	K071564
Device Name	MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
Applicant	Philips Medical Systems
Product Code	DRG · Cardiovascular
Decision Date	Aug 31, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical healthrelated patient information. The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter information derived from approved medical devices. Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.

Device Story

Motiva System facilitates remote patient monitoring; connects home-based patients to clinical care teams. Inputs: physiological data (blood pressure, weight, glucose) from approved medical devices via Bluetooth/wired link to an in-home Internet Protocol Set Top Box. System transmits data via broadband to a Medical Server; clinical staff access data via Motiva Clinical Client software. System enables care plan assignment, educational video delivery, health surveys, and text messaging. Used in home settings by patients; clinical settings by healthcare professionals. Output: patient data, care plan tasks, and communication tools for providers. Benefits: supports chronic condition management (CHF, COPD, diabetes) through remote monitoring and patient engagement. Does not provide automated diagnosis or treatment decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

System comprises off-the-shelf Internet communication/AV devices and approved medical sensors. Connectivity: Bluetooth v1.2 (2.402-2.480 GHz FHSS) and broadband Internet. Power: AC wall plug for hub, batteries for sensors. Software: Proprietary Motiva Application and Clinical Client software. No significant physical or material characteristics; utilizes standard consumer electronic components.

Indications for Use

Indicated for patients in non-clinical settings requiring remote care management of chronic conditions (e.g., CHF, COPD, diabetes). Used for remote education, motivation, and communication, and for automatic collection of physiological data from approved medical devices. Not for automated treatment decisions or emergency care.

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

BL Management Remote Care Management System (K051470)

Related Devices

K130360 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION · Constant Care, LLC · Jul 15, 2013
K011779 — AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM · Avid Care Corp. · Jul 13, 2001
K222398 — Care Team Portal · Vivify Health, Inc. · Feb 6, 2023
K111922 — VOCARE MYHEALTH TABLET · Vocare, Inc. · Dec 2, 2011
K120941 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM · Constant Care, LLC · Jul 3, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ ## 071564 25 AUG 3 1 2007 #### 510(k) Summary Philips Model 453564036921 Prepared 8 January 2007 Owners' Name: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 #### Contacts: | Contact Person: | Alternate Contact: | |-------------------------------|----------------------------------| | Rick Schul | Joe Ouellette | | Email: rick.schul@philips.com | Email: joe.ouellette@philips.com | | Telephone: (978) 659-2622 | Telephone: (978) 659-4308 | | Fax: (978) 659-3456 | Fax: (978) 659-3456 | ### Device Name: | Trade or Proprietary Name: | Motiva Monitor Device Connectivity | |----------------------------|----------------------------------------------------------------------------------------------------------| | Common Name: | Telemedicine System | | Classification Name: | Radiofrequency physiological signal transmitters and receivers (21 CFR 870.2910, Product Code DRG) | ### Legally Marketed Predicate Device: | Sponsor | Predicate Device | 510(k) Number | |---------------------|---------------------------------------------------|---------------| | BL Healthcare, Inc. | BL Management Remote Care Management System | K051470 | Image /page/0/Picture/10 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in uppercase letters above a shield-like shape. Inside the shield, there is a globe-like design with horizontal lines representing waves and star-like shapes. The logo is in black and white. {1}------------------------------------------------ ### Device Description #### Overview The Motiva Monitor Device Connectivity (Motiva System) uses broadband and wireless technologies to create a link between the user and the user's Care Team. Information, such as educational videos, health surveys, and messages are sent to the user's television by way of a broadband connection. If the user has been supplied a Home Measurement Device, such as a Blood Pressure Monitor, Glucose Meter and Weight scale, readings are delivered to Motiva and retrievable by both the user and members of the user's Care Team. Based on the user's answers to assessment and stratification questions, The Motiva System enables the staff member to assign a Care Plan to the patient that provides a schedule for the delivery of educational materials, creates tasks for Care Team members when limits are exceeded, automates duties such as the delivery of reminders and motivational messages, and alerts Care Team members to users who may be at risk for not meeting care plan requirements. #### How the device functions A user interacts with the Motiva System by periodically (typically once or twice per day) using one or more measurement devices such as Blood Pressure Monitor, Glucose Meter or Weight Scale located in their home. These devices employ a wireless (Bluetooth) or wired link to communicate measurement data to an Internet Protocol Set Top Box, also located in the user's home. In turn, the Set Top Box communicates with the Medical Server (which includes Motiva Application software) using the user's broadband Internet connection. The information is sent to the healthcare professional's clinical client (containing Motiva Clinical Client software), which allows the healthcare professional to communicate back to the user in his/her home via the Internet to his or her own television set. #### Scientific Concept The scientific concept that forms the basis of the device are the telemonitoring studies that have shown that most persons with conditions such as Congestive Heart Failure (CHF) , Chronic Obstructive Pulmonary Disease (COPD), diabetes can safely and effectively monitor their conditions through telemonitoring. Image /page/1/Picture/8 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a rectangular box above a shield-like shape. Inside the shield, there is a circle containing a stylized representation of waves and stars. The waves are depicted as two horizontal lines, and the stars are represented by cross-like shapes. {2}------------------------------------------------ Significant Physical and Performance Characteristics The Motiva System is a collection of off-the-shelf and custom designed Internet communication, audio / video interconnection devices and approved measuring devices and as such does not contain any significant physical or performance characteristics. - The design of the device focuses largely on the software of the home . and clinical user interfaces and is not significant. - Materials used are largely standard off-the-shelf and slightly modified . consumer electronic Internet communication and audio / video interconnection devices and as such the device's materials and physical properties are not significant. #### Intended Use Statement Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical healthrelated patient information. The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter information derived from approved medical devices. Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional. Image /page/2/Picture/7 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" at the top, above a shield-shaped emblem. Inside the shield, there is a circle containing two stars and two wavy lines. The stars are positioned on the top left and bottom right of the circle, while the wavy lines are in the middle. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is a handwritten number, "K071564". The text is clear and easily readable against the white background. The image appears to be a scan or a photograph of a document or label. Explanation of differences of Motiva System and Predicate Device Intended Use Statements Underlined significant portions of Intended Uses are compared. The predicate device's Intended Use statement is reproduced in whole and in sequence paragraph by paragraph in the table below. | Predicate Device: BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | Impact of differences to intended use of device and safety and effectiveness | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The purpose of the BL Healthcare Remote Care Management system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. | The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter information derived from approved medical devices. | Same, no impact. | | This system is installed by or with support from trained professionals. | | Difference, Intended Use Statement does not address installation. No impact as the Motiva System is installed by trained professionals according to established installation procedures. | Image /page/3/Picture/4 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font at the top of a shield-shaped emblem. Inside the emblem, there is a stylized representation of a globe with wavy lines across the middle and four stars placed around it. {4}------------------------------------------------ # く07月667 PHILIPS | Predicate Device: BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | Impact of differences to intended use of device and safety and effectiveness | |-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | This device is not intended to provide time sensitive data or alarms. | Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. | Difference, Intended use statement does not address data and alarms specifically. No impact as intent to not provide automatec decisions is the same. | | This system may not be used as a substitute for direct medical intervention or emergency care. | Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. | Same, No Impact. | | Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional. | All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional. | Same, No Impact. | Image /page/4/Picture/2 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font above a shield-shaped emblem. Inside the emblem is a circle containing two wavy lines, resembling water, and four stars, two above and two below the wavy lines. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the number "4071564" in a smaller font. The text appears to be part of a label or logo. The image is in black and white. Technological Characteristics Summary Differences are identified in the table below and are compared in the 2nd table. | Device | BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | Difference | |-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological Characteristic | | | | | Indications for use | Enable healthcare providers to manage chronic conditions of patients remotely | Enable healthcare providers to manage chronic conditions of patients remotely | Same | | Intended use | Telemedicine system | Telemedicine system | Same | | Intended users | Home users | Home users | Same | | Site of use | Home; clinic | Home; clinic | Same | | Data Collection Software | Proprietary Software | Proprietary Software | Same | | Communication method with Remote Care Management System | Broadband Internet connection | Broadband Internet connection | Same | | Types of sensors which can be interfaced (wired or wirelessly) to receiver hub | Blood Pressure Weight Glucose levels | Blood Pressure Weight Glucose levels | Same | | Implementation method of collecting clearance by data from sensors | External communication device | Un-modified off-the- shelf 510(k) approved sensors | Difference 1 | | Sensor Software | Unchanged | Unchanged | Same | | Connectivity | Wireless to hub | Wireless to hub | Same | | Communication method of hub with devices | Wireless RF protocol | Bluetooth Serial Port Profile | Difference 2 | | Communications protocol | Proprietary | Bluetooth v1.2 | Difference 3 | | Wireless frequency | 915MHz FCC assigned channel | 2.402 to 2.480 GHz (FHSS) ISM Band | Difference 4 | | Device | BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | Difference | | Technological Characteristic | | | | | Power Source | Wall plug for hub (a/c) and batteries in devices | Wall plug for hub (a/c) and batteries for 510(k) approved sensor devices | Same | | Display | On devices, hub, and monitors connected to Remote Care Management System | On 510(k) approved sensor devices and Television connected to Remote Care Management System | Same | | Video conferencing | 2 way video conference via a broadband internet connection | Not applicable | Difference 5 | | Medicine reminders | The system reminds the user to take medication if the information is programmed by the Healthcare Provider | The system reminds the user to take medication if the information is programmed by the Healthcare Provider | Same | | Video User Training | Instructional video clips may be viewed by the user by selecting them from the menu if enabled by the Healthcare Provider | Health condition related educational videos may be viewed by the user by selecting them from the menu if enabled by the Healthcare Provider | Same | | Care Plan Surveys | Not applicable | Care plan surveys may be completed if enabled by Healthcare Provider | Difference 6 | | Messages | Not applicable | Text messages may be sent between Healthcare Provider and patient to communicate various types of information | Difference 7 | | Device Difference # | BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | How technological characteristics of submitted device compare to predicate device | | 1) Implementation method of collecting clearance by data from sensors | External communication device | Un-modified off-the- shelf 510(k) approved sensors | Similar but communication is more direct. No external communication device utilized. Approved measurement devices are utilized as-is with data transmitted from approved measurement devices to Set Top Box via Bluetooth Adapter or wired interface cable. | | 2) Communication method of hub with devices | Wireless RF protocol | Bluetooth Serial Port Profile | Very similar but non-proprietary, industry standard communication method is employed. | | Device Difference # | BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | How technological characteristics of submitted device compare to predicate device | | 3) Communications protocol | Proprietary | Bluetooth v1.2 | Very similar but non-proprietary, industry standard communication method is employed. | | 4) Wireless frequency | 915MHz FCC assigned channel | 2.402 to 2.480 GHz (FHSS) ISM Band | Very similar but non-proprietary, industry standard communication method is employed. | | 5) Video conferencing | 2 way video conference via a broadband internet connection | Not applicable | Similar, user to healthcare provider communications are accomplished with message capability and care plan responses. | | 6) Care Plan Surveys | Not applicable | Care plan surveys may be completed if enabled by Healthcare Provider | Responses to care plans serve as a form of communication similar to that which occurs with video conferencing. | | Device Difference # | BL Healthcare Remote Management system K051470 | Motiva Monitor Device Connectivity | How technological characteristics of submitted device compare to predicate device | | 7) Messages | Not applicable | Text messages may be sent between Healthcare Provider and patient to communicate various types of information | Messages serve as a form of communication similar to that which occurs with video conferencing. | Image /page/5/Picture/4 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font at the top. Below the word is a circular emblem containing a stylized representation of stars and waves. The emblem is enclosed within a shield-like shape. {6}------------------------------------------------ ## ५०71564 PHILIPS Image /page/6/Picture/2 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font above a shield-shaped emblem. Inside the shield, there is a globe-like design with wavy lines representing water and stars scattered around. The logo is black and white. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the text "KO?1564" in smaller, handwritten-style letters. The text is slightly blurred, and the background is white. Comparison of differences of technological characteristics between predicate device and submitted device. Image /page/7/Picture/3 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font at the top. Below the text is a shield-shaped emblem containing a circle with wavy lines and four stars. The wavy lines are arranged horizontally in the center of the circle, and the stars are positioned around the circle. {8}------------------------------------------------ ## K071564 PHILIPS Image /page/8/Picture/2 description: The image shows the Philips logo, which consists of the word "PHILIPS" above a shield-shaped emblem. Inside the shield, there are wavy lines representing water, a four-pointed star at the top, and another four-pointed star at the bottom. The logo is in black and white. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS", there is a handwritten string of characters that appears to be "KO71564". The text is black against a white background. Non-clinical and clinical performance data. Substantial equivalence is not based on non-clinical or clinical performance data. : Image /page/9/Picture/4 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font above a circular emblem. The emblem contains two wavy lines and four stars. . {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 3 1 2007 Philips Medical Systems c/o Mr. Rick Schul Senior Manager, Quality and Regulatory 3000 Minuteman Road Andover, MA 01810-1099 Re: K071564 Trade/Device Name: Motiva Monitor Device Connectivity Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitters and receivers Regulatory Class: Class II Product Code: DRG, DXN, FRW Dated: June 7, 2007 Received: June 7, 2007 Dear Mr. Schul: 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. {11}------------------------------------------------ #### Page 2 - Mr. Rick Schul 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Blymmma for Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {12}------------------------------------------------ #### Indications for Use 510(k) Number (if known): To be assigned Device Name: Motiva Monitor Device Connectivity Indications for Use: Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical healthrelated patient information. The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter, information derived from approved medical devices. Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional. Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No -(21 CFR 801 Subpart C) Rick Schul Quality & Regulatory Manager Philips Medical Systems : : Date: May 17, 2007 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bhammuma scular Devices 4 - 1