(85 days)
Not Found
No
The description focuses on data collection, communication, and automated task assignment based on pre-defined rules and thresholds, not on learning or adaptive algorithms.
No
The device is described as a communication tool for remote patient management, collecting and transmitting information, but explicitly states it is not intended to provide automated treatment decisions or act as a substitute for professional healthcare judgment.
No
The device collects, documents, and transmits health-related patient information and data from approved medical devices (like blood pressure monitors, glucose meters, and weight scales) to healthcare providers. However, the "Intended Use" explicitly states that "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." This indicates it's a communication and data collection tool, not a device that makes a diagnosis itself.
No
The device description explicitly mentions the use of hardware components such as "Internet Protocol Set Top Box," "Blood Pressure Monitor," "Glucose Meter," and "Weight Scale," which are integral to the system's functionality. While software is a key component, the system relies on these physical devices for data collection and communication.
Based on the provided information, the Motiva device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Motiva is used to collect, document, and transmit historical health-related patient information and to enable communication between healthcare providers and patients. It explicitly states it is not intended to provide automated treatment decisions or be a substitute for professional healthcare judgment. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details how Motiva collects data from approved medical devices (like blood pressure monitors, glucose meters, and weight scales) and facilitates communication. It does not describe any process of analyzing biological samples or performing diagnostic tests on specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Motiva appears to be a remote patient monitoring and communication system that integrates data from other medical devices, rather than a device that performs diagnostic testing itself.
N/A
Intended Use / 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.
Product codes
DRG, DXN, FRW
Device Description
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.
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.
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
Used in non-clinical settings; home patients; healthcare providers; healthcare professional.
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
Substantial equivalence is not based on non-clinical or clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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