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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Philips Motiva Monitor Device Connectivity.

This submission does not contain a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than providing detailed performance studies or specific acceptance criteria.

The document explicitly states: "Substantial equivalence is not based on non-clinical or clinical performance data." This means that the FDA's decision to clear this device was based on its similarity in intended use and technological characteristics to an existing device (BL Healthcare Remote Care Management System K051470), and not on a separate performance study with acceptance criteria.

Therefore, many of the requested points about acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable or findable within this specific 510(k) summary. I can, however, extract the comparative information that is present regarding technological characteristics and intended use.

Acceptance Criteria and Device Performance (Not applicable for this 510(k) summary)

As stated in the document, "Substantial equivalence is not based on non-clinical or clinical performance data." This means specific acceptance criteria and a performance study demonstrating the device meets them were not part of this 510(k) submission. The FDA cleared this device based on its substantial equivalence to a predicate device.

Details of the Substantial Equivalence Comparison (Not a performance study)

While not a performance study against acceptance criteria, the document does contain a comparison of technological characteristics and intended use between the subject device (Motiva Monitor Device Connectivity) and the predicate device (BL Healthcare Remote Care Management system K051470).

1. Table of Key Comparisons:

Feature	Predicate Device (BL Healthcare K051470)	Subject Device (Motiva Monitor Device Connectivity)	Comparison Outcome / Impact
Intended Use	Collect & transmit medical info (weight, BP, glucose) to healthcare provider.	Collect, document & transmit historical health-related patient info; communication tool for remote education, motivation, and communication; automatic collection of in-home patient parameters from approved medical devices.	Similar in core function. Motiva adds explicit communication/education aspects. No impact on safety/effectiveness.
Treatment Decisions	Not intended to provide time-sensitive data or alarms.	Not intended to provide automated treatment decisions, nor be a substitute for professional healthcare judgment.	Similar in intent to avoid automated decisions. No impact.
Professional Judgment	Interpretation requires clinical judgment by experienced medical professional.	All patient medical diagnosis and treatment by appropriate healthcare professional.	Same. No impact.
Data Collection Software	Proprietary Software	Proprietary Software	Same.
Communication Method (System)	Broadband Internet connection	Broadband Internet connection	Same.
Types of Sensors	Blood Pressure, Weight, Glucose levels	Blood Pressure, Weight, Glucose levels	Same.
Sensor Data Collection Implementation	External communication device	Un-modified off-the-shelf 510(k) approved sensors	Difference 1: Subject device is more direct, using approved measurement devices "as-is" with data transmitted via Bluetooth Adapter or wired interface cable. This is considered "similar but communication is more direct."
Hub-Device Communication	Wireless RF protocol	Bluetooth Serial Port Profile	Difference 2: Subject device uses Bluetooth, an industry-standard method, vs. predicate's proprietary RF. Considered "very similar but non-proprietary, industry standard communication method is employed."
Communications Protocol	Proprietary	Bluetooth v1.2	Difference 3: Subject device uses Bluetooth v1.2, an industry-standard protocol, vs. predicate's proprietary protocol. Considered "very similar but non-proprietary, industry standard communication method is employed."
Wireless Frequency	915MHz FCC assigned channel	2.402 to 2.480 GHz (FHSS) ISM Band	Difference 4: Subject device uses the 2.4 GHz ISM band, an industry-standard frequency, vs. predicate's 915MHz. Considered "very similar but non-proprietary, industry standard communication method is employed."
Video Conferencing	2-way video conference	Not applicable	Difference 5: Subject device does not have video conferencing. This is compensated by message capability and care plan responses, serving similar communication functions. Considered "similar, user to healthcare provider communications are accomplished with message capability and care plan responses."
Care Plan Surveys	Not applicable	May be completed if enabled by Healthcare Provider	Difference 6: Subject device has care plan surveys. Considered "responses to care plans serve as a form of communication similar to that which occurs with video conferencing."
Messages	Not applicable	Text messages between Healthcare Provider and patient	Difference 7: Subject device has text messaging. Considered "messages serve as a form of communication similar to that which occurs with video conferencing."

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable. The document explicitly states that substantial equivalence is not based on non-clinical or clinical performance data. Therefore, there was no "test set" in the context of device performance outlined in this 510(k).

3. Number of Experts and Qualifications:
* Not applicable. See point 2.

4. Adjudication Method:
* Not applicable. See point 2.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No. An MRMC study was not conducted or reported in this 510(k) summary. The claim of substantial equivalence was not based on human performance improvements with or without AI assistance.

6. Standalone Performance Study:
* No. A standalone algorithm performance study was not conducted or reported. The submission states, "Substantial equivalence is not based on non-clinical or clinical performance data."

7. Type of Ground Truth Used:
* Not applicable. Since no performance study was conducted, there was no ground truth established to evaluate the device's performance against.

8. Sample Size for the Training Set:
* Not applicable. This device is described as a "collection of off-the-shelf and custom designed Internet communication, audio / video interconnection devices and approved measuring devices." The "design of the device focuses largely on the software of the home and clinical user interfaces." There is no indication of a deep learning or AI model with a distinct "training set" in the modern sense that would require a ground truth for training within this document. The software itself is proprietary but isn't described as using a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
* Not applicable. See point 8.

Summary of 510(k) Approach:

This 510(k) submission for the Philips Motiva Monitor Device Connectivity relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (BL Healthcare Remote Care Management System K051470) based on:

Equivalent Intended Use: The overall purpose and clinical context are similar.
Similar Technological Characteristics: While there are some differences (e.g., Bluetooth vs. proprietary RF, direct sensor connection vs. external communication device), Philips argues that these differences do not raise new questions of safety or effectiveness. The new features like surveys and text messages are presented as alternative communication methods that achieve similar goals to the predicate's video conferencing.

The absence of detailed performance data, acceptance criteria, or clinical study results is consistent with a 510(k) pathway that primarily focuses on comparing the new device to a predicate, rather than proving a specific performance claim through novel studies.

Summary

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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 signaltransmitters and receivers (21 CFR 870.2910,Product Code DRG)

Legally Marketed Predicate Device:

Sponsor	Predicate Device	510(k) Number
BL Healthcare, Inc.	BL ManagementRemote CareManagement 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.

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Device Description

Overview

How the device functions

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.

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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.

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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: BLHealthcare RemoteManagement systemK051470	Motiva Monitor DeviceConnectivity	Impact of differencesto intended use ofdevice and safety andeffectiveness
The purpose of the BLHealthcare RemoteCare Managementsystem is to collect andtransmit medicalinformation such asweight, blood pressureand pulse rate, andblood glucose from thepatients on completionof their testing andtransmit these results totheir healthcare providerat another facility.	The Motiva MonitorDevice Connectivity isused in conjunction withMotiva's Guide Serviceas a communication toolenabling healthcareproviders the ability toremotely educate,motivate, andcommunicate with theirpatients, in combinationwith the ability toautomatically collect inhome patient parameterinformation derived fromapproved medicaldevices.	Same, no impact.
This system is installedby or with support fromtrained professionals.		Difference, IntendedUse Statement does notaddress installation. Noimpact as the MotivaSystem is installed bytrained professionalsaccording to establishedinstallation 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.

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く07月667 PHILIPS

Predicate Device: BLHealthcare RemoteManagement systemK051470	Motiva Monitor DeviceConnectivity	Impact of differencesto intended use ofdevice and safety andeffectiveness
This device is notintended to provide timesensitive data or alarms.	Motiva is not intended toprovide automatedtreatment decisions, noris it to be used as asubstitute forprofessional healthcarejudgment.	Difference, Intended usestatement does notaddress data andalarms specifically. Noimpact as intent to notprovide automatecdecisions is the same.
This system may not beused as a substitute fordirect medicalintervention oremergency care.	Motiva is not intended toprovide automatedtreatment decisions, noris it to be used as asubstitute forprofessional healthcarejudgment.	Same, No Impact.
Interpretation of theinformation collectedand transmitted requiresclinical judgment by anexperienced medicalprofessional.	All patient medicaldiagnosis and treatmentare to be performedunder the directsupervision andoversight of anappropriate healthcareprofessional.	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.

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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
TechnologicalCharacteristic
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 methodwith Remote CareManagement System	Broadband Internetconnection	Broadband Internetconnection	Same
Types of sensors whichcan be interfaced (wiredor wirelessly) to receiverhub	Blood PressureWeightGlucose levels	Blood PressureWeightGlucose levels	Same
Implementation methodof collecting clearanceby data from sensors	Externalcommunication device	Un-modified off-the-shelf 510(k) approvedsensors	Difference 1
Sensor Software	Unchanged	Unchanged	Same
Connectivity	Wireless to hub	Wireless to hub	Same
Communication methodof hub with devices	Wireless RF protocol	BluetoothSerial Port Profile	Difference 2
Communicationsprotocol	Proprietary	Bluetooth v1.2	Difference 3
Wireless frequency	915MHz FCC assignedchannel	2.402 to 2.480 GHz(FHSS)ISM Band	Difference 4
Device	BL HealthcareRemote ManagementsystemK051470	Motiva MonitorDevice Connectivity	Difference
TechnologicalCharacteristic
Power Source	Wall plug for hub (a/c)and batteries indevices	Wall plug for hub (a/c)and batteries for510(k) approvedsensor devices	Same
Display	On devices, hub, andmonitors connected toRemote CareManagement System	On 510(k) approvedsensor devices andTelevision connectedto Remote CareManagement System	Same
Video conferencing	2 way videoconference via abroadband internetconnection	Not applicable	Difference 5
Medicine reminders	The system remindsthe user to takemedication if theinformation isprogrammed by theHealthcare Provider	The system remindsthe user to takemedication if theinformation isprogrammed by theHealthcare Provider	Same
Video User Training	Instructional video clipsmay be viewed by theuser by selecting themfrom the menu ifenabled by theHealthcare Provider	Health conditionrelated educationalvideos may beviewed by the user byselecting them fromthe menu if enabledby the HealthcareProvider	Same
Care Plan Surveys	Not applicable	Care plan surveysmay be completed ifenabled byHealthcare Provider	Difference 6
Messages	Not applicable	Text messages maybe sent betweenHealthcare Providerand patient tocommunicate varioustypes of information	Difference 7
DeviceDifference #	BL HealthcareRemoteManagementsystemK051470	Motiva MonitorDevice Connectivity	Howtechnologicalcharacteristicsof submitteddevice compareto predicatedevice
1) Implementationmethod of collectingclearance by data fromsensors	Externalcommunicationdevice	Un-modified off-the-shelf 510(k) approvedsensors	Similar butcommunicationis more direct.No externalcommunicationdevice utilized.Approvedmeasurementdevices areutilized as-is withdata transmittedfrom approvedmeasurementdevices to SetTop Box viaBluetoothAdapter or wiredinterface cable.
2) Communicationmethod of hub withdevices	Wireless RFprotocol	BluetoothSerial Port Profile	Very similar butnon-proprietary,industrystandardcommunicationmethod isemployed.
DeviceDifference #	BL HealthcareRemoteManagementsystemK051470	Motiva MonitorDevice Connectivity	Howtechnologicalcharacteristicsof submitteddevice compareto predicatedevice
3) Communicationsprotocol	Proprietary	Bluetooth v1.2	Very similar butnon-proprietary,industrystandardcommunicationmethod isemployed.
4) Wireless frequency	915MHz FCCassigned channel	2.402 to 2.480 GHz(FHSS)ISM Band	Very similar butnon-proprietary,industrystandardcommunicationmethod isemployed.
5) Video conferencing	2 way videoconference via abroadband internetconnection	Not applicable	Similar, user tohealthcareprovidercommunicationsareaccomplishedwith messagecapability andcare planresponses.
6) Care Plan Surveys	Not applicable	Care plan surveysmay be completed ifenabled by HealthcareProvider	Responses tocare plans serveas a form ofcommunicationsimilar to thatwhich occurswith videoconferencing.
DeviceDifference #	BL HealthcareRemoteManagementsystemK051470	Motiva MonitorDevice Connectivity	Howtechnologicalcharacteristicsof submitteddevice compareto predicatedevice
7) Messages	Not applicable	Text messages maybe sent betweenHealthcare Providerand patient tocommunicate varioustypes of information	Messages serveas a form ofcommunicationsimilar to thatwhich occurswith videoconferencing.

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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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

Regulation Number and Section

§ 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).