PATIENT DATA HANDLER & DEVICES (PDH&D)

K063484 · Intermed Advisors, Inc. · DRG · Dec 22, 2006 · Cardiovascular

Device Facts

• Record ID: K063484
• Device Name: PATIENT DATA HANDLER & DEVICES (PDH&D)
• Applicant: Intermed Advisors, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The PDH&D is indicated for use in non-clinical settings to collect and transmit historical patient data to healthcare professionals to help support effective management of their patients.

Device Story

PDH&D system collects historical physiological data—blood glucose, blood pressure, weight, peak flow, oxygen saturation—from peripheral biometric devices; transmits data via Bluetooth to Patient Data Handler (PDH); PDH forwards data to central Data Center via phone line or cable modem. Healthcare providers/care managers access patient data via InterMed Patient Provider Online Tool (IPPOT) secure website. System acts as communication tool; does not provide automated treatment decisions or replace professional judgment. Used in non-clinical settings; operated by patients/caregivers. Output enables provider review of historical trends to support chronic disease management.

Clinical Evidence

No clinical data. Bench testing only; verification and validation activities confirmed device performance according to requirements and specifications.

Technological Characteristics

System includes PDH unit and peripheral biometric devices. Data transmission: Bluetooth (peripheral to PDH), phone line/cable modem (PDH to Data Center). Connectivity: Networked via secure website (IPPOT) requiring username/password. Software: Web-based interface for provider data review.

Indications for Use

Indicated for patients in non-clinical settings requiring collection and transmission of historical physiological data (blood glucose, blood pressure, weight, peak flow, oxygen saturation) to healthcare professionals for disease management.

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

• Health Hero Network, Health Buddy Appliance, #K050567 (and K060843)
• A&D Medical UA-767PBT Digital Blood Pressure Monitor, # K043217

Submission Summary (Full Text)

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K063484

DEC 2 2 2006

### 510(K) SUMMARY

| SUBMITTER'S NAME: | InterMed Advisor's, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT INFORMATION: | 828 Massachusetts Avenue<br>Arlington, MA 02476<br>Phone: [phone]<br>Fax: [phone] |
| CONTACT PERSON: | Christina Vullo, Director of Regulatory Affairs |
| DATE PREPARED: | September 29, 2006 |
| TRADE NAME: | Patient Data Handler & Devices (PDH&D) |
| COMMON NAME: | Patient Data Handler & Devices (PDH&D) |
| CLASSIFICATION NAME: | Radiofrequency Physiological Signal Transmitter<br>and Receiver (21 CFR 870.2910, Product Code<br>DRG) |
| PREDICATE DEVICES: | Health Hero Network, Health Buddy Appliance,<br>#K050567 (and K060843)<br>A&D Medical UA-767PBT Digital Blood Pressure<br>Monitor, # K043217 |
| INDICATIONS FOR USE: | The PDH&D is indicated for use in non-clinical<br>settings to collect and transmit historical patient<br>data to healthcare professionals to help support<br>effective management of their patients. |
| DEVICE DESCRIPTION: | The PDH&D includes the Patient Data Handler<br>(PDH) and peripheral biometric devices for the<br>monitoring of chronic diseases. It is intended to be<br>used as a communication tool, enabling Healthcare<br>Providers and Care Managers to receive historical<br>patient data including blood glucose levels, blood<br>pressure, weight, peak flow volume, and oxygen<br>saturation levels. Providers may review patient<br>information over the InterMed Patient Provider<br>Online Tool (IPPOT).<br><br>The PDH&D is not intended to provide automated<br>treatment decisions, nor is it to be used as a<br>substitute for a professional healthcare judgment. |

InterMed Advisors, Inc. Premarket Notification - September 29, 2006
Patient Data Handler & Devices

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All patient medical diagnosis and treatment are to

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be performed under the supervision and oversight of a healthcare professional.

#### TECHNOLOGICAL CHARACTERISTICS:

The PDH&D securely transmits physiological patient data from biometric devices to InterMed's Data Center. The data transfer between peripheral devices and the PDH occurs via Bluetooth Radio. This is the same platform used by the A&D Medical UA-767PBT Digital Blood Pressure Monitor. The data transfer between the PDH and the Data Center occurs via a phone line or cable modem. The Data Center may generate session content that is downloaded onto individual PDH units. The IPPOT is available for viewing by Care Managers and Care Providers over a secure website. It requires a username and password for security purposes.

#### NONCLINICAL TESTS:

CONCLUSIONS:

Nonclinical tests were performed to ensure the safety and efficacy of the PDH&D.

The results of Verification and Validation activities have indicated that the PDH&D performs according to requirements and specifications and represents a residual minor risk to the user. They support InterMed's determination of substantial equivalence.

InterMed Advisors, Inc. Premarket Notification - September 29, 2006 Patient Data Handler & Devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2006

Intermed Advisors, Inc. c/o Daniel W. Lehtonen Director of Regulatory Affairs 828 Massachusetts Avenue Arlington, MA 02476

Re: K063484

Trade/Device Name: Patient Data Handler and Devices (PDH&D) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: December 7, 2006 Received: December 8, 2006

Dear Mr. Lehtonen:

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.

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

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#### Page 2 - Mr. Lehtonen

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

B. Zimmerman Jr.

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

Enclosure

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11063484 510(k) Number (if known):

Device Name:_Patient Data Handler & Devices (PDH&D)

Indications for Use:

The PDH&D is indicated for use in non-clinical settings to collect and transmit historical patient data to healthcare professionals to help support effective management of their patients.

B. Bummmo

Division Sign-Off Division of Cardiovascular Devices 510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use AND/OR (21 CFR 807 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

InterMed Advisors, Inc. Premarket Notification - September 29, 2006 Patient Data Handler & Devices

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