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 Description

The PDH&D includes the Patient Data Handler (PDH) and peripheral biometric devices for the monitoring of chronic diseases. It is intended to be used as a communication tool, enabling Healthcare Providers and Care Managers to receive historical patient data including blood glucose levels, blood pressure, weight, peak flow volume, and oxygen saturation levels. Providers may review patient information over the InterMed Patient Provider Online Tool (IPPOT).

The PDH&D is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

AI/ML Overview

The provided K063484 510(k) submission for the Patient Data Handler & Devices (PDH&D) does not contain the detailed acceptance criteria and study information typically found for devices that rely on performance metrics to establish substantial equivalence.

Instead, this submission primarily focuses on establishing substantial equivalence based on technological characteristics and nonclinical tests related to safety and efficacy, without reporting specific performance metrics against pre-defined acceptance criteria.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, sensitivity, specificity, data transmission success rate). The submission generally states the device "performs according to requirements and specifications."
Reported Device Performance: No specific numerical performance figures are provided. The conclusion states "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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided, as there is no indication of a study involving expert-established ground truth for performance evaluation of patient data. The device's function is data collection and transmission, not diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified, as there's no indication of a study involving human interpretation or adjudication for the device's function.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool; it's a data handler and transmitter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the "Nonclinical Tests" section describes activities that would be considered standalone testing of the device's functionality: "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..."
However, the specific metrics and results of these standalone tests are not detailed. The focus is on the secure transmission of data via Bluetooth and phone/cable modem.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the nonclinical tests mentioned, the "ground truth" would likely be the expected behavior of the device based on its design specifications. For example, successful data transmission (data sent matches data received), correct display of information on the IPPOT, and adherence to security protocols. It wouldn't involve clinical "ground truth" like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable/Not specified. The PDH&D is a data handling and transmission device, not a machine learning or AI-driven system that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary of what is present in the submission regarding performance:

The submission focuses on nonclinical Verification and Validation (V&V) activities to demonstrate "safety and efficacy" and that the device "performs according to requirements and specifications."

Key aspects highlighted in the "TECHNOLOGICAL CHARACTERISTICS" section, implicitly forming the basis for performance evaluation, include:

Secure transmission of physiological patient data from biometric devices to InterMed's Data Center.
Data transfer between peripheral devices and the PDH via Bluetooth Radio (same platform as a predicate device).
Data transfer between the PDH and the Data Center via phone line or cable modem.
The Data Center generates session content for PDH units.
The IPPOT (InterMed Patient Provider Online Tool) is available over a secure website, requiring username and password.

The "CONCLUSION" states that these V&V activities support substantial equivalence and indicate "a residual minor risk to the user."

In essence, this 510(k) submission establishes substantial equivalence primarily through comparison of technological characteristics to a predicate device and general statements about successful nonclinical testing, rather than through a detailed breakdown of clinical performance metrics against specific acceptance criteria.

Summary

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K063484

DEC 2 2 2006

510(K) SUMMARY

SUBMITTER'S NAME:	InterMed Advisor's, Inc.
CONTACT INFORMATION:	828 Massachusetts AvenueArlington, MA 02476Phone: (781) 648-4935Fax: (866) 639-3935
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 Transmitterand Receiver (21 CFR 870.2910, Product CodeDRG)
PREDICATE DEVICES:	Health Hero Network, Health Buddy Appliance,#K050567 (and K060843)A&D Medical UA-767PBT Digital Blood PressureMonitor, # K043217
INDICATIONS FOR USE:	The PDH&D is indicated for use in non-clinicalsettings to collect and transmit historical patientdata to healthcare professionals to help supporteffective management of their patients.
DEVICE DESCRIPTION:	The PDH&D includes the Patient Data Handler(PDH) and peripheral biometric devices for themonitoring of chronic diseases. It is intended to beused as a communication tool, enabling HealthcareProviders and Care Managers to receive historicalpatient data including blood glucose levels, bloodpressure, weight, peak flow volume, and oxygensaturation levels. Providers may review patientinformation over the InterMed Patient ProviderOnline Tool (IPPOT).The PDH&D is not intended to provide automatedtreatment decisions, nor is it to be used as asubstitute 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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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).