The intended use of the HA System is for the collection, transmission, and persistence of medical measurement data and patient care data for the sole purpose of encouraging and tracking a patient's progress against the goals set between the Healthcare Professional and the patient. The goals would be established independent of the HA System in the pursuit of providing care for a chronic or post acute condition and/or to promote patient wellness.

The HA System would enable Healthcare Professionals to make use of the persisted information as a guide in delivering ongoing feedback to their patients, to set periodic reminders for patients to act on scheduled activities such as taking a vital measurement, and to receive notifications for events they configure such as ar out of range vital measurement.

The HA System can record physiological information such as:

Blood pressure measurements
Pulse rate measurements
Body weight measurements
Blood glucose levels
Body temperature measurements
Blood oxygen saturation (%SpO2) levels

The HA System can be used by Healthcare Professionals to create health related questionnaires, exercise plans and nutrition plans; to forward these items to the patients; and to receive the patient responses for the related questionnaires, exercise activities, and nutrition activities.

The HA System is not intended for diagnosis or as a substitute for medical care; it is also not intended to provide real-time data. The data is not used for time-critical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Device Description

The Healthanywhere (HA) System is a user-friendly software system which provides the ability to remotely monitor basic wellness parameters. The HA System is comprised of an HA Client Application, anHA Server and the Healthcare Professional Portal (HCPP).

The HA Client Application provides capabilities to perform data collection, data transmission, message display, reminders/notifications, and reporting. It is used to collect data including vital measurements from noninvasive, commercially available, off-the-shelf, wireless medical peripherals, and patient care updates. The user data is transmitted though the HA Client Application to the HA Server using off-the-shelf. FCCapproved wireless/cellular/wired connectivity (including but not limited to GPRS, CDMA, WiFi, or Wired Ethernet) which is provided through the FCC-approved host hardware platform or through an external FCC approved wireless adapter.

The HA Server hosts the Healthcare Professional Portal (HCPP), a web application which is used to administer the HA System and users. The HCPP application provides user registration, care management, us configuration set-up, and data management. Based on specific parameters set by Healthcare Professionals, reminders and messages are scheduled and sent from the HA Server to the HA Client Applications.

AI/ML Overview

The provided document is a 510(k) summary for the Healthanywhere (HA) System, which is a software system for remotely monitoring basic wellness parameters. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with detailed acceptance criteria and statistical analysis.

Based on the document, here's what can be extracted and what information is not provided:

Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in a measurable format often seen for diagnostic or AI-driven systems. Its focus is on the functional equivalence and safety of collecting, transmitting, and persisting medical data, rather than on the accuracy of an automated interpretation or diagnosis. The "performance" demonstrated is the ability to successfully perform these data management functions.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is for a data collection and transmission system, not an analytical or diagnostic device that typically requires a test set of medical data for performance validation.
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 provided and is not applicable to the type of device described. The HA System's purpose is to collect data, not to interpret or diagnose it using AI, thus no "ground truth" established by medical experts for a test set is relevant to this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable, as there is no test set for diagnostic accuracy or interpretation mentioned.
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
A MRMC study was not mentioned and is not applicable. The HA System is a data management tool, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not mentioned and is not applicable. The device's primary function is data collection and transmission, with human healthcare professionals ultimately using the data for guidance. There isn't an "algorithm-only" performance to evaluate in the context of diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not applicable. The device collects physiological data from FDA-approved peripherals; the ground truth for that data would be inherently provided by the measurement from the peripheral itself, not by a separate expert consensus or pathology review related to the HA System's function.
The sample size for the training set
This information is not provided and is not applicable. The HA System is a software system for data management and transmission, not a machine learning model that requires a training set.
How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no mention of a training set for a machine learning model.

Summary of the study/evidence provided (based on the document):

The Healthanywhere (HA) System's review focuses on demonstrating substantial equivalence to an existing predicate device, The Hermes System (K050929).

Acceptance Criteria (Implied for Substantial Equivalence):
The implicit acceptance criteria are that the HA System functions similarly to the predicate device in its intended use, technological characteristics, and safety profile. This means it can:
- Collect, transmit, and persist medical measurement data and patient care data.
- Support the specified physiological information (Blood pressure, Pulse rate, Body weight, Blood glucose, Body temperature, Blood oxygen saturation).
- Enable Healthcare Professionals to create questionnaires, exercise plans, and nutrition plans, and receive patient responses.
- Operate within the specified hardware and software platforms and connectivity methods.
- Maintain the same limitations and contraindications as the predicate (e.g., not for diagnosis, real-time data, or time-critical care).
Study/Proof of Acceptance:
The "study" or evidence presented for FDA clearance is a 510(k) comparison to a predicate device (The Hermes System, K050929). The document states:
- "The Healthanywhere System is substantially equivalent to The Hermes System (K050929) in that it allows patients to record data from equivalent devices using equivalent methods." (Page 3)
- The comparison focuses on the "intended use" and "technological characteristics" being similar.
This means the device meets its "acceptance criteria" by demonstrating that its fundamental nature, functionality, and safety are the same as another device already cleared by the FDA. There is no mention of a formal clinical performance study with statistical endpoints, sample sizes, or expert adjudication related to the HA System's data management capabilities in this document. The performance is assessed by showing it can successfully integrate with approved medical peripherals and transmit data reliably, similar to the predicate.

Summary

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··· Healthanywhere

510(k) Summary

Section 5

SEP 2 1 2009

Submitter:	Healthanywhere, Inc.
Address:	515 Legget Drive Suite 700
	Ottawa, ON K2K 3G4
	Canada
Phone number:	613-271-0283
Fax number:	613-271-9831
Contact person:	Shawn Slade, Director of Product Development and Operations
Date prepared:	8/28/2009
Trade name:	Healthanywhere System
Device classification:	870.2910, DRG, Physiological Transmitter and Receiver
Substantial equivalence claimed to:	The Hermes System, Palaistra Systems Inc, (K050929)

K091220

Device Description:

Intended use:

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*** Healthanywhere

Image /page/1/Picture/1 description: The image shows the text "Page" with the number "2" above and to the right of it. The word "of" is to the right of "Page", and the number "3" is above and to the right of "of". This appears to be indicating page 2 of 3.

The HA System can record physiological information such as:

Blood pressure measurements .
Pulse rate measurements
Body weight measurements .
. Blood glucose levels
Body temperature measurements .
� Blood oxygen saturation (%SpO2) levels

The HA System can be used by Healthcare Professionals to create health related questionnaires, exercise plans and nutrition plans; to forward these items to the patients; and to receive/review patient responses to the related questionnaires, exercise activities, and nutrition activities.

The HA System is not intended for diagnosis or as a substitute for medical care; it is alsonot intended to provide real-time data. The data is not used for time-critical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Summary of technological characteristics:

There are two distinct subsystems in the HA System – the client software runs on a Microsoft Windows and BlackBerry platforms; and the server components run on a LINUX platform hosted in a secure data centre.

The HA Client Application is distributed on the following hardware platforms: BlackBerry (models: 8100, 8120, 8130, 8300, 8320, 8330, 8820, 8830); PC (models: Samsung NP-Q1U Tablet PC, Dell Inspirion Mini 10 Notebook, Dell Latitude XT Tablet PC, Dell Optiplex SX280, ELO TouchSystems 17A2 Touchcomputer

The HA Client Application is a standalone software application which collects information from off-the-shel Bluetooth-enabled medical peripherals, such as a Blood Pressure monitor, using a Bluetooth wireless connection. To transmit data from the medical peripherals to the Healthanywhere Client Application, the HA Client Application makes use of the enibedded Bluetooth software on all of the hardware platforms listed above except for the Dell Optiplex SX280 and ELO TouchSystems 17A2 which require an external D-Link DBT-122 Bluetooth Adaptor. The following wireless, commercially-available medical peripherals are supported by the HA Client Application:

AND UA-767PBT Blood Pressure Monitor .
. AND UC-321PBT Weight Scale
Nonin 9560 Pulse Oximeter .
Polymap PWR-08-03 Bluetooth Adaptor ●

Note: The application supports manually entered thermometer measurements; the choice of a thermomet is based on user preference and is independent from the HA Client Application

The HA Client Application uses the internet to route information to the HA Server via HTTPS or SSL over HTTP protocols and maintains the data stack until an acknowledgement is transmitted from the server indicating that the information is successfully persisted in the server-side database. Periodically, the client application connects to the server to resynchronize with the updates set by the Healthcare Professional including patient care settings, reminders, and notifications via a secure connection over HTTPS. All platforms noted above connect to the internet via a customer preferred option and carrier or internet service provider using off-the-shelf, FCC approved wireless/cellular/wired connectivity (including but not limited to

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· Healthanywhere

GPRS, CDMA, WiFi, or Wired Ethernet) which is provided through the FCC-approved host hardware platform or through an external FCC approved wireless adapter.

The HCPP web application runs in any standard web browser. HCPP enables Healthcare Professionals to perform program administration and vital signs monitoring. HCPP uses role-based controls and patient group to limit access to the patient care data; only an authorized Healthcare Professional can access patient data within a specific group of patients. HCPP users can configure patient care based on individual patient assessments.

Substantial equivalence:

The Healthanywhere System is substantially equivalent to The Hermes System (K050929) in that it allows patients to record data from equivalent devices using equivalent methods.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with three waves emanating from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP & 1 2009

Healthanywhere, Inc. c/o Mr. Shawn Slade Director Product Development and Operations 515 Legget Drive, Suite 700 Ottawa, Ontario CANADA K2K 3G4

Re: K091220

Trade/Device Name: Healthanywhere (HA) System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: August 28, 2009 Received: September 11, 2009

Dear Mr. Slade:

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.

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Page 2 - Mr. Shawn Slade

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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ealthanywhere

Page 8 of 21

Section 4 Indications for Use Statement

K091220 510(k) Number: >

Device Name: Healthanywhere System

Indications for Use:

The HA System would enable Healthcare Professionals to make use of the persisted information as a guide i delivering ongoing feedback to their patients, to set periodic reminders for patients to act on scheduled activities such as taking a vital measurement, and to receive notifications for events they confenue such as ar out of range vital measurement.

The HA System can record physiological information such as:

Blood pressure measurements
Pulse rate measurements
Body weight measurements
Blood glucose levels
Body temperature measurements
Blood oxygen saturation (%SpO2) levels

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH. Offi Device Evaluation (ODE)

(Division Sign-Off Division of Cardiovascular Dev

Healthanywhere System

510(k) Number

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).