The VoCare MyHealth Tablet™ is a remote patient monitor device available by prescription. The VoCare MyHealth Tablet™ is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The VoCare MyHealth Tablet™ provides quidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology.

The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The VoCare MyHealth Tablet™ stores and displays the information on the LCD screen and transmits the information to the VoCare secure host server using FCC approved Wi-Fi or Ethernet.

Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.

The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

A list of devices that are compatible with the VoCare MyHealth Tablet™ will be available in the user's manual and the VoCare website.

Device Description

The VoCare MyHealth Tablet™ is a remote patient monitoring device available via prescription.

The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server. Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System.

The VoCare System consists of:

VoCare System Hardware:
The physical component of VoCare System is the VoCare MyHealth Tablet™, which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera, microphone, speaker, and a reminder light mounted on top left corner of the case. The VoCare MyHealth Tablet™ contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls.
VoCare MyHealth Tablet™ Software Application:
The VoCare MyHealth Tablet™ executes the VoCare MyHealth Tablet™ Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server.
VoCare Clinician Access System (CAS) Software Application:
The VoCare Clinician Access System (CAS), which is associated with and manages multiple VoCare MyHealth Tablet™ devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition.

The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when, timecritical care is not required. The system is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the VoCare MyHealth Tablet™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for performance metrics.

Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the format requested. It focuses on non-clinical testing and substantial equivalence.

Here's an analysis of the information available in the document related to your questions:

Acceptance Criteria and Device Performance

The document does not explicitly define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a medical device that performs diagnosis or classification. The "acceptance criteria" here relate to the successful completion of non-clinical engineering and usability tests.

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance
Bench Testing (VoCare procedures & specifications)	"The results demonstrated that the VoCare System met performance and design specification requirements." (Specific metrics are not detailed).
Usability Testing (duplicated operating conditions)	"The results demonstrated that the VoCare System met performance and design specification requirements." (Specific usability metrics or outcomes are not detailed).
Performance Standards Testing (IEC 60601-1, IEC 60601-1-2)	"The results demonstrated that the VoCare System met performance and design specification requirements." (Compliance with these general electrical safety and electromagnetic compatibility standards is indicated, but specific test values are not provided).
Substantial Equivalence to Predicate Devices	The VoCare System is deemed "substantially equivalent to the predicate devices in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source and display method."

Specific Study Details Not Applicable/Provided

Given this is a 510(k) submission based on non-clinical testing and substantial equivalence, the following points are largely not applicable or not provided in the document:

Sample size used for the test set and the data provenance: Not applicable as there isn't a "test set" in the context of clinical performance metrics for diagnosis/classification. The non-clinical testing likely involved a limited number of devices/systems under test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, was not established for this submission. The "ground truth" for non-clinical engineering tests would be the established engineering specifications.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a remote patient monitoring system, not an AI-powered diagnostic tool requiring MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a system for collecting and transmitting data; it does not perform "standalone" diagnostic algorithms. It facilitates data collection for human review.
The type of ground truth used: For regulatory purposes in this 510(k), the "ground truth" for the non-clinical tests was adherence to engineering specifications and international standards (IEC 60601-1, IEC 60601-1-2).
The sample size for the training set: Not applicable. This is not a machine learning/AI diagnostic model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of the Device and Submission Type

The VoCare MyHealth Tablet™ is a remote patient monitoring system intended to connect to various medical sensors (glucose meters, weight scales, blood pressure monitors, pulse oximeters), collect and display data, and transmit it to a secure server for healthcare professionals to review.

Key points from the submission:

Intended Use: Remote patient monitoring, not diagnosis or real-time data for time-critical care.
Non-Clinical Testing: Bench testing, usability testing, and compliance with IEC 60601-1 and IEC 60601-1-2 standards were performed.
Conclusion: The non-clinical tests demonstrated the system met performance and design specifications. The device was deemed substantially equivalent to predicate devices based on technological characteristics and intended use.

This 510(k) submission demonstrates that for a device like the VoCare MyHealth Tablet™ (a data collection and transmission system), the regulatory burden is met through non-clinical engineering and usability testing, as well as by demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than through clinical studies with specific diagnostic acceptance criteria.

Summary

{0}------------------------------------------------

DEC - 2 2011

510(K) Summary

VoCare, Inc. VoCare MyHealth Tablet™

K111922

Premarket Notification

SUBMITTED BY

VoCare, Inc. Purdue Technology Center 5225 Exploration Drive Indianapolis, IN 46241 USA

ESTABLISHMENT REGISTRATION NUMBER Pending

Pending

OWNER/OPERATOR NUMBER

CONTACT PERSON

Primary Steve Peabody CEO and President VoCare, Inc. Phone: 317.973.1003 Fax: 765.482.5003

Alternate Ed Leer Chief Information Officer VoCare, Inc. Phone: 317.973.1003 Fax: 765.482.5003

SUBMISSION PREPARED BY Bonnie Butner VoCare, Inc. Phone: 317.973.1003

June 22, 2011 DATE PREPARED

CLASSIFICATION NAME Transmitters and Receivers, Physiological Signal, Radiofrequency

DEVICE CLASS

REGULATION NUMBER 870.2910 (Product Code DRG)

Remote Patient Monitoring System

Class II

VoCare MyHealth Tablet™ PROPRIETARY NAME

IDENTIFICATION OF PREDICATE DEVICE(S)

Predicate devices include:

Intel Health Guide PHS6000 (K080798) -
MedApps 2.0 (K083862) -
Waldo Health Waldo Patient Monitor -(K110334)

VoCare Inc. 5225 Exploration Drive Indianapolis, IN 46261 USA

COMMON NAME

Phone: 317-973-1003
Fax: 765-482-5003
Page 1 of 3

{1}------------------------------------------------

KII1922

DEVICE DESCRIPTION

The VoCare MyHealth Tablet™ is a remote patient monitoring device available via prescription.

The VoCare System consists of:

1. VoCare System Hardware:
  The physical component of VoCare System is the VoCare MyHealth Tablet™, which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera, microphone, speaker, and a reminder light mounted on top left corner of the case. The VoCare MyHealth Tablet™ contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls.
1. VoCare MyHealth Tablet™ Software Application:
  The VoCare MyHealth Tablet™ executes the VoCare MyHealth Tablet™ Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server.
1. VoCare Clinician Access System (CAS) Software Application:
  The VoCare Clinician Access System (CAS), which is associated with and manages multiple VoCare MyHealth Tablet™ devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition.

Care Inc. 5225 Exploration Drive Indianapolis, IN 46261 USA

Phone: 317-973-1003
Fax: 765-482-5003

Page 2 of 3

{2}------------------------------------------------

INDICATIONS FOR USE

The VoCare MyHealth Tablet™ is a remote patient monitoring device. The VoCare MvHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The VoCare MyHealth Tablet™ stores and displays the information on the LCD screen and transmits the information to the VoCare secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, or Ethernet.

Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.

The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

A list of devices that are compatible with the VoCare System will be available in the user's manual and the VoCare website.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The VoCare System is substantially equivalent to the predicate devices in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source and display method.

DISCUSSION OF NON-CLINICAL TESTING

Non-clinical testing consisted of bench testing using VoCare procedures and specifications, usability testing under duplicated operating conditions and performance standards testing in accordance with IEC 60601-1 and IEC 60601-1-2. The results demonstrated that the VoCare System met performance and design specification requirements.

CONCLUSIONS

The subject and predicate device(s) are substantially equivalent in terms of intended use and technological characteristics. Non-clinical mechanical test results demonstrate that the VoCare System performance is satisfactory and suitable for its intended use.

VoCare Inc. 5225 Exploration Drive Indianapolis, IN 46261 USA

Phone: 317-973-1003
Fax: 765-482-5003

Page 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized emblem with three curved shapes, resembling a person or a symbol of support. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.

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

DEC - 2 2011

VoCare, Inc. c/o Mr. Steve Peabody CEO and President Purdue Technology Center 5225 Exploration Drive Indianapolis, IN 46241

Re: K111922

Trade/Device Name: VoCare MyHealth Tablet™ (Remote Patient Monitoring System) Regulation Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: Class II (two) Product Code: DRG Dated: October 31, 2011 Received: November 1, 2011

Dear Mr. Peabody:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

Page 2 - Mr. Steve Peabody

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 (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/ReportalProblem/default.htm for the CDRI4'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.

signature

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

VoCare MyHealth Tablet™

Indications for Use:

Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.

A list of devices that are compatible with the VoCare MyHealth Tablet™ will be available in the user's manual and the VoCare website.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K111922

Page 1 of 1

VoCare Inc 5225 Exploration Drive Indianapolis, IN 46261 USA

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).