This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home.

This medical device is a software based device which runs on a Windows based Computer or netbook. This medical device receives readings from supported FDA approved devices in the home and serves as a remote communication link between the home and the physician or qualified medical provider. The physician or qualified medical provider will review the patient information from a web interface and may make medication changes and transmit those changes back to the patient for display on the Home Medical Station(HMS).

This medical device receives blood pressure, heart rate and blood glucose readings from the supported FDA approved medical devices via USB or serial connection to the HMS. The HMS communicates with the server via standard wireless or wired communication protocols such as cellular data, and wired or wireless internet.

HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-7901T and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink.

This medical device is automation of the exiting process of reporting results to the physician over the phone.

This medical device is not intended to provide real time monitoring. It is not intended for emergency calls or for transmission of any time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment.

This medical device uses standard communication protocols and encryption to protect patient privacy.

Device Description

The Ascot HMMS (Home Medical Monitoring System) is a software based device which receives readings in the home or clinical setting from various FDA approved devices (such as home Blood Pressure monitor with pulse or Glucose testing monitor) and transmits readings to the Ascot Central Server (ACS) for review by the Physician. If the Physician modifies medication dosages, the patient medication dosage instructions ordered by the Physician, are transmitted back to the patient and displayed on the HMS. Receipt of each transmission is confirmed within the system.

The Ascot HMMS (Home Medical Monitoring System) reduces risks to health because it speeds up the communication between the Physician and the patient. It improves accuracy because readings are transmitted directly from the home to server for later review by the Physician.

AI/ML Overview

The Ascot Home Medical Monitoring System (HMMS) is a software-based device intended to automate the process of reporting medical readings (blood pressure, pulse, blood glucose) from a patient's home to a physician and transmitting medication dosage changes back to the patient. It acts as a communication link between FDA-approved medical devices used at home and a central server for physician review.

Here's an analysis of the acceptance criteria and study information provided:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria with numerical thresholds for the device's performance. Instead, it focuses on the device's functional equivalence to predicate devices and its ability to accurately and securely transmit data and facilitate communication. The "acceptance criteria" are implied by the claims made and the comparison to predicate devices, which suggest the device must perform these functions reliably and securely.

Below is a table summarizing the claimed features and implied performance:

Acceptance Criteria (Implied)	Reported Device Performance (Ascot HMMS)
Data Upload Functionality	Yes, through standard RS232, Bluetooth, or USB Connection.
Data Support/Assistance	Through trained healthcare staff, staff training, written instructions & Ascot support.
Data Storage	On computer media.
Reports & Graphs Generation	Based on readings obtained.
Review Readings Interface	Web Interface.
Enable Patient & Healthcare Professional Sharing	Yes.
Provide Feedback to Patient	Yes, authorized by Physician only.
Support for Specific Devices	Blood glucose, non-invasive blood pressure. Specifically tested with: OneTouch Ultra Mini, OneTouch Ultra 2, OneTouch UltraLink (Blood Glucose Monitors); Omron HEM-790IT, HoMedics BPA-260-CB (Automatic Blood Pressure Monitors).
Intended for Home Setting Use	Yes.
Method of Transmitting Data to Physician	Transmitted across secure computer connection to Ascot server database. Eliminates reporting errors from manual methods.
Web Viewer for Physician Access	Yes.
No Diagnosis Provided	No. (Explicitly stated)
No Provision of New Prescriptions	New prescriptions are not handled or ordered in the HMMS. (Explicitly stated)
Security and Privacy	Uses standard communication protocols and encryption to protect patient privacy. (Explicitly stated)
Not a Primary Alarm Source / Not for Emergency Use	Not a primary alarm source. Not intended for emergency calls or time-critical data. Not a substitute for direct medical supervision or emergency intervention. (Explicitly stated)
Not a Substitute for Professional Healthcare Judgment	Not a substitute for professional healthcare judgment. (Explicitly stated)
Reducing Risks and Improving Accuracy (Comparative Claim)	Reduces risks to health because it speeds up the communication between the Physician and the patient. Improves accuracy because readings are transmitted directly from the home to server for later review by the Physician, eliminating reporting errors inherent in the former process (phone reporting). (Claimed benefit over existing manual process, not a direct performance metric).
Confirmation of Transmission and Receipt	Receipt of each transmission (readings to server, dosage instructions to patient) is confirmed within the system.
Physician Role and Qualifications	For review by the Physician (qualified medical professional who can change medication dosages, e.g., Nurse Practitioners or Physician Assistants).
Patient Option for Former Process	If the patient prefers, they may still report readings using the former process. (Functional flexibility)

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" sample size or data provenance in the context of an evaluative study that would typically be described for a diagnostic or AI/ML device. The submission focuses on functional equivalence to predicates and validation of data transmission capabilities. The "devices which have been tested to operate with the Ascot Home Medical Monitoring System" (OneTouch Ultra Mini, OneTouch Ultra 2, OneTouch UltraLink, Omron HEM-790IT, HoMedics BPA-260-CB) implicitly form the "test set" for demonstrating compatibility and successful data exchange, but no specific number of test cases or patients is provided for this. These are tests of system integration and function, not clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and therefore not provided in the document. The device is a data management and communication system, not a diagnostic tool that requires expert-established ground truth for its output. The "ground truth" for this device would be whether the data is transmitted accurately and securely, and if medication instructions are accurately displayed, functionality that is typically verified through system testing and validation rather than expert consensus on medical conditions.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in studies where a diagnosis or interpretation of medical images/data is being assessed for accuracy against a consensus ground truth. The Ascot HMMS does not provide diagnoses or interpretations.

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

An MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for devices that assist human readers in tasks like image interpretation or diagnosis. The Ascot HMMS is a data management and communication system, not an AI-assisted diagnostic tool.

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

This information is not applicable in the traditional sense. The device is a software system for data transmission and management, which inherently involves human interaction (patient providing readings, physician reviewing and giving instructions). Its performance is evaluated on its ability to accurately and securely transmit data, rather than on an "algorithm only" performance in a diagnostic context. The core function is providing the data to the human-in-the-loop (the physician) for their decision-making.

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

The document does not describe "ground truth" in terms of medical outcomes or diagnoses. For this device, the "ground truth" related to its performance would be the accurate and secure transmission of physiological readings from the patient device to the server, and the accurate display of physician-ordered medication changes to the patient. This would be established through technical validation and system testing, ensuring data integrity, security, and correct communication protocols, rather than medical consensus or pathology.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning algorithms is not applicable to this device as described. The Ascot HMMS is a software system for data management and transmission, not an AI/ML-based diagnostic or predictive algorithm that requires a training set.

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

As there is no described training set for an AI/ML algorithm, this information is not applicable.

Summary

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

K103643 P1/5

OCT - 6 2011

510(k) Summary

GENERAL COMPANY INFORMATION COMPANY NAME/ADDRESS/PHONE/FAX:

Ascot Technologies, Inc. 267 Hogans Valley Way Cary, NC 27513 Tel: 919-388-1776 Fax: 919-481-3203

NAME OF CONTACT:

Mary Ellen Randall President (919) 388-1776

DATE PREPARED:

Original December 8, 2010 Updated February 2, 2011 Updated September 18, 2011 Updated October 5, 2011

TRADE NAME:

Ascot Home Medical Monitoring System (HMMS)

COMMON NAME:

Health Management System Software

DEVICE NAME:

Ascot Home Medical Monitoring System (HMMS)

CLASSIFICATION NAME:

The following classifications appear applicable:

ProductCode	Classification Name	Class	CFRSection
DRG	Radiofrequency physiological signal transmitterand receiver	II	870.2910

COMPARISON TO PREDICATE DEVICE

We claim substantial equivalence to the currently legally cleared ACCU-CHEK® Advisor Insulin Guidance Software (K043529) and OneTouch® Zoom™ Diabetes Management Program (K081318), Confidant 2.6 (K083331), and FORA GW 9014 TeleHealth Gateway Telemedicine System (K100427).

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

K103643 P 2/5

COMPARISON TO PREDICATE DEVICE

Feature/Claim	ACCU-Chek®AdvisorSoftware	OneTouch®Zoom™DiabetesManagementProgram	Confidant2.6	FORATelehealthGateway	Ascot HMMS
Data Upload	Yes	No. Dataobtained fromDataVault	Yes throughstandardcommunicationtechnologies.	Yes throughstandardcommunicationtechnologies.	Yes throughstandardRS232,Bluetooth orUSBConnection
Support	Through callcentersupport,labeling &health careprofessionals	Unknown.	Unknown	Unknown	Throughtrained healthcare staff, stafftraining,writteninstructions &Ascot support.
Data Storage	On computermedia	On computermedia	On computermedia	On Computermedia	On computermedia
Reports &Graphs	Based onreadingsobtained	Based onreadingsobtained	Based onreadingsobtained	Based onreadingsobtained	Based onreadingsobtained
ReviewReadings	On Computer	Web Interface	On cellphone.	WebInterface	Web Interface
Enablespatient &health careprofessionalto sharereadings	Yes	Yes.	Yes.	Yes.	Yes.
Providesfeedback topatient	No.	No.	Yes.Automated.	No.	Yes.Authorized ByPhysician only.
DevicesSupported	BloodGlucose	Blood Glucose	Bloodglucose, non-invasivebloodpressure,weight.	Bloodglucose,bloodpressure,Weight,temp, bodyfat,hydration.	Blood glucose,non-invasiveblood pressure.
Feature/Claim	ACCU-Chek®AdvisorSoftware	OneTouch®Zoom™DiabetesManagementProgram	Confidant2.6	FORATelehealthGateway	Ascot HMMS
Intended Use:Home setting	Yes.	Yes.	Yes.	Yes.	Yes.
Method oftransmittingdata tophysician	Brought in atappointment,read offpatient'smachine orcalled in toPhysician.	Transmittedacrosscomputerconnection toremotedatabase hostedby Microsoft.	Unknown.Readings aretransmitted toa centraldatabase.	Transmittedacrossstandardcomputerconnection toremotedatabase.	Transmittedacross securecomputerconnection toAscot serverdatabase.
WebViewer	No. Patientbrings inreadings.	Readings readthroughHealthVaultaccount.	Feedback topatient's cellphone.	Yes.	Yes. Readingstransmittedeliminatingreportingerrors.
ProvidesDiagnosis	No.	No.	No.	No.	No.

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

K103643 p3/5

DEVICE DESCRIPTION

The HMMS is automation of the existing process of reporting readings to the physician over the phone and receiving verbal instructions for dosage changes. New prescriptions are not handled or ordered in the HMMS.

The Ascot HMMS (Home Medical Monitoring System) is a software based device which receives readings in the home or clinical setting from various FDA approved devices (such as home Blood Pressure monitor with pulse or Glucose testing monitor) and transmits readings to the Ascot Central Server (ACS) for review by the Physician. (For the purposes of this submission, Physician refers to a qualified medical professional who can change medication dosages, such as Nurse Practitioners or Physician Assistants.) If the Physician modifies medication dosages, the patient medication dosage instructions ordered by the Physician, are transmitted back to the patient and displayed on the HMS. Receipt of each transmission is confirmed within the system.

If the patient prefers, they may still report readings using the former process.

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

K103643 p4/5

Device Name	File Number	How Connected	Type Device
OneTouch Ultra Mini	K061118	Serial Cable	Blood GlucoseMonitor
OneTouch Ultra 2	K053529	Serial Cable	Blood GlucoseMonitor
OneTouch UltraLink	K073231	Serial Cable	Blood GlucoseMonitor
Omron HEM-790IT(Product Line extension ofModel HEM780N3)	K061822	USB Cable	Automatic BloodPressure Monitor(includes pulse)
HoMedics BPA-260-CB(Model HL868BF)	K092161	USB Cable	Blood PressureMonitor (includespulse)

Devices which have been tested to operate with the Ascot Home Medical Monitoring System include:

INTENDED USE

The HMMS is intended for use in the home or at clinical settings as a means to collect physiological readings, measured by FDA approved devices, and transmit to a Physician for review. The readings are accessed by a qualified medical professional (such as Physician or Nurse Practitioner) for review. The qualified medical professional may make medication dosage changes and transmit those changes back to the patient. The patient confirms the receipt of the medication changes are displayed on the patient's Ascot Home Medical Station (HMS).

The HMS receives readings measured by various FDA approved medical devices (such as blood pressure with pulse or blood glucose monitor) via standard connections including RS232, Bluetooth, or USB connection. The HMS communicates with the Ascot Central Server (ACS) via standard wireless or wired communication protocols including cellular data and wireless internet.

The HMMS does not make any decisions on the data that it conveys.

The HMMS does not provide diagnosis of any disease or medical condition.

The HMMS is not a substitute for professional healthcare judgment.

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

K103643 p5/5

The HMMS uses standard communication protocols and encryption to protect patient privacy.

The HMMS Viewer is not a primary alarm source.

The full viewer is for use by qualified medical personnel only.

There is a limited viewer interface for use by the patient in reviewing their own readings and staff for adding notes to patient file and follow up call, if instructed by Physician.

End of 510(k) Summary Section

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

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

Ascot Technologies, Inc. c/o Ms. Mary Ellen Randall President 267 Hogans Valley Way Cary, NC 27513

6 2011

Re: K103643

Trade/Device Name: Ascot Home Medical Management System (HMMS) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 18, 2011 Received: September 20, 2011

Dear Ms. Randall:

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.

{6}------------------------------------------------

Page 2 – Ms. Mary Ellen Randall

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number: K103643

Device Name: Ascot Home Medical Monitoring System (HMMS)

Prescription Use

This medical device is indicated for use by patients with known or suspected hypertension or diabetes that a physician wants to monitor blood pressure, pulse, and/or blood glucose at home.

HMMS has been tested to work with Homedics BPA-260-CBL, Omron HEM-7901T and OneTouch Ultra Mini, OneTouch Ultra 2 and OneTouch UltraLink.

This medical device is automation of the exiting process of reporting results to the physician over the phone.

This medical device does not provide diagnosis of any disease or medical condition and is not a substitute for professional healthcare judgment.

This medical device uses standard communication protocols and encryption to protect patient privacy.

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

r-The-Counter Use 1 CFR 801 Subpart C)

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

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103643

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).