GENESIS TOUCH SYSTEM by HONEYWELL HOMMED, LLC

The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmitted.via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional.

The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.

Device Description

The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System uses text and voice prompts to help the user acquire vital signs information. Once all data is collected, it is forwarded at the user's discretion, as a data packet to a central viewing station for retrospective review by a healthcare provider. The Genesis Touch Retrospective Physiological Monitoring System is intended for use with adult and pediatric patients over twelve years of age. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring.

AI/ML Overview

The provided text does not contain specific acceptance criteria or reported device performance metrics in a tabular format. It focuses on regulatory aspects and substantial equivalence to a predicate device rather than detailed performance study results.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table specifying acceptance criteria (e.g., minimum accuracy percentages, specific thresholds for vital sign measurement agreement) or corresponding quantitative device performance results. The performance section mentions "Risk based verification and validation testing" but does not elaborate on specific metrics or acceptance thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "Due to the equivalent indications for use of this system to its predicate, no clinical tests were performed as part of the performance testing." This implies that there was no dedicated test set with human or patient data for a clinical performance study of the Genesis Touch System itself, as its performance relies on the FDA-cleared wireless medical devices it connects to.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

As no clinical tests were performed, there were no experts used to establish ground truth for a test set related to the Genesis Touch System's vital sign measurement accuracy. The system's function is data collection, display, and transmission, relying on the accuracy of connected, already-cleared medical devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set for performance was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or reported. The device is a "Retrospective Physiological Monitoring System" that collects and transmits data; it is not an AI-driven diagnostic tool that would typically involve human reader improvement studies.

6. Standalone Performance:

The document states, "Risk based verification and validation testing based on FDA guidance... was performed to ensure that the data is collected and transmitted as intended to the central server."

While this indicates standalone testing of the software's functionality, it does not provide specific standalone performance metrics like accuracy, sensitivity, or specificity for vital sign measurements, as the device itself does not measure vital signs directly but rather collects them from other FDA-cleared devices. The "performance" refers to the correct collection, display, and transmission of data.

7. Type of Ground Truth Used:

For the "Risk based verification and validation testing," the ground truth would likely be established by:

Known input values: For data collection and transmission tests, the input from the connected vital sign devices would be considered the "ground truth" for what the system should collect and transmit.
System specifications/requirements: The ground truth for software functionality would be whether the software performs according to its defined specifications for data handling, user interface, and communication protocols.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI, as the device is described as a "proprietary software application" for data collection and transmission, not an AI model that requires training.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI model.

Summary

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K11 2858 pg 1 of 3

JAN 2 4 2012

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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92 Honeywell HomMed Genesis™ Touch System

(a) (1) Submitter:		Honeywell HomMed, LLC
Address:		3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045
Corporate Contact:		Greg Lillegard, Director of QualityHoneywell HomMed, LLC
Telephone:		Ph: (262) 252-262-6062Fax: (262)252-262-6119
Establishment Registration #:		3004183721
Submission Contact:		Honeywell HomMed, LLCPh: (262) 252-5838Fax: (262) 252-6119Date: 09/27/2011	Claudia Jackson, Regulatory Affairs Specialist3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045
(2) Trade Name:	Honeywell HomMed Genesis Touch System
(3) Predicate Device:	Honeywell HomMed Genesis DM, K101242
Common Name:	Patient Vital Signs Monitor
Classification Name:
	RegulationNumber	Code		DeviceClass
	870.2910	DRG	Radiofrequency Physiological SignalTransmitter and Receiver	II
	Medical device product codes also supported by Genesis Touch System

DXN

FRI

DQA

870.1130

880.2700

870.2700

(4) Device Description:

System

Oximeter

by means of separate medical devices

Patient Weight Scale

Noninvasive Blood Pressure Measurement

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Monitoring System is intended for use with adult and pediatric patients over twelve years of age. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring.

(5) Indications for Use:
The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure. pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmitted via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional.

The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve vears of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.

(6) Technological Characteristics:
Genesis Touch Retrospective Physiological Monitoring System (Genesis Touch System) is substantially equivalent to the predicate device. HomMed Genesis DM. K101242 as an application of a dedicated software/hardware platform, with the function of data collection and display from standard parameters such as interfaceable peripheral medical device types, data transmission, and communication to the central server.

Genesis Touch Retrospective Physiological Monitoring System is a proprietary software application that operates on a dedicated commercially available off the shelf (COTS) touch screen tablet with the minimum performance specifications consistent with typical tablet computer hardware and equipment specifications.

(b) Performance Data:
The Genesis Touch System is a proprietary software application running on a dedicated tablet platform with minimum performance specifications consistent with typical tablet computer hardware and equipment specifications. Similar to the dedicated software/hardware platform functionality of the Genesis DM (K101242) operating system, the Genesis Touch application restricts, or "locks down", the system's functionality such that the user cannot install other programs, nor use the device for any other purpose other than the intended use.

Genesis Touch System is substantially equivalent to the predicate device, Honeywell HomMed Genesis DM, K101242, as a dedicated software/hardware platform application, for user vital signs data collection and display from noninvasive medical device peripherals, as well as communication and transmission of the data to a central server for retrospective review.

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K112858 pg. 3 of 3

Risk based verification and validation testing based on FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff and in accordance with FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained on Medical Devices" was performed to ensure that the data is collected and transmitted as intended to the central server.

The Honeywell HomMed Genesis Touch System complies with the following voluntary standard:

Medical Device Software Software Life Cycle Processes . IEC 62304
Due to the equivalent indications for use of this system to its predicate, no clinical tests were performed as part of the performance testing.

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

JAN 2 4 2012

Honeywell HomMed c/o Ms. Claudia Jackson 3400 Intertech Dr., Suite 200 Brookfield, WI 53045

Re: Ki12858

Trade/Device Name: Genesis Touch System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: January 9, 2012 Received: January 10, 2012

Dear Ms. Jackson:

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.

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Page 2 - Ms. Claudia Jackson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be actived 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 of A rat 607), havese events) (21 CFR 803); good manufacturing practice requirements as set Gorth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand by over of 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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Indications for Use

510(k) Number (if known): K112858

Honeywell HomMed Genesis Touch System Device Name:

Indications For Use:

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

Over-The-Counter Use X (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	Page 1 of
510(k) Number	K112858

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).