(116 days)
Not Found
No
The summary describes a system for collecting, displaying, and transmitting vital signs data for retrospective review. There is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function within the device. The performance studies focus on data collection and transmission accuracy, not on the performance of any analytical algorithms.
No
The device is described as a "Retrospective Physiological Monitoring System" that collects, displays, and transmits vital signs for retrospective review. It is explicitly stated that it is "not intended for emergency use or real-time monitoring" and "does not have auditory or visual alarms for out-of-limit parameters," indicating it is for monitoring purposes, not active treatment or therapy.
No
This device is for monitoring and transmitting vital signs for retrospective review, not for diagnosing medical conditions. It explicitly states it is "not intended for emergency use or real-time monitoring" and lacks alarms, pointing away from a diagnostic function.
No
The device description explicitly states it collects data from "commercially available FDA cleared wireless medical devices designed for home use," indicating it interacts with and relies on external hardware components for data acquisition. While the Genesis Touch System itself might be primarily software, its function is dependent on these external hardware devices.
Based on the provided text, the Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Genesis Touch system clearly states it monitors vital signs like blood pressure, pulse oximetry, pulse rate, weight, and temperature. These are direct physiological measurements from the patient, not analyses of bodily specimens.
- The intended use and device description focus on collecting, displaying, and transmitting vital signs data. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System falls under the category of a physiological monitoring system, not an IVD.
N/A
Intended Use / 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 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.
Product codes
DRG, DXN, FRI, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients over twelve years of age
Intended User / Care Setting
Home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Due to the equivalent indications for use of this system to its predicate, no clinical tests were performed as part of the performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K11 2858 pg 1 of 3
JAN 2 4 2012
【】
I
II
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 200 | ||||
| Brookfield, Wisconsin 53045 | |||||
| Corporate Contact: | Greg Lillegard, Director of Quality | ||||
| Honeywell HomMed, LLC | |||||
| Telephone: | Ph: (262) 252-262-6062 | ||||
| Fax: (262)252-262-6119 | |||||
| Establishment Registration #: | 3004183721 | ||||
| Submission Contact: | Honeywell HomMed, LLC | ||||
| Ph: (262) 252-5838 | |||||
| Fax: (262) 252-6119 | |||||
| Date: 09/27/2011 | Claudia Jackson, Regulatory Affairs Specialist | ||||
| 3400 Intertech Drive, Suite 200 | |||||
| Brookfield, 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: | |||||
| Regulation | |||||
| Number | Code | Device | |||
| Class | |||||
| 870.2910 | DRG | Radiofrequency Physiological Signal | |||
| Transmitter 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:
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
System
Oximeter
by means of separate medical devices
Patient Weight Scale
Noninvasive Blood Pressure Measurement
1
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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.
4
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
5
Indications for Use
510(k) Number (if known): K112858
Honeywell HomMed Genesis Touch System Device Name:
Indications For Use:
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.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
1
(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 |