(52 days)
Not Found
No
The description focuses on vital sign measurement, data transmission, and display, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a vital signs monitor that retrospectively monitors vital signs and is not intended for emergency use or real-time monitoring, nor does it appear to be used for treatment purposes.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. This device is described as a "vital signs monitoring system" designed to "retrospectively monitor vital signs" and is "not intended for emergency use or real-time monitoring." While it collects data that could be used by a healthcare professional for diagnosis, its primary described function is monitoring rather than actively diagnosing. It measures parameters that are indicators of health/illness rather than directly identifying a disease or condition.
No
The device description explicitly states it is a "vital signs monitoring system" that "measures noninvasive blood pressure, pulse rate, and weight." It also mentions "four serial ports available for external options" and a "communication system." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Honeywell HomMed Genesis OTC Monitor 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, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Genesis OTC Monitor clearly states it measures vital signs like noninvasive blood pressure, pulse rate, and weight. These are direct physiological measurements from the patient, not analyses of biological specimens.
- The intended use and device description focus on monitoring vital signs directly from the patient. There is no mention of collecting or analyzing biological samples.
Therefore, the Honeywell HomMed Genesis OTC Monitor falls under the category of a vital signs monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DRG
Device Description
The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, and weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.
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
Not Found
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)
The Honeywell HomMed Genesis Monitor System (Genesis OTC and its predicate Genesis) utilized within the environments for which it is marketed performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices. Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The test results demonstrated that the Genesis is in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary Honeywell HomMed Genesis OTC Monitor System
9 2006
| Date: | April 11, 2006 |
|---|---|
| Consultant Contact: | Tommie J. Morgan, Ph.D., President |
| Morgan Consultants Inc. | |
| 2018 North Durham Drive | |
| Houston, TX 77008 | |
| 713.880.5111 Voice or 713.880.3494 Fax | |
| Company: | Michael Leigh, Director Regulatory/Quality |
| Honeywell HomMed, LLC | |
| 3400 Intertech Drive, Suite 200 | |
| Brookfield, WI 53045 | |
| 262.252.5794 Voice or 262.252.6119 Fax | |
| Trade Name: | Honeywell HomMed Genesis OTC Monitor |
| Common Name: | Vital Signs Monitor |
| Classification Name: | Cardiovascular and Respiratory Devices, Class II |
| Product Code: | NIBP Measurement System, DXN |
Predicate Device(s): HomMed Genesis Patient Monitor System K040799
The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring Device Description: The system measures noninvasive blood pressure, pulse rate, and svstem. weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.
The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively Indications for Use: monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, Data from optional commercial stand-alone products extend and weight. Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
- The Honeywell HomMed Genesis OTC is the remarketing of a previously Intended Use: approved product for OTC use. It is intended for personal use where use of the system allows retrospective review of certain physiological functions. The Genesis OTC collects vital signs data (including noninvasive blood pressure, pulse rate, and weight plus data from optional add-on devices) then can transmit the data to a central viewing station via a communication network. Genesis OTC Monitor is intended for use with adult and pediatric patients over twelve years of age.
Genesis OTC Monitor employs the same technologies as the predicate device, Technology: HomMed Genesis Patient Monitor System, K040799.
HomMed LLC G-OTC 510 Summary 4-06.doc
Page 1 of 2
4-11-06 Prepared by MCI
1
The Honeywell HomMed Genesis OTC Monitor complies with the following voluntary standards:
-
Medical Electrical Safety EN 60601-1
EMC Compliance -
IEC 601-1-2
. -
ISO 10993-5,10-11 Biocompatibility ●
-
The Honeywell HomMed Genesis Monitor System (Genesis OTC and its Test Summary: predicate Genesis) utilized within the environments for which it is marketed performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices. Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The test results demonstrated that the Genesis is in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.
-
It is the Honeywell HomMed position that the results of these evaluations Conclusion: demonstrate the Genesis OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device, HomMed Genesis Patient Monitor.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with a serpent coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2006
Honeywell HomMed, LLC c/o Tornmie J. Morgan, Ph.D. President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008
Re: K061087
Trade Name: Honeywell HomMed Genesis OTC Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: April 12, 2006 Received: April 18, 2006
Dear Dr. Morgan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 – Dr. Tommie Morgan
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Honeywell HomMed·Genesis OTC Monitor Device Name:
Indications For Use:
The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from Signs. Vitar Signe Include noninteers extend Genesis OTC Monitor's measurement ophonar commercial other proate control can be transmitted via a communication capabilitios. Data nom the station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
Prescription Use (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)
Page 1 of ___1