(142 days)
Not Found
Not Found
No
The document describes a system for collecting, transmitting, and displaying vital signs data retrospectively. There is no mention of AI, ML, or any form of automated analysis or interpretation of the data beyond simple display and storage. The analysis is performed by healthcare professionals.
No.
The device is a monitoring system that collects and transmits vital signs data for retrospective analysis by healthcare professionals, without providing real-time critical care monitoring or local alarms, indicating it is for observation rather than direct treatment.
No
Explanation: The device is described as a "Patient Monitor" system that measures vital signs and transmits data for display, analysis, and monitoring. It explicitly states it is "not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status," which differentiates it from a device primarily used for diagnosing a condition or disease. It collects data for retrospective analysis rather than direct diagnostic interpretation.
No
The device description explicitly states it is a "portable patient vital signs monitoring system" that "measures pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight." These are hardware-based measurements, indicating the device includes physical components beyond just software.
Based on the provided information, the HomMed Genesis Patient Monitor with Options is not an In Vitro Diagnostic (IVD) 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 HomMed Genesis monitors vital signs directly from the patient (pulse oximetry, blood pressure, pulse rate, weight). While it can import data from some stand-alone products that might involve specimens (glucose meter, prothrombin time), the core function of the Genesis itself is not the analysis of these specimens. It's a data collection and transmission device for vital signs.
The description clearly states it monitors "patient vital signs" and transmits this data for "display, analysis and monitoring by healthcare professionals." This aligns with the function of a patient monitor, not an IVD.
N/A
Intended Use / Indications for Use
The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status.
HomMed Genesis is intended for use with adult and pediatric patients over twelve years of age. The card reader functionality of HomMed Genesis allows a single patient to use multiple monitors or multiple patients to use a single monitor.
Product codes
DXN
Device Description
The HomMed Genesis Patient Monitor System with Options (HomMed Genesis) is a portable patient vital signs monitoring system. The system measures pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. HomMed Genesis will have four serial ports available for external options. The Genesis acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.
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 and/or in healthcare facilities. Healthcare professionals.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
HomMed Sentry III Patient Monitor System with Card Reader
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
510(k) Summary
HomMed Genesis Patient Monitor System
| Date: | March 25, 2004 |
|---|---|
| Submitter: | HomMed, LLC |
| 19275 West Capitol Dr., Suite 200 | |
| Brookfield, WI 53045 | |
| 262 783-5440 Voice | |
| 262 783-5441 Fax | |
| Consultant | |
| Contact: | Tommie J. Morgan, Ph.D., President |
| Morgan Consultants Inc. | |
| 2018 North Durham Drive | |
| Houston, TX 77008 | |
| 713 880-5111 Voice | |
| 713 880-3494 Fax | |
| Trade Name: | HomMed Genesis Patient Monitor System with Options |
| Common Name: | Patient Vital Signs Monitor with Options |
| Classification Name: | Oximeter |
| Classification Number: | DQA |
| Predicate Device(s): | HomMed Sentry III Patient Monitor System with Card Reader |
| Device Description: | The HomMed Genesis Patient Monitor System with Options (HomMed |
| Genesis) is a portable patient vital signs monitoring system. The system | |
| measures pulse oximetry (optional), noninvasive blood pressure, pulse | |
| rate, and weight. HomMed Genesis will have four serial ports available for | |
| external options. The Genesis acquires the patient vital signs data and | |
| displays it. The data can also be transmitted via the communication | |
| system through the Skytel or PageNet Pager Network to a central station | |
| for storage with retrospective display and analysis. | |
| Intended Use: | Genesis is a system designed to monitor patient vital signs at home and/or |
| in healthcare facilities. Vital signs include pulse oximetry (optional), | |
| noninvasive blood pressure, pulse rate, and weight. Vital signs data is | |
| transmitted via modem to a central viewing station for display, analysis |
Vital signs data is r display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status. Genesis is intended for use with adult and pediatric patients over twelve years of age. The card reader
1
functionality allows a single patient to use multiple monitors or multiple patients to use a single monitor.
- The HomMed Genesis employs the same technologies as the predicate Technology: device, HomMed Sentry III Patient Monitor System with Card Reader.
- The Genesis monitor complies with the following voluntary standards: Test Summary:
- Medical Electrical Safety EN 60601-1 . EMC Compliance IEC 601-1-2 .
- Biocompatibility ISO 10993-5,10-11 .
- It is the HomMed position that the results of these measures demonstrate Conclusion: HomMed Genesis is as safe, as effective and performs as well as the leqally marketed predicate device, HomMed Sentry III Patient Monitor System with Card Reader.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2004
HomMed, LLC c/o Tommie J. Morgan, Ph.D. President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008
Re: K040799
Trade Name: HomMed Genesis Patient Monitor System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 29, 2004 Received: July 30, 2004
Dear Dr. Morgan:
We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your bection 310(x) pennially equivalent (for the indications felerenced above and have determined ly marketed predicate devices marketed in interstate for use stated in the chelosure) to regarry maneton in the Medical Device American be and Ford. For d. First commerce prior to May 28, 1776, the enaordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the dev devices that have been recalismed in assessoval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, manece the de requirements for annual registration, listing of general controls provisions of the rice 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 If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major and division FDA may be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of I can's concerning your device in the Federal Register.
3
Page 2 - Tommie J. Morgan, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination dots not mean Please be advised that FDA s issualled of a button complies with other requirements of the Act that FDA has made a decemination that your steered by other Federal agencies. You must or any Federal statures and regulations administers of a limited to: registration and listing (21 comply with all the Act s requirements, moractice requirements as setting practice requirements as sets CFK Part 807), labeling (21 CFR Part 820); and If applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation confior provisions (Declons of Colorions of Concelled in your Section 510(k)
This letter will allow you to begin marketing your device as described in your This letter will anow you to begin manteeing your intileting your device to a legally premarket nothleadon. The PDA maining of basification 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 If you ucsire specific advice for your of 1011) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whsolanding by reference to premariconsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil Rf Ogden
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):
HomMed Genesis Patient Monitor with Options Device Name:
Indications For Use:
The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status.
HomMed Genesis is intended for use with adult and pediatric patients over twelve years of age. The card reader functionality of HomMed Genesis allows a single patient to use multiple monitors or multiple patients to use a single monitor.
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 | |
| K Number | K040799 |
| Page | 1 of 1 |