HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
Device Facts
| Record ID | K040799 |
|---|---|
| Device Name | HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS |
| Applicant | Hommed, LLC |
| Product Code | DXN · Cardiovascular |
| Decision Date | Aug 18, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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 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 functionality allows a single patient to use multiple monitors or multiple patients to use a single monitor.
Device Story
Portable patient vital signs monitor; measures pulse oximetry, noninvasive blood pressure, pulse rate, and weight. Features four serial ports for external options; supports data export from glucose meters, spirometers, and prothrombin time devices. Operates in home or healthcare facilities; used by patients and monitored by healthcare professionals. Data transmitted via modem to central station for retrospective display and analysis; no local alarms or real-time critical care monitoring. Card reader allows multi-patient/multi-monitor flexibility. Benefits include remote patient monitoring and longitudinal data tracking for clinical decision-making.
Clinical Evidence
Bench testing only. Compliance with EN 60601-1, IEC 601-1-2, and ISO 10993-5, 10-11 standards demonstrated.
Technological Characteristics
Portable monitor with serial ports for external sensors. Measures pulse oximetry, NIBP, pulse rate, weight. Connectivity via modem for data transmission to central station. Biocompatibility per ISO 10993-5, 10-11. Electrical safety per EN 60601-1; EMC per IEC 601-1-2.
Indications for Use
Indicated for adult and pediatric patients over 12 years of age for monitoring vital signs including pulse oximetry, noninvasive blood pressure, pulse rate, and weight in home or healthcare settings. Not for real-time critical care monitoring.
Regulatory Classification
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.
Predicate Devices
- HomMed Sentry III Patient Monitor System with Card Reader
Submission Summary (Full Text)
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## 510(k) Summary
## HomMed Genesis Patient Monitor System
| Date: | March 25, 2004 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | HomMed, LLC<br>19275 West Capitol Dr., Suite 200<br>Brookfield, WI 53045<br>262 783-5440 Voice<br>262 783-5441 Fax |
| Consultant<br>Contact: | Tommie J. Morgan, Ph.D., President<br>Morgan Consultants Inc.<br>2018 North Durham Drive<br>Houston, TX 77008<br>713 880-5111 Voice<br>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<br>Genesis) is a portable patient vital signs monitoring system. The system<br>measures pulse oximetry (optional), noninvasive blood pressure, pulse<br>rate, and weight. HomMed Genesis will have four serial ports available for<br>external options. The Genesis acquires the patient vital signs data and<br>displays it. The data can also be transmitted via the communication<br>system through the Skytel or PageNet Pager Network to a central station<br>for storage with retrospective display and analysis. |
| Intended Use: | Genesis is a system designed to monitor patient vital signs at home and/or<br>in healthcare facilities. Vital signs include pulse oximetry (optional),<br>noninvasive blood pressure, pulse rate, and weight. Vital signs data is<br>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
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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.
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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.
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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
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## 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) | |
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| Division of Cardiovascular Devices | |
| K Number | K040799 |
| Page | 1 of 1 |
