(142 days)
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.
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.
The provided text is a 510(k) summary for the HomMed Genesis Patient Monitor System. It outlines the device description, intended use, and a comparison with a predicate device. However, it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria beyond general compliance with voluntary standards.
The summary states:
- "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: 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."
This indicates that the device's acceptance is primarily based on substantial equivalence to a predicate device and compliance with general safety and EMC standards, rather than specific performance metrics (like accuracy, sensitivity, specificity, etc.) for its vital sign measurements as would be expected for a diagnostic AI/ML device.
Therefore, many of the requested details about acceptance criteria and a study proving device performance cannot be extracted directly from this document.
Here's an attempt to answer based on the available information, noting the missing details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: | Not specified. The document states it "performs as well as the legally marketed predicate device, HomMed Sentry III Patient Monitor System with Card Reader." However, specific numerical performance metrics (e.g., accuracy, precision for blood pressure, pulse rate, oximetry, weight) are not provided as acceptance criteria, nor are corresponding results. |
| Safety: Medical Electrical Safety EN 60601-1 compliance | Complies with EN 60601-1 |
| EMC: EMC Compliance IEC 601-1-2 compliance | Complies with IEC 601-1-2 |
| Biocompatibility: ISO 10993-5,10-11 compliance | Complies with ISO 10993-5,10-11 |
Comment: The document focuses on regulatory compliance and equivalence rather than specific performance metrics for the vital sign measurements themselves. For a device measuring vital signs like blood pressure, pulse oximetry, and pulse rate, one would typically expect to see performance criteria related to accuracy, bias, and precision against a reference standard. These are absent here, likely because the 510(k) process in this instance relies heavily on the predicate device's established performance.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document does not describe a clinical performance study with a test set.
- Data Provenance: Not applicable, as no specific performance study with a test set is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no specific performance study with a ground truth-established test set is detailed.
4. Adjudication method for the test set
- Not applicable, as no specific performance study with a test set requiring adjudication is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic imaging tool with human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone vital signs monitor. Its performance is compared to a predicate device, and it complies with voluntary standards. However, the document does not detail specific standalone performance studies for accuracy of the vital sign measurements against a gold standard as one might see for an AI algorithm. Its function is to acquire and transmit data, not to perform complex algorithmic interpretations that require "human-in-the-loop" interaction in the typical AI/ML sense.
7. The type of ground truth used
- Not applicable, as no specific performance study with a ground truth is detailed. Performance is asserted based on technological equivalence to a predicate device and compliance with general safety standards.
8. The sample size for the training set
- Not applicable, as this device does not appear to involve AI/ML that would require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). It is a hardware system for measuring physiological parameters.
9. How the ground truth for the training set was established
- Not applicable.
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510(k) Summary
HomMed Genesis Patient Monitor System
| Date: | March 25, 2004 |
|---|---|
| Submitter: | HomMed, LLC19275 West Capitol Dr., Suite 200Brookfield, WI 53045262 783-5440 Voice262 783-5441 Fax |
| ConsultantContact: | Tommie J. Morgan, Ph.D., PresidentMorgan Consultants Inc.2018 North Durham DriveHouston, TX 77008713 880-5111 Voice713 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 (HomMedGenesis) is a portable patient vital signs monitoring system. The systemmeasures pulse oximetry (optional), noninvasive blood pressure, pulserate, and weight. HomMed Genesis will have four serial ports available forexternal options. The Genesis acquires the patient vital signs data anddisplays it. The data can also be transmitted via the communicationsystem through the Skytel or PageNet Pager Network to a central stationfor storage with retrospective display and analysis. |
| Intended Use: | Genesis is a system designed to monitor patient vital signs at home and/orin healthcare facilities. Vital signs include pulse oximetry (optional),noninvasive blood pressure, pulse rate, and weight. Vital signs data istransmitted 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) | |
|---|---|
| Division of Cardiovascular Devices | |
| K Number | K040799 |
| Page | 1 of 1 |
§ 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).