(39 days)
Not Found
No
The summary describes a device for retrospective vital sign monitoring and data transmission, with no mention of AI, ML, or related concepts.
No
The device is described as a monitor designed to retrospectively monitor vital signs, not to treat or cure any medical condition.
Yes
The device monitors vital signs (blood pressure, pulse rate, and weight) which are physiological parameters used to assess a patient's health status, thus aiding in diagnosis.
No
The device description explicitly mentions "Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display," indicating the presence of hardware components beyond just software. The performance studies also include "electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing," which are typical for hardware devices.
Based on the provided information, the Honeywell HomMed Genesis DM Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device monitors vital signs like noninvasive blood pressure, pulse rate, and weight. These are measurements taken directly from the patient's body, not from a sample in vitro (in a lab setting).
- Lack of Mention of Samples: There is no mention of collecting or analyzing biological samples.
Therefore, the Honeywell HomMed Genesis DM Monitor falls under the category of a medical device for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Honeywell HomMed Genesis DM 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 DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, FRI, DQA, NBW, BZH, FLL, GIS, DPS, NXB
Device Description
The Honeywell HomMed Genesis DM 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 DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime 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
Not Found
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)
Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The software validation results demonstrated that the Genesis DM Monitor was in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for software.
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.
HomMed Genesis OTC, K061087, Omron Automatic Blood Pressure Monitor Model:HEM-780N3, K061822
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
10/242 510(k) Summary for Honeywell HomMed Genesis DM Monitor
| Submitter: | Honeywell HomMed, LLC | ||||
|---|---|---|---|---|---|
| Address: | 3400 Intertech Drive, Suite 200 | ||||
| JUN 1 1 2010 | |||||
| Brookfield, Wisconsin 53045 | |||||
| Corporate Contact: | Emily Vande Hei, Regulatory Manager and Quality Champion | ||||
| Honeywell HomMed, LLC | |||||
| Telephone: | Ph: (262) 783-5440 | ||||
| Fax: (262) 783-5441 | |||||
| Establishment Registration #: | 3004183721 | ||||
| Submission Contact: | Emily Vande Hei, Regulatory Manager and Quality Champion | ||||
| Honeywell HomMed, LLC | |||||
| 3400 Intertech Drive, Suite 200 | |||||
| Brookfield, Wisconsin 53045 | |||||
| Ph: (262) 252-6082 | |||||
| Fax: (262) 252-6119 | |||||
| Trade Name: | Genesis DM Monitor | ||||
| Predicate Device: | HomMed Genesis OTC, K061087 | ||||
| Omron Automatic Blood Pressure Monitor Model:HEM-780N3, K061822 | |||||
| Common Name: | Patient Vital Signs Monitor | ||||
| Classification Name: | |||||
| 270.2910 | DRG | Radiofrequency Physiological Signal | II | ||
| 2019 10 | Transmitter and Receiver | ||||
| edical device product codes also supported by Genesis DM by means | |||||
| of separate medical devices | |||||
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement | |||
| System | II | ||||
| 880.2700 | FRI | Patient Weight Scale | I | ||
| 870.2700 | DQA | Oximeter | II | ||
| 862.1345 | NBW | Glucose Test System | II | ||
| 868.1860 | BZH | Meter, Peak Flow, Spirometry | II · | ||
| 880.2910 | FLL | Thermometer, Electronic, Clinical | II | ||
| 864.7750 | |||||
| 870-2340 | GIS | Test, Time, Prothrombin | II | ||
| 890.5060 | DPS | ||||
| NXB | Electrocardiograph | ||||
| Medication Reminder | II | ||||
| T |
Intended Use:
The Honeywell HomMed Genesis DM Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional
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commercial stand-alone products extend Genesis DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or realtime monitoring.
Performance Data:
Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The software validation results demonstrated that the Genesis DM Monitor was in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for software.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding medical device software.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Honeywell HomMed c/o Ms. Emily Vande Hei Regulatory Manager and Quality Champion 3400 Intertech Drive, Suite 200 Brookfield, WI 53045
JUN 1 1 2010
Re: K101242
Trade/Device Name: Genesis DM, Model 6053000A1 Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: DRG Dated: June 1, 2010 Received: June 3, 2010
Dear Ms. Vande Hei:
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. Iisting 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 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 – Ms. Emily Vande Hei
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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,
as 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):
101242
Device Name: Honeywell HomMed Genesis DM
Indications For Use:
Prescription Use
(Part 21 CFR 801 Subpart D)
The Honeywell HomMed Genesis DM 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, purc "weight" bala non" opilorial from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Million is not intended for emergency use or realtime monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. Watsd
Over-The-Counter Use _
(21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number