GENESIS DM MODEL: 6053000A1

K101242 · Honeywell Hommed, LLC · DRG · Jun 11, 2010 · Cardiovascular

Device Facts

• Record ID: K101242
• Device Name: GENESIS DM MODEL: 6053000A1
• Applicant: Honeywell Hommed, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

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 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.

Device Story

Genesis DM Monitor functions as a remote patient monitoring hub; collects vital sign data including noninvasive blood pressure, pulse rate, and weight; integrates data from optional commercial stand-alone medical devices. Device transmits collected data via communication module to central viewing station for clinician review. Used in home or clinical settings; operated by patients or healthcare providers. Output allows clinicians to retrospectively review patient physiological trends; supports clinical decision-making by providing longitudinal data. Benefits include improved patient management through remote monitoring without requiring real-time intervention.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing. Software validation confirmed compliance with FDA guidelines and functional specifications.

Technological Characteristics

Remote vital signs monitor; supports noninvasive blood pressure, pulse rate, weight, and other physiological signals via external modules. Connectivity via communication module to central viewing station. Software-based data collection and transmission. Complies with applicable electrical, mechanical, and EMC safety standards.

Indications for Use

Indicated for retrospective monitoring of vital signs, including noninvasive blood pressure, pulse rate, and weight, in patients requiring remote physiological data collection. Not for emergency use or real-time monitoring.

Regulatory Classification

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.

Predicate Devices

• HomMed Genesis OTC (K061087)
• Omron Automatic Blood Pressure Monitor Model:HEM-780N3 (K061822)

Submission Summary (Full Text)

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## 10/242 510(k) Summary for Honeywell HomMed Genesis DM Monitor

| Submitter: | | Honeywell HomMed, LLC | | | |
|-------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------|--|
| Address: | | 3400 Intertech Drive, Suite 200<br>JUN 1 1 2010<br>Brookfield, Wisconsin 53045 | | | |
| Corporate Contact: | | Emily Vande Hei, Regulatory Manager and Quality Champion<br>Honeywell HomMed, LLC | | | |
| Telephone: | | Ph: [phone]<br>Fax: [phone] | | | |
| Establishment Registration #: | | 3004183721 | | | |
| Submission Contact: | | Emily Vande Hei, Regulatory Manager and Quality Champion<br>Honeywell HomMed, LLC<br>3400 Intertech Drive, Suite 200<br>Brookfield, Wisconsin 53045<br>Ph: [phone]<br>Fax: [phone] | | | |
| Trade Name: | Genesis DM Monitor | | | | |
| Predicate Device: | HomMed Genesis OTC, K061087<br>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<br>edical device product codes also supported by Genesis DM by means<br>of separate medical devices | | |
| | 870.1130 | DXN | Noninvasive Blood Pressure Measurement<br>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<br>870-2340 | GIS | Test, Time, Prothrombin | II | |
| | 890.5060 | DPS<br>NXB | Electrocardiograph<br>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.

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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.

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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 [phone] or [phone] 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

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## 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