GENESIS OTC MONITOR

K061087 · Honeywell Hommed, LLC · DRG · Jun 9, 2006 · Cardiovascular

Device Facts

• Record ID: K061087
• Device Name: GENESIS OTC MONITOR
• Applicant: Honeywell Hommed, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Honeywell HomMed Genesis OTC Monitor is the remarketing of a previously approved product for OTC use. It is intended for personal use where use of the system allows retrospective review of certain physiological functions. The Genesis OTC collects vital signs data (including noninvasive blood pressure, pulse rate, and weight plus data from optional add-on devices) then can transmit the data to a central viewing station via a communication network. Genesis OTC Monitor is intended for use with adult and pediatric patients over twelve years of age.

Device Story

System for retrospective vital sign monitoring; measures noninvasive blood pressure, pulse rate, and weight; includes four serial ports for optional add-on devices. Device acquires data and displays it locally; transmits data via communication module to central viewing station. Intended for personal use by patients (adults/pediatric >12 years) in home settings. Not for emergency or real-time monitoring. Healthcare providers access transmitted data at central stations to review physiological trends. Benefits include remote patient monitoring and retrospective health tracking.

Clinical Evidence

Bench testing only. Testing included EMC, electrical safety, mechanical durability, and environmental (temperature/humidity) testing. Biocompatibility testing performed per ISO 10993-5, 10, and 11. No clinical data provided.

Technological Characteristics

Vital signs monitor with NIBP, pulse, and weight measurement capabilities. Features four serial ports for external device connectivity. Complies with EN 60601-1 (electrical safety), IEC 601-1-2 (EMC), and ISO 10993 (biocompatibility). Data transmission via communication module to central station.

Indications for Use

Indicated for retrospective monitoring of vital signs (noninvasive blood pressure, pulse rate, weight) in adult and pediatric patients over 12 years of age. Not intended 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 Patient Monitor System (K040799)

Submission Summary (Full Text)

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## 510(k) Summary Honeywell HomMed Genesis OTC Monitor System

9 2006

| Date: | April 11, 2006 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consultant 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 or 713.880.3494 Fax |
| Company: | Michael Leigh, Director Regulatory/Quality<br>Honeywell HomMed, LLC<br>3400 Intertech Drive, Suite 200<br>Brookfield, WI 53045<br>262.252.5794 Voice or 262.252.6119 Fax |
| Trade Name: | Honeywell HomMed Genesis OTC Monitor |
| Common Name: | Vital Signs Monitor |
| Classification Name: | Cardiovascular and Respiratory Devices, Class II |
| Product Code: | NIBP Measurement System, DXN |

Predicate Device(s): HomMed Genesis Patient Monitor System K040799

The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring Device Description: The system measures noninvasive blood pressure, pulse rate, and svstem. weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.

The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively Indications for Use: monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, Data from optional commercial stand-alone products extend and weight. Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.

- The Honeywell HomMed Genesis OTC is the remarketing of a previously Intended Use: approved product for OTC use. It is intended for personal use where use of the system allows retrospective review of certain physiological functions. The Genesis OTC collects vital signs data (including noninvasive blood pressure, pulse rate, and weight plus data from optional add-on devices) then can transmit the data to a central viewing station via a communication network. Genesis OTC Monitor is intended for use with adult and pediatric patients over twelve years of age.
Genesis OTC Monitor employs the same technologies as the predicate device, Technology: HomMed Genesis Patient Monitor System, K040799.

HomMed LLC G-OTC 510 Summary 4-06.doc

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4-11-06 Prepared by MCI

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The Honeywell HomMed Genesis OTC Monitor complies with the following voluntary standards:

- Medical Electrical Safety EN 60601-1
EMC Compliance

- IEC 601-1-2
.

- ISO 10993-5,10-11 Biocompatibility ●
- The Honeywell HomMed Genesis Monitor System (Genesis OTC and its Test Summary: predicate Genesis) utilized within the environments for which it is marketed performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices. Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The test results demonstrated that the Genesis is in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.
- It is the Honeywell HomMed position that the results of these evaluations Conclusion: demonstrate the Genesis OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device, HomMed Genesis Patient Monitor.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with a serpent coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

Honeywell HomMed, LLC c/o Tornmie J. Morgan, Ph.D. President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008

Re: K061087

Trade Name: Honeywell HomMed Genesis OTC Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: April 12, 2006 Received: April 18, 2006

Dear Dr. Morgan:

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, listing 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 such 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 – Dr. Tommie Morgan

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar for

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):

Honeywell HomMed·Genesis OTC Monitor Device Name:

Indications For Use:

The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from Signs. Vitar Signe Include noninteers extend Genesis OTC Monitor's measurement ophonar commercial other proate control can be transmitted via a communication capabilitios. Data nom the station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.

Prescription Use (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)

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