SENTRY OTC MONITOR

K061088 · Honeywell Hommed, LLC · DRG · Jun 9, 2006 · Cardiovascular

Device Facts

• Record ID: K061088
• Device Name: SENTRY 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 Sentry OTC is the remarketing of a previously approved product for OTC use. It is intended for personal use and use of the system allows retrospective review of certain physiological functions. The Sentry OTC collects vital signs data (including noninvasive blood pressure, pulse rate, oral temperature, and weight) then can transmit the data to a central review station via a communication network. The Sentry OTC is intended for use with adult and pediatric patients over twelve years of age.

Device Story

Vital signs monitoring system for home use; collects noninvasive blood pressure, pulse rate, oral temperature, and weight data. Device displays collected data and transmits it via communication module to central viewing station for retrospective review by healthcare providers. Not for emergency or real-time monitoring. Intended for adult and pediatric patients over 12 years old. System supports optional commercial stand-alone products to extend measurement capabilities. Healthcare providers use transmitted data to review physiological trends; supports remote patient management workflows.

Clinical Evidence

Bench testing only. Testing included EMC, electrical safety, mechanical durability, and environmental (temperature/humidity) testing. Device performance was evaluated against applicable FDA reviewer's guides for respiratory devices and electronic thermometers. No clinical data provided.

Technological Characteristics

Vital signs monitor with serial ports for external modules. Complies with EN 60601-1 (electrical safety), IEC 601-1-2 (EMC), and ISO 10993-5, 10-11 (biocompatibility). Connectivity via communication module to central station. Standalone/networked architecture.

Indications for Use

Indicated for retrospective monitoring of vital signs (noninvasive blood pressure, pulse rate, oral temperature, weight) in adult and pediatric patients over 12 years of age. 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 Sentry IIIB Patient Monitor System (K040651)

Submission Summary (Full Text)

{0}------------------------------------------------

K06/088

## 510(k) Summary

## Honeywell HomMed Sentry OTC Monitor

| Date: | April 11, 2006 JUN - 9 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 Sentry OTC Monitor |
| Common Name: | Vital Signs Monitor |
| Classification Name: | Cardiovascular and Respiratory Devices, Class II |
| Product Code: | NIBP Measurement System, DXN |
| Predicate Device: | HomMed Sentry IIIB Patient Monitor System K040651 |
| Device Description: | The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system.<br>The system measures noninvasive blood pressure, pulse rate, oral temperature<br>and weight. The Sentry OTC Monitor has six serial ports available for external<br>options. The Sentry OTC Monitor acquires the vital signs data and displays it. The<br>data can be transmitted via the communication module to a central viewing station. |
| Indications for Use: | The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively<br>monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral<br>temperature and weight. Data from optional commercial stand-alone products<br>extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry<br>OTC Monitor can be transmitted via a communication module to a central viewing<br>station for display. The Sentry OTC Monitor is not intended for emergency use or<br>real-time monitoring. |
| Intended Use: | The Honeywell HomMed Sentry OTC is the remarketing of a previously approved<br>product for OTC use. It is intended for personal use and use of the system allows<br>retrospective review of certain physiological functions. The Sentry OTC collects<br>vital signs data (including noninvasive blood pressure, pulse rate, oral<br>temperature, and weight) then can transmit the data to a central review station via<br>a communication network. The Sentry OTC is intended for use with adult and<br>pediatric patients over twelve years of age. |

- The Honeywell HomMed Sentry OTC Monitor employs the same technologies of Technology: the predicate device, HomMed Sentry IIIB Patient Monitor System, K040651.
HomMed LLC S-OTC 510 Summary 4-06.doc

Page 1 of 2

Image /page/0/Picture/7 description: The image shows a series of connected circles and lines. The circles are arranged horizontally and are connected by horizontal lines above and below them. The last circle on the right has a diagonal line extending from its upper right side.

4-11-06
Prepared by MCI

{1}------------------------------------------------

The Honeywell HomMed Sentry Monitor(s) complies with the following voluntary standards:

- . EN 60601-1
- Medical Electrical Safety
- IEC 601-1-2 .
- EMC Compliance
- . ISO 10993-5,10-11 Biocompatibility
- Test Summary: The Honeywell HomMed Sentry System (Sentry OTC and its predicate Sentry IIIB) 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 and electronic thermometers. Completed EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing demonstrate compliance with applicable standards. The test results demonstrated that the Sentry 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.
- Conclusion: It is the Honeywell HomMed position that the results of these evaluations demonstrate the Sentry OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device, HomMed Sentry IIIB Patient Monitor.

Page 2 of 2

Image /page/1/Picture/10 description: The image shows a drawing of a train. The train has a series of connected cars, each with a rounded bottom. There are horizontal lines above the cars, possibly representing the train tracks or the roof of the train. The drawing is simple and appears to be hand-drawn.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

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

Re: K061088

Trade Name: Honeywell HomMed Sentry 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.

{3}------------------------------------------------

## 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,

Bhimimar for

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

K0101088 510(k) Number (if known):

Honeywell HomMed Sentry OTC Monitor Device Name:

Indications For Use:

The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral temperature and weight. Data from optional commercial stand-alone products extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Sentry 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)

Page 1 of

Bhummanan

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K061088

Image /page/4/Picture/13 description: The image shows a close-up of a braided or woven material. The material appears to be made of thin strands that are interlaced to create a textured pattern. The strands are dark in color, and the overall appearance of the material is somewhat rough and uneven. The braid is made of two strands that are woven together.