(52 days)
Not Found
No
The summary describes a vital signs monitor that collects and transmits data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function.
No.
The device is described as a vital signs monitor that retrospectively monitors vital signs and is not intended for emergency use or real-time monitoring. It does not provide any therapeutic intervention.
No.
The device is designed to retrospectively monitor vital signs and transmit that data, but it is explicitly stated that it is "not intended for emergency use or real-time monitoring," which are common characteristics of diagnostic devices used to make immediate medical decisions. It monitors rather than diagnoses.
No
The device description explicitly states it is a "vital signs monitoring system" that "measures noninvasive blood pressure, pulse rate, oral temperature and weight." It also mentions "six serial ports available for external options" and a "communication module," all of which indicate the presence of hardware components beyond just software. The performance studies also mention testing for "EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity," further confirming it is a hardware device with integrated software.
Based on the provided information, the Honeywell HomMed Sentry OTC 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 Honeywell HomMed Sentry OTC Monitor measures vital signs directly from the patient's body (noninvasive blood pressure, pulse rate, oral temperature, and weight). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs, not performing diagnostic tests on biological samples.
Therefore, the device falls under the category of a vital signs monitor, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
DXN, DRG
Device Description
The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature and weight. The Sentry OTC Monitor has six serial ports available for external options. The Sentry OTC Monitor acquires the vital signs data and displays it. The data can be transmitted via the communication module to a central viewing station.
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
adult and pediatric patients over twelve years of age.
Intended User / Care Setting
personal use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HomMed Sentry IIIB Patient Monitor System K040651
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 |
| Morgan Consultants Inc. | |
| 2018 North Durham Drive | |
| Houston, TX 77008 | |
| 713.880.5111 Voice or 713.880.3494 Fax | |
| Company: | Michael Leigh, Director Regulatory/Quality |
| Honeywell HomMed, LLC | |
| 3400 Intertech Drive, Suite 200 | |
| Brookfield, WI 53045 | |
| 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. |
| The system measures noninvasive blood pressure, pulse rate, oral temperature | |
| and weight. The Sentry OTC Monitor has six serial ports available for external | |
| options. The Sentry OTC Monitor acquires the vital signs data and displays it. The | |
| 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 |
| 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. | |
| 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. |
- 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
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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.
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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
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