(52 days)
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 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.
The provided text is a 510(k) summary for the Honeywell HomMed Sentry OTC Monitor, which is a vital signs monitoring system. It leverages a predicate device (HomMed Sentry IIIB Patient Monitor System K040651) and highlights compliance with various voluntary standards.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for specific vital sign measurements (e.g., blood pressure accuracy in mmHg, pulse rate deviation). Instead, it uses a qualitative statement of compliance with standards and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1 (Medical Electrical Safety) | Demonstrated compliance |
| Compliance with IEC 601-1-2 (EMC Compliance) | Demonstrated compliance |
| Compliance with ISO 10993-5, 10-11 (Biocompatibility) | Demonstrated compliance |
| Performance consistent with FDA reviewer's guides for respiratory devices and electronic thermometers | "performs consistent with guidelines and standards" |
| Compliance with EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing | "demonstrate compliance with applicable standards" |
| Performance within specifications and functional requirements | "performed within its specifications and functional requirements" |
| As safe, as effective, and performs as well as the predicate device (HomMed Sentry IIIB Patient Monitor) | "results of these evaluations demonstrate the Sentry OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a defined sample size for clinical validation focusing on vital sign accuracy. The "Test Summary" refers to engineering and quality assurance testing (EMC, electrical, mechanical durability, safety, temperature/humidity).
- Sample Size for Test Set: Not specified for clinical performance validation. The document focuses on regulatory compliance testing.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified. The testing described appears to be laboratory-based engineering and quality assurance testing rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the testing described is primarily engineering and compliance-oriented, there is no mention of "experts" in the sense of clinical specialists establishing a "ground truth" for patient data. The ground truth for electrical, mechanical, and temperature/humidity tests would be established by reference standards and calibrated equipment.
4. Adjudication Method for the Test Set
Not applicable. The testing described does not involve a human-reader or diagnostic output that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an imaging or diagnostic device requiring human interpretation, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the testing described appears to be standalone performance of the device against engineering standards and compliance requirements. The statement "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..." implies standalone performance evaluation. No human interpretation of the output is involved for the device's basic function of measuring vital signs.
7. Type of Ground Truth Used
The ground truth used for the reported tests would be:
- Reference Standards/Calibrated Equipment: For electrical, mechanical, EMC, temperature, and humidity testing.
- Regulatory Standards: For safety and biocompatibility.
- Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence is the performance of the legally marketed predicate device, the HomMed Sentry IIIB Patient Monitor System (K040651). The device is stated to perform "as safe, as effective and performs as well as" the predicate.
8. Sample Size for the Training Set
Not applicable. This device is a vital signs monitor, not an AI/ML-based diagnostic algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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K06/088
510(k) Summary
Honeywell HomMed Sentry OTC Monitor
| Date: | April 11, 2006 JUN - 9 2006 |
|---|---|
| Consultant Contact: | Tommie J. Morgan, Ph.D., PresidentMorgan Consultants Inc.2018 North Durham DriveHouston, TX 77008713.880.5111 Voice or 713.880.3494 Fax |
| Company: | Michael Leigh, Director Regulatory/QualityHoneywell HomMed, LLC3400 Intertech Drive, Suite 200Brookfield, WI 53045262.252.5794 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 temperatureand weight. The Sentry OTC Monitor has six serial ports available for externaloptions. The Sentry OTC Monitor acquires the vital signs data and displays it. Thedata can be transmitted via the communication module to a central viewing station. |
| Indications for Use: | The Honeywell HomMed Sentry OTC Monitor is designed to retrospectivelymonitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oraltemperature and weight. Data from optional commercial stand-alone productsextend the Sentry OTC Monitor's measurement capabilities. Data from the SentryOTC Monitor can be transmitted via a communication module to a central viewingstation for display. The Sentry OTC Monitor is not intended for emergency use orreal-time monitoring. |
| Intended Use: | The Honeywell HomMed Sentry OTC is the remarketing of a previously approvedproduct for OTC use. It is intended for personal use and use of the system allowsretrospective review of certain physiological functions. The Sentry OTC collectsvital signs data (including noninvasive blood pressure, pulse rate, oraltemperature, and weight) then can transmit the data to a central review station viaa communication network. The Sentry OTC is intended for use with adult andpediatric 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
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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.
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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 (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
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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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§ 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).