Central Station's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. The Central Station displays the data and system alerts for review and interpretation by a healthcare professional. Central Station is not intended for emergency use or real-time monitoring.

Device Description

AI/ML Overview

The provided text describes the Honeywell HomMed Central Station, Version 3.5, a software system for retrospectively receiving, displaying, and storing monitored vital signs parameters and related data.

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

Acceptance Criteria (Functional/Specification Requirements)	Reported Device Performance
Compliance with guidelines and standards referenced in FDA reviewer's guides	Demonstrated compliance with guidelines and standards.
Performance within specifications and functional requirements for software	Performed within its specifications and functional requirements for software.
Ability to retrospectively receive, display, and store monitored vital signs parameters and related data	Intended and validated to retrospectively receive, display, and store monitored vital signs parameters and related data.
Display of data and system alerts for review and interpretation by a healthcare professional	Displays data and system alerts for review and interpretation by a healthcare professional.
Acceptance of data from Honeywell HomMed Patient Monitors (Sentry and Genesis) and Honeywell HomMed MedPartner	Accepts data from these specified devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" in the traditional sense of a clinical or image-based study. The performance data section refers to "software validation results." This suggests that the testing was primarily focused on the software's functionality, data integrity, and compliance with specifications, rather than a clinical trial with patient data.

Sample Size for Test Set: Not specified, but likely refers to various data inputs and scenarios used during software validation.
Data Provenance: Not specified. Given the nature of a software validation for a "Central Station," it's probable that various types of simulated or recorded vital signs data would have been used to test the system's ability to receive, display, and store. It's not a direct patient study with geographical or temporal data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For a software system like the Central Station, "ground truth" would likely refer to the correctness of the data received, displayed, and stored, and the proper functioning of alerts based on predefined thresholds. The "experts" would likely be software testers, quality assurance personnel, and potentially clinical subject matter experts validating the accuracy of the displayed information against expected results. However, their numbers and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that this is a software system for data display and storage, traditional adjudication methods for diagnostic images or clinical outcomes might not directly apply. The "adjudication" would likely be the verification of software outputs against expected behavior, potentially involving multiple testers or a structured review process, but no specific method is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a "Central Station" software system, not an AI-powered diagnostic tool that directly assists human readers in interpreting medical images or making clinical diagnoses. Its function is to display and store vital signs data for review by healthcare professionals.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The entire study implicitly describes a standalone performance, as the "Central Station" software is the primary subject. The "software validation results demonstrated that the Central Station 3.5 System was in compliance... and that it performed within its specifications and functional requirements for software." This indicates a focus on the algorithm's direct functionality in processing and presenting data. However, it's crucial to understand that while the software operates standalone in processing, its intended use is for review and interpretation by a healthcare professional, meaning it's inherently part of a human-in-the-loop workflow.

7. Type of Ground Truth Used

The ground truth for this device would be defined by the correctness of software functionality and data integrity. This means:

The system accurately receives data from specified patient monitors.
The system accurately displays the vital signs parameters and related data.
The system accurately stores the data.
System alerts function correctly based on intended logic.
The software complies with established guidelines and standards.

This is fundamentally a functional and performance validation against predefined software requirements and industry standards, rather than a clinical ground truth like pathology or patient outcomes.

8. Sample Size for the Training Set

This information is not applicable/not provided. The Honeywell HomMed Central Station is described as a software system that receives, displays, and stores vital signs data. It is not an AI/ML device that requires a "training set" in the context of machine learning model development. The software's logic and functionality are likely rule-based or algorithmic, programmed to perform specific tasks, rather than learned from a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of software device.

Summary

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K0534/53

510(k) Summary for Honeywell HomMed Central Station

Submitter:	Honeywell HomMed, LLC	MAY - 5 2006
Address:	3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045
Corporate Contact:	Michael Leigh, Director of Regulatory/QualityHoneywell HomMed, LLC
Telephone:	Ph: (262) 783-5440Fax: (262) 783-5441
Establishment Registration #:	3004183721
Submission Contact:	Tommie J. Morgan Ph.D., PresidentMorgan Consultants, Inc.2018 North DurhamHouston, Texas 77008Ph: (713) 880-5111Fax: (713) 880-3494
Trade Name:	Central Station, Version 3.5
Predicate Device:	HomMed Central Station
Common Name:	Patient Vital Signs Monitor Viewing Station
Classification Name:	Non-Invasive Blood Pressure Measurement SystemProduct Code: DXN

Intended Use:

Performance Data:

Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. Central Station accepts data from Honeywell HomMed Patient Monitors (Sentry and Genesis) as well as the Honeywell HomMed MedPartner. The software validation results demonstrated that the Central Station 3.5 System 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.

510 Summary CS 3.5.doc

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Image /page/1/Picture/0 description: The image shows the logos for Honeywell and HomMed. The Honeywell logo is on top, and the HomMed logo is below it. To the right of the logos is a medical symbol that includes a heart and wings.

STERILIZATION STATEMENT OF NON-APPLICABILITY

STERILIZATION INFORMATION

Sterilization issues do not apply to this Honeywell HomMed Central Station and associated hardware components or attachments used with Central Station une they are not supplied sterile nor are they intended to be used in sterile environments or applications unless noted.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2006

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

Re: K053453

Trade Name: HomMed Central Station, Version 3.5 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: April 21, 2006 Received: April 27, 2005

Dear Mr. 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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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfimmerman 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): Ko53453

Device Name: Central Station, Version 3.5

Indications For Use:

Prescription Use X (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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sion of Cardiovascular Devices
510(k) Number K053453

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).