Central Station's intended use is to retrospectively receive; display and store monitored vital signs parameters and related data. Central Station displays the data and system alerts for review and evaluation 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 a 510(k) submission for the Honeywell HomMed Central Station version 4.0. It primarily focuses on the device's intended use and the general compliance of its software. However, it does not contain detailed acceptance criteria, specific device performance metrics, or a study that rigorously proves the device meets such criteria in a quantitative sense as typically expected for medical device performance evaluation (e.g., accuracy, sensitivity, specificity).

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Implicit Criteria:	Explicitly Stated Performance:
Software compliance with guidelines and standards referenced in FDA reviewer's guides	Demonstrated compliance with guidelines and standards.
Performance within specifications	Performed within its specifications.
Performance within functional requirements for software	Performed within its functional requirements for software.
Ability to retrospectively receive, display, and store monitored vital signs parameters and related data	Functions as intended: retrospectively receives, displays, and stores monitored vital signs parameters and related data.
Ability to display data and system alerts	Displays data and system alerts for review and evaluation by a healthcare professional.
Not intended for emergency use or real-time monitoring	Device explicitly states "not intended for emergency use or real-time monitoring."
Compatibility with Honeywell HomMed Patient Monitors (Sentry and Genesis) and MedPartner	Accepts data from Honeywell HomMed Patient Monitors (Sentry and Genesis) and MedPartner.

Missing Information: The document does not provide quantitative acceptance criteria (e.g., specific accuracy thresholds, uptime requirements, response times, or error rates for display/storage) or specific performance metrics that would typically be a result of a direct performance study. The reported "performance" is a high-level statement of compliance with general expectations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The data refers to "monitored vital signs parameters and related data" but there is no information on the origin or nature of this data used for validation. The device's intended use is to "retrospectively receive; display and store" data, which implies it handles retrospective data, but this doesn't clarify the nature of data used for testing its own performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. The device is a "Patient Vital Signs Monitor Viewing Station" and its validation focused on software compliance, specifications, and functional requirements. It does not involve interpretation tasks where expert ground truth would be established for diagnostic accuracy, for example. The "review and evaluation by a healthcare professional" refers to the intended use of the displayed data, not the validation of the device itself by experts.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The validation described is for software compliance and functionality, not for diagnostic or interpretive performance requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done.
Effect Size of Improvement: Not applicable. This device is not an AI-assisted diagnostic tool; it is a data display and storage system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The description of "software validation results demonstrated that the Central Station System was in compliance with the guidelines and standards ... and that it performed within its specifications and functional requirements for software" implies a standalone evaluation of the software's ability to process, display, and store data. However, it's not "algorithm only" in the sense of a predictive or diagnostic algorithm. It's a functional software system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not explicitly stated as "ground truth" in a clinical sense. For software validation, the "ground truth" would be the expected behavior or outcome based on the software's specifications and requirements. For example, if a vital sign reading is X, the "ground truth" for the display function is that it should display X correctly. The document only mentions that the software "performed within its specifications and functional requirements," implying that its output was compared against its design requirements for proper functioning.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. It is a software system for data display and storage.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on the regulatory compliance and general functional validation of a software system designed to receive, display, and store vital sign data. It explicitly states that "the software validation results demonstrated that the Central Station 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 type of submission relies on demonstrating that the software meets its pre-defined design and functional requirements rather than clinical performance metrics often associated with diagnostic or AI-powered devices. The absence of quantitative performance data, expert reviews, or MRMC studies is consistent with the nature of this device as a data viewing station rather than a diagnostic tool.

Summary

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510(k) Summary for Honeywell HomMed Central Station version 4.0

Submitter:	Honeywell HomMed, LLC
Address:	3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045	SEP - 7 2007
Corporate Contact:	Michael Leigh, Director of Regulatory/QualityHoneywell HomMed, LLC
Telephone:	Ph: (262) 783-5440Fax: (262) 783-5441
Establishment Registration #:	3004183721
Submission Contact:	Michael Leigh, Director of Regulatory/QualityHoneywell HomMed, LLC3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045Ph: (262) 252-5794Fax: (262) 252-6105
Trade Name:	Central Station, Version 4.0
Predicate Device:	HomMed Central Station, Version 3.5, K053453
Common Name:	Patient Vital Signs Monitor Viewing Station
Classification Name:	Non-Invasive Blood Pressure Measurement SystemProduct Code: DYN

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 (e.g. Sentry and Genesis) as well as the Honeywell HomMed MedPartner. The software validation results demonstrated that the Central Station 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.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Honeywell HomeMed, LLC c/o Mr. Michael Leigh Director of Regulatory/Quality 3400 Intertech Drive, Suite 200 Brookfield, Wisconsin 53045

Re: K072272

Central Station, Version 4.0 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 13, 2007 Received: August 15, 2007

Dear Mr. Leigh:

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 - Mr. Michael Leigh

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,

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):

Device Name: Honeywell HomMed Central Station 4.0

Indications For Use:

Central Station's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. 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.

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)

Blummeto

Divisio 510(k) Num

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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).