HOMMED CENTRAL STATION, VERSION 3.5

K053453 · Honeywell Hommed, LLC · DXN · May 5, 2006 · Cardiovascular

Device Facts

• Record ID: K053453
• Device Name: HOMMED CENTRAL STATION, VERSION 3.5
• Applicant: Honeywell Hommed, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Central Station Version 3.5 is a software-based viewing station for retrospective patient data management. It receives vital signs parameters and system alerts from Honeywell HomMed patient monitors (Sentry, Genesis) and the MedPartner device. The system operates on a standard PC platform. It does not perform real-time monitoring or emergency alerting. Healthcare professionals use the station to review and interpret stored patient data to assist in clinical decision-making. The device benefits patients by providing a centralized repository for longitudinal vital signs review.

Clinical Evidence

Bench testing only. Software validation demonstrated compliance with FDA guidelines and functional specifications for the Central Station 3.5 system.

Technological Characteristics

Software-based system operating on a standard PC. Receives data from Honeywell HomMed patient monitors (Sentry, Genesis) and MedPartner. Non-sterile. No specific hardware materials or connectivity protocols (e.g., DICOM/HL7) detailed beyond standard PC compatibility.

Indications for Use

Indicated for healthcare professionals to retrospectively review, display, and store vital signs parameters and system alerts transmitted from patient monitors. Not for emergency use or real-time monitoring.

Regulatory Classification

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.

Predicate Devices

• HomMed Central Station

Submission Summary (Full Text)

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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 200<br>Brookfield, Wisconsin 53045 | |
| Corporate Contact: | Michael Leigh, Director of Regulatory/Quality<br>Honeywell HomMed, LLC | |
| Telephone: | Ph: [phone]<br>Fax: [phone] | |
| Establishment Registration #: | 3004183721 | |
| Submission Contact: | Tommie J. Morgan Ph.D., President<br>Morgan Consultants, Inc.<br>2018 North Durham<br>Houston, Texas 77008<br>Ph: [phone]<br>Fax: [phone] | |
| 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 System<br>Product Code: DXN | |

Intended Use:

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.

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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# 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 [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,

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:

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.

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