HONEYWELL HOMMED CENTRAL STATION 4.0

K072272 · Honeywell Hommed, LLC · DXN · Sep 7, 2007 · Cardiovascular

Device Facts

• Record ID: K072272
• Device Name: HONEYWELL HOMMED CENTRAL STATION 4.0
• Applicant: Honeywell Hommed, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Special
• 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. 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 Story

Central Station v4.0 is a software-based viewing station for retrospective analysis of patient vital signs. It receives data from Honeywell HomMed patient monitors (e.g., Sentry, Genesis) and the MedPartner system. The software operates on a standard PC; it stores and displays vital signs and system alerts for review by healthcare professionals. It does not perform real-time monitoring or emergency alerting. By centralizing historical data, it assists clinicians in evaluating patient status over time, supporting clinical decision-making through organized data presentation.

Clinical Evidence

Bench testing only. Software validation confirmed the system complies with FDA guidelines and performs within functional specifications. No clinical data provided.

Technological Characteristics

Software-only system operating on commercially available PC hardware. Connectivity via data transmission from Honeywell HomMed patient monitors. No specific materials or energy sources defined as it is a software application.

Indications for Use

Indicated for healthcare professionals to retrospectively review and evaluate 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, Version 3.5 (K053453)

Submission Summary (Full Text)

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

| Submitter: | Honeywell HomMed, LLC | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | 3400 Intertech Drive, Suite 200<br>Brookfield, Wisconsin 53045 | SEP - 7 2007 |
| Corporate Contact: | Michael Leigh, Director of Regulatory/Quality<br>Honeywell HomMed, LLC | |
| Telephone: | Ph: [phone]<br>Fax: [phone] | |
| Establishment Registration #: | 3004183721 | |
| Submission Contact: | Michael Leigh, Director of Regulatory/Quality<br>Honeywell HomMed, LLC<br>3400 Intertech Drive, Suite 200<br>Brookfield, Wisconsin 53045<br>Ph: [phone]<br>Fax: [phone] | |
| 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 System<br>Product Code: DYN | |

#### Intended 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 evaluation 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 (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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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 [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,

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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