(144 days)
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Not Found
No
The summary describes a software system for receiving, displaying, and storing vital signs data, with no mention of AI or ML capabilities.
No
The device is a retrospective data display and storage system, not actively used for treatment or diagnosis.
No
The Central Station receives, displays, and stores monitored vital signs parameters for review and interpretation by a healthcare professional; it does not perform any analysis or provide a diagnosis itself.
Yes
The device description explicitly states that Central Station is a "software system that operates on a commercially available PC system." It receives data from external hardware devices (Patient Monitors and MedPartner) but is itself described solely as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Central Station's Function: The Central Station's intended use is to receive, display, and store monitored vital signs parameters and related data. This data is collected from patient monitors (Sentry and Genesis) and a MedPartner device, which are external devices measuring physiological parameters.
- No Sample Analysis: The description does not mention any analysis of biological samples. The device is processing data that has already been collected from the patient by other devices.
Therefore, the Central Station is a data management and display system for patient monitoring data, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HomMed Central Station
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
K0534/53
510(k) Summary for Honeywell HomMed Central Station
| Submitter: | Honeywell HomMed, LLC | MAY - 5 2006 |
|---|---|---|
| Address: | 3400 Intertech Drive, Suite 200 | |
| Brookfield, Wisconsin 53045 | ||
| Corporate Contact: | Michael Leigh, Director of Regulatory/Quality | |
| Honeywell HomMed, LLC | ||
| Telephone: | Ph: (262) 783-5440 | |
| Fax: (262) 783-5441 | ||
| Establishment Registration #: | 3004183721 | |
| Submission Contact: | Tommie J. Morgan Ph.D., President | |
| Morgan Consultants, Inc. | ||
| 2018 North Durham | ||
| Houston, Texas 77008 | ||
| Ph: (713) 880-5111 | ||
| Fax: (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 System | |
| 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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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:
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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On-island sign-off
sion of Cardiovascular Devices
510(k) Number K053453