(23 days)
Not Found
No
The summary describes a software system for receiving, displaying, and storing vital signs data. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on data management and display, not algorithmic analysis or prediction.
No.
The device is described as a software system to retrospectively receive, display, and store monitored vital signs parameters and related data for review and evaluation by a healthcare professional. It is explicitly stated that it is not intended for emergency use or real-time monitoring and does not provide any treatment or therapy.
No
The device retrospectively displays and stores monitored vital signs parameters for review and evaluation by a healthcare professional. It is explicitly stated that it is "not intended for emergency use or real-time monitoring," nor does it provide a diagnosis or aid in diagnosis.
Yes
The device description explicitly states "Central Station is a software system that operates on a commercially available PC system". While it interacts with hardware (Patient Monitors and MedPartner), the device itself, as described, is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "retrospectively receive; display and store monitored vital signs parameters and related data." It is for review and evaluation by a healthcare professional. This describes a system for managing and reviewing patient data collected by other devices, not a device that performs tests on biological samples in vitro.
- Device Description: The description confirms it's a software system that operates on a PC and accepts data from patient monitors. This further supports its role as a data management and display system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Performing tests in vitro (outside the body)
- Providing diagnostic information based on laboratory analysis
The device's function is to handle and display data from patient monitoring devices, which are typically considered medical devices but not IVDs.
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. 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.
Product codes (comma separated list FDA assigned to the subject device)
DYN, 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 (e.g. Sentry and Genesis) as well as the Honeywell HomMed MedPartner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
510(k) Summary for Honeywell HomMed Central Station version 4.0
| Submitter: | Honeywell HomMed, LLC | |
|---|---|---|
| Address: | 3400 Intertech Drive, Suite 200 | |
| Brookfield, Wisconsin 53045 | SEP - 7 2007 | |
| 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: | Michael Leigh, Director of Regulatory/Quality | |
| Honeywell HomMed, LLC | ||
| 3400 Intertech Drive, Suite 200 | ||
| Brookfield, Wisconsin 53045 | ||
| Ph: (262) 252-5794 | ||
| Fax: (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 System | |
| 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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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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