(27 days)
Not Found
No
The summary describes a data server for storing and accessing patient physiological data and events. There is no mention of AI, ML, or any algorithms that process or interpret the data beyond storage and retrieval. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a data server that stores and relays patient data; it does not directly treat or diagnose patients. Its intended use explicitly states it is "NOT intended to be the sole source for patient data" and is "NOT a patient monitoring device," indicating it facilitates data management rather than providing therapeutic intervention.
No
The device is described as a Patient Data Server, intended for centralized intermediate term storage of patient data. It explicitly states it is "NOT a patient monitoring device" and is "NOT intended to be the sole source for patient data." Its function is to store and relay data, not to interpret or diagnose.
No
The device description explicitly states that the Unity Network® Patient Data Server is a "system of hardware and software" and operates on "standard commercially available server class hardware."
Based on the provided text, the Unity Network® Patient Data Server is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the storage and access of patient-centric events and physiological data collected from acquisition devices. It is used in conjunction with bedside monitors and central monitoring stations. This describes a system for managing and accessing patient monitoring data, not for performing tests on biological samples.
- Device Description: The description reinforces that the device stores and relays data from monitoring devices. It explicitly states that it is "NOT a patient monitoring device." IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The text does not mention any activities related to:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Performing tests or assays.
- Providing diagnostic information based on laboratory results.
The Unity Network® Patient Data Server is a data management and storage system for patient monitoring data, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Unity Network® Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network® Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network® Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
Product codes
MSX
Device Description
The Unity Network® Patient Data Server provides a caregiver the ability to view patient centric events and physiological data that was collected from acquisition devices on the Unity Network prior to the current monitoring session. The Unity Network® Patient Data Server stores at least 500 alarm histories (400 arrhythmia events and 100 ST history events) and at least 72 hours of physiological data per unique patient identifier. Information from the Unity Network® Patient Data Server can be accessed by a GEMS-IT device that implements the Unity Network® Patient Data Server's proprietary data exchange protocol.
The Unity Network® Patient Data Server is a system of hardware and software that operates on standard commercially available server class hardware and interfaces with the Unity Network®. The Unity Network® Patient Data Server system obtains and stores data from devices that are connected and admitted to a monitoring device on the Unity Network® and relays that data to connected clients for viewing. Only clients that are connected to Unity Network® and have access to a proprietary application protocol interface can access the data stored in the Unity Network® Patient Data Server.
The Unity Network® Patient Data Server system provides data to central station monitoring devices, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity Network® Patient Data Server, the clinician is instructed to obtain the data from the primary bedside
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
adult, pediatric and neonatal patients
Intended User / Care Setting
licensed healthcare practitioner. ... within a hospital or facility providing patient care.
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
The Unity Network® Patient Data Server complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network® Patient Data Server:
- Risk Analysis ●
- Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
- Environmental testing ●
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these measurements demonstrated that the Unity Network® Patient Data Server is as safe, as effective, and perform as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001268 GE Marquette Prism Information Server Applications (MPIS)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
K032582 p1/2
SEP 1 7 2003
Unity Network® Patient Data Server 510k Premarket Notification Submission
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | August 18, 2003 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Karen Lunde |
| Sr. Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-3329 | |
| Fax: (414) 918-8114 | |
| Device: | |
| Trade Name: | Unity Network® Patient Data Server |
| Common/Usual Name: | Computer, Information Network Server |
| Classification Names: | 21 CFR 870.2300 System, Network and Communication, Physiological |
| Predicate Device: | K001268 GE Marquette Prism Information Server Applications (MPIS) |
| Device Description: | The Unity Network® Patient Data Server provides a caregiver the ability |
| to view patient centric events and physiological data that was collected | |
| from acquisition devices on the Unity Network prior to the current | |
| monitoring session. The Unity Network® Patient Data Server stores at | |
| least 500 alarm histories (400 arrhythmia events and 100 ST history | |
| events) and at least 72 hours of physiological data per unique patient | |
| identifier. Information from the Unity Network® Patient Data Server can | |
| be accessed by a GEMS-IT device that implements the Unity Network® | |
| Patient Data Server's proprietary data exchange protocol. |
The Unity Network® Patient Data Server is a system of hardware and
software that operates on standard commercially available server class
hardware and interfaces with the Unity Network®. The Unity Network®
Patient Data Server system obtains and stores data from devices that
are connected and admitted to a monitoring device on the Unity
Network® and relays that data to connected clients for viewing. Only
clients that are connected to Unity Network® and have access to a
proprietary application protocol interface can access the data stored in
the Unity Network® Patient Data Server.
The Unity Network® Patient Data Server system provides data to
central station monitoring devices, and is NOT a patient monitoring
device. The clinician is instructed to always reference the primary
bedside monitor before making any patient care decisions. In the event
that data is not available via the Unity Network® Patient Data Server,
the clinician is instructed to obtain the data from the primary bedside |
1
K052582 p2/2
Unity Network® Patient Data Server 510k Premarket Notification Submission
- Intended Use: The Unity Network® Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network® Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network® Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
- Technology: The Unity Network® Patient Data Server system consists of standard server class hardware purchased from an OEM and loaded with application software developed by GE Medical Systems Information Technologies.
The server is connected to two networks: Unity Network® and the hospital's Intranet. The Unity Network® is a currently marketed proprietary network connecting patient monitors. Applications communicate over the Unity Network® using a proprietary protocol in order to obtain or provide data to devices on the network. The hospital's Intranet refers to the existing network within the hospital from which a user can gain access to the product for configuration and servicing.
Test Summary:
The Unity Network® Patient Data Server complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network® Patient Data Server:
- Risk Analysis ●
- Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
- Environmental testing ●
Conclusion:
The results of these measurements demonstrated that the Unity Network® Patient Data Server is as safe, as effective, and perform as well as the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows a black and white seal. The seal is circular and contains an image of an eagle with three lines representing its wings. The text around the seal reads "HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2003
GE Medical Systems Information Technologies c/o Ms. Karen Lunde Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K032582
Trade Name: Unity Network® Patient Data Server Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II (two) Product Code: MSX Dated: August 18, 2003 Received: August 21, 2003
Dear Ms. Lunde:
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.
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
3
Page 2 - Ms. Karen Lunde
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Prem D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Unknown; 510(k) filed on August 11, 2003 510(k) Number (if known):
Unity Network® Patient Data Server Device Name
Indications for Use:
The Unity Network® Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network® Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network® Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Valeria
510(k) |