(30 days)
Not Found
No
The summary describes a data networking and conversion device, with no mention of AI or ML capabilities.
No
The device is described as a system for data collection and clinical information management, acquiring and transmitting patient data. It is explicitly stated that it is "not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices," which are common functions of therapeutic devices.
No
The device is described as a data collection and management system, not one that directly diagnoses medical conditions. It acquires and transmits data but does not perform diagnostic analysis itself.
No
The device description explicitly states that the Unity Network ID acquires digital data from eight serial ports and converts the data, indicating the presence of hardware components (serial ports and conversion hardware) in addition to software.
Based on the provided information, the Unity Network ID is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "data collection and clinical information management through networks with independent bedside devices." It explicitly states it's "not intended for monitoring purposes" and "not intended to control any of the clinical devices." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. This device does not perform such examinations.
- Device Description: The description focuses on acquiring digital data from other devices, converting it, and transmitting it. This is a data management and communication function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Unity Network ID is a data management and communication device for clinical information, not an IVD.
N/A
Intended Use / Indications for Use
The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
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
Not Found
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)
Test Summary: The Unity Network ID 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 system:
- 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 .
The results of these measurements demonstrated that the Unity Conclusion: Network ID is as safe, as effective, and performs as well as the predicate devices.
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.
K040559 Unity Network ID
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
§ 870.2300 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
JUL - 8 2005
Pg 1/2
K 05/518
| Section 2 Summary
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | May 23, 2005 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 | |
| USA | |
| Contact Person: | Ronald N. Blaski |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: 414-362-2348 | |
| Fax: 414-362-2585 | |
| Device: | |
| Trade Name: | Unity Network ID |
| Common/Usual Name: | 21 CFR 870.2300 Monitor, Physiological, Patient |
| Classification Name: | 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Predicate Device: | K040559 Unity Network ID |
| Device Description: | The Unity Network ID system communicates patient data from sources |
| other than GE Medical Systems Information Technologies equipment to | |
| a clinical information system, central station, and/or GE Medical | |
| Systems Information Technologies patient monitors. |
The Unity Network ID acquires digital data from eight serial ports,
converts the data to Unity Network protocols, and transmits the data
over the monitoring network to a Unity Network device such as a patient
monitor, clinical information system or central station. |
| Intended Use: | The Unity Network ID is indicated for use in data collection and clinical
information management through networks with independent bedside
devices.
The Unity Network ID is not intended for monitoring purposes, nor is the
Unity Network ID intended to control any of the clinical devices
(independent bedside devices/ information systems) it is connected to. |
| Technology: | The Unity Network ID employs the same functional technology as the
predicate device. |
. I
ﺮﺳﺎ ﺑﻌ
1
Test Summary: The Unity Network ID 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 system:
- 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 .
The results of these measurements demonstrated that the Unity Conclusion: Network ID is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2005
GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K051518
Trade Name: Unity Network ID V4 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: June 6. 2005 Received: June 10, 2005
Dear Mr. Blaski:
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 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
3
Page 2-Mr. Ronald N. Blaski
or any Federal statutes and regulations administered by other Federal agencies. You must or ally it catal statutes and regulations and 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 (21 CFR Part 820); and if applicable, the electronic forth in the quality by becalls (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro nein marketing your device as described in your Section 510(k) I ms letter will anow you to cognifinating of substantial equivalence of your device to a legally prematics notification. "The elassification 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 If you desire specific acreoliance at (301) 594-4646. Also, please note the regulation entitled, Contiact the Office of Company of Set notification" (21CFR Part 807.97) you may obtain. IMISOranuing of reference to preveresponsibilities under the Act may be obtained from the Other general 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) filed on March 1, 2004
510(k) Number (if known):
Device Name: Unity Network ID
Indications For Use:
The Unity Network ID is indicated for use in data collection and clinical information
management through networks with independent bedside devices. The Unity Network ID is
not intended for monitoring purposes, nor is the Unity Network ID intended to control any of
the clinical devices (independent bedside devices/ information systems) it is connected to.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051518
41