(27 days)
Edwards HemoSphere (K163381), GE Aisys CS2 (K170872), GE Giraffe Incubator (K101788), GE Giraffe Omnibed Incubator (K101788), GE Giraffe Warmer (K070377), GE Panda Warmer (K070377), Maquet Flow-i (K160665), Maquet Servo-n (K151814), Maquet Servo-s (K123149), Maquet Servo-U (K151814), Nellcor PM1000N (K141518)
No
The summary describes a data collection and communication device that converts data protocols. There is no mention of AI, ML, or any analytical capabilities that would suggest the use of such technologies. The testing focuses on data integrity and protocol conversion, not algorithmic performance.
No
The device is described as a system for data collection and clinical information management, specifically for communicating patient data, not for providing therapy or treatment.
No
The device is described as a data collection and clinical information management system, not for diagnosing medical conditions. It collects and transmits patient data from independent devices to a clinical information system, central station, or patient monitors.
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 circuitry) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "data collection and clinical information management through networks with independent bedside devices." It explicitly states it's "not intended for monitoring purposes." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. This device's purpose is data transfer and management, not analysis of biological samples.
- Device Description: The description focuses on acquiring digital data from other devices, converting protocols, and transmitting data. It doesn't mention any interaction with biological specimens or performing diagnostic tests.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or assays
- Any of the typical components or functions of an IVD.
Therefore, the Unity Network ID is a medical device focused on data communication and management within a clinical setting, not an In Vitro Diagnostic device.
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 (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, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. 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)
Summary of Non-Clinical Tests:
The Unity Network ID V9 and its applications were tested to, and comply with, applicable voluntary standards. The Unity Network ID V9 was tested to assure that the device meets its design specifications. Testing included all new or modified features.
The following quality assurance measures were applied to the development and testing of the of the system:
Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Unity Network ID V9, did not require clinical studies to support substantial equivalence.
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.
Unity Network ID V8 (K170199)
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.
Edwards HemoSphere (K163381), GE Aisys CS2 (K170872), GE Giraffe Incubator (K101788), GE Giraffe Omnibed Incubator (K101788), GE Giraffe Warmer (K070377), GE Panda Warmer (K070377), Maquet Flow-i (K160665), Maquet Servo-n (K151814), Maquet Servo-s (K123149), Maquet Servo-U (K151814), Nellcor PM1000N (K141518)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2018
GE Healthcare Brandon O'Shea Senior Regulatory Affairs Leader 8200 West Tower Ave. Milwaukee, Wisconsin 53223
Re: K183116
Trade/Device Name: Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 8, 2018 Received: November 9, 2018
Dear Brandon O'Shea:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
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) K183116
Device Name Unity Network ID
Indications for Use (Describe)
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 (information systems) it is connected to.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K183116
| Date: | 8 November 2018 |
|---|---|
| Submitter: | GE Healthcare |
| 8200 W. Tower Ave. | |
| Milwaukee, WI 53223 | |
| Primary Contact | |
| Person: | Brandon O'Shea |
| Regulatory Affairs Leader | |
| GE Medical Systems Information Technologies, Inc. | |
| Email: brandon.oshea@ge.com | |
| Ph: (414) 323-3147 | |
| Secondary Contact | |
| Person: | Monica Morrison |
| Senior Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Ph: (608) 515-3077 | |
| Device Trade Name: | Unity Network ID |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names: | 21 CFR 870.2300 Monitor, Physiological, Patient |
| (without arrhythmia detection or alarms) | |
| Product Code: | MWI |
| Predicate Device(s): | Unity Network ID V8 (K170199) |
| Device Description: | The Unity Network ID system communicates patient data |
| from sources other than GE Medical Systems Information | |
| Technologies, Inc. equipment to a clinical information | |
| system, central station, and/or GE Medical Systems | |
| Information Technologies Inc. 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 device converts the output from independent bedside |
| device's RS-232 protocol into the Unity Network protocol. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The Unity Network ID V9 and its applications were tested to, | |
| and comply with, applicable voluntary standards. The Unity | |
| Network ID V9 was tested to assure that the device meets its | |
| design specifications. Testing included all new or modified | |
| features. | |
| The following quality assurance measures were applied to | |
| the development and testing of the of the system: | |
| Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Unity Network | |
| ID V9, did not require clinical studies to support substantial | |
| equivalence. |
510(k) Summary
In accordance with 21 CFR 807.92 the following summary information is provided:
4
5
K183116
| Comparison: | Hardware:
- No change to the Unity Network ID hardware
- Update encoding of cables to detect newly supported devices (no change to physical cable) |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software:
Add interface support for the following third-party devices:
a) Edwards HemoSphere (K163381)
b) GE Aisys CS2 (K170872)
c) GE Giraffe Incubator (K101788)
d) GE Giraffe Omnibed Incubator (K101788)
e) GE Giraffe Warmer (K070377)
f) GE Panda Warmer (K070377)
g) Maquet Flow-i (K160665)
h) Maquet Servo-air (Not for sale in US)
i) Maquet Servo-n (K151814)
j) Maquet Servo-s (K123149)
k) Maquet Servo-U (K151814)
l) Nellcor PM1000N (K141518) |
| Conclusion: | GE Healthcare considers the Unity Network ID V9 to be as safe, as effective, and its performance is substantially equivalent to the predicate device(s). |