(27 days)
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.
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.
This document primarily describes a 510(k) premarket notification for the GE Healthcare Unity Network ID, focusing on its substantial equivalence to a predicate device, Unity Network ID V8 (K170199). It does not contain information about acceptance criteria for device performance with specific metrics or detailed study results where a device's performance is measured against those criteria.
The information provided describes the device's function (data collection and clinical information management), its intended use, and the changes made from the predicate device (primarily software updates to support new third-party devices).
However, it explicitly states:
"The Unity Network ID V9 was tested to assure that the device meets its design specifications. Testing included all new or modified features."
and
"The subject of this premarket submission, Unity Network ID V9, did not require clinical studies to support substantial equivalence."
Therefore, based on the provided text, I cannot describe the acceptance criteria and study as requested, because specific performance acceptance criteria and a study demonstrating the device meets those criteria are not detailed.
The document only states that non-clinical tests were performed to ensure compliance with voluntary standards and design specifications. It lists general quality assurance measures applied during development and testing but does not provide specific performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical performance study for AI/machine learning devices.
Here's a breakdown of the specific points you requested, noting what is and isn't available in the provided text:
-
A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide a table of acceptance criteria nor reported device performance metrics against such criteria. It states the device "meets its design specifications" and "comply with, applicable voluntary standards," but no specifics are given.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: No test set sample sizes or data provenance are mentioned as no clinical studies were performed. The testing described is non-clinical verification and validation of design specifications.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available: Since no clinical studies were required and no test sets with ground truth are described, there is no information about experts establishing ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available: No clinical test set or adjudication method is described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable/Not Available: This device is a data collection and management system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available: This device is not an algorithm for diagnostic or prognostic purposes, but rather an interface for data transmission. Standalone performance in the context of an algorithm is not relevant here.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available: No ground truth in the context of a clinical performance study is mentioned.
-
The sample size for the training set
- Not Applicable/Not Available: This device is not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would involve configuring it to correctly interpret and transmit data from specific third-party devices, which is part of its design and verification process, not a machine learning training process.
-
How the ground truth for the training set was established
- Not Applicable/Not Available: See point 8.
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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
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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 ContactPerson: | Brandon O'Shea |
| Regulatory Affairs Leader | |
| GE Medical Systems Information Technologies, Inc. | |
| Email: brandon.oshea@ge.com | |
| Ph: (414) 323-3147 | |
| Secondary ContactPerson: | 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 datafrom sources other than GE Medical Systems InformationTechnologies, Inc. equipment to a clinical informationsystem, central station, and/or GE Medical SystemsInformation Technologies Inc. patient monitors. |
| The Unity Network ID acquires digital data from eight serialports, converts the data to Unity Network protocols, andtransmits the data over the monitoring network to a UnityNetwork device such as a patient monitor, clinical informationsystem or central station. | |
| Intended Use: | The Unity Network ID is indicated for use in data collectionand clinical information management through networks withindependent bedside devices. The Unity Network ID is notintended for monitoring purposes, nor is the Unity NetworkID intended to control any of the clinical devices(independent bedside devices / information systems) it isconnected to. |
| Technology: | The device converts the output from independent bedsidedevice's RS-232 protocol into the Unity Network protocol. |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: |
| The Unity Network ID V9 and its applications were tested to,and comply with, applicable voluntary standards. The UnityNetwork ID V9 was tested to assure that the device meets itsdesign specifications. Testing included all new or modifiedfeatures. | |
| The following quality assurance measures were applied tothe 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 NetworkID V9, did not require clinical studies to support substantialequivalence. |
510(k) Summary
In accordance with 21 CFR 807.92 the following summary information is provided:
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K183116
| Comparison: | Hardware:1) No change to the Unity Network ID hardware2) 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). |
§ 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).