(64 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 (independent bedside devices/ information systems) it is connected to.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Unity Network ID device:
The provided text does not contain acceptance criteria presented as quantitative metrics or specific performance thresholds for the Unity Network ID. Instead, it describes general quality assurance measures and states a conclusion that the device performs as well as its predicate. Therefore, much of the requested information cannot be extracted directly from this document.
Here's what can be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative) | Reported Device Performance | Comments |
|---|---|---|
| Not specified quantitatively | "as safe" | The document states the device performs "as safe, as effective, and performs as well as the predicate device." However, no specific performance metrics or acceptance thresholds are provided in this summary. |
| Not specified quantitatively | "as effective" | |
| Not specified quantitatively | "performs as well" |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the provided summary.
- Data provenance: Not specified in the provided summary (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document describes testing related to system verification and validation, but not expert-based ground truth establishment for clinical performance.
4. Adjudication method for the test set
- Not applicable/Not specified. The testing described (Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Verification, Integration testing, Final acceptance testing, Performance testing, Safety testing, Environmental testing) does not indicate a need for a clinical adjudication method.
5. 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
- No. An MRMC comparative effectiveness study is not mentioned. The device, Unity Network ID, is a data communication system and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The listed "Performance testing," "Safety testing," and "Environmental testing," along with "Subsystem Verification," "Integration testing (System verification)," and "Final acceptance testing (Validation)" would constitute standalone testing of the device's functionality and performance as a data communication system. The device itself does not involve a human in the loop for its core function of data transmission.
7. The type of ground truth used
- For the technical and performance testing of a data communication system like Unity Network ID, the "ground truth" would be established by:
- Functional Specifications/Requirements: The device is expected to correctly acquire, convert, and transmit data according to its design specifications.
- Industry Standards: Compliance with relevant voluntary standards (as mentioned in "Section 4.2 Specific Standards and Guidance").
- Predicate Device Performance: The underlying assumption and stated conclusion is that the device performs "as well as the predicate device," implying a comparative baseline for performance.
- Objective Measurements: Performance, safety, and environmental testing would rely on objective measurements against predefined criteria (though these criteria are not detailed in this summary).
8. The sample size for the training set
- Not applicable. The Unity Network ID describes a data communication hardware/software system, not a machine learning or AI algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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SEP 2 1 2007
| 510(k) Summary of Safety and Effectiveness |
|---|
| -------------------------------------------- |
| Date: | July 18, 2007 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Lisa M. Baumhardt |
| Regulatory Affairs Program Manager | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-3242 | |
| Fax: (414) 362-2585 | |
| E-mail: Lisa.Baumhardt@med.ge.com | |
| Secondary ContactPerson: | John Pendergast |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-2506 | |
| Fax: (414) 362-2585 | |
| E-mail: john.pendergast@med.ge.com | |
| 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) |
| Predicate Devices: | K051518 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 clinica! devices (independent bedside devices/ information systems) it is connected to. |
| Technology: | The Unity Network ID employs the same functional technology as the predicate device. |
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: :
4
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Test Summary:
The subject of this 510(k) is a design modification for the Unity Network ID. The Unity Network ID complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:
- Risk Analysis .
- Requirements Reviews ◆
- Design Reviews .
- Subsystem 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 ID is as safe, as effective, and performs as well as the predicate device.
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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
SEP 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Lisa Baumhardt Regulatory Affairs Program Manager 8200 West Tower Ave Milwaukee, WI 53223
Re: K071982
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: August 23, 2007 Received: August 24, 2007
Dear Ms. Baumhardt:
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 - Ms. Lisa Baumhardt
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 (OS) 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,
B.Bommemafor
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 K071982
510(k) Number (if known):
Unity Network ID
Indications for Use:
Device Name:
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 _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR . (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumma
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071982
Page 1 of 1
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§ 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).