(85 days)
The NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including: . Asystole Ventricular-Fibrillation NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard System also provides notification for high and low heart rates.
The NetGuard Automated Clinician Alert System is an ambulatory ECG patient monitoring system designed to provide clinicians notification of potentially lethal cardiac events in adult patients, within a healthcare facility. The NetGuard System is a prescription device to be used by licensed clinicians in a healthcare facility.
The provided text is a 510(k) Summary for the NetGuard Automated Clinician Alert System. While it states that the device has undergone performance testing in compliance with FDA guidance and recognized standards, it does not explicitly detail specific acceptance criteria or the results of the study in a quantitative manner that would allow for a table of acceptance criteria and reported device performance.
Here's an analysis of what information is present and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- NOT PROVIDED DIRECTLY. The document states: "The NetGuard System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. The FDA guidance Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003), was utilized in the planning and conduct of all performance testing." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for arrhythmia detection) and the device's measured performance against those criteria are not listed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- NOT PROVIDED. The document does not mention the sample size for any test sets or the provenance of any data used for testing.
3. 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 PROVIDED. The document does not describe how ground truth was established, nor does it mention the number or qualifications of any experts involved in such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- NOT PROVIDED. There is no information regarding any adjudication methodology.
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
- NOT APPLICABLE / NOT PROVIDED. The NetGuard System is described as an "Automated Clinician Alert System" and an "Arrhythmia detector and Alarm." It is designed to automatically detect and alert clinicians to "potentially lethal cardiac events" like Asystole and Ventricular-Fibrillation, as well as high and low heart rates. This implies a standalone detection system rather than an AI-assisted human reading system. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or suggested by the device's function as presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- IMPLIED, BUT NO DETAILS PROVIDED. The description of the device as an "Automated Clinician Alert System" and an "Arrhythmia detector and Alarm" strongly suggests that its primary function is standalone detection. The text states, "NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected." However, no specific standalone performance metrics (e.g., sensitivity, false positive rate, detection delay) are reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- NOT PROVIDED. The document does not specify how the ground truth for performance testing was established. Given the nature of cardiac arrhythmias, it would typically involve expert cardiologists confirming events on ECG recordings, but this is not stated.
8. The sample size for the training set
- NOT APPLICABLE / NOT PROVIDED. The document does not describe the device as an AI/ML device that requires a "training set" in the modern sense. It refers to "performance testing" but does not elaborate on a training phase distinct from testing or the data used for such a phase.
9. How the ground truth for the training set was established
- NOT APPLICABLE / NOT PROVIDED. Similar to point 8, this is not addressed.
In summary:
The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and general compliance with regulatory standards. It lacks the detailed performance metrics, study methodologies, and data specifics typically found in a clinical study report for AI/ML-based medical devices or even for more traditional devices that undergo rigorous quantitative performance assessment for specific detection tasks. The document's purpose is a regulatory filing stating compliance, not a detailed technical and clinical performance report.
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innovation is the best medicine
Ko71805 p / 2-
510(k) Summary SEP 2 6 2007 NetGuard Automated Clinician Alert System
This 510(K) Summary is provided in accordance with 21 CFR 807.92.
| Date: | June 29, 2007 |
|---|---|
| Submitter: | Datascope Corp.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Kathleen KramerSupervisor, Clinical and Regulatory AffairsTelephone: 201-995-8169Facsimile: 201-995-8605 |
| Device Trade Name: | NetGuard Automated Clinician Alert System |
| Common Name: | Arrhythmia detector and Alarm |
| Device Classification: | Arrhythmia detector and Alarm21 CFR 870.1025, Product code: DSI, Class: II |
| Predicate Devices: | Micropaq™ Vital Signs Monitor, Welch Allyn, K021681Acuity® Central Monitoring Station, Welch Allyn, K052160 |
| Device description: | The NetGuard Automated Clinician Alert System is an ambulatoryECG patient monitoring system designed to provide cliniciansnotification of potentially lethal cardiac events in adult patients,within a healthcare facility.The NetGuard System is a prescription device to be used bylicensed clinicians in a healthcare facility. Departments where thedevice may be used include:• Post Operative Recovery Room• Emergency Department• Medical/Surgical Patient Floors |
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The NetGuard Automated Clinician Alert System is intended for
innovation is the best medicine
Indications for Use:
use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including: . Asystole Ventricular-Fibrillation � NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard System also provides notification for high and low heart rates. Technological Comparison to Predicate Device: The NetGuard System is technically equivalent to Welch Allyn's Acuity Central Monitoring Station (K052160) and Micropaq Vital Signs Monitor (K021681) with respect to technical and performance characteristic including, but not limited to, transmitting frequency, data storage, patient management, data review, measured physiological parameters and alarm management. Summary of Performance Testing: The NetGuard System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. The FDA guidance Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003), was utilized in the planning and conduct of all performance testing. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). Conclusion: Based on the above description, technological comparison, performance testing and the supporting documentation it can be concluded that the NetGuard device is safe, effective and substantially equivalent to the predicate device.
501(K) Summary
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2007
Datascope Corp. c/o Ms. Kathleen Kramer Supervisor, Clinical and Regulatory Affairs 800 MacArthur Blvd. Mahwah, NJ 07430
Re: K071805
NetGuard Automated Clinician Alert System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and Alarm Regulatory Class: Class II (two) Product Code: DSI Dated: June 29, 2007 Received: July 2, 2007
Dear Ms. Kramer:
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. Kathleen Kramer
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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
M.A. Hillemann
An 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): Κολιθός
Device Name: NetGuard Automated Clincian Alert System
Indications For Use:
The NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including:
Asystole Ventricular-Fibrillation
NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard system also provides notification for high and low heart rates.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) | ✓ |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. A. Willebronne
cular Devices
510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.