(126 days)
The ViewPoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The ViewPoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity.
The ViewPoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ViewPoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The ViewPoint Telemetry System is an expansion to the ViewPoint Central Monitoring System, previously cleared by FDA under K011540. There have been no significant changes to ViewPoint Central Monitoring System since its clearance. The standard configuration of the ViewPoint Central Monitoring System consists of the ViewPoint Central Station, network printers, displays, keyboard, speakers, universal power supply and a mouse.
The ViewPoint Telemetry System is an ambulatory monitoring system that is designed to be used in the hospital/clinical environment to acquire and transmit ECG data derived from wireless physiological monitor(s) via RF telemetry transmitter(s) and receiver(s). The ViewPoint Telemetry System consists of three components: the ViewPoint Server (Server), Access Point, and ViewPoint Telepack 2.4 (Telepack). The ViewPoint Telemetry System uses the capability of bi-directional communication with the Server, via an Access Point network installed throughout the specified coverage area. These Access Points interface with the Server through an Ethernet connection. The Server does not collect data directly from patients; rather, it receives data through the Access Point from monitors, such as a Telepack, performs ST/Arrhythmia analysis, and then forwards it to the ViewPoint Central Station.
The provided text describes the ViewPoint Telemetry System, a cardiac arrhythmia monitor. However, it does not explicitly detail specific acceptance criteria or a dedicated study with performance metrics that directly prove the device meets particular criteria. Instead, it outlines the device's intended use, its components, and its substantial equivalence to predicate devices, supported by a general statement about completed development activities and testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred and note when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance | Comments |
|---|---|---|---|
| Safety | As safe as predicate devices | Deemed "as safe" | Based on overall development activities and testing. No specific quantitative safety metrics are provided. |
| Effectiveness | As effective as predicate devices | Deemed "as effective" | Based on overall development activities and testing. No specific quantitative effectiveness metrics (e.g., sensitivity, specificity for arrhythmia detection) are provided. |
| Performance | Performs as well as predicate devices | Deemed to "perform as well" | Based on overall development activities and testing. No specific quantitative performance metrics are provided. |
| Physiological Monitoring | Acquire and monitor ECG | Yes | Stated as a capability. |
| Monitor Heart Rate from ECG | Yes | Stated as a capability. | |
| Detect Lethal Arrhythmia | Yes | Stated as a capability. | |
| Detect Non-Lethal Arrhythmia | Yes | Stated as a capability. | |
| Perform ST Segment Analysis | Yes | Stated as a capability. | |
| Networking/Communication | Bi-directional communication with Server via Access Point | Yes | Stated as a capability. |
| Use 2.4 GHz ISM wireless band | Yes | Stated as a capability. | |
| Frequency hopping spread spectrum transmission | Yes | Stated as a capability. | |
| Ambulatory Use | Allow for patient mobility | Yes | Stated as a design feature and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "Performance testing" and "Hardware and Software validation" but does not provide details on sample sizes for any specific test sets.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe the establishment of a ground truth for performance evaluation in a clinical study.
4. Adjudication method for the test set
- Not specified.
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, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device described appears to be a monitoring system that processes data, not an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device performs "ST/Arrhythmia analysis" and detects "various ECG arrhythmia events and select physiological parameter limit violations" autonomously. The document implies that this processing is done by the system, and then the information is displayed to clinicians. While not explicitly called a "standalone performance study," the system's ability to perform these analyses without direct human intervention suggests an inherent standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are provided for these algorithmic detections.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the context of a 510(k) submission and substantial equivalence for a monitoring system, it's highly likely that engineering tests and comparisons to predicate device behavior were used. Clinical ground truth (e.g., confirmed arrhythmia diagnoses by cardiologists) for performance metrics is not detailed in this summary.
8. The sample size for the training set
- Not applicable. The document describes a medical device for monitoring, not an AI/ML algorithm that requires a distinct "training set" in the modern sense. The "development" process included "Hardware and software testing" and "Code design and code reviews," which would typically involve internal testing and validation against known standards and specifications, rather than machine learning training.
9. How the ground truth for the training set was established
- Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.
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510(k) Summary of Safety and Effectiveness
| Date: | June 1, 2003 |
|---|---|
| Submitter: | Patient Monitoring DivisionDatascope Corp. |
| Contact Person: | Susan E. MandyDirector, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201)995-8025Fax: (201)995-8605 |
| Device trade name: | ViewPoint Telemetry System |
| Common/usual name: | Cardiac Arrythmia Monitor |
| Classification names: | 21 CFR 870.2300- Cardiac monitor21 CFR 870.1025- Arrhythmia detector and alarm21 CFR 870.2910- Radiofrequency physiological signal transmitter andreceiver |
| Predicate Devices: | K021681 Micropaq Vital Signs MonitorK022453 Acquity Central Monitoring StationK020524 PatientNet Monitoring System |
| Device Description: | The ViewPoint Telemetry System is an expansion to the ViewPoint CentralMonitoring System, previously cleared by FDA under K011540. There have beenno significant changes to ViewPoint Central Monitoring System since its clearance.The standard configuration of the ViewPoint Central Monitoring System consists ofthe ViewPoint Central Station, network printers, displays, keyboard, speakers,universal power supply and a mouse. |
| The ViewPoint Telemetry System is an ambulatory monitoring system that isdesigned to be used in the hospital/clinical environment to acquire and transmitECG data derived from wireless physiological monitor(s) via RF telemetrytransmitter(s) and receiver(s). The ViewPoint Telemetry System consists of threecomponents: the ViewPoint Server (Server), Access Point, and ViewPoint Telepack2.4 (Telepack). The ViewPoint Telemetry System uses the capability of bi-directional communication with the Server, via an Access Point network installedthroughout the specified coverage area. These Access Points interface with theServer through an Ethernet connection. The Server does not collect data directlyfrom patients; rather, it receives data through the Access Point from monitors,such as a Telepack, performs ST/Arrhythmia analysis, and then forwards it to theViewPoint Central Station. |
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The Telepack communicates ECG signals and control/status messages to the Server through an Access Point utilizing the 2.4 GHz ISM wireless band, via a frequency hopping spread spectrum transmission technique. The Telepack is battery powered to allow for patient mobility. As stated in Section 2, the expanded Indication for Use of the ViewPoint Central Intended Use: Monitoring System is the inclusion of the ViewPoint Telemetry System as follows: The ViewPoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ViewPoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. The physiological parameters monitored include ECG, Heart Rate from ECG, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the ViewPoint Server for ECG processing via Ethernet. This information can be displayed, trended, stored, and printed at the ViewPoint Central Station. Technology: The ViewPoint Telemetry System is substantially equivalent to the Welch Allyn Micropaq, Welch Allyn Acquity Central Monitoring Station and GE Medical Systems PatientNet Monitoring System. The predicate systems are capable of monitoring ECG in ambulatory patients, as well as detecting lethal and non-lethal arrythmias, and analyzing ST segments. The ViewPoint Telemetry System, complies with the voluntary standards identified Test Summary: in section six of this submission. Datascope's product development process required that the following activities be completed during the development of the ViewPoint Telemetry System: · Requirements specification review · Hardware and software testing • Code design and code reviews · Environmental/EMC testing · Safety testing · Performance testing · Hardware and Software validation Conclusion: The results of all testing demonstrate that the ViewPoint Telemetry System is as
safe, as effective, and performs as well as the predicate devices.
:
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Datascope Corporation c/o Ms. Susan E. Mandy Director, Clinical and Regulatory Affairs Patient Monitoring Division 800 MacArthur Blvd. Mahwah, NJ 07430
Re: K031760
Trade Name: ViewPoint Central Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (arrhythmia detector and alarm) Regulatory Class: Class III (three) Product Code: MHX Dated: September 5, 2003 Received: September 8, 2003
Dear Ms. Mandy:
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. Susan E. Mandy
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 Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
CMAedasmeys
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
ViewPoint Central Monitoring System: (K011540)
The Indications for use for the ViewPoint Central Monitoring System include:
- Viewing real time patient clinical and demographic data ●
- Graphical and numeric trending of clinical data
- Storing and printing of clinical and demographic data ●
- Setting independent alarm limits for data sent by the bedside monitor.
The clinical data displayed by the ViewPoint Central Monitoring System is obtained from one or more Datascope compatible physiological monitors and includes: ECG waveforms, Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (SpO2), Heart Rate, Respiration Rate, Temperature, CO2 inspired and end-tidal, Ventricular Arrythmia analysis and ST Segment analysis.
The ViewPoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The ViewPoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity.
ViewPoint Telemetry System:
The ViewPoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ViewPoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.
The physiological parameters monitored include ECG, Heart Rate from ECG, Lethal and Non-Lethal Arthythmia Detection and ST Segment Analysis. Received data is sent to the ViewPoint Server for ECG processing via Ethernet. This information can be displayed, trended, stored, and printed at the ViewPoint Central Station.
Meher Myn for BOZ
(Signature of Applicant)
510(k) Number
§ 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.