(126 days)
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No
The document describes a standard telemetry system for monitoring physiological data and detecting arrhythmia events and parameter limit violations. There is no mention of AI or ML in the intended use, device description, or any other section. The analysis performed is described as "ST/Arrhythmia analysis," which is a standard signal processing technique, not necessarily indicative of AI/ML.
No.
The device is a monitoring system that acquires and processes physiological data but does not directly provide therapy or therapeutic intervention to the patient.
Yes
The device is intended to acquire and monitor physiological data, process it to detect arrhythmia events and physiological parameter limit violations, and perform ST/Arrhythmia analysis, all of which are diagnostic functions.
No
The device description explicitly lists hardware components such as a Server, Access Point, and Telepack, which are integral to the system's function of acquiring and transmitting physiological data.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for acquiring and monitoring physiological data (specifically ECG and other parameters) from patients. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that receives data from wireless physiological monitors connected to patients. It processes this data for analysis (ST/Arrhythmia). This is consistent with patient monitoring, not in vitro testing of specimens.
- No mention of specimens: There is no mention of the device interacting with or analyzing any biological specimens.
Therefore, the ViewPoint Central Monitoring System and ViewPoint Telemetry System are patient monitoring systems, not IVDs.
N/A
Intended Use / Indications for Use
- 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.
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.
Product codes
MHX
Device Description
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
| Date: | June 1, 2003 |
|---|---|
| Submitter: | Patient Monitoring Division |
| Datascope Corp. | |
| Contact Person: | Susan E. Mandy |
| Director, Clinical & Regulatory Affairs | |
| Patient Monitoring Division | |
| Datascope Corp. | |
| Telephone: (201)995-8025 | |
| Fax: (201)995-8605 | |
| Device trade name: | ViewPoint Telemetry System |
| Common/usual name: | Cardiac Arrythmia Monitor |
| Classification names: | 21 CFR 870.2300- Cardiac monitor |
| 21 CFR 870.1025- Arrhythmia detector and alarm | |
| 21 CFR 870.2910- Radiofrequency physiological signal transmitter and | |
| receiver | |
| Predicate Devices: | K021681 Micropaq Vital Signs Monitor |
| K022453 Acquity Central Monitoring Station | |
| K020524 PatientNet Monitoring System | |
| Device Description: | 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. |
1
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.
:
2
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
4
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