(7 days)
Not Found
No
The document describes modifications to an existing telemetry system to enable specific arrhythmia calls (Pause, Bradycardia, Tachycardia). There is no mention of AI, ML, image processing, training data, or performance metrics typically associated with AI/ML algorithms. The focus is on standard physiological parameter monitoring and analysis.
No
The device is described as a telemetry system intended to measure and produce visual and audible alarms for various physiological parameters (heart rate, ECG, oxygen saturation, pulse rate, ST segment analysis). It is used for monitoring, not for treating a condition.
Yes
The device is indicated for measuring physiological parameters like heart rate, ECG arrhythmia, arterial oxygen saturation, pulse rate, and ST segment analysis, and producing visual and audible alarms for these. These functions are used by healthcare professionals to assess a patient's medical condition, which is a diagnostic purpose.
No
The device description explicitly states that the MultiView WorkStation Infinity Telemetry System (K972714) has been modified. The predicate device (K972714) is a telemetry system, which inherently includes hardware components for patient monitoring. The summary does not indicate that the modification transforms the entire system into a software-only device; it only describes the addition of specific arrhythmia calls.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MultiView WorkStation Infinity Telemetry System measures and monitors physiological parameters directly from the patient's body (heart rate, ECG, oxygen saturation, pulse rate, ST segment analysis). This is done in vivo (within the living body).
- Intended Use: The intended use describes monitoring patients and providing alarms based on these physiological measurements. It does not involve analyzing samples taken from the patient.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic. It is a patient monitoring system.
N/A
Intended Use / Indications for Use
Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate ●
- ECG Arrhythmia Analysis .
- Arterial oxygen saturation .
- . Pulse rate
- ST segment analysis .
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Product codes (comma separated list FDA assigned to the subject device)
74DSI
Device Description
The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patient populations
Intended User / Care Setting
Healthcare Professionals (Physicians, Nurses, Technicians)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k): Device Modification Siemens MultiView WorkStation Infinity Telemetry System
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: November 5, 1998
Trade Name, Common Name and Classification Name:
A. Trade Name:
Siemens MultiView WorkStation Infinity Telemetry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification
Number | Class | Regulation Number |
|-----------------------------------------------------------------|--------------------------|-------|-------------------|
| Cardiac monitor | 74DRT | II | 21 CFR 870.2300 |
| Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 |
| Pulse oximeter | 74DQA | II | 21 CFR 870.2700 |
| Radiofrequency physiological signal transmitter and
receiver | 74DRG | II | 21 CFR 870.2910 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathode-Ray Tube Display | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment Monitor with Alarm | 74MLD | III | 21 CFR 870.1025 |
Legally Marketed Device Identification:
Siemens MultiView WorkStation Infinity Telemetry System
Description of Modification:
The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.
Intended Use: (Same as K972714)
Biocompatability: Not applicable Sterilization: Not applicable Standards and Guidances: (Same as K972714)
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1998
Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
K983980 Re: Siemens MultiView Workstation Infinity Telemetry System Regulatory Class: III (three) Product Code: 74 DSI Dated: November 5, 1998 Received: November 9, 1998
Dear Mr. Simard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. David Simard
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_K983980
Device Name: __ Siemens MultiView WorkStation Infinity Telemetry System
Indications for Use: (Same as K972714)
Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate ●
- ECG Arrhythmia Analysis .
- Arterial oxygen saturation .
- . Pulse rate
- ST segment analysis .
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
MRI Compatibility Statement:
The MultiView WorkStation Infinity Telemetry System is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Krave
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _