(5 days)
No
The summary describes hardware and software modifications to a conventional telemetry system to accommodate an additional electrode, but there is no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a telemetry system used to measure and monitor physiological parameters like heart rate, ECG, and oxygen saturation. It provides visual and audible alarms for these parameters but does not actively treat or intervene in a patient's condition.
Yes
The device is indicated 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." These are diagnostic parameters used by healthcare professionals to evaluate a patient's condition.
No
The device description explicitly states that hardware and software modifications were implemented to adapt the current telemetry transmitter/receiver. This indicates the device includes hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the INFINITY MultiView WorkStation Telemetry System clearly indicates it is used to measure physiological parameters directly from the patient (Heart rate, ECG, oxygen saturation, pulse rate, ST segment analysis) using electrodes and sensors attached to the body.
- The intended use and device description focus on monitoring vital signs. The system is designed to acquire and display real-time physiological data from the patient, not to analyze samples like blood, urine, or tissue.
Therefore, the INFINITY MultiView WorkStation Telemetry System falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patien 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
Product codes
74DRT, 74BWS, 74DQA, 74DRG, 74DSI, 74DXJ, 74MLD, MHX
Device Description
The current conventional 5-lead telemetry transmitter has been modified with a sixth electrode connection.
By adding this sixth electrode connection to the current telemetry, more data is available to clinicians with which to evaluate the patient. This new 6-lead transmitter complies with the Wireless Medical Telemetry Service (WMTS) operating in the dedicated frequency band of 608-614 MHz.
To adapt the current telemetry transmitter/receiver to accommodate the sixth electrode connection, hardware and software modifications were implemented.
The Indications for Use have not changed with the additional electrode connection. Testing has been performed in accordance with internal design control procedures and the FDA Draft Reviewer Guidance, November 1993, and indicates no affect on the safety or efficacy of the INFINITY MVWS Telemetry System.
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 patien 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)
Testing has been performed in accordance with internal design control procedures and the FDA Draft Reviewer Guidance, November 1993, and indicates no affect on the safety or efficacy of the INFINITY MVWS Telemetry System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
1. 510(k) SUMMARY
as required per 807.92(c)
DEC 1 8 2002
Submitters Name. Address:
Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Establishment Registration Number: 1220063 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: December 11, 2002
Trade Name, Common Name and Classification Name: Trade Name:
INFINITY MultiView WorkStation Telemetry Modification
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:
INFINITY MultiView WorkStation Telemetry Enhancement K972714
K983980 INFINITY MultiView WorkStation Telemetry Modifications
K003179 INFINITY Telemetry System Modifications
Other Relevant Submissions
K023569 INFINITY MultiView WorkStation Modifications K012770 INFINITY MicrO2+
Page 1 of 2
Siemens Medical Solutions, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
Device Description:
The current conventional 5-lead telemetry transmitter has been modified with a sixth electrode connection.
By adding this sixth electrode connection to the current telemetry, more data is available to clinicians with which to evaluate the patient. This new 6-lead transmitter complies with the Wireless Medical Telemetry Service (WMTS) operating in the dedicated frequency band of 608-614 MHz.
To adapt the current telemetry transmitter/receiver to accommodate the sixth electrode connection, hardware and software modifications were implemented.
The Indications for Use have not changed with the additional electrode connection. Testing has been performed in accordance with internal design control procedures and the FDA Draft Reviewer Guidance, November 1993, and indicates no affect on the safety or efficacy of the INFINITY MVWS Telemetry System.
Intended Use: Same as K003179
Assessment of non-clinical performance data for equivalence: Section J
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: Section J
Page 2 of 2
Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
00 Corporate Boulevaro
DEC 1 8 2002
Siemens Medical Solutions, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923
Re: K024108
Trade Name: Siemens INFINITY MultiView WorkStation Telemetry System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: December 11, 2002 Received: December 13, 2002
Dear Ms. Greco:
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.
3
Page 2 -- Ms. Penelope H. Greco
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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Y. Gottlie
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _
Device Name: __ Siemens INFINITY MultiView WorkStation Telemetry System
Indications for Use:
Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patien 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
MRI Compatibility Statement:
The Infinity MultiView WorkStation 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)
Kallattur
ular Devices
510(k) Number K04108