SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM

K024108 · Siemens Medical Solutions USA, Inc. · MHX · Dec 18, 2002 · Cardiovascular

Device Facts

• Record ID: K024108
• Device Name: SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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

Device Story

The INFINITY MultiView WorkStation Telemetry System is a cardiac monitoring platform. This modification adds a sixth electrode connection to the existing 5-lead telemetry transmitter, allowing for increased data acquisition for patient evaluation. The system operates within the Wireless Medical Telemetry Service (WMTS) 608-614 MHz band. It processes physiological signals—ECG, pulse rate, SpO2—to provide real-time monitoring, arrhythmia detection, and ST segment analysis. Used in clinical environments by physicians, nurses, and technicians, the system generates visual and audible alarms to alert staff to patient status changes. The output assists clinicians in diagnostic and therapeutic decision-making. The device is not MRI compatible.

Clinical Evidence

No clinical data provided. Bench testing was performed in accordance with internal design control procedures and the FDA Draft Reviewer Guidance (November 1993) to verify the safety and efficacy of the hardware and software modifications.

Technological Characteristics

Telemetry transmitter with 6-lead electrode configuration; operates in WMTS band (608-614 MHz). System includes hardware and software modifications to support the additional electrode input. Connectivity is wireless. Not MRI compatible.

Indications for Use

Indicated for adult and pediatric patients requiring monitoring of heart rate, ECG arrhythmia, arterial oxygen saturation, pulse rate, or ST segment analysis in clinical settings under professional supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• INFINITY MultiView WorkStation Telemetry Enhancement (K972714)
• INFINITY MultiView WorkStation Telemetry Modifications (K983980)
• INFINITY Telemetry System Modifications (K003179)

Reference Devices

• INFINITY MultiView WorkStation Modifications (K023569)
• INFINITY MicrO2+ (K012770)

Submission Summary (Full Text)

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## 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: [phone] Fax: [phone] 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<br>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<br>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: [phone] Fax: [phone]

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## 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: [phone] Fax: [phone]

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# 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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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### 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