MORTARA SURVEYOR TELEMETRY CENTRAL STATION

K060135 · Mortara Instrument, Inc. · MHX · May 15, 2006 · Cardiovascular

Device Facts

• Record ID: K060135
• Device Name: MORTARA SURVEYOR TELEMETRY CENTRAL STATION
• Applicant: Mortara Instrument, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Surveyor Telemetry Central Station is designed to monitor up to 24 adult patients during cardiovascular problematic situations, through ambulatory transmitter sources. When used as a Telemetry Central Station System, Surveyor Central is designed to work with ECG only or multiparemeter transmitters for ECG and SpO2. For each patients ECG waveforms, HR, ST values and other parameters (if available) will be displayed. The Mortara Surveyor Central Telemetry System is intended for centralized ECG monitoring of hospital patients connected to telemetry transmitters such as the Mortara X12 Ambulatory Telemetry Transmitter (K974149), (presently marketed as the X12+), or other compatible telemetry transmitters. Patients are moving in a defined area, of a variable size depending on layout and thickness of walls. In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs. The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Device Story

System consists of ambulatory ECG telemetry transmitters (e.g., X12+), antenna network, and PC-based Central Station software. Transmitters acquire continuous 12-lead ECG, A/D convert, and transmit via wireless RF to antenna network. Receivers in Central Station decode waveforms/status. Central Station software performs real-time arrhythmia and ST-segment analysis for up to 24 patients simultaneously. Output includes real-time ECG leads, QRS complexes, ST levels, and audiovisual alarms based on defined profiles. Data stored for 72 hours for review/printing. Used by trained medical personnel in clinical settings to assist in diagnosis and management of cardiovascular conditions; enables remote monitoring of mobile patients within defined facility areas.

Clinical Evidence

Bench testing only. Device performance validated against recognized standards including IEC 60601-1 (General safety), IEC 60601-1-1 (Medical electrical systems), IEC 60601-1-4 (Programmable electrical medical systems), ANSI/AAMI EC11 (Diagnostic ECG devices), ANSI/AAMI EC13 (Cardiac monitors), and ANSI/AAMI EC57 (Testing/reporting performance of arrhythmia monitoring algorithms). No clinical trial data provided.

Technological Characteristics

PC-based telemetry central station; wireless RF communication; 12-lead ECG acquisition; SpO2 support. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-4, ANSI/AAMI EC11, ANSI/AAMI EC13, ANSI/AAMI EC57, UL 2601-01. Software-based arrhythmia and ST-segment analysis. Supports up to 24 patients. 72-hour data storage.

Indications for Use

Indicated for ECG monitoring of adult patients in clinical settings (Coronary Care, Step-Down, Emergency Departments) by trained medical professionals. Used for arrhythmia evaluation, chest pain assessment, pacemaker evaluation, post-MI/surgery recovery monitoring, therapeutic intervention documentation, and clinical/epidemiological research. Not for use in highly invasive environments like operating theatres.

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

• Mortara Model ST Central Station (K922927)
• Datex-Ohmeda S/3 Telemetry Central System (K000882)

Reference Devices

• Mortara X12 Ambulatory Telemetry Transmitter (K974149)

Submission Summary (Full Text)

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K060135

### 510(k): Device Summary

### Submitter:

Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs Mortara Instrument, Inc. 7865 N. 86" Street Milwaukee, WI 53224 [phone] Fax: [phone] Phone: Harlan Van Matre (see above) Contact:

| Trade Name: | Surveyor Telemetry Central Station | |
|--------------------------|----------------------------------------------------------------------|-------------|
| Common Name: | Telemetry Central Station Monitor | |
| Classification Name: | The following Class II classifications appear to be applicable: | |
| Device Name | Classification Name | CFR Section |
| Surveyor Central Station | Electrocardiograph | 870.2340 |
| | Arrhythmia detector and alarm | 870.1025 |
| | Monitor, ST Segment with Alarm | 870.1025 |
| | Patient Physiological Monitor, (with arrhythmia detection or alarms) | 870.1025 |

### Legally marketed devices to which S. E. is claimed

The Surveyor Telemetry Central Station is an evolution of a legally marketed Mortara predicate device.

- Mortara Model ST Central Station, (K922927) .
- Datex-Ohmeda S/3 Telemetry Central System (K 000882) .

### Description:

The Surveyor Telemetry Central Station is a diagnostic tool intended to acquire, and provide real time ECG data of patients that require ECG monitoring during cardiovascular problematic situations. The cardiac data provided is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Surveyor Telemetry Central Station will be used for centralized ECG monitoring in a telemetry system consisting of three main components: the ambulatory ECG telemetry transmitters (X12 Ambulatory Transmitters), the receivers combined with an antenna network and the Central Station software application running on a PC.

The transmitter is attached to the patient and acquires a continuous 12-lead ECG signal. The signal is A/D converted and digital data is sent to the Central Station using wireless radiofrequency communication.

The antenna network receives the data sent by the transmitters. The network delivers the signal to the receivers installed in the Central Station PC. The receivers decode the data containing the ECG waveforms and status from the transmitters.

The Central Station retrieves the data from the receivers and performs arrhythmia and ST analysis on the signal. The result of the analysis can trigger an audiovisual alarm. The priority of each arrhythmia and ST alarm is defined in the alarm profile.

When used as a Telemetry Central Station, Surveyor Central Station is designed to work with ECG only or multi-parameter transmitters for ECG and SpO2. The Central Station can simultaneously retrieve, display and analyze ECG signals for up to 24 patients.

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A single patient can be selected for reviewing data in the single patient view, which includes following displayed and printed data:

- All 12 real-time ECG leads. .
- Current average and reference QRS complex with current ST levels for all leads .
- The Central Station also stores waveforms, measurement data and alarms for 72 hours. The . waveforms can be reviewed and printed

### Intended Use:

The Surveyor Telemetry Central Station is designed to monitor up to 24 adult patients during cardiovascular problematic situations, through ambulatory transmitter sources. When used as a Telemetry Central Station System, Surveyor Central is designed to work with ECG only or multiparemeter transmitters for ECG and SpO2. For each patients ECG waveforms, HR, ST values and other parameters (if available) will be displayed.

The Mortara Surveyor Central Telemetry System is intended for centralized ECG monitoring of hospital patients connected to telemetry transmitters such as the Mortara X12 Ambulatory Telemetry Transmitter (K974149), (presently marketed as the X12+), or other compatible telemetry transmitters. Patients are (101-140), (produkt) manoving in a defined area, of a variable size depending on layout and thickness of walls. In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs.

The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

#### Indications for Use:

The Surveyor Central Telemetry System is intended for ECG analysis in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements

The Surveyor Central Telemetry System is indicated for use:

- ECG monitoring of adult patients in Coronary Care Units, Step-Down Units, Emergency . Departments. It is not designed for use in highly invasive environments, such as an operating theatre.
- Centralized ECG monitoring through a telemetry network of adult palients. Continuous analysis is . provided for all connected patients. It is not designed for use in highly invasive environments, such as an operating theatre.
- Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an . audio-visual alarm according to the alarm profile.
- . Chest Pain Evaluation.
- Evaluation of adult patients with pacemakers. .
- Evaluation of a patient's response after resuming occupational activities (e.g., after . M.I. or cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of . patients.
- Clinical and epidemiological research studies. .

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# Standards Data Form for Abbreviated 510(k)s

510(k) Number:

K060135

Standard Organization No: Or Standard Identification No:

IEC 60601-1 IEC 60601-1-1:2001 IEC 60601-1-4 A1:1999 ANSI/AAMI EC11-1991 ANSI/AAMI EC13:2002 (physiologic alarm) ANSI/AAMI EC57 :1998 UL 2601-01

## Or CDRH Internal Reference No:

| Declaration of Conformity Elements: | | | | |
|-------------------------------------------------------|-----|----|----|--|
| Any Adaptations Applied | yes | no | X | |
| Any Requirements Not Applicable | yes | X | no | |
| Any Deviations Applied | yes | no | X | |
| Any Differences in Device Tested and Finished Product | yes | no | X | |
| *Is There a Third Party or Test Lab Involved | yes | no | X | |

Was there another standard used in the review of this submission? yes X no

If another standard was used, please fill out an additional form.

* This is not the third party that reviews 510ks

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

Mr. Harlan L. Van Matre Manager of Quality Assurance and Regulatory Affairs Mortara Instruments, Incorporated 7865 North 86th Street Milwaukee, Wisconsin 53224

Re: K060135

Trade/Device Name: Mortara Surveyor Telemetry Central Station Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: February 27, 2006 Received: April 27, 2006

Dear Mr. Van Matre:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowe 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 101 use surved in the encrease 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backan............................................................................................................................ that FDA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations adminities as ut not limited to: registration and listing comply with all the Act STequirements, modaling, and manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice the (2) CFR Part 807); labelling (21 CFR Pair 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction control provisions (occions of revice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your Secti I his letter will anow you to begin mankemily of substantial equivalence of your device to a legally premarket nothication. The PDA intallig of backership vour 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 If you desire specific advice for your do not on the course note the regulation entitled, contact the Office of Comphance at (501) - 15 - 17 - 17 - 17 807.97). You may obtain "Misoranding by reference to promance roomans. The Act from the Division of Small
other general information on your responsibilities under the Act from the 1900 Call of 1900 other general international and Consumer Assistance at its toll-free number [phone] or Mallulacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Bhimima for

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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# Indications for Use

KU60135 510(k) Number (if known):

### Device Name:

### Mortara Surveyor Telemetry Central Station

Indications for Use:

The Surveyor Central Telemetry System is indicated for use:

- in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring . in a clinical setting, by qualificu modion propan are partients. The personnel must and use of the oyoten? Commilar problematic situations and emergency procedures or pathologies related to cardiac involvements.
- centralized ECG monitoring through a telemetry network of adult patients in Coronary Care Contrailed EOO monitoring areasy Departments. It is not designed for use in highly invasive environments, such as an operating theatre.
- Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
- Chest Pain Evaluation.
- Evaluation of adult patients with pacemakers.
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups o patients.
- Clinical and epidemiological research studies.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Us (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenstons

(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K060135

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