MINI TELEMETRY SYSTEM

K110556 · Wipro GE Healthcare Private, Ltd. · HGM · Jul 19, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110556
• Device Name: MINI TELEMETRY SYSTEM
• Applicant: Wipro GE Healthcare Private, Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination. The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area. The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Device Story

Wireless telemetry system for maternal-fetal monitoring; transmits heart rate and uterine activity signals from ambulatory mother to remote receiver connected to fetal/maternal monitor. Input: ultrasound Doppler, FECG, MECG, TOCO, or IUPC signals via transducers. Transmitter worn by mother via strap; receiver placed near monitor. Principle: analog signal acquisition, voltage-controlled oscillator, RF transmission. Output: raw physiological signals displayed on compatible Corometrics monitors. Used in clinical settings under healthcare practitioner supervision. Benefits: allows maternal mobility during labor/antepartum monitoring while maintaining continuous data transmission to bedside monitor.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical, mechanical, safety, reliability, and system design verification protocols. Compliance with IEC 60601-1, IEC 60601-1-6, ISO 10993-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-37, IEC 60601-2-49, and IEC 60601-1-8 demonstrated.

Technological Characteristics

Wireless telemetry system; analog signal acquisition; RF transmission (WMTS/MEDRADIO). Components: transmitter (TX 2051411-004) and receiver (RX 2051412-004). Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), IEC 62304 (software). Connectivity: proprietary wireless link to compatible Corometrics monitors.

Indications for Use

Indicated for ambulatory pregnant women during antepartum period and labor. Used for monitoring fetal heart rate (via ultrasound or FECG), maternal heart rate (MECG), and uterine activity (TOCO or IUPC). Not for use in mobile vehicles.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Corometrics Model 330 Fetal Maternal Telemetry System (K910260)

Reference Devices

• CORO 170 Series fetal monitors (K993751 / K991905)
• CORO 120 Series Maternal fetal monitors (K0332252)
• CORO 250 Series Maternal fetal monitors (K050583)

Submission Summary (Full Text)

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JUL 1 9 2011

## Premarket Notification 510(k) Summary

As required by section 807.92

## Mini Telemetry System

## GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

| Date: | 24 Feb, 2011 |
|---------------------------|---------------------------------------------------------|
| Submitter: | Wipro GE Healthcare Private Ltd. |
| | 4, kadugodi industrial area |
| | bangalore, INDIA 560067 |
| Primary Contact Person: | Ms Agata Smieja |
| | GE Healthcare, |
| | Phone - [phone] |
| | Fax - [phone] |
| Secondary Contact Person: | Sanjukta DebRoy |
| | GE Healthcare, |
| | Phone: [phone] |
| | Fax: [phone] |
| Device: | MINI TELEMETRY SYSTEM |
| Trade Name: | |
| Common/Usual Name: | Maternal Fetal Telemetry System |
| Classification Names: | Device Classification name: System Monitoring Perinatal |
| | Classification Product Code: HGM |
| Product Code: | |
| Predicate Device(s): | Corometrics Model 330 Fetal Maternal Telemetry System |
| | K910260 |

| Device Description: | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Mini Telemetry System provides a wireless means of<br>transmitting heart rate and uterine activity signals from an<br>ambulatory mother to a fetal or maternal/fetal monitor. It includes<br>receiver (RX 2051412-004) and transmitter (TX 2051411-004)<br>subsystems. |
| | The system monitors fetal heart rate through ultrasound Doppler<br>technology, ECG (Fetal ECG or Maternal ECG), and uterine<br>activity (TOCO or IUPC) signals individually or in combination. |
| | The transmitter stays along with mother acquiring data from<br>transducers and transmitting it to the remote Receiver placed next<br>to the monitor in the room. The Mini Transmitter is carried by the |

688

Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such nay not be disclosed to others not employed by General Electric Co. All rights reserved

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| mother using the strap mechanism. One end of the transducers<br>are connected to the transmitter and the other end comes in<br>contact with the mother to acquire data. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|
| This system acquires and transmits data wirelessly to the receiver. | | |
| The Mini Telemetry system itself is an accessory to the main<br>fetal/maternal fetal monitor. | | |
| The Mini Telemetry system is compatible with the following<br>Corometrics brand monitors: | | |
| Name of the Monitors | 510(k) Number | |
| CORO 170 Series fetal | K993751 / K991905 | |
| | | |
| monitors | | |
| CORO 120 Series Maternal | K0332252 | |
| fetal monitors | | |
| CORO 250 Series Maternal | K050583 | |
| fetal monitors | | |

Indication for Use:

The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination.

The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area.

The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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#### Technology: The Mini Telemetry employs the same fundamental scientific technology as its predicate device, which includes: analogue acquisition section, voltage controlled oscillator and RF transmission.

The Mini Telemetry design includes the same parametric acquisition sections as in the predicate device for Ultrasound, Utcrine Activity and Electrocardiogram with additional display capability, incorporating semiconductors to reduce the size and weight of the system.

The same Radio Telemetry module from the predicate device is used in Mini Telemetry System.

Determination Summary of Non-Clinical Tests:

# of Substantial

Equivalence:

Verification and Testing activities establish the performance, functionality, usability, safety, and reliability characteristics of Mini Telemetry System.

The table below indicates the names of the Standard and their specific location in the 510(k) document.

| Standards No: | Standards<br>Organization | Standards Title | Location |
|--------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| IEC 60601-1 :<br>1988 + A1<br>1991 + A2<br>1995 | IEC | Medical Electrical Equipment - Part 1:<br>General Requirements for Safety | 17 Annex<br>D.1 |
| IEC 60601-1-<br>6, 2006 | IEC | Medical electrical equipment - Part 1-6:<br>General requirements for safety - Collateral<br>standard: Usability | 18 Annex<br>E.12 |
| ISO 10993-1,<br>2009 | ISO | Biological Evaluation of Medical Devices -<br>Part I Evaluation and Testing within a Risk<br>Management Process | 15 Annex<br>B.I |
| IEC 60601-1-<br>2, 2007 | IEC | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Electromagnetic compatibility | 17 Annex<br>D.2 |
| IEC 62304,<br>2006 | IEC | Medical Device Software, Software<br>LifeCycle Process | Refer to<br>Section<br>16 |
| IEC 60601-2-<br>37 : 2001+ A1<br>: 2004, +A2 :<br>2005 | IEC | Medical electrical equipment Part 2-37:<br>Particular requirements for the safety of<br>ultrasonic medical diagnostic and monitoring<br>equipment | 18 Annex<br>G.2 |
| IEC 60601-2-<br>49, 2001 | IEC | Particular requirements for the safety of<br>multifunction patient monitoring equipment | 18 Annex<br>G.2 |
| IEC 60601-1- | IEC | Medical electrical equipment -- Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>General requirements, tests and guidance for<br>alarm systems in medical electrical<br>equipment and medical electrical systems | 18 Annex<br>G.3 |

#### 690

Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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| FCC 47 CFR<br>Part 95; Part<br>95: Personal<br>Radio Services | FCC | Personal Radio Services<br>Subpart H: WMTS<br>Subpart I: MEDRADIO | 18 Annex<br>G.I |
|---------------------------------------------------------------|---------------------------|-------------------------------------------------------------------|-----------------|
| Standards No: | Standards<br>Organization | Standards Title | Location |
| FCC 47 CFR<br>Part 2 | FCC | FCC SAR Test Report | 18 Annex<br>G.4 |

The following quality assurance measures were applied to the development of the system:

- Risk Analysis .
- . Requirements Reviews
- Design Reviews .

#### Summary of Simulated Use Setting:

The Design verification of Mini Telemetry System has been divided into several protocols that include clectrical, mechanical, safety Testing, reliability, and system design verification protocols.

The performance testing included testing on unit level, system level, as well as usability, biocompatibility, and safety parameters.

The results of the Design verification testing protocols have been documented in Section 18 of this 510(k) application.

The results demonstrate that the Mini Telemetry system meets all design requirements and performance claims.

The subject of this premarket submission, Mini Telemetry System, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Mini Telemetry Systems to be as safe and as effective as the predicate device, and the performance to be substantially equivalent to the predicate device.

Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60! Silver Spring, MD 20993-0002

Wipro GE Healthcare Private Ltd. c/o Ms. Agata Smieja Regulatory Affairs Director GE Healthcare 8880 Gorman Road LAUREL MD 20723-5800

JUL 19 2011

Re: K110556

> Trade Name: Mini Telemetry System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring and accessories Regulatory Class: II Product Code: HGM Dated: June 17, 2011 Received: June 17, 2011

Dear Ms. Smieja:

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 predicated 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. Please note: CDRH does not evaluate informations against informations and warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations of class III (PMA)
found in the Code of Federal Result in This a viate example 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.

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); backed device reporting (reporting (1 CFR Parting of medical device-related

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## Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, the electronic the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of receited to premarker notification" (21CFR Part 803).
CFR Part 803), please go to CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Huckert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

### Enclosure

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#### Indications for Use

510(k) Number (if known): KI10556

Mini Telemetry System Device Name:

Indications for Use:

The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante parturn period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination.

The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area.

The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hesler Lewin

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