PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A

K023931 · Philips Medical Systems, Inc. · HGM · Feb 24, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K023931
• Device Name: PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
• Applicant: Philips Medical Systems, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Philips M2720A Cordless Fetal Transducer System is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum). The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.

Device Story

System measures, processes, and transmits fetal parameters to Philips Series 50 fetal monitors via radio telemetry. Comprises base station (M2720A) and three wireless transducers: Toco (M2725A) for external uterine activity; Ultrasound (M2726A) for fetal heart rate/movement; optional ECG/auxiliary (M2727A) for direct fetal scalp ECG or maternal ECG. Designed for ambulatory patients, including use in water/hydrotherapy. Replaces wired connections of predicate systems with integrated front-end circuitry in transducers. Operated by clinicians in clinical settings; output displayed on fetal monitor for trace interpretation to support labor/delivery management. Benefits include patient mobility during monitoring.

Clinical Evidence

Bench testing only. Verification and validation activities included environmental, electrical safety, EMC, radio telemetry, biocompatibility, and user evaluations for consumer accuracy. Hardware and software verification and cable interface testing were performed. No clinical trial data presented.

Technological Characteristics

Wireless perinatal monitoring system using radio telemetry. Includes base station and three transducers (Toco, Ultrasound, ECG/Aux). Features integrated front-end circuitry within transducers for direct signal processing. Designed for use in clinical environments, including hydrotherapy. Software-based verification conducted.

Indications for Use

Indicated for pregnant women from approximately 22 weeks gestation through delivery. Used for continuous fetal monitoring during antepartum testing and labor/delivery (intrapartum) for resting or ambulatory patients, including during hydrotherapy. Contraindicated for home use; requires supervision by trained healthcare practitioners.

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

• Philips M1310A Fetal Telemetry System-Series 50T (K942887)
• Philips M1350A Intrapartum Fetal Monitor (K900480)
• Philips M1350B Perinatal Monitoring System (K954351)
• Philips M1351A Perinatal Monitoring System (K921957)
• Philips M1353A Fetal Monitor (K921956)
• Philips M2600A Telemetry Systems (K993516)
• Philips M2600A Telemetry Systems (K980429)
• Philips M2600A Telemetry Systems (K961165)

Submission Summary (Full Text)

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## 510(k) Summary (As required by 21 C.F.R. §807.92)

| Submitted by: | Markus Stacha<br>Philips Medizin Systeme Boeblingen GmbH<br>Cardiac and Monitoring Systems<br>Hewlett-Packard Str.2<br>71034 Boeblingen<br>Germany | | FEB 2 4 2003 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------|
| Date of Summary: | November 22, 2002 | | |
| Device Name | Philips Avalon CTS Cordless Fetal Transducer System | | |
| Common Name | Perinatal Monitoring System | | |
| Classification Name | Regulation Number | Classification Name | |
| | 21 C.F.R §884.2740 | Perinatal Monitoring System and<br>Accessories | |
| Predicate Devices | Philips M1310A Fetal Telemetry System-Series 50T (K942887),<br>Philips M1350A Intrapartum Fetal Monitor (K900480), Philips<br>M1350B Perinatal Monitoring System (K954351), Philips<br>M1351A Perinatal Monitoring System (K921957), Philips<br>M1353A Fetal Monitor (K921956) and the Philips M2600A<br>Telemetry Systems (K993516, K980429, and K961165). | | |
| Modifications | The modification incorporates the front-end circuitry for each<br>parameter into the transducer, thereby replacing the cable used in<br>the predicate versions by a direct hardware connection. There are<br>no modifications to the device design that affect safety &<br>effectiveness of the Perinatal Monitoring System. | | |
| Device Description | The Perinatal Monitoring System operates by measuring,<br>processing, and transmitting standard fetal parameters to any<br>Philips Series 50 fetal monitor using radio transmission<br>technology. A group of three wireless transducers is available to<br>obtain specific fetal data in the antepartum period and during labor<br>and delivery. The transducers are designed to operate while the<br>patient is ambulatory, including activity taking place in a<br>submerged water environment, like bathing and hydrotherapy.<br>The devices are identified by the following model numbers:<br>System and Base Station M2720A; Toco transducer M2725A<br>(measures uterine activity externally); US transducer M2726A<br>(measures fetal heart rate and fetal movement profile); and the<br>optional ECG/auxiliary transducer M2727A (measures DECG or<br>direct fetal scalp ECG and MECG or maternal ECG). | | |

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K023931 p 2/2

| Intended Use | The intended use of the modified device, as described in its<br>labeling, has not changed from that of the predicate device as a<br>result of the modifications. The Philips M2720A Cordless Fetal<br>Transducer System is indicated for pregnant women from about 22<br>weeks of gestation on through delivery. It is intended for<br>continuous cordless fetal monitoring in connection with a fetal<br>monitor for resting or ambulating patients, also usable during<br>hydrotherapy, for antepartum testing and labor and delivery<br>(intrapartum).<br><br>The system should only be used by, or under the direct supervision<br>of, a licensed physician or other health care practitioner who is<br>trained in the use of fetal heart rate monitors and in the<br>interpretation of fetal heart rate traces. It is not intended for home<br>use. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics | The Philips Avalon CTS Cordless Fetal Transducer System and<br>accessories have the same technological characteristics as the<br>legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to<br>establish the performance and reliability characteristics of the<br>modified device.<br><br>Testing involved environmental, electrical safety, EMC, radio<br>telemetry, biocompatibility and user evaluations for consumer<br>accuracy. Hardware and software verification testing and cable<br>interface verification testing were also conducted. Test results<br>showed substantial equivalence. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2003

Mr. Markus Stacha Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str.2 71034 Böblingen GERMANY

Re: K023931

Trade/Device Name: M2720A Avalon CTS Cordless Fetal Transducer System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: November 22, 2002 Received: November 26, 2002

Dear Mr. Stacha:

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 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.

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.

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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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) you may obtain. 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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## Indications for Use Statement

510(k) Number (if known)

六023931

Device Name: The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories

Indications for Use: The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum).

The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use.

OR

Over-The-Counter Use

David h. Ingram

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(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number

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