PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

K052795 · Philips Medizin Systeme Boeblingen GmbH · HGM · Dec 30, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052795
• Device Name: PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Philips Avalon Fetal Monitors FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves. The Avalon FM20 and FM30 are intended for use by trained health care professionals in labor and delivery rooms and in antepartum testing areas. They are not intended for use in intensive care units, operating rooms or for use outside the health care facilities.

Device Story

Avalon FM20/FM30 are fetal/maternal monitors for antepartum testing and labor/delivery. Inputs: fetal/maternal heart rate (ultrasonic/ECG), uterine activity (external/internal), maternal NIBP, SpO2. Operation: processes physiological signals to display, store, and record patient data/waveforms; generates alarms for abnormal readings. Used in clinical settings (labor/delivery, antepartum) by trained healthcare professionals. Output: real-time monitoring data/alarms on device display; assists clinicians in assessing fetal/maternal status during labor. Benefits: continuous physiological surveillance to support clinical decision-making.

Clinical Evidence

No clinical data. Verification and validation were established through bench testing, including system-level performance tests and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications.

Technological Characteristics

Perinatal monitoring system for fetal/maternal physiological parameters. Includes ultrasonic transducers, ECG, NIBP, and SpO2 sensors. Features display, storage, and recording capabilities. Connectivity includes patient connectors for transducers/electrodes. Class II device. Software-based signal processing for heart rate and uterine activity monitoring.

Indications for Use

Indicated for use by trained health care professionals for monitoring physiological parameters including uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women, and fetal heart rate, in labor and delivery rooms and antepartum testing areas.

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 Series 50XM (M1350B) Fetal/Maternal Monitor (K954351)
• K041235
• K042845
• K051106
• K051366
• K030973
• K033715
• K032979
• K042306
• K970456
• Clinical Innovations devices (K954955)

Submission Summary (Full Text)

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K052795

All Area partig

DEC 3 0 2005

SECTION 8.0 -

510 (k) SUMMARY

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## 510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

- 1. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 Email: [e-mail]
This summary was prepared on September 30, 2005.

- 2. The name of the devices is the Philips Avalon Fetal Monitors FM20 and FM30. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|-----------------------------------------------------------|----------------|--------------------------|----------------------------------------------------------------|
| Obstetrical and<br>Gynecological<br>Monitoring<br>Devices | \$884.2660, II | MAA<br>HEL<br>HEK<br>KNG | Fetal ultrasonic monitor and<br>accessories |
| | \$884.2675, II | HGP | Fetal scalp circular (spiral)<br>electrode and applicator |
| | \$884.2700, II | HGS<br>KXO<br>HFO<br>HFN | Intrauterine pressure monitor<br>and accessories |
| | \$884.2720, II | HFM | External uterine contraction<br>monitor and accessories |
| | \$884.2740, II | HGM | Perinatal monitoring system and<br>accessories |
| | \$884.2960, II | HGL | Obstetric ultrasonic transducer<br>and accessories |
| Circulatory<br>System Devices | \$870.1100, II | DSJ | Alarm, Blood Pressure |
| | \$870.1110, II | DSK | Computer, Blood Pressure |
| | \$870.1130, II | DXN | System, Measurement, Blood-<br>Pressure, Non-Invasive |
| | \$870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer Signal |
| | \$870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate Alarm) |
| | \$870.2340, II | DPS | Electrocardiograph |
| | \$870.2600, I | DRJ | System, Signal Isolation |
| | \$870.2700, II | DQA | Oximeter |
| | \$870.2810, I | DSF | Recorder, Paper Chart |
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |

- 3. The modified devices Avalon Fetal Monitors FM20 and FM30 are substantially equivalent to previously cleared Philips devices marketed pursuant to K954351, K041235, K042845, K051106,

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K051366, K030973, K033715, K032979, K042306, K970456, and Clinical Innovations devices marketed pursuant to K954955.

- 4. The subject devices Philips Avalon Fetal Monitors FM20 and FM30 are modification of the legally marketed Philips Series 50XM (M1350B) Fetal/Maternal Monitor (K954351) and offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) during antepartum testing and labor and delivery.
- 5. The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same intended use as the legally marketed predicate device Philips Series 50XM (M1350B) Fetal/Maternal Monitor. The Philips Avalon Fetal Monitors FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves. The Avalon FM20 and FM30 are intended for use by trained health care professionals in labor and delivery rooms and in antepartum testing areas. They are not intended for use in intensive care units, operating rooms or for use outside the health care facilities.
- 6. The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same technological characteristics as the legally marketed predicate devices.
- 7. Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicates. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips Avalon Fetal Monitors FM20 and FM30 meet all reliability requirements and performance claims.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Mr. Markus Stacha Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str. 2 71034 Böblingen GERMANY

DEC 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K052795

Trade/Device Name: Avalon Fetal Monitors FM20 and FM30 Regulation Number: 21 CFR \$884.2740 Regulation Name: Perinatal monitoring system and accessories Product Code: HGM Regulation Number: 21 CFR §870.1130 Regulation Name: Noninvasive blood pressure measurement system Product Code: DXN Regulatory Class: II Dated: November 30, 2005 Received: December 2, 2005

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 (Premarket Approval), 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 vour device in the Federal Register.

Please be advised that FI)A 's issuance of a substantial equivalence determination does not mean that FIDA 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 (OS) 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.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

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# Indications for Use

## 510(k) Number (if known): K052795

Device Name: Philips Avalon Fetal Monitors FM20 and FM30.

## Indications for Use:

#### Avalon Fetal Monitor FM30:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas.

## Avalon Fetal Monitor FM20:

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rate in labor and delivery rooms and in antepartum testing areas."

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | Yes |
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AND/OR

| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | No |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K052795 |
|---------------|---------|
|---------------|---------|