Avalon Fetal/Maternal 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, oxygen saturation, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal 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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50: 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 rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Device Description

The legally marketed Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40, and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG wave, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2) with pulse rate, during antepartum testing and labor and delivery.

The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal pulse rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal Pulse Rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored.

Device Modifications: Operation of the models FM20 (M2702A) and FM30 (M2703A) with an internal rechargeable power source (optional) to support fetal/maternal monitoring during transport within healthcare facilities. Modification of the existing Toco transducer M2734A to include maternal pulse measurement, using plethysmography at an alternative body location (abdomen). The modified transducer is labeled M2734B 'Toco MP'. Automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report. The new software G.02.xx, which is a modification of the software F.01.xx (cleared with K102958) to support the before listed modifications / additions. Additionally, the option to equip the Avalon Fetal/Maternal Monitors with maternal SpO2 measurement is enabled now also for the model FM20 (M2702A).

AI/ML Overview

This submission describes the Philips Avalon Fetal/Maternal Monitor FM20/30, FM40/50, Release G.0. The primary focus of the provided text regarding new functionalities is on the M2734B 'Toco MP' transducer, which measures maternal pulse rate via plethysmography at the abdomen, and automated antepartum fetal/maternal trace interpretation and NST report generation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for the modified device functionalities. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." For the new Toco MP transducer, the performance is reported as meeting the requirements through comparison with ECG-derived maternal heart rate.

Acceptance Criteria Category	Specific Criteria (from predicate specifications, inferred)	Reported Device Performance (for modified features)
M2734B Toco MP Transducer	Accuracy of maternal pulse rate measurement (over full range)	Maternal pulse rate obtained from Toco MP transducer was recorded, compared, and evaluated against ECG-derived maternal heart rate (MECG). Implied to be accurate and meet predicate specifications for heart rate monitoring.
Antepartum Trace Interpretation & NST Report	Comparative performance against OB TraceVue G.00 (K100420)	Comparative test performed against the implementation in OB TraceVue G.00. Implied to be equivalent or better.
Overall Safety & Effectiveness	As safe, as effective, and perform as well or better than predicate devices. No new questions concerning safety or effectiveness.	"Non-clinical and clinical verification and validation results demonstrate that the Avalon fetal/maternal monitors with software G.02.xx are as safe, as effective, and perform as well or better as the predicate devices with software F.01.xx. The modified devices do not introduce new questions concerning the safety or effectiveness and are, therefore, substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

M2734B Toco MP Transducer Clinical Study: The document states, "For the clinical validation of the M2734B 'Toco MP' transducer a clinical study has been performed. The patient population was covering a variety of body mass indices (BMI) and skin colors."
- Sample Size: The exact numerical sample size for this clinical study is not specified in the provided text.
- Data Provenance: The country of origin is not specified. The study is described as a "clinical study," implying it was prospective, gathering new data for the validation.
Non-clinical Testing: "Some tests included the use of previously recorded patient raw signals and traces." This suggests some retrospective data was used in the non-clinical testing phase. The origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document describes clinical studies and comparative tests but does not detail the process of establishing ground truth with expert involvement for the test set, nor the number or qualifications of such experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text mentions "compared and evaluated" for the Toco MP transducer data, but no specific adjudication method (e.g., 2+1, 3+1, none) is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC study was mentioned. The device involves "automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report." This implies an algorithmic interpretation. While the NST report might assist human readers, no study comparing human readers with and without this AI assistance, or quantifying an effect size, is described. The comparison was for the algorithm's output against a predicate algorithm (OB TraceVue G.00).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance test for the antepartum trace interpretation algorithm was done. The document states: "Comparative test of antepartum fetal/maternal trace interpretation and NST report against the implementation in OB TraceVue G.00 (K100420)." This testing evaluates the algorithm's output independently by comparing it to an existing cleared algorithm, which is a form of standalone performance evaluation against a defined standard.

7. The Type of Ground Truth Used

For the M2734B Toco MP Transducer: The ground truth for maternal pulse rate was "ECG derived maternal heart rate (MECG)." This is a well-established and highly accurate physiological measurement, serving as a reliable reference standard.
For the Automated Antepartum Trace Interpretation/NST Report: The ground truth was the "implementation in OB TraceVue G.00 (K100420)." This means the new algorithm's output was compared to the output of a previously cleared, predicate software. This isn't a direct "pathology" or "outcomes data" ground truth, but rather a comparative standard against a known, accepted performance of another device.

8. The Sample Size for the Training Set

The document does not specify a training set nor its sample size. The description of modifications primarily concerns new hardware (Toco MP transducer) and software features (NST report, internal power source). While the NST report would likely involve some form of algorithmic development, no details about its training data are provided.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, information on how its ground truth was established is not provided.

Summary

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K|11083 510(k) Summary Avalon Fetal/Maternal Monitor FM20/30, FM40/50, Release G.0

Submitters Name:

AUG 1 7 2011

Michael Asmalsky Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 D-71034 Böblingen, Germany Fax: +49 7031 463-2442 Tel: +49 7031 463-1277 Email: michael.asmalsky@philips.com

Date of Summary:

This summary was prepared on July 11th, 2011.

Trade Name of the Device:

Philips Fetal/Maternal Monitor Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A), FM50 (M2705A) with software revision G.02.xx ("G.0" release)

Common Name:

Fetal monitor

Classification:

Device Panel	Classification	ProCode	Description
Obstetrical andGynecologicalMonitoring Devices	§884.2740, II	HGM	Perinatal monitoringsystem and accessories
Circulatory SystemDevices	§870.2780, II	JOM	Plethysmograph

Predicate Device:s

. "

Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM30, FM40, and FM50 with software revision F.01.xx (K102958) Philips IntelliVue Patient Monitors MP5 (K071426 ) Philips IntelliVue Patient Monitors MP2/X2 (K072070) Philips OB TraceVue Obstetrical Information Management System Rev. G.00 K100420 (July 26th 2010)

Device Description:

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The Avalon Fetal/Maternal Monitor FM20 provides the following exter measurement parameters:

Up to three Fetal Heart Rates (FHR) via ultrasound (US) -
Fetal Movement Profile -
Uterine activity via external Toco
Maternal pulse rate
Maternal Heart Rate via maternal ECG
Non-invasive blood pressure (NIBP)
Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:

One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
Uterine activity via intrauterine pressure (IUP) -
Maternal ECG (MECG) wave -

*) Note: maximum three fetal heart rates can be monitored.

The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:

Up to three Fetal Heart Rates (FHR) via ultrasound (US) -
Fetal Movement Profile -
Uterine activity via external Toco -
Maternal Pulse Rate .
Maternal Heart Rate via maternal ECG
Non-invasive blood pressure (NIBP).
Pulse oximetry (maternal SpO2)

The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:

One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG) *) -
-Uterine activity via intrauterine pressure (IUP)
Maternal ECG (MECG) wave -

*) Note: maximum three feta! heart rates can be monitored.

Device Modifications

The device modifications of the subject Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40, and FM50 include the following changes:

Operation of the models FM20 (M2702A) and FM30 (M2703A) with an internal rechargeable power source (optional) to support fetal/maternal monitoring during transport within healthcare facilities. This additional use case is a minor extension of the intended use.

Modification of the existing Toco transducer M2734A to include maternal pulse measurement, using plethysmography at an alternative body location (abdomen). The modified transducer is labeled M2734B 'Toco MP'.

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Automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report.
The new software G.02.xx, which is a modification of the software F.01.xx (cleared with K102958) to support the before listed modifications / additions.
Additionally, the option to equip the Avalon Fetal/Maternal Monitors with maternal SpO2 measurement is enabled now also for the model FM20 (M2702A).

All other measurement parameters that contain signal acquisition and physiological algorithms remain unchanged in this Premarket Notification.

Indications for Use:

Avalon Fetal/Maternal 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, oxygen saturation, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal 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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

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

Avalon Fetal/Maternal Monitor FM50:

Technological Characteristics:

The fundamental scientific technology employed in the operation of the Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 has not changed from that of the predicate devices as a result of the modification.

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Non-clinical Testing:

Verification and validation activities established the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing involved system level and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. Some tests included the use of previously recorded patient raw signals and traces. The bench tests included:

Cross Channel Verification (CCV) testing including maternal pulse from the M2734B Toco MP transducer as a signal source
M2734B Toco MP maternal pulse rate accuracy over the full range
Comparative test of antepartum fetal/maternal trace interpretation and NST report against the implementation in OB TraceVue G.00 (K100420)
Testing of generic hazards as indicated by the Risk management summary
Testing of battery-related hazards for the FM20/FM30 as indicated by the Risk management summary
Interface testing to the OB TraceVue system including date/time and patient identification - Testing of the alarms functionality
Regression testing for the Toco measurement and for the software G.02.xx
Testing of the additional minor enhancements introduced with software G.02.xx
Product Safety and Electromagnetic Compatibility according to IEC 60601-1+A1+A2 and IEC 60601-1-2+A1.

Clinical Testing:

For the clinical validation of the M2734B 'Toco MP' transducer a clinical study has been performed. The patient population was covering a variety of body mass indices (BMI) and skin colors. The maternal pulse rate obtained from the Toco MP transducer has been recorded together with the ECG derived maternal heart rate (MECG) and subsequently compared and evaluated.

Conclusion:

Non-clinical and clinical verification and validation results demonstrate that the Avalon fetal/maternal monitors with software G.02.xx are as safe, as effective, and perform as well or better as the predicate devices with software F.01.xx. The modified devices do not introduce new questions concerning the safety or effectiveness and are, therefore, substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002

Mr. Michael Asmalsky Senior Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 BÖBLINGEN 71034 GERMANY

AUG 1 7 2011

Re: K111083 Trade/Device Name: Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Regulation Number: 21 CFR$ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, HGL Dated: July 11, 2011 Received: July 13, 2011

Dear Mr. Asmalsky:

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. Please note: CDRH does not evaluate information related to contract liability 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 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

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.htm 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 the reporting of adverse events under the MDR regulation (21 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Hubert Lemon 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): K11/083

Philips Avalon FM20(M2702A), FM30(M2703A), Device Name: FM40 (M2704A) and FM50 (M2705A) .

Indications for Use:

Avalon Fetal/Maternal Monitor FM20:

Avalon Fetal/Maternal 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 prequant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM40:

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

Avalon Fetal/Maternal Monitor FM50:

Prescription Use(Part 21 CFR 801 Subpart D)	Yes	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)	No
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

ConcurredatoDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and
Urological Devices

510(k) Number	K111083
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Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
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.(b)
Classification. Class II (performance standards).