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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal 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 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 Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) 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 (MHR) via maternal ECG
Non-invasive blood pressure (NIBP)

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

Single Fetal Heart Rate via direct ECG (DECG)
Twin Fetal Heart Rates via direct ECG (DECG) and/or ultrasound
Uterine activity via intrauterine pressure (IUP)
Maternal ECG (MECG)
Pulse oximetry (maternal Sp02).
*) Note: maximum three FHR's 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 (MHR) via maternal ECG
Non-invasive blood pressure (NIBP).
Pulse oximetry (maternal Sp02).

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

Single Fetal Heart Rate via direct ECG *) (DECG)
Twin Fetal Heart Rates , via direct ECG (DECG) and/or ultrasound "
Uterine activity via intrauterine pressure , (IUP)
Maternal ECG (MECG) ,
" Note: maximum three FHR's can be monitored.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K102958) does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format.

Instead, it refers to the existing specifications cleared for the predicate devices as the basis for Pass/Fail criteria. The study concluded that the modified algorithm met these unstated criteria.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance (Explicitly Stated)
"Pass/Fail criteria were based on the specifications cleared for the predicate devices" (K071800 and K092028).	"test results showed substantial equivalence."
"The results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims."	The improved ultrasound performance algorithm addressed "problems with halving and doubling of the fetal heart rate and mistaken display of maternal heart rate for fetal heart rate."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Some tests included the use of previously recorded patient traces," but doesn't quantify the number of traces or patients.
Data Provenance: Not explicitly stated. The term "previously recorded patient traces" suggests retrospective data, but the country of origin is not mentioned.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. It's unclear how ground truth was established from the "previously recorded patient traces" or if any adjudication was performed for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, there is no mention of a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance.
Effect Size: Not applicable, as no MRMC study was reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes, the document describes "system level and regression tests" and testing of "the improved ultrasound performance algorithm." This implies a standalone evaluation of the algorithm's performance in addressing the identified issues of heart rate inaccuracies (halving, doubling, maternal heart rate mistaken for fetal). The focus of the 510(k) is on the algorithm modification itself.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. The document mentions using "previously recorded patient traces." For evaluating the accuracy of fetal heart rate detection and differentiation from maternal heart rate, an accurate reference (e.g., from a different, highly accurate monitoring method, or expert review of the original traces) would be required, but this is not detailed.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document discusses an "improved ultrasound performance algorithm" which was a modification to existing devices. There is no mention of a "training set" in the context of machine learning or AI development in this summary. The algorithm improvement seems to be a programmatic enhancement rather than a machine learning model trained on data.

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

How Ground Truth Was Established for Training Set: Not applicable, as no training set for an AI/ML model is indicated. The improvements described are algorithm modifications to address specific known problems with heart rate detection.

Summary

{0}------------------------------------------------

K10299

MAR 1 8 2011

8.0 510(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.

The submitter of this premarket notification is: . Michael Asmalsky Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany

Tel: +49 7031 463-1277 Fax: +49 7031 463-2442 Email: michael.asmalsky@philips.com

This summary was prepared on March 18th, 2011

{1}------------------------------------------------

8.1 Indications The indications for use of the subject devices for Use has not changed.

Indications for Use:

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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

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 rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal 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 Monitor FM50:

{2}------------------------------------------------

8.2 Device Names

The names of the devices are the Philips Avalon Fetal Monitors FM20 (M2702A), FM30 (M2703A),FM40 (M2704A) and FM50 (M2705A).

legally marketed devices Philips 8.3 Device The Avalon Description Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) 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 (MHR) via maternal ECG
-Non-invasive blood pressure (NIBP)

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

Single Fetal Heart Rate via direct ECG -(DECG)
-Twin Fetal Heart Rates via direct ECG (DECG) and/or ultrasound ''
-Uterine activity via intrauterine pressure (IUP)
Maternal ECG (MECG) "
י Pulse oximetry (maternal Sp02).

*) Note: maximum three FHR's 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 י
-Maternal Pulse Rate
Maternal Heart Rate (MHR) via maternal ECG י
Non-invasive blood pressure (NIBP). י
-Pulse oximetry (maternal Sp02).

CONFIDENTIAL

Page 137

{3}------------------------------------------------

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

'Single Fetal Heart Rate via direct ECG *) (DECG)
Twin Fetal Heart Rates , via direct ECG (DECG) and/or ultrasound "
Uterine activity via intrauterine pressure , (IUP)
Maternal ECG (MECG) ,

" Note: maximum three FHR's can be monitored.

{4}------------------------------------------------

8.4 Device The Philips Avalon Fetal Monitors FM20 (M2702A), Classification FM30(M2703A), FM40(M2704A) and FM50(M2705A) and where applicable including their accessories are classified under ProCcode HGM, classification 884.2740, ·Perinatal monitoring system and their accessories.

Device Panel	Classification	ProCode	Description
Obstetrical andGynecologicalMonitoring Devices	$884.2740, II	HGM	Perinatal monitoringsystem and accessories

The subject devices Philips Avalon Fetal Monitors 8.5 Subject FM30, FM40 and FM50 are substantially devices FM20, equivalent to previously cleared Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 marketed pursuant to K071800 and K092028.

modification of the Philips Avalon Fetal 8.6 The Modifications Monitors FM20, FM30, FM40 and FM50 only provides an improved ultrasound performance algorithm of the released ultrasound transducers and TMIF interface cables to be used with the Philips Avalon Fetal monitors FM20, FM30, FM40 and FM50. The software changes were made to address problems with halving and doubling of the fetal heart. rate and mistaken display of maternal heart rate for fetal heart rate.

8.7 The subject devices Philips Avalon Fetal Monitors Technological FM20, FM30, FM40 and FM50 have the same Characteristics characteristics as the legally marketed predicate devices Avalon Fetal Monitors FM20, FM30, FM40 and FM50 .

{5}------------------------------------------------

K102958 page 6 of 6

8.8 Verification and Validation

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. 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 traces.

The results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

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

Mr. Michael Asmalsky Regulatory Affairs Engineer Philips Medizin Systeme Boblingen GmbH Hewlett-Packard Str. 2 71034 BOBLINGEN GERMANY

MAR 1 8 2011

Re: K102958

Trade Name: Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, & FM50) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: February 21, 2011 Received: March 3, 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

{7}------------------------------------------------

Page 2

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/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.

Sincerely yours,

Hubert Lenoir 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

{8}------------------------------------------------

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

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

Indications for Use:

Avalon Fetal Monitor FM20:

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

Avalon Fetal Monitor FM30:

Avalon Fetal Monitor FM40:

Avalon Fetal Monitor FM50:

Prescription Use ___Yes Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use __ No_ (21 CFR 807 Subpart C)

(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 Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102958

Page 16

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).