The Philips Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal Monitors are intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. All monitors are intended for monitoring fetal heart rates, fetal movement profiles, maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50 maternal oxygen saturation (Sp02). The FM30 and FM50 are additionally intended for maternal ECG and for invasive monitoring of fetal Direct ECG and intrauterine pressure. All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother. All monitors are intended for use by trained health care professionals. They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare and for example in doctors' offices, and in private households.

Device Description

The subject devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 are a modification of the legally marketed Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 and offer monitoring of fetal heart rates, fetal movement profiles, fetal Direct ECG, maternal uterine activity, maternal heart rates, maternal pulse rates, maternal ECG, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (Sp02) during antepartum testing and labor and delivery. The modification of the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 only permits specific Sp02 sensors, which are already cleared for the Philips picoSATIIplus SpO2 pulse oximetry module, the Philips Intellivue X2 (M3002A) multi measurement module and the Philips M1020B Sp02 plug-in module, to be also used with the Philips Avalon Fetal monitors FM30, FM40 and FM50.

AI/ML Overview

The Philips Avalon Fetal Monitors (FM20, FM30, FM40, and FM50) are a modification of previously cleared devices, primarily to permit the use of specific SpO2 sensors already cleared for other Philips modules. The submission focuses on demonstrating substantial equivalence to these predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that "hazard criteria were based on the Pass/Fail analysis. specifications cleared for the predicate devices and test results showed substantial equivalence." This implies that the acceptance criteria for the modified devices were the same performance specifications as those established for the predicate devices. The study concludes that the "results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims."

Acceptance Criteria (Implied)	Reported Device Performance
Performance, functionality, and reliability characteristics	Meets all reliability requirements and performance claims, demonstrating substantial equivalence to predicate devices.
Compliance with specifications cleared for predicate devices	Test results showed substantial equivalence to predicate device specifications.
Pass/Fail analysis based on hazard criteria	Testing involved regression and system-level tests; hazard criteria met.

Study Details:

Sample Size and Data Provenance (Test Set):
- The document does not specify the sample size used for the test set.
- The data provenance (country of origin, retrospective/prospective) is not mentioned.
Number of Experts and Qualifications (Ground Truth for Test Set):
- The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
Adjudication Method (Test Set):
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance and substantial equivalence, not human reader improvement with AI assistance.
Standalone Performance Study:
- A standalone performance study was implicitly done, as "Verification and Validation testing activities" were conducted to "establish the performance, functionality, and reliability characteristics of the modified devices." This testing was against predefined specifications, indicating an algorithm-only (device-only) performance assessment.
Type of Ground Truth Used:
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The ground truth for the verification and validation appears to be the "specifications cleared for the predicate devices."
Sample Size for Training Set:
- The document does not mention a training set, as the evaluation method described is primarily focused on verification and validation against pre-established specifications for the modified device, rather than training a new algorithm from data.
How Ground Truth for Training Set was Established:
- Not applicable, as no training set is mentioned in the context of this submission. The device is a modification of an existing, cleared device, implying its core algorithms were already established and validated. The current submission focuses on verifying continued performance after a component modification.

Summary

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KD92028.-p.1/4

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.

FEB 1 7 2010

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

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

This revised summary was prepared on August 14th, 2009.

8.1 Device Names

The names of the devices are the Philips Avalon Fetal Monitors FM20, FM30,FM40 and FM50. Classification names are as follows.

Device Panel	Classification	ProCode	Description
Obstetrical andGynecologicalMonitoringDevices	§884.2660, II	MAA	Fetal ultrasonic monitor andaccessories
	§884.2660, II	HEL
	§884.2660, II	HEK	accessories
	§884.2660, II	KNG
	§884.2675, II	HGP	Fetal scalp circular (spiral)electrode and applicator
	§884.2700, II	HGS
	§884.2700, II	KXO	Intrauterine pressure monitorand accessories
	§884.2700, II	HFO
	§884.2720, II	HFN
	§884.2720, II	HFM	External uterine contractionmonitor and accessories
	§884.2740, II	HGM	Perinatal monitoring systemand accessories
	§884.2960, II	HGL	Obstetric ultrasonictransducer and accessories
CirculatorySystem Devices	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.1110, II	DSK	Computer, Blood Pressure
	§870.1130, II	DXN	System, Measurement, Blood-Pressure, Non-Invasive
	§870.2060, II	DRQ	Amplifier and SignalConditioner, TransducerSignal
	§870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & RateAlarm)
	§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 andElectrode, incl. PatientConnector

•

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8.2 Subject devices

The subject devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 are substantially equivalent to the previously cleared Philips Avalon Fetal Monitors FM20 . FM30, FM40 and FM50 marketed pursuant to K052795, K062137 and K071800.

K0920Z8

8.3 Modifications

The modification of the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 only permits specific Sp02 sensors, which are already cleared for the Philips picoSATIIplus SpO2 pulse oximetry module, the Philips Intellivue X2 (M3002A) multi measurement module and the Philips M1020B Sp02 plug-in module, to be also used with the Philips Avalon Fetal monitors FM30, FM40 and FM50.

8.4 Intended uge

modified devices have the same intended use as The previously cleared for the legally marketed predicate devices Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 (K052795, K062137 and K071-800). .

Intended Use: The Philips Avalon FM20, FM30, FM40 and Fetal/Maternal Monitors are intended for non-FM50 invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery.

monitors are intended for monitoring fetal and All Arr monitors rates, fetal movement profiles, maternal maternal issues, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50 maternal oxygen saturation (Sp02).

The FM30 and FM50 are additionally intended for maternal ECG and for invasive monitoring of fetal Direct ECG and intrauterine pressure.

All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and related waves, data recording patient and transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother.

All monitors are intended for use by trained health care professionals.

They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare and 1.50 are are are and for example in doctors' offices, and in private households.

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K092028 D. 3/4

Contraindications: All monitors are NOT intended for: conviduring defibrillation, electro-surgery, or magnetic resonance imaging (MRI).

ECG measurements on patients connected to external । electrical stimulators or with cardiac pacemakers.

use with the IUP/ECG patient module (M2738A) in । domestic establishments and those connected directly to public low-voltage supply network that supplies the buildings used for domestic purposes.

The before is the same intended use as previously cleared for the Philips Avalon Fetal Monitors FM20, FM30, FM40 and FM50 (K052795, K062137 and K071800). The intended use and 1430 (Results) is a subset of the intended use of the FM20 and FM30.

As a summary, the following table provides an overview about the monitored parameters per fetal monitor.

Monitored Parameters	FM20	FM30	FM40	FM50
Up to threeFetal HeartRates (FHR) viaultrasound (US)*	Yes	Yes	Yes	Yes
Single FetalHeart Rate viadirect ECG(DFHR) *	--	Yes	--	Yes
Fetal Direct ECG(DECG)	--	Yes	--	Yes
Fetal MovementProfile	Yes	Yes	Yes	Yes
Uterine activityvia externalToco	Yes	Yes	Yes	Yes
Uterine activityvia intrauterinepressure (IUP)	--	Yes	--	Yes
Pulse oximetry(maternal SpO2)	--	Yes	Yes	Yes
Maternal PulseRate	Yes	Yes	Yes	Yes
Maternal HeartRate (MHR) viamaternal ECG	Yes	Yes	Yes	Yes
Maternal ECG(MECG)	--	Yes	--	Yes
Non-invasiveblood pressure(NIBP)	Yes	Yes	Yes	Yes

*: A maximum of three fetal heart rates can be monitored (including max. one DECG)

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

109 20 28

8 . ୧ Verification and Validation

testing activities validation, and Verification, establish the performance, functionality, and reliability characteristics of the modified devices with respect to predicate. Testing involved level and system the regression tests as well as testing from the hazard criteria were based on the Pass/Fail analysis. specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims.

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Image /page/4/Picture/0 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 graphic of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 71034 Böblingen GERMANY

FEB 1 7 2010

Re: K092028 · ·

Trade Name: Philips Avalon Fetal Monitors, model FM20, FM30, FM40 and FM50 Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: October 19, 2009 Received: October 22, 2009

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 Devise-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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Page 2 -

adverse events) (21 CFR 803); 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.

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.goy/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,

anine M. Morri Acting 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): K092028

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 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:

Prescription Use (Part 21 CFR 801 Subpart D)

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)
11 A1 11
100

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number _

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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).