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

Device Description

The modified devices 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 maternal oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.

AI/ML Overview

The provided text describes a 510(k) summary for the Philips Avalon Fetal Monitors FM20 and FM30, specifically for a modification that introduces the capability of monitoring fetal heart rates of triplets. However, the text does not include detailed acceptance criteria or a specific study that quantitatively proves the device meets such criteria.

The information mainly focuses on establishing substantial equivalence to a predicate device, regulatory classifications, and the general scope of the device's intended use and functionality.

Here's a breakdown of what is and is not available in the provided text regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Available. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" but does not provide details of these criteria nor specific reported performance metrics against them. It only states that "test results showed substantial equivalence" and "the results demonstrate that the Philips Avalon Fetal Monitors FM20 and FM30 meet all reliability requirements and performance claims." There are no quantitative performance numbers (e.g., sensitivity, specificity, accuracy, error rates) reported for the device, especially concerning the triplet monitoring capability.

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

Not Available. The document mentions "performance tests, regression tests, and testing from hazard analysis" but does not specify the sample size (number of patients, records, or fetal heart rate traces) used for any of these tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable/Not Available. Since no specific performance study with a 'ground truth' is described (such as for diagnostic accuracy), there's no mention of experts establishing ground truth or their qualifications. The device is a physiological monitor, not typically one that requires expert-established ground truth for its core function in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set:

Not Applicable/Not Available. As no detailed performance study requiring adjudication is described, this information is not present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Not Available. The document does not describe any MRMC comparative effectiveness study, nor does it mention any AI component or the effect size of AI assistance on human readers. The device is a monitor, not an AI-assisted diagnostic tool in the sense of image analysis.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable/Not Available. This device is a monitor, not a standalone algorithm in the typical sense of AI/ML. Its function is to acquire and display physiological parameters. While it processes signals, the "algorithm only" performance metric as described for AI is not relevant here.

7. The Type of Ground Truth Used:

Not Available. As no specific performance study requiring ground truth is described, this information is not present. For a physiological monitor, "ground truth" typically refers to the accuracy of the measurements against a gold standard instrument, but details of such testing are not provided beyond a general statement of meeting specifications.

8. The Sample Size for the Training Set:

Not Applicable/Not Available. The document describes a traditional medical device (fetal monitor) and a modification for triplet monitoring. It does not indicate the use of machine learning or AI that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable/Not Available. Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable.

In summary, the provided 510(k) summary focuses on regulatory compliance through substantial equivalence, indicating that the device's modification (triplet monitoring) was verified through "performance tests, regression tests, and testing from hazard analysis" against existing predicate specifications. However, it does not provide the detailed, quantitative performance data, sample sizes, or specifics of ground truth establishment that you requested for a comprehensive understanding of the device's acceptance criteria and the study proving it.

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: markus.stacha@philips.com

This summary was prepared on July 21, 2006.

1. 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 andGynecologicalMonitoringDevices	$884.2660, II	MAAHELHEKKNG	Fetal ultrasonic monitor andaccessories
	$884.2675, II	HGP	Fetal scalp circular (spiral)electrode and applicator
	$884.2700, II	HGSKXOHFOHFN	Intrauterine pressure monitorand accessories
	$884.2720, II	HFM	External uterine contractionmonitor and accessories
	$884.2740, II	HGM	Perinatal monitoring system andaccessories
CirculatorySystem Devices	$884.2960, II	HGL	Obstetric ultrasonic transducerand accessories
	$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, Transducer Signal
	$870.2300, II	DRT	Monitor, Cardiac (incl.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 andElectrode, incl. PatientConnector

1. The modified devices Philips Avalon Fetal Monitors FM20 and FM30 are substantially equivalent to previously cleared

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Philips Avalon Fetal Monitors FM20 and FM30 marketed pursuant to K052795.

1. The modification of the Philips Avalon Fetal Monitors FM20 and FM30 introduces the capability of monitoring fetal heart rates of triplets.
1. The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same intended use as the legally marketed predicate device Philips Avalon Fetal Monitors FM20 and FM30. 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 maternal 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
1. The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same technological characteristics as the legally marketed predicate devices Avalon Fetal Monitors FM20 and FM30.

intensive care units, operating rooms or outside the health

care facilities.

1. 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 performance tests, regression tests, and testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices 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.
  -2-

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures, possibly representing health, family, and community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2006

Mr. Markus Stacha Senior Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 1 71034 Böblingen GERMANY

Re: K062137

Trade/Device Name: Philips Avalon Fetal Monitors FM20 and FM30 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: HGM and DXN Dated: July 21, 2006 Received: July 26, 2006

Dear Mr. Stacha:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following ultrasound transducer intended for use with the Philips Avalon Fetal Monitors FM20 and FM30, as described in your premarket notification:

Transducer Model Number

M2736A, 1 MHz Ultrasound Transducer

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Page 2 - Mr. Markus Stacha

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small

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Page 3 -- Mr. Markus Stacha

Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Mr. Glenn Bell at (301) 594-1180.

Sincerely yours,

David A. Leppsm

for

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

Enclosures

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Indications for Use

510(k) Number (if known):_KOG2 137

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

Prescription Use Yes Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (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)

David A. Seymour

(Division Sign-Off) Division of Reproductive, Abdomi 510(k) Number

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).