(87 days)
No
The document describes a standard fetal monitor and does not mention any AI or ML capabilities.
No
The device is a monitor used for surveillance and diagnosis, not to treat a disease or condition.
No
The device is described as a monitor of physiological parameters (e.g., heart rate, blood pressure, oxygen saturation) and does not indicate that it diagnoses conditions or diseases.
No
The device description explicitly states that the Philips Avalon Fetal Monitors FM20 and FM30 are "monitors" intended for noninvasive and invasive monitoring of physiological parameters, implying the use of hardware sensors and components to acquire these parameters. The description of generating alarms, displaying, storing, recording, and transmitting data further supports this, as these functions are typically integrated into a hardware device.
Based on the provided information, the Avalon Fetal Monitor FM20 and FM30 are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that these monitors are used for non-invasive monitoring of physiological parameters of pregnant women and fetuses. They are monitoring things like heart rate, uterine activity, blood pressure, and oxygen saturation directly from the patient, not analyzing samples taken from the patient.
- The description focuses on monitoring vital signs and physiological processes. This is characteristic of medical devices used for patient monitoring, not for diagnostic testing of biological samples.
Therefore, these devices fall under the category of patient monitoring devices, not IVD devices.
N/A
Intended Use / Indications for Use
Excludinq the added intended use location of private households, the intended use is the same as previously cleared for the legally marketed predicate device Philips Avalon Fetal Monitors FM20(M2702A)and FM30(M2703A) (K052795 and K062137) .
The Philips Avalon FM20 (M2702A), FM30 (M2703A), Fetal/Maternal Monitors are intended for noninvasive monitoring of parameters of pregnant women during antepartum testing and labor and delivery. The FM30 is additionally intended for invasive monitoring.
All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, oxyqen saturation (SpO2).
All monitors are intended for generating alarms fetal and maternal parameters, from for displaying, storing and recordinq 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 facilities outside hospitals, for example in doctors' offices, and for home use.
Contraindications: All monitors are NOT intended for :
- use during 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 the public low-voltage supply network that supplies buildings used for domestic purposes .
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.
Product codes
MAA, HEL, HEK, KNG, HGP, HGS, KXO, HFO, HFN, HFM, HGM, HGL, DSJ, DSK, DXN, DRQ, DRT, DPS, DRJ, DQA, DSF, DSA
Device Description
The names of the devices are the Philips Avalon Fetal Monitors FM20 and FM30.
The subject devices Philips Avalon Fetal Monitors FM20 and FM30 have the same technoloqical characteristics as the legally marketed predicate devices Avalon Fetal Monitors FM20 and FM30.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 facilities outside hospitals, for example in doctors' offices, and for home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K071800 p 1/3
SEP 27 2007
This summary of 510(k) safety and effectiveness 5.0 510(k) information is submitted in accordance with the Summary 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 June 26th, 2007.
5.1 Device The names of the devices are the Philips Avalon Names Fetal Monitors FM20 and FM30. Classification names are as follows.
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Obstetrical and | |||
| Gynecological | |||
| Monitoring | |||
| Devices | $884.2660, II | MAA | |
| HEL | |||
| HEK | |||
| KNG | Fetal ultrasonic monitor and | ||
| accessories | |||
| $884.2675, II | HGP | Fetal scalp circular (spiral) | |
| electrode and applicator | |||
| $884.2700, II | HGS | ||
| KXO | |||
| HFO | |||
| HFN | Intrauterine pressure monitor | ||
| and accessories | |||
| $884.2720, II | HFM | External uterine contraction | |
| monitor and accessories | |||
| $884.2740, II | HGM | Perinatal monitoring system and | |
| accessories | |||
| $884.2960, II | HGL | Obstetric ultrasonic transducer | |
| and accessories | |||
| Circulatory | |||
| System 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 Signal | |
| Conditioner, 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 and | |
| Electrode, incl. Patient | |||
| Connector |
1
K071800 P²/3
5.2 Subject The subject devices Philips Avalon Fetal Monitors devices
FM20 and FM30 are substantially equivalent to previously cleared Philips Avalon Fetal Monitors FM20 and FM30 marketed pursuant to K052795 and K062137.
- The modification of the Philips Avalon Fetal 5.3 Monitors FM20 and FM30 only introduces the Modifications capability for healthcare professionals of monitoring pregnant women at private households
2
K071800. P 3/3
5.4 Intended Use
Excludinq the added intended use location of private households, the intended use is the same as previously cleared for the legally marketed predicate device Philips Avalon Fetal Monitors FM20(M2702A)and FM30(M2703A) (K052795 and K062137) .
The Philips Avalon FM20 (M2702A), FM30 (M2703A), Fetal/Maternal Monitors are intended for noninvasive monitoring of parameters of pregnant women during antepartum testing and labor and delivery. The FM30 is additionally intended for invasive monitoring.
All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, oxyqen saturation (SpO2).
All monitors are intended for generating alarms fetal and maternal parameters, from for displaying, storing and recordinq 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 facilities outside hospitals, for example in doctors' offices, and for home use.
Contraindications: All monitors are NOT intended for :
- use during 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 the public low-voltage supply network that supplies buildings used for domestic purposes .
The subject devices Philips Avalon Fetal Monitors FM20 and FM30 have the same technoloqical characteristics as the legally marketed predicate devices Avalon Fetal Monitors FM20 and FM30.
5.5 Technoloqical Characteristics
3
Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a symbol consisting of three stylized human figures with flowing lines connecting them. The figures are arranged in a vertical stack, with the top figure being the largest and the bottom figure being the smallest.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SFP 2 7 2007
Mr. Michael Asmalsky Regulatory Affairs Engineer Philips Medizin Systeme Boblingen GmbH Ultrasound and Monitoring - Patient Monitoring Hewlett-Packard Str.2, D-71034 Boeblingen, Germany
Re: K071800
Trade Name: Phillips Avalon Fetal Monitors FM20 (M2702A) and FM30 (M2073A) Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: June 26, 2007 Received: July 2, 2007
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 Amerodments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Concessible Act (Act) that do not require approval of a premarket approval application (PMA). You COSIII COSIII 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, FPA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" inside a circular border. Below the logo, there is a cursive text that reads "Protecting and Promoting Public Health". The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text is slightly blurry, suggesting it may be a scan or a low-resolution image.
4
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 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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 Manufacturers, International and Consumer Assistance at its. toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address hitp://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Philips Avalon Fetal Monitors FM20 (M2702A) and FM30 (M2703A) .
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.
Prescription Use Yes (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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071807