(88 days)
No
The summary describes a standard fetal monitor with physiological parameter monitoring, display, storage, and alarm functions. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is described as a "Fetal Monitor" and its intended use is for "monitoring of the physiological parameters." Monitoring is a diagnostic function, not a therapeutic one.
No
The primary function of this device is monitoring physiological parameters and displaying/storing the data, not making a diagnosis based on that data.
No
The device description explicitly states it is a "Fetal Monitor" and describes monitoring of physiological parameters, generating alarms, displaying, storing, and recording patient data and related waves, which are functions of a hardware device with integrated software. The predicate device is also a "Fetal/Maternal Monitor," further indicating a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The Avalon Fetal Monitor FM20 and FM30 are described as devices that monitor physiological parameters of pregnant women and the fetus in vivo (within the living body). They use sensors and probes applied to the patient to measure things like heart rate, uterine activity, blood pressure, and oxygen saturation.
- Lack of Specimen Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is to directly measure physiological signals from the patient.
Therefore, the Avalon Fetal Monitor FM20 and FM30 fall under the category of medical devices used for patient monitoring, not in vitro diagnostics.
N/A
Intended Use / 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 rate 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 rate in labor and delivery rooms and in antepartum testing areas.
Product codes (comma separated list FDA assigned to the subject device)
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 subject devices Philips Avalon Fetal Monitors FM20 and FM30 are modification of the legally marketed Philips Series 50XM (M1350B) Fetal/Maternal Monitor (K954351) and offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) during antepartum testing and labor and delivery.
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
pregnant women
Intended User / Care Setting
trained health care professionals in labor and delivery rooms and in antepartum testing areas.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954351, K041235, K042845, K051106, K051366, K030973, K033715, K032979, K042306, K970456
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
All Area partig
DEC 3 0 2005
SECTION 8.0 -
510 (k) SUMMARY
1
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: 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 September 30, 2005.
- 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
-
- 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 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 |
2
K051366, K030973, K033715, K032979, K042306, K970456, and Clinical Innovations devices marketed pursuant to K954955.
-
- The subject devices Philips Avalon Fetal Monitors FM20 and FM30 are modification of the legally marketed Philips Series 50XM (M1350B) Fetal/Maternal Monitor (K954351) and offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) during antepartum testing and labor and delivery.
-
- The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same intended use as the legally marketed predicate device Philips Series 50XM (M1350B) Fetal/Maternal Monitor. 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 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 intensive care units, operating rooms or for use outside the health care facilities.
-
- The modified devices Philips Avalon Fetal Monitors FM20 and FM30 have the same technological characteristics as the legally marketed predicate devices.
-
- 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 system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Mr. Markus Stacha Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str. 2 71034 Böblingen GERMANY
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K052795
Trade/Device Name: Avalon Fetal Monitors FM20 and FM30 Regulation Number: 21 CFR $884.2740 Regulation Name: Perinatal monitoring system and accessories Product Code: HGM Regulation Number: 21 CFR §870.1130 Regulation Name: Noninvasive blood pressure measurement system Product Code: DXN Regulatory Class: II Dated: November 30, 2005 Received: December 2, 2005
Dear Mr. Stacha:
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.
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, FDA may publish further announcements concerning vour device in the Federal Register.
Please be advised that FI)A 's issuance of a substantial equivalence determination does not mean that FIDA 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 (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.
4
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K052795
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 rate 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 rate in labor and delivery rooms and in antepartum testing areas."
| Prescription Use
| (Part 21 CFR 801 Subpart D) | Yes |
|---|---|
| ------------------------------------------------- | ----- |
AND/OR
| Over-The-Counter Use
| (21 CFR 807 Subpart C) | No |
|---|---|
| ------------------------------------------------ | ---- |
(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 | K052795 |
|---|---|
| --------------- | --------- |