(90 days)
Not Found
No
The summary describes a system for measuring, processing, and transmitting standard fetal parameters using radio transmission technology. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for continuous cordless fetal monitoring, measuring and transmitting fetal parameters. It is a diagnostic and monitoring device, not one that directly treats a condition or disease.
Yes
The device measures, processes, and transmits standard fetal parameters (fetal heart rate, uterine activity, fetal movement profile, DECG, MECG) to a fetal monitor for interpretation, which are used to assess the health of the fetus. This process of collecting and providing data to interpret a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly mentions hardware components (transducers, base station) and the summary of performance studies includes hardware verification testing.
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.
- Device Function: The Philips Avalon CTS Cordless Fetal Transducer System measures physiological parameters directly from the pregnant woman and the fetus (uterine activity, fetal heart rate, fetal movement, direct fetal ECG, maternal ECG). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring the pregnant woman and fetus during pregnancy and labor, not analyzing biological samples for diagnostic purposes.
Therefore, this device falls under the category of a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum).
The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.
Product codes
85 HGM
Device Description
The Perinatal Monitoring System operates by measuring, processing, and transmitting standard fetal parameters to any Philips Series 50 fetal monitor using radio transmission technology. A group of three wireless transducers is available to obtain specific fetal data in the antepartum period and during labor and delivery. The transducers are designed to operate while the patient is ambulatory, including activity taking place in a submerged water environment, like bathing and hydrotherapy. The devices are identified by the following model numbers: System and Base Station M2720A; Toco transducer M2725A (measures uterine activity externally); US transducer M2726A (measures fetal heart rate and fetal movement profile); and the optional ECG/auxiliary transducer M2727A (measures DECG or direct fetal scalp ECG and MECG or maternal ECG).
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 from about 22 weeks of gestation on through delivery.
Intended User / Care Setting
licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended 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
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved environmental, electrical safety, EMC, radio telemetry, biocompatibility and user evaluations for consumer accuracy. Hardware and software verification testing and cable interface verification testing were also conducted. Test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results showed substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K942887, K900480, K954351, K921957, K921956, K993516, K980429, K961165
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
KD23931 p 1/2
510(k) Summary (As required by 21 C.F.R. §807.92)
| Submitted by: | Markus Stacha
Philips Medizin Systeme Boeblingen GmbH
Cardiac and Monitoring Systems
Hewlett-Packard Str.2
71034 Boeblingen
Germany | | FEB 2 4 2003 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------|
| Date of Summary: | November 22, 2002 | | |
| Device Name | Philips Avalon CTS Cordless Fetal Transducer System | | |
| Common Name | Perinatal Monitoring System | | |
| Classification Name | Regulation Number | Classification Name | |
| | 21 C.F.R §884.2740 | Perinatal Monitoring System and
Accessories | |
| Predicate Devices | Philips M1310A Fetal Telemetry System-Series 50T (K942887),
Philips M1350A Intrapartum Fetal Monitor (K900480), Philips
M1350B Perinatal Monitoring System (K954351), Philips
M1351A Perinatal Monitoring System (K921957), Philips
M1353A Fetal Monitor (K921956) and the Philips M2600A
Telemetry Systems (K993516, K980429, and K961165). | | |
| Modifications | The modification incorporates the front-end circuitry for each
parameter into the transducer, thereby replacing the cable used in
the predicate versions by a direct hardware connection. There are
no modifications to the device design that affect safety &
effectiveness of the Perinatal Monitoring System. | | |
| Device Description | The Perinatal Monitoring System operates by measuring,
processing, and transmitting standard fetal parameters to any
Philips Series 50 fetal monitor using radio transmission
technology. A group of three wireless transducers is available to
obtain specific fetal data in the antepartum period and during labor
and delivery. The transducers are designed to operate while the
patient is ambulatory, including activity taking place in a
submerged water environment, like bathing and hydrotherapy.
The devices are identified by the following model numbers:
System and Base Station M2720A; Toco transducer M2725A
(measures uterine activity externally); US transducer M2726A
(measures fetal heart rate and fetal movement profile); and the
optional ECG/auxiliary transducer M2727A (measures DECG or
direct fetal scalp ECG and MECG or maternal ECG). | | |
1
K023931 p 2/2
| Intended Use | The intended use of the modified device, as described in its
labeling, has not changed from that of the predicate device as a
result of the modifications. The Philips M2720A Cordless Fetal
Transducer System is indicated for pregnant women from about 22
weeks of gestation on through delivery. It is intended for
continuous cordless fetal monitoring in connection with a fetal
monitor for resting or ambulating patients, also usable during
hydrotherapy, for antepartum testing and labor and delivery
(intrapartum).
The system should only be used by, or under the direct supervision
of, a licensed physician or other health care practitioner who is
trained in the use of fetal heart rate monitors and in the
interpretation of fetal heart rate traces. It is not intended for home
use. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The Philips Avalon CTS Cordless Fetal Transducer System and
accessories have the same technological characteristics as the
legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to
establish the performance and reliability characteristics of the
modified device.
Testing involved environmental, electrical safety, EMC, radio
telemetry, biocompatibility and user evaluations for consumer
accuracy. Hardware and software verification testing and cable
interface verification testing were also conducted. Test results
showed substantial equivalence. |
2
Image /page/2/Picture/1 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 image of an eagle or other bird with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2003
Mr. Markus Stacha Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str.2 71034 Böblingen GERMANY
Re: K023931
Trade/Device Name: M2720A Avalon CTS Cordless Fetal Transducer System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: November 22, 2002 Received: November 26, 2002
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 (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); 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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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
Page 2
4
Indications for Use Statement
510(k) Number (if known)
六023931
Device Name: The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories
Indications for Use: The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum).
The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use.
OR
Over-The-Counter Use
David h. Ingram
(Division Sign-Off)
Division of Reproductive, A and Radiological Devices 510(k) Number
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