(90 days)
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.
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).
The provided text describes the 510(k) summary for the Philips Avalon CTS Cordless Fetal Transducer System but does not contain specific acceptance criteria or a detailed study proving the device meets said criteria.
The submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and general verification/validation testing. It states that "Test results showed substantial equivalence," but does not provide the specific performance metrics, sample sizes, or methodologies of these tests in a way that allows for a comprehensive answer to your request.
Therefore, I cannot fill out the requested table or answer most of the questions directly from the provided text. I can only extract general information about the testing performed.
Here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
- The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics (e.g., accuracy, sensitivity, specificity) for the fetal monitoring parameters. It simply states that "Test results showed substantial equivalence," implying that the performance met internal benchmarks or was comparable to predicate devices.
2. Sample size used for the test set and the data provenance
- Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as there's no mention of a ground truth established by experts for performance evaluation.
4. Adjudication method for the test set
- Not applicable, as there's no mention of an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done, nor is AI involved in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a hardware system for continuous fetal monitoring with radio transmission technology. There is no mention of a standalone algorithm or AI performance. The system's output is intended to be interpreted by healthcare practitioners.
7. The type of ground truth used
- Not specified. The testing mentioned (environmental, electrical safety, EMC, radio telemetry, biocompatibility, and user evaluations for consumer accuracy, hardware/software verification, cable interface verification) focuses on the device's functional and safety characteristics rather than its diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
However, the document does mention the following general information about testing:
- Study That Proves the Device Meets Acceptance Criteria:
- "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."
Key Point: This 510(k) summary focuses on demonstrating that the modified device has "the same technological characteristics" as the predicate devices and that general verification and validation testing confirmed "substantial equivalence" for its intended use, rather than presenting a detailed clinical performance study with explicit acceptance criteria.
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KD23931 p 1/2
510(k) Summary (As required by 21 C.F.R. §807.92)
| Submitted by: | Markus StachaPhilips Medizin Systeme Boeblingen GmbHCardiac and Monitoring SystemsHewlett-Packard Str.271034 BoeblingenGermany | 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 andAccessories | ||
| Predicate Devices | Philips M1310A Fetal Telemetry System-Series 50T (K942887),Philips M1350A Intrapartum Fetal Monitor (K900480), PhilipsM1350B Perinatal Monitoring System (K954351), PhilipsM1351A Perinatal Monitoring System (K921957), PhilipsM1353A Fetal Monitor (K921956) and the Philips M2600ATelemetry Systems (K993516, K980429, and K961165). | ||
| Modifications | The modification incorporates the front-end circuitry for eachparameter into the transducer, thereby replacing the cable used inthe predicate versions by a direct hardware connection. There areno 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 anyPhilips Series 50 fetal monitor using radio transmissiontechnology. A group of three wireless transducers is available toobtain specific fetal data in the antepartum period and during laborand delivery. The transducers are designed to operate while thepatient is ambulatory, including activity taking place in asubmerged 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 theoptional ECG/auxiliary transducer M2727A (measures DECG ordirect fetal scalp ECG and MECG or maternal ECG). |
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K023931 p 2/2
| Intended Use | The intended use of the modified device, as described in itslabeling, has not changed from that of the predicate device as aresult of the modifications. The Philips M2720A Cordless FetalTransducer System is indicated for pregnant women from about 22weeks of gestation on through delivery. It is intended forcontinuous cordless fetal monitoring in connection with a fetalmonitor for resting or ambulating patients, also usable duringhydrotherapy, for antepartum testing and labor and delivery(intrapartum).The system should only be used by, or under the direct supervisionof, a licensed physician or other health care practitioner who istrained in the use of fetal heart rate monitors and in theinterpretation of fetal heart rate traces. It is not intended for homeuse. |
|---|---|
| Technologicalcharacteristics | The Philips Avalon CTS Cordless Fetal Transducer System andaccessories have the same technological characteristics as thelegally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted toestablish the performance and reliability characteristics of themodified device.Testing involved environmental, electrical safety, EMC, radiotelemetry, biocompatibility and user evaluations for consumeraccuracy. Hardware and software verification testing and cableinterface verification testing were also conducted. Test resultsshowed substantial equivalence. |
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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.
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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
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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
Page __ of ___________________________________________________________________________________________________________________________________________________________________
§ 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).