(63 days)
Not Found
No
The summary describes a system for wireless transmission of fetal monitoring data (ultrasound and tocodynamometer) to a separate monitor. There is no mention of any processing or analysis of this data using AI or ML techniques. The device acts as an accessory for data acquisition and transmission.
No.
The device is used for monitoring fetal heart rate and maternal contractions, which is diagnostic and observational, not therapeutic.
Yes
The device detects and evaluates fetal heart rate and uterine contractions, providing signals for a monitoring or recording system, which are used to assess the health of the fetus and mother.
No
The device description explicitly states it includes hardware components: 1 Ultrasound (US) transducer, 1 Tocodynamometer (TOCO) transducer, and 1 Base Station.
No, 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 F1 Mothership Wireless Transducers are used for external monitoring of fetal heart rate and maternal contractions. They do not analyze samples taken from the body. They are sensing and transmitting signals from the patient's body surface to a monitoring system.
Therefore, based on the provided information, 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 F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is singleton pregnancies only. It is not intended for home use.
The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and function for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers.
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 race traces.
Product codes (comma separated list FDA assigned to the subject device)
HGM
Device Description
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a perinatal monitoring accessory that integrates with GE Corometrics series monitors. The accessory's intended use is for antepartum and intrapartum wireless measurement and recording of fetal heart rate and maternal contractions. The intended use environment is a clinical setting, in the labor and delivery room of a hospital. The F1 is equipped with 1 Ultrasound (US) transducer, 1 Tocodynamometer (TOCO) transducer, and 1 Base Station. The Base Station transmits data wirelessly between the US/TOCO transducers (respectively) and a separate FDA-cleared fetal monitor ("monitor"), and is connected directly to the monitor via wired connection. The monitor must be used with the F1 accessory for display and recording of signals.
The Ultrasound and TOCO Transducers are water-resistant and may be used in the shower and tub during the first stage of labor, but not during the second stage of labor (underwater delivery), and should not be submerged or operated underwater. The Transducers may be used in the shower and tub in the same manner as when used away from water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Pregnant women from about 22 weeks gestation through delivery.
Intended User / Care Setting
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. Intended use environment is a clinical setting, in the labor and delivery room of a hospital.
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
A pilot clinical testing was performed on pregnant women (n=5) to verify efficacy of the wireless EFM accessory in the measurement of the fetal heart rate (FHR) and uterine contractions in a simulated antepartum and intrapartum environment, as compared to standard wired EFM.
The Clinical Measurement Accuracy of both US and TOCO devices was tested using standard benchtop testing techniques common in the fetal monitoring industry. For the US transducer, accuracy was measured using a fetal heart rate simulator. The fetal simulator is able to provide discrete simulated fetal heart rates to the US transducers over a clinically meaningful range of several heart rates. The TOCO transducer was tested to verify that the device could measure pressure over a clinically-relevant range of pressures (simulating uterine contractions) in a monotonic fashion.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test: The hypothesis of this clinical study was that wireless electronic fetal monitoring (EFM) can provide equivalent performance to standard, wired EFM. We performed pilot clinical testing on pregnant women (n=5) to verify efficacy of the wireless EFM accessory in the measurement of the fetal heart rate (FHR) and uterine contractions in a simulated antepartum and intrapartum environment, as compared to standard wired EFM in order to demonstrate substantial equivalence.
Clinical Measurement Accuracy Test: The Clinical Measurement Accuracy of both US and TOCO devices was tested using standard benchtop testing techniques common in the fetal monitoring industry. For the US transducer, accuracy was measured using a fetal heart rate simulator. The fetal simulator is able to provide discrete simulated fetal heart rates to the US transducers over a clinically meaningful range of several heart rates. The TOCO transducer was tested to verify that the device could measure pressure over a clinically-relevant range of pressures (simulating uterine contractions) in a monotonic fashion.
Based on the comparison and analysis, the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is substantially equivalent to the predicate device.
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.
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.
Not Found
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
Farus, LLC Rahul Singh President 1240 Keystone Way Vista, CA 92081
Re: K171865
Trade/Device Name: F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: II Product Code: HGM Dated: June 20, 2017 Received: June 26, 2017
Dear Rahul Singh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171865
Device Name
F 1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
Indications for Use (Describe)
The F 1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is singleton pregnancies only. It is not intended for home use.
The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and function for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers.
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 race traces.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K171865
Contact Information 1.
| Submitted by: | Farus, LLC
1240 Keystone Way
Vista, CA 92081 |
|------------------------|---------------------------------------------------------------------------------|
| Official Correspondent | Rahul Singh, PhD
CEO
760-542-8260
877-403-6203
rssingh@farusllc.com |
2. Device Information
Date Prepared:
| Trade Name: | F1 Mothership Wireless Transducers for Feta
Ultrasonic and Tocodynamometer Monitoring |
|-------------------------------|------------------------------------------------------------------------------------------|
| Common Name: | Transducers for Fetal Monitoring |
| Classification
Regulation: | 884.2740; Perinatal monitoring system and
accessories |
| Classification: | Class II |
| Product Code: | HGM; system, monitoring, perinatal |
August 23, 2017
3. Predicate Device
| 3.1 | Predicate Device: | Avalon CTS Cordless Fetal Transducer System |
|---|---|---|
| 510(K) Number: | K023931 | |
| Owned by: | Philips Medical Systems | |
| Nederland B.V. Post bus 10.000 | ||
| 5680 DA Best | ||
| Netherlands | ||
| Manufactured by: | Philips Medizin Systeme Boeblingen GmbH | |
| Cardiac and Monitoring Systems | ||
| Hewlett-Packard Str. 2 | ||
| 71034 Boeblingen | ||
| Germany |
4
Device Description 4..
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a perinatal monitoring accessory that integrates with GE Corometrics series monitors. The following table lists GE Corometrics series monitors that are compatible with the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring:
| Manufacturer and Model Number | 510(k) Number |
|---|---|
| GE Corometrics 116 | K891595 |
| GE Corometrics 120 Series | K032252 |
| GE Corometrics 126 | |
| GE Corometrics 128/128F | |
| GE Corometrics 129/129F | |
| GE Corometrics 250 Series | K050583 |
| GE Corometrics 250cx | |
| GE Corometrics 256 | |
| GE Corometrics 259 | |
| GE Corometrics 259cx |
The accessory's intended use is for antepartum and intrapartum wireless measurement and recording of fetal heart rate and maternal contractions. The intended use environment is a clinical setting, in the labor and delivery room of a hospital. The F1 is equipped with 1 Ultrasound (US) transducer, 1 Tocodynamometer (TOCO) transducer, and 1 Base Station. The Base Station transmits data wirelessly between the US/TOCO transducers (respectively) and a separate FDA-cleared fetal monitor ("monitor"), and is connected directly to the monitor via wired connection. The monitor must be used with the F1 accessory for display and recording of signals.
The Ultrasound and TOCO Transducers are water-resistant and may be used in the shower and tub during the first stage of labor, but not during the second stage of labor (underwater delivery), and should not be submerged or operated underwater. The Transducers may be used in the shower and tub in the same manner as when used away from water.
5. Indications for Use
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is designed for use in singleton pregnancies only. It is not intended for home use.
The Ultrasound Transducer detects and evaluates fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and functioning as a connection for signals to pass
5
through from the patient to the monitoring or recording system. No other usage is intended for the transducers.
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 the fetal heart rate traces.
Predicate Comparison 6.
The following table compares the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring to the predicate device with respect to indications for use, technological characteristics, and materials:
| F1 Mothership ireless Transducers
for Fetal Ultrasonic and
Tocodynamometer Monitoring
| (K171865) | Philips Avalon CTS (K023931) | ||
|---|---|---|---|
| Intended Use | |||
| Indications for Use | |||
| Statement | The F1 Mothership Wireless | ||
| Transducers for Fetal Ultrasonic and | |||
| Tocodynamometer Monitoring are | |||
| intended for continuous wireless | |||
| fetal monitoring indicated for | |||
| pregnant women from about 22 | |||
| weeks gestation through delivery: to | |||
| be used during antepartum and | |||
| intrapartum monitoring. This device | |||
| is designed for use in singleton | |||
| pregnancies only. It is not intended | |||
| for home use. | |||
| The Ultrasound Transducer detects | |||
| and evaluates fetal heart rate during | |||
| uterine contractions, and the Toco | |||
| Transducer detects uterine | |||
| contractions. The Transducers are to | |||
| provide a means of sensing and | |||
| functioning as a connection for | |||
| signals to pass through from the | |||
| patient to the monitoring or | |||
| recording system. No other usage is | |||
| intended for the transducers. | |||
| 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 the fetal | |||
| heart rate traces. | 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. | |||
| Physical Characteristics | |||
| F1 Mothership ireless Transducers | |||
| for Fetal Ultrasonic and | |||
| Tocodynamometer Monitoring | |||
| (K171865) | Philips Avalon CTS (K023931) | ||
| Weight | (With | ||
| Transducers) | 700mAh | ||
| AC Mains (Base | |||
| Station) | Supply | ||
| Voltages | 90-264 V | 90-240 V | |
| Frequency | |||
| Range | 50-60 Hz | Same | |
| Power | |||
| Consumption | 40 W | 15VA |
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7
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring have the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.
7. Performance Testing
7.1 Non-Clinical Tests
A series of tests were performed to verify the performance and safety of the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring. These included:
- Electromagnetic Compatibility (EMC) Testing per IEC 60601-1:2007 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- FCC Test- CFR Title 47 Part 15 Subpart B and Industry Canada ICES-003 ●
- . Electrical Safety Testing per ANSI/AAMI 60601-1:2005/(R)2012 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance
- . Mechanical Safety Test per ANSI/AAMI 60601-1:2005/(R)2012 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance
- . Thermal Safety per IEC 60601-2-37 Medical electrical equipment- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- Ingress Protection Code Test per IEC 60529 Degrees of protection provided by enclosures
- Biocompatibility Test – Patient-contacting materials used are equivalent to
8
those used in previously-cleared perinatal monitoring devices
- Validation Test Simulated testing to gather feedback on usability of o accessory and compare usability to standard fetal monitoring systems
- 0 Battery Test – Bench testing to verify run time and charge time for transducers
- o Wireless Range Test – Bench testing to verify wireless range of transducers
- 0 Wireless Coexistence Test – Bench testing to verify transducers can coexist with other wireless equipment; used "AAMI TIR69 Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems" for guidance issued February 28, 2017
- Acoustic Output Test – Bench testing to verify acoustic parameters and safety of ultrasound transducer
- . Code Compilation Summary Test- Software testing to verify prevention of memory leak
- Data Transmission Test – Software testing to verify data transmission between transducers and base station
- 0 Pairing Verification Test – Software testing to verify pairing between transducers and base station
- o Charging Verification Test – Software testing to verify operation in initiating and controlling battery charge
- o System Performance Verification Test – Software testing to verify overall system performance by examining operations at various stages of charging
- . TOCO Strain Performance Test – Software testing to verify TOCO transducer operation at the unit level
- US Performance Test – Software testing US transducer operation at the unit level
- . TOCO Base Station Operations Test – Software testing to verify base station operation for the TOCO at the unit level
- US Base Station Operations Test – Software testing to verify base station operation for the US at the unit level
- 0 Interoperability Test – Testing to verify Mothership system is compatible with claimed GE monitors
In addition, the following guidance documents were reviewed and consulted in preparing this document:
- "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," Center for Devices and Radiological Health, FDA, 2008.
- "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices," Center for Devices and Radiological Health, FDA, 2005.
- 0 "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," Center for Devices and Radiological Health, FDA, 2002.
9
- 0 "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff," Center for Devices and Radiological Health, FDA, 2013.
- 0 "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff", Center for Devices and Radiological Health, FDA, 2014.
- . "Applying Human Factors and Usability Engineering to Medical Devices," Center for Devices and Radiological Health, FDA, 2011.
7.2 Clinical Tests
- Clinical Test
- o The hypothesis of this clinical study was that wireless electronic fetal monitoring (EFM) can provide equivalent performance to standard, wired EFM. We performed pilot clinical testing on pregnant women (n=5) to verify efficacy of the wireless EFM accessory in the measurement of the fetal heart rate (FHR) and uterine contractions in a simulated antepartum and intrapartum environment, as compared to standard wired EFM in order to demonstrate substantial equivalence.
- 0 Clinical Measurement Accuracy Test
- The Clinical Measurement Accuracy of both US and TOCO devices was o tested using standard benchtop testing techniques common in the fetal monitoring industry. For the US transducer, accuracy was measured using a fetal heart rate simulator. The fetal simulator is able to provide discrete simulated fetal heart rates to the US transducers over a clinically meaningful range of several heart rates. The TOCO transducer was tested to verify that the device could measure pressure over a clinically-relevant range of pressures (simulating uterine contractions) in a monotonic fashion.
Performance Data and Conclusions 8.
Based on the comparison and analysis above, the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is substantially equivalent to the predicate device.