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.

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.

AI/ML Overview

The provided text describes specific performance testing for the F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring, but it does not provide a clear table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists various non-clinical and clinical tests performed.

Therefore, I cannot create the requested table of acceptance criteria and reported device performance from the given information.

However, I can extract information related to the other points you've asked for, based on the provided text, and will indicate where information is not present.

Here's a summary of what's available and what's missing:

1. A table of acceptance criteria and the reported device performance

Not provided: The document lists the types of tests performed (e.g., EMC, electrical safety, wireless range, acoustic output, accuracy) but does not present a table with specific numerical acceptance criteria (e.g., "Accuracy must be ±X%") or the precise, quantified reported performance against those criteria. It states that tests were performed to "verify performance and safety" and "verify efficacy" or "verify operation." For US accuracy, it mentions "accuracy was measured using a fetal heart rate simulator" but doesn't state the measured accuracy value. For TOCO, it notes the ability to "measure pressure over a clinically-relevant range...in a monotonic fashion."

2. Sample sized used for the test set and the data provenance

Test Set Sample Size: "pilot clinical testing on pregnant women (n=5)."
Data Provenance: The study was a "pilot clinical testing on pregnant women" which implies prospective data collection, specifically "in a simulated antepartum and intrapartum environment." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Farus, LLC, based in Vista, CA, USA, suggesting a U.S.-based study is likely, though not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided: The document mentions that 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." However, it does not specify how ground truth was established for the clinical test, nor does it list the number or qualifications of any experts involved in defining or adjudicating ground truth.

4. Adjudication method for the test set

Not provided: The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth in the clinical test.

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

Not applicable / Not done: This device is a medical accessory for monitoring fetal heart rate and uterine contractions, not an AI or diagnostic imaging device that would typically involve human readers interpreting results with or without AI assistance. The clinical test compared the wireless EFM accessory's performance to "standard, wired EFM" in terms of "efficacy in the measurement."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, for certain functional aspects: The device itself performs sensing and data transmission. Several non-clinical bench tests (e.g., Wireless Range Test, Wireless Coexistence Test, Acoustic Output Test, Code Compilation Summary Test, Data Transmission Test, Pairing Verification Test, Charging Verification Test, System Performance Verification Test, TOCO Strain Performance Test, US Performance Test, TOCO Base Station Operations Test, US Base Station Operations Test, Interoperability Test) assessed the device's standalone performance and its proper functioning. The "Clinical Measurement Accuracy Test" on a fetal heart rate simulator also represents a standalone assessment of the transducers' accuracy.

7. The type of ground truth used

For clinical measurement accuracy: A "fetal heart rate simulator" that provides "discrete simulated fetal heart rates" was used as ground truth for the US transducer. For the TOCO transducer, the ground truth was "clinically-relevant range of pressures (simulating uterine contractions)."
For pilot clinical testing: The performance was compared to "standard, wired EFM" which served as the reference or ground truth in that specific context to demonstrate "substantial equivalence."

8. The sample size for the training set

Not applicable / Not provided: The device described is a hardware accessory (transducers and base station) for monitoring, not a machine learning or AI algorithm that would typically require a "training set" in the conventional sense. The document does not mention any training data for the device.

9. How the ground truth for the training set was established

Not applicable / Not provided: As no training set is mentioned for an AI/ML algorithm, this question is not relevant to the information provided.

Summary

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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.

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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

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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.

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, LLC1240 Keystone WayVista, CA 92081
Official Correspondent	Rahul Singh, PhDCEO760-542-8260877-403-6203rssingh@farusllc.com

2. Device Information

Date Prepared:

Trade Name:	F1 Mothership Wireless Transducers for FetaUltrasonic and Tocodynamometer Monitoring
Common Name:	Transducers for Fetal Monitoring
ClassificationRegulation:	884.2740; Perinatal monitoring system andaccessories
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 SystemsNederland B.V. Post bus 10.0005680 DA BestNetherlands
	Manufactured by:	Philips Medizin Systeme Boeblingen GmbHCardiac and Monitoring SystemsHewlett-Packard Str. 271034 BoeblingenGermany

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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.

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

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through from the patient to the monitoring or recording system. No other usage is intended for the transducers.

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 Transducersfor Fetal Ultrasonic andTocodynamometer Monitoring(K171865)	Philips Avalon CTS (K023931)
Intended Use
Indications for UseStatement	The F1 Mothership WirelessTransducers for Fetal Ultrasonic andTocodynamometer Monitoring areintended for continuous wirelessfetal monitoring indicated forpregnant women from about 22weeks gestation through delivery: tobe used during antepartum andintrapartum monitoring. This deviceis designed for use in singletonpregnancies only. It is not intendedfor home use.The Ultrasound Transducer detectsand evaluates fetal heart rate duringuterine contractions, and the TocoTransducer detects uterinecontractions. The Transducers are toprovide a means of sensing andfunctioning as a connection forsignals to pass through from thepatient to the monitoring orrecording system. No other usage isintended for the transducers.The system should only be used by,or under the direct supervision of, alicensed physician or other healthcare practitioner who is trained inthe use of fetal heart rate monitorsand in the interpretation of the fetalheart rate traces.	The Philips M2720A Cordless FetalTransducer System is indicated forpregnant women from about 22weeks of gestation on throughdelivery. It is intended forcontinuous cordless fetalmonitoring in connection with afetal monitor for resting orambulating patients, also usableduring hydrotherapy, forantepartum testing and labor anddelivery (intrapartum).The system should only be usedby, or under the direct supervisionof, a licensed physician or otherhealth care practitioner who istrained in the use of fetal heartrate monitors and in theinterpretation of fetal heart ratetraces. It is not intended for homeuse.
Physical Characteristics
		F1 Mothership ireless Transducersfor Fetal Ultrasonic andTocodynamometer Monitoring(K171865)	Philips Avalon CTS (K023931)
Weight	(WithTransducers)	< 2.0 kg (4.4 lbs)	2.9 kg (6.4 lbs)
Dimensions	Base Station	278 x 207 x 65mm11.0" x 8.2" x 2.6"	350 x 240 x 75mm13.8" x 9.5" x 3.0"
	Probe	103 x 70 x 25mm4.06"x2.76"x0.98"	100 x 76 x 37mm3.94"x2.99"x1.46"
Materials
US	Casing	ABS	ABS/Desmopan
TOCO	Casing	ABS	ABS/Desmopan
	Button	EVA	Desmopan
Belt		Polyester	Same
Technological Characteristics
US	Mode ofOperation	Pulsed wave Doppler	Same
	CenterFrequency	1.151 MHz	1 MHz
	Peak-negativeacousticpressure	<30 kPa	Same
	Spatial-averagetemporalaverageintensity	<20 mW/cm2	Same
	Accuracy	± 5%	Same
	Wired orWireless	Wireless	Same
TOCO	Mode ofOperation	Strain gauge	Same
	Pressurerelationship	Monotonically increasing	Same
	Wired orWireless	Wireless	Same
Base Station	Line-of-SightRange	150 m	100 m
	Antenna	50 Ω	Same
	Water IngressProtectionCode	IPX1	Same
		F1 Mothership ireless Transducersfor Fetal Ultrasonic andTocodynamometer Monitoring(K171865)	Philips Avalon CTS (K023931)
Power / Energy Source
Battery	Type	Lithium ion	Same
	Capacity	1850 mAh	>700mAh
AC Mains (BaseStation)	SupplyVoltages	90-264 V	90-240 V
	FrequencyRange	50-60 Hz	Same
	PowerConsumption	40 W	15VA

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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

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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.

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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.

Regulation Number and Section

§ 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).