F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

K171865 · Farus, LLC · HGM · Aug 24, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171865
• Device Name: F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
• Applicant: Farus, LLC
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

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.

Device Story

Perinatal monitoring accessory for GE Corometrics series monitors; consists of 1 ultrasound (US) transducer, 1 tocodynamometer (TOCO) transducer, and 1 base station. US transducer uses pulsed wave Doppler to detect fetal heart rate; TOCO transducer uses strain gauge to detect uterine contractions. Base station transmits signals wirelessly from transducers to a connected FDA-cleared fetal monitor for display and recording. Used in clinical labor and delivery settings by physicians or trained healthcare practitioners. Transducers are water-resistant for use in shower/tub during first stage of labor. Provides continuous monitoring to assist clinical decision-making during pregnancy and delivery.

Clinical Evidence

Pilot clinical study (n=5) on pregnant women compared wireless EFM performance to standard wired EFM in simulated antepartum/intrapartum environments. Bench testing verified US transducer accuracy using fetal heart rate simulators and TOCO transducer pressure measurement range. No adverse events reported.

Technological Characteristics

Materials: ABS (casing), EVA (button), Polyester (belt). US: Pulsed wave Doppler, 1.151 MHz center frequency, <30 kPa peak-negative acoustic pressure. TOCO: Strain gauge, monotonically increasing pressure relationship. Wireless transmission to base station. Power: Li-ion battery (1850 mAh). IPX1 water ingress protection. Connectivity: Wired connection to GE Corometrics monitors.

Indications for Use

Indicated for pregnant women from approx. 22 weeks gestation through delivery for continuous wireless fetal monitoring during antepartum and intrapartum periods. Designed for singleton pregnancies only. Not for home use.

Regulatory Classification

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.

Predicate Devices

• Avalon CTS Cordless Fetal Transducer System (K023931)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:12px;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| <span style="font-size:12px;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary K171865

#### Contact Information 1.

| Submitted by: | Farus, LLC<br>1240 Keystone Way<br>Vista, CA 92081 |
|------------------------|---------------------------------------------------------------------------------|
| Official Correspondent | Rahul Singh, PhD<br>CEO<br>760-542-8260<br>877-403-6203<br>[e-mail] |

### 2. Device Information

Date Prepared:

| Trade Name: | F1 Mothership Wireless Transducers for Feta<br>Ultrasonic and Tocodynamometer Monitoring |
|-------------------------------|------------------------------------------------------------------------------------------|
| Common Name: | Transducers for Fetal Monitoring |
| Classification<br>Regulation: | 884.2740; Perinatal monitoring system and<br>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<br>Nederland B.V. Post bus 10.000<br>5680 DA Best<br>Netherlands |
| | Manufactured by: | Philips Medizin Systeme Boeblingen GmbH<br>Cardiac and Monitoring Systems<br>Hewlett-Packard Str. 2<br>71034 Boeblingen<br>Germany |

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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.

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

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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<br>for Fetal Ultrasonic and<br>Tocodynamometer Monitoring<br>(K171865) | Philips Avalon CTS (K023931) | | |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Intended Use | | | |
| Indications for Use<br>Statement | The F1 Mothership Wireless<br>Transducers for Fetal Ultrasonic and<br>Tocodynamometer Monitoring are<br>intended for continuous wireless<br>fetal monitoring indicated for<br>pregnant women from about 22<br>weeks gestation through delivery: to<br>be used during antepartum and<br>intrapartum monitoring. This device<br>is designed for use in singleton<br>pregnancies only. It is not intended<br>for home use.<br>The Ultrasound Transducer detects<br>and evaluates fetal heart rate during<br>uterine contractions, and the Toco<br>Transducer detects uterine<br>contractions. The Transducers are to<br>provide a means of sensing and<br>functioning as a connection for<br>signals to pass through from the<br>patient to the monitoring or<br>recording system. No other usage is<br>intended for the transducers.<br>The system should only be used by,<br>or under the direct supervision of, a<br>licensed physician or other health<br>care practitioner who is trained in<br>the use of fetal heart rate monitors<br>and in the interpretation of the fetal<br>heart rate traces. | The Philips M2720A Cordless Fetal<br>Transducer System is indicated for<br>pregnant women from about 22<br>weeks of gestation on through<br>delivery. It is intended for<br>continuous cordless fetal<br>monitoring in connection with a<br>fetal monitor for resting or<br>ambulating patients, also usable<br>during hydrotherapy, for<br>antepartum testing and labor and<br>delivery (intrapartum).<br>The system should only be used<br>by, or under the direct supervision<br>of, a licensed physician or other<br>health care practitioner who is<br>trained in the use of fetal heart<br>rate monitors and in the<br>interpretation of fetal heart rate<br>traces. It is not intended for home<br>use. | |
| Physical Characteristics | | | |
| | | F1 Mothership ireless Transducers<br>for Fetal Ultrasonic and<br>Tocodynamometer Monitoring<br>(K171865) | Philips Avalon CTS (K023931) |
| Weight | (With<br>Transducers) | < 2.0 kg (4.4 lbs) | 2.9 kg (6.4 lbs) |
| Dimensions | Base Station | 278 x 207 x 65mm<br>11.0" x 8.2" x 2.6" | 350 x 240 x 75mm<br>13.8" x 9.5" x 3.0" |
| | Probe | 103 x 70 x 25mm<br>4.06"x2.76"x0.98" | 100 x 76 x 37mm<br>3.94"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 of<br>Operation | Pulsed wave Doppler | Same |
| | Center<br>Frequency | 1.151 MHz | 1 MHz |
| | Peak-negative<br>acoustic<br>pressure | <30 kPa | Same |
| | Spatial-<br>average<br>temporal<br>average<br>intensity | <20 mW/cm2 | Same |
| | Accuracy | ± 5% | Same |
| | Wired or<br>Wireless | Wireless | Same |
| TOCO | Mode of<br>Operation | Strain gauge | Same |
| | Pressure<br>relationship | Monotonically increasing | Same |
| | Wired or<br>Wireless | Wireless | Same |
| Base Station | Line-of-Sight<br>Range | 150 m | 100 m |
| | Antenna | 50 Ω | Same |
| | Water Ingress<br>Protection<br>Code | IPX1 | Same |
| | | F1 Mothership ireless Transducers<br>for Fetal Ultrasonic and<br>Tocodynamometer Monitoring<br>(K171865) | Philips Avalon CTS (K023931) |
| Power / Energy Source | | | |
| Battery | Type | Lithium ion | Same |
| | Capacity | 1850 mAh | >700mAh |
| AC Mains (Base<br>Station) | Supply<br>Voltages | 90-264 V | 90-240 V |
| | Frequency<br>Range | 50-60 Hz | Same |
| | Power<br>Consumption | 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 Chargi…