Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum

K200975 · Huntleigh Healthcare Limited · HGM · Jun 24, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K200975
• Device Name: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
• Applicant: Huntleigh Healthcare Limited
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jun 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors (Team3 fetal monitors) are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities. Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications: 1) Single or twin fetal heart rates by means of ultrasound 2) Uterine activity - externally sensed 3) Fetal movement - maternally sensed and externally via ultrasound 4) Maternal heart rate and oxygen saturation via pulse oximetry 5) Maternal non-invasive blood pressure. Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: 1) Single or twin fetal heart rates by means of ultrasound and/or FECG 2) Maternal heart rate via ECG electrodes 3) Uterine activity - externally or internally sensed 4) Fetal movement - maternally sensed and externally via ultrasound 5) Maternal heart rate and oxygen saturation via pulse oximetry 6) Maternal non-invasive blood pressure.

Device Story

Multi-function fetal monitor for antepartum/intrapartum use; bedside, trolley, or wall-mounted. Inputs: ultrasound transducers (fetal heart rate), tocodynamometer/IUP (uterine activity), pulse oximetry (maternal SpO2/HR), ECG electrodes (maternal/fetal HR), and manual fetal movement switch. Transforms physiological signals into real-time visual data on 8.4" color touchscreen and optional thermal printout. Used by clinicians in hospitals/clinics to assess fetal well-being and labor progress. Output affects clinical decision-making regarding labor management and fetal distress intervention. Benefits include continuous, multi-parameter monitoring to improve maternal/fetal outcomes.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified via biocompatibility (ISO 10993-1), electrical safety (AAMI/ANSI ES60601-1), EMC, and functional testing of hardware/software interactions including ultrasound, FECG, SpO2, NIBP, and alarm systems.

Technological Characteristics

Mains/battery-powered monitor; 8.4" color LCD touchscreen; ultrasound (1 MHz, 3 kHz repetition), FECG (peak-peak detection), NIBP, SpO2, and uterine activity sensors. Connectivity via RS232. Biocompatibility per ISO 10993-1. Electrical safety per AAMI/ANSI ES60601-1. IP30/IP31 ingress protection. Software level of concern: Major.

Indications for Use

Indicated for pregnant women from 28th week of gestation through delivery for non-invasive and invasive monitoring of fetal and maternal physiological parameters in clinical/hospital settings by trained healthcare professionals.

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

• Sonicaid FM820E and FM830E (K090285)

Reference Devices

• Intran Plus IUP 400 (K955443)

Submission Summary (Full Text)

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June 24, 2020

Huntleigh Healthcare Limited Steve Monks QRE Director 35 Portmanmoor Road Cardiff, CF24 5HN UK

Re: K200975

> Trade/Device Name: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: II Product Code: HGM, HEL, HGP, HFM, KXO, DRT, DOA, DXN Dated: April 9, 2020 Received: April 13, 2020

Dear Steve Monks:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200975

### Device Name

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum

## Indications for Use (Describe)

The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

- 1) Single or twin fetal heart rates by means of ultrasound
- 2) Uterine activity externally sensed
- 3) Fetal movement maternally sensed and externally via ultrasound
- 4) Maternal heart rate and oxygen saturation via pulse oximetry
- 5) Maternal non-invasive blood pressure

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

- 1) Single or twin fetal heart rates by means of ultrasound and/or FECG
- 2) Maternal heart rate via ECG electrodes
- 3) Uterine activity externally or internally sensed
- 4) Fetal movement maternally sensed and externally via ultrasound
- 5) Maternal heart rate and oxygen saturation via pulse oximetry
- 6) Maternal non-invasive blood pressure

Type of Use (Select one or both, as applicable)

| ☑ Research Use Only (21 CFR 801.5 Subpart B) |
|------------------------------------------------------|
| ☐ For In Vitro Diagnostic Use (21 CFR 809 Subpart C) |

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary K200975

| Date Summary Prepared: | June 18, 2020 |
|------------------------|----------------------------------------------------------------------------------------------------|
| Submitter/Applicant: | Huntleigh Healthcare Limited<br>Unit 35, Portmanmoor Road<br>Cardiff<br>CF24 5HN<br>United Kingdom |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact: | Steve Monks - QRE Compliance Director |

#### 5.1 Device Information

| Device Trade Name: | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | Perinatal monitoring system and accessories |
| Regulation Number: | 21 CRF 884.2740 |
| Product Codes: | HGM, HEL, HGP, HFM, KXO, DRT, DQA, DXN |
| Product Code Name: | HGM, system, monitoring, perinatal |
| | HEL, monitor, heart rate, fetal, ultrasonic<br>HGP, electrode, circular (spiral), scalp and applicator<br>HFM, monitor, uterine contraction, external (for use in clinic) |
| | KXO, monitor, pressure, intrauterine |
| | DRT, monitor, cardiac (incl. cardiotachometer & rate alarm) |
| | DQA, oximeter |
| | DXN, system, measurement, blood-pressure, non-invasive |
| Regulatory Class: | II |
| Review Panel: | Obstetrics/Gynecology |

#### 5.2 Predicate Device Information

| Predicate Device: | Sonicaid FM820E and FM830E (K090285) manufactured by<br>Huntleigh Healthcare Ltd., Diagnostic Products Division. |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| | The predicate device has not been subject to a design-<br>related recall. |

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#### 5.3 Indications for Use

The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors (Team3 fetal monitors) are indicated for use by trained healthcare professionals in noninvasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

- 1) Single or twin fetal heart rates by means of ultrasound
- 2) Uterine activity externally sensed
- 3) Fetal movement maternally sensed and externally via ultrasound
- 4) Maternal heart rate and oxygen saturation via pulse oximetry
- 5) Maternal non-invasive blood pressure

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

- 1) Single or twin fetal heart rates by means of ultrasound and/or FECG
- 2) Maternal heart rate via ECG electrodes
- 3) Uterine activity externally or internally sensed
- 4) Fetal movement maternally sensed and externally via ultrasound
- 5) Maternal heart rate and oxygen saturation via pulse oximetry
- 6) Maternal non-invasive blood pressure

#### 5.4 Device Description

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy.

The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface.

The units are powered either from local mains electrical supply or an optional internal rechargeable battery.

The Sonicaid Team3 fetal monitors include the following:

- · 8.4" Color LCD Display with LED backlighting.
- · Touch screen user interface.
- · Monitoring of up to two fetal heart rates via independent ultrasound transducers.
- · Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers.
- · Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor.
- Monitoring of maternal Non-Invasive Blood Pressure . (NIBP).

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K200975 Page 3 of 8

- Monitoring of fetal heart rate via ECG.
- Maternal heart rate (eMHR).
- · Capture of maternally sensed fetal movements via a cabled switch.
- · Chart printout via (optional) inbuilt thermal printer
- · Data output via RS232.

Model Names:

Sonicaid Team3 Antepartum: TEAM3A Sonicaid Team3 Intrapartum: TEAM3I

#### 5.5 Comparison of Intended Use and Technological Characteristics

The following table compares the subject device to the predicate with respect to the indications for use and technological characteristics:

| Device & Predicate | Subject Device | Predicate Device |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device(s): | K200975 | K090285 |
| General Device Characteristics | | |
| Manufacturer and Device | Huntleigh Healthcare Ltd.<br>Sonicaid Team3 Antepartum and<br>Sonicaid Team3 Intrapartum | Huntleigh Healthcare Ltd.<br>Sonicaid FM830 Encore |
| Classification | II | II |
| Product Code | HGM | HGM |
| Regulation | 21 CFR 884.2740 | 21 CFR 884.2740 |
| Indications for Use | The Sonicaid Team3 Antepartum<br>and Sonicaid Team3 Intrapartum<br>fetal monitors (Team3 fetal monitors)<br>indicated for use by trained<br>healthcare professionals in non-<br>invasive and invasive monitoring of<br>physiological parameters in pregnant<br>women and fetuses, during the<br>antepartum and intrapartum periods<br>of pregnancy. The Team3 fetal<br>monitors are intended for pregnant<br>women from the 28th week of<br>gestation, through to term and<br>delivery. The devices are intended<br>for use in clinical and hospital-type<br>facilities.<br>Sonicaid Team3 Antepartum is<br>suitable for use when there is a need<br>to monitor the following physiological<br>applications:<br>1) Single or twin fetal heart rates by<br>means of ultrasound<br>2) Uterine activity - externally<br>sensed<br>3) Fetal movement - maternally<br>sensed and externally via ultrasound<br>4) Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>5) Maternal non-invasive blood<br>pressure | The Huntleigh Healthcare Ltd<br>Sonicaid FM820 and FM830<br>Encore fetal monitors are<br>indicated for use by trained<br>healhtcare professionals in<br>non-invasive and invasive<br>monitoring of physiological<br>parameters in pregnant adult<br>human females, and fetuses,<br>during the intrapartum and<br>antepartum periods of<br>pregnancy. The devices are<br>intended for use in clinical<br>and hospital-type facilities.<br>They are not intended for use<br>in intensive care units,<br>operating room, or in<br>transport monitoring<br>applications.<br>Sonicaid FM820E is suitable<br>for use when there is a need<br>to monitor the following<br>physiological parameters:<br>● single or twin fetal heart<br>rates by means of<br>ultrasound<br>● fetal or maternal heart<br>rate by ecg<br>● uterine activity-externally<br>or internally sensed<br>● fetal movement |
| | Sonicaid Team3 Intrapartum is<br>suitable for use when there is a need<br>to monitor the following physiological<br>applications:<br>1) Single or twin fetal heart rates by<br>means of ultrasound and/or FECG<br>2) Maternal heart rate via ECG<br>electrodes<br>3) Uterine activity - externally or<br>internally sensed<br>4) Fetal movement - maternally<br>sensed and externally via ultrasound<br>5) Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>6) Maternal non-invasive blood<br>pressure | maternally sensed<br>Sonicaid FM830E is suitable<br>for use when there is a need<br>to monitor the following<br>physiological parameters:<br>single or twin fetal heart<br>●<br>rates by means of<br>ultrasound<br>fetal or maternal heart<br>●<br>rate by ecg<br>uterine activity-externally<br>●<br>or internally sensed<br>fetal movement-<br>●<br>maternally sensed<br>maternal heart rate and<br>●<br>oxygen saturation via<br>pulse oximetry<br>maternal non-invasive<br>●<br>blood pressure |
| Electrical Safety – Device Classification | | |
| Protection against ingress<br>of water and particulates | Main unit: IP30<br>Main unit with protective cover: IP31<br>Transducers: IPX7 (Ultrasound,<br>TOCO) | Main unit: Not provided<br>Main unit with protective<br>cover: Not provided<br>Transducers: IPX4 (TOCO),<br>IPX7 (Ultrasound) |
| Ultrasound | | |
| Channels | 2 | 2 |
| FHR Range | 30 – 240 bpm | 30 - 240 bpm |
| Mode | Directional Pulsed Laser | Directional Pulsed Laser |
| Repetition Rate | 3 kHz | 3 kHz |
| Frequency | 1 MHz | 1 MHz |
| Resolution | 16 bits | 16 bits |
| Alerts | High and low heart rate<br>Signal Loss | High and low heart rate<br>Signal Loss |
| Safety | Type CF | Type CF |
| Connector | 3 x Huntleigh 12-pole socket | 2 x Nikolay 12-pole socket |
| Ultrasound Transducer | Sonicaid ACC-OBS-008 | Sonicaid ACC-OBS-008 |
| TOCO | | |
| TOCO Range | 0 - 100 relative units | 0 - 100 relative units |
| Channels | 1 | 1 |
| TOCO Resolution | 100% = 120 g | 100% = 120 g |
| Offset range<br>Alerts | + 375 g<br>TOCO persistence alert (TPA) | + 100 g<br>None |
| Safety | Type CF | Type CF |
| Connector | Huntleigh 12-pole (pink) | Nikolay 12-pole (pink) |
| Intrauterine Pressure Sensor | | |
| Channels | 1 | 1 |
| Sensor | Intran Plus IUP 400 (K955443) | Intran Plus IUP 400<br>(K955443) |
| Safety | Type CF | Type CF |
| Connector | Huntleigh 12-pole (pink)…