Sonicaid Team3

K241368 · Huntleigh Healthcare , Ltd. · HGM · Feb 3, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K241368
• Device Name: Sonicaid Team3
• Applicant: Huntleigh Healthcare , Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: PCCP, 3rd-Party Reviewed

Intended Use

The 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: - Single or twin fetal heart rates by means of ultrasound - Uterine activity externally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure - CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound and/or FECG - Maternal heart rate via ECG electrodes - Uterine activity externally or internally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure

Device Story

Sonicaid Team3 is a perinatal monitoring system for clinical/hospital use by trained professionals. It inputs fetal heart rate (ultrasound/FECG), uterine activity (external/internal), maternal heart rate (ECG/pulse oximetry), maternal oxygen saturation, and non-invasive blood pressure. The device processes these signals to provide real-time monitoring and includes the Dawes-Redman CTG Analysis software to assess antepartum cardiotocographs. The system outputs physiological data and analysis results to a color TFT LCD display and thermal printer. The Dawes-Redman algorithm evaluates traces against defined criteria to identify normal or non-reassuring records, assisting clinicians in decision-making. The device is not intended for use in latent or established labor when using the Dawes-Redman analysis. Benefits include improved identification of fetal status during pregnancy.

Clinical Evidence

Bench testing only. Software verification and validation testing were conducted for the Dawes-Redman CTG Analysis and overall system performance. Cybersecurity testing was performed per FDA guidance.

Technological Characteristics

Perinatal monitoring system; includes ultrasound, tocodynamometer, FECG, maternal ECG, pulse oximetry, and NIBP modules. Materials: Novodur P2H-AT, Kraiburg TPE, TF6 FMA Elastomer. Display: 17x12.8cm color TFT LCD. Printer: 128mm thermal array. Connectivity: RS232, Ethernet, DVI, USB, wireless telemetry. Power: 85-264Vac or 5200mAh Li-ion battery. Software: Dawes-Redman CTG Analysis (embedded).

Indications for Use

Indicated for pregnant women from 28 weeks gestation through delivery for non-invasive and invasive monitoring of physiological parameters (fetal heart rate, uterine activity, fetal movement, maternal heart rate, oxygen saturation, blood pressure) during antepartum and intrapartum periods by trained healthcare professionals in clinical/hospital settings.

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 Team3 Fetal Monitor (K200975)

Reference Devices

• Dawes-Redman CTG Analysis (K992607)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 3, 2025

Huntleigh Healthcare Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K241368

Trade/Device Name: Sonicaid Team3 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and accessories Regulatory Class: II Product Code: HGM Received: October 22, 2024

Dear Prithul Bom:

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 (the 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 available 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.

The FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is

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consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rele"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 -S

Monica D. Garcia, Ph.D. 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) K241368

Device Name Sonicaid Team3

### Indications for Use (Describe)

The 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: - Single or twin fetal heart rates by means of ultrasound

- Uterine activity externally sensed
- Fetal movement maternally sensed and externally via ultrasound
- Maternal heart rate and oxygen saturation via pulse oximetry
- Maternal non-invasive blood pressure
- CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met

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

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

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

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 — K241368 Sonicaid Team 3

| Name & Address: | Huntleigh Healthcare Limited<br>Unit 35, Portmanmoor Road<br>Cardiff<br>CF24 5HN<br>United Kingdom |
|-----------------|----------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Prepared: | February 3, 2025 |
| Contact: | Steve Monks |

#### Device Information 1.

| Device Name: | Sonicaid Team3 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Perinatal Monitoring System |
| Regulation Name: | Perinatal monitoring system and accessories |
| Regulation Number: | 21 CFR 884.2740 |
| Regulatory Class: | II |
| Product Code: | HGM (system, monitoring, perinatal) |
| Additional Product<br>Codes: | HEL - Monitor, Heart Rate, Fetal, Ultrasonic<br>HGP – Electrode, Circular (spiral), Scalp and Applicator<br>HFM - Monitor, Uterine Contraction, External (For Use in Clinic)<br>KXO - Monitor, Pressure, Intrauterine<br>DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)<br>DQA – Oximeter<br>DXN - System, Measurement, Blood-Pressure, Non-invasive |

# 2. Predicate Device

Predicate Device:

Sonicaid Team3 Fetal Monitor, manufactured by Huntleigh Healthcare Ltd., cleared under K200975

#### 3. Device Description

The Sonicaid Team3, subject device, is a fetal monitoring device designed for perinatal monitoring and includes a software function, the Dawes-Redman CTG Analysis, previously cleared under K992607. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses during antepartum and intrapartum periods. The subject device includes systems and

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accessories intended to perform perinatal monitoring as aligned with product code HGM.

Features included in the subject device are the Dawes Redman analysis, used to assess clinically indicated antepartum cardiotocographs (CTGs) in pregnancies from 26 weeks gestation onwards, assisting physicians in identifying normal and nonreassuring traces. The Dawes-Redman software is embedded in the subject device, ensuring integration with the existing hardware. The device is not intended for use in latent or established labor due to the influence of additional factors such as labor contractions and pharmacological agents.

# 4. Indications for Use

The 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:

- Single or twin fetal heart rates by means of ultrasound
- · Uterine activity externally sensed
- Fetal movement maternally sensed and externally via ultrasound
- · Maternal heart rate and oxygen saturation via pulse oximetry
- · Maternal non-invasive blood pressure
- · CTG Analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met

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

- Single or twin fetal heart rates by means of ultrasound and/or FECG.
- · Maternal heart rate via ECG electrodes
- · Uterine activity externally or internally sensed
- Fetal movement maternally sensed and externally via ultrasound
- · Maternal heart rate and oxygen saturation via pulse oximetry
- · Maternal non-invasive blood pressure

### 5. Comparison of Intended Use and Technological Characteristics with Predicate and Reference Device

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

| Device and Predicate<br>Device(s): | Predicate Device (K200975) | Subject Device (K241368) |
|------------------------------------|----------------------------|--------------------------|
|------------------------------------|----------------------------|--------------------------|

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K241368
Page 3 of 8
HUNTLEIGHUNTLEIGH
HUNTLEIGHTTLEIGHTMLY

A MEMBER OF THE ARJO FAMILY

| Manufacturer | Huntleigh Healthcare Ltd. | Huntleigh Healthcare Ltd. | | | | Maternal<br>Oximetry<br>(MSpO2) | Method: Differential optical<br>transmission Saturation Range:<br>1-<br>100% MSpO2<br>Accuracy: 70-100%<br>$\pm$ 1SD<br>Pulse Range: 30-240 bpm<br>Accuracy: $\pm$ 3 bpm | Method: Differential optical<br>transmission Saturation Range:<br>1-<br>100% MSpO2<br>Accuracy: 70-100%<br>$\pm$ 1SD<br>Pulse Range: 30-240 bpm<br>Accuracy: $\pm$ 3 bpm |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II | II | | Mode: Directional Pulsed<br>Doppler FHR Range: 30-240<br>bpm Frequency 1MHz<br>Safety: Type CF<br>Protection Type: Piezo 8 element<br>Ispta: <3mW/cm2 Material:<br>Novodur P2H-AT | Mode: Directional Pulsed<br>Doppler FHR Range: 30-240<br>bpm Frequency 1MHz<br>Safety: Type CF<br>Protection Type: Piezo 8 element<br>Ispta: <3mW/cm2 Material:<br>Novodur P2H-AT | Dawes Redman<br>Software Analysis | N/A | No. of criteria: 'Met or 'Not Met'<br>Measurement Parameters: Signal<br>Loss, Fetal Movements per hour,<br>Basal Heart Rate, Accelerations,<br>Decelerations, High and Low<br>variation episodes, Short term<br>variation<br><br>Firmware embedded in the<br>Team3 (fetal monitor |
| Product Code | HGM | HGM | Toco | Type: Tocodynamometer<br>Material: Body – Novodur P2H-<br>AT, Faceplate - Kraiburg TPE<br>TF6 FMA<br>Elastomer | Type: Tocodynamometer<br>Material: Body – Novodur P2H-<br>AT, Faceplate – Kraiburg TPE<br>TF6 FMA<br>Elastomer | Patient Event Marker | Channels: 1 Indication: Audio,<br>visual & printed | |
| Regulation | 21 CFR 884.2740 | 21 CFR 884.2740 | Fetal ECG | Channels: 1<br>FHR Range: 30-240<br>bpm | Channels: 1<br>FHR Range: 30-240<br>bpm | Display | Type: Colour TFT LCD<br>Size: 17 x 12.8cm (6.7<br>x 5") | |
| Intended Use | System and Accessories intended<br>to perform perinatal monitoring | System and Accessories intended<br>to perform perinatal monitoring | External Uterine<br>Activity | Channels: 1<br>Range: 0-100 Relative Units<br>Sensitivity: 100%FSD=120g<br>Offset range: ± 375g Alerts: Toco<br>Persistence Alert | Channels: 1<br>Range: 0-100 Relative Units<br>Sensitivity: 100%FSD=120g<br>Offset range: ± 375g Alerts: Toco<br>Persistence Alert | Printer | Print Head: 128mm Thick Film<br>Thermal Array<br>Speeds: 1, 2 or 3cm/min,<br>20cm/min fast forward | |
| Configuration | Monitoring Hardware only | Monitoring Hardware and Dawes<br>Redman CTG Software | Internal Uterine<br>Activity | Channels: 1 Range: 0-<br>100mmHg or 1-13.3kPa<br>Sensitivity: 5µV/V/mmHg | Channels: 1 Range: 0-<br>100mmHg or 1-13.3kPa<br>Sensitivity: 5µV/V/mmHg | Controls and Indicators | Power on/off: On/standby touch<br>switch with indicator Audio<br>volume up/down: Volume<br>up/down touch screen 'button' | |
| Indications for Use | The Team3 fetal monitors are<br>indicated for use by trained<br>healthcare professionals in non-<br>invasive and invasive monitoring<br>of physiological parameters in<br>pregnant women and fetuses,<br>during the antepartum and<br>intrapartum periods of pregnancy.<br>The Team3 fetal monitors are<br>intended for pregnant women<br>from the 28th week of gestation,<br>through to term and delivery. The<br>devices are intended for use in<br>clinical and hospital-type facilities.<br>Sonicaid Team3 Antepartum is<br>suitable for use when there is | The Team3 fetal monitors are<br>indicated for use by trained<br>healthcare professionals in non-<br>invasive and invasive monitoring<br>of physiological parameters in<br>pregnant women and fetuses,<br>during the antepartum and<br>intrapartum periods of pregnancy.<br>The Team3 fetal monitors are<br>intended for pregnant women<br>from the 28th week of gestation,<br>through to term and delivery. The<br>devices are intended for use in<br>clinical and hospital-type facilities.<br>Sonicaid Team3 Antepartum is<br>suitable for use when there is. | Maternal eMHR | Reference: eMHR Channels:<br>1 Electrode Type: Standard<br>ECG<br>MHR Range: 30-240<br>bpm | Reference: eMHR Channels:<br>1 Electrode Type: Standard<br>ECG<br>MHR Range: 30-240<br>bpm | Interfaces | RS232-CRS: Yes<br>Ethernet - CRS: Yes DVI: 1<br>channel, DVI-I connector | |
| | | | Maternal Non-<br>Invasive Blood<br>Pressure | Method: Oscillometric OEM: PAR<br>Medizintechnik BP Ranges:<br>Systolic<br>25-280mmHg,<br>Diastolic 10- 220mmHg<br>Pulse Range: 30- 240bpm<br>BP Accuracy:<br>±1.7mmHg Safety Limiters:<br>Over- inflation 300mmHg,<br>Duration 15s | Method: Oscillometric OEM: PAR<br>Medizintechnik BP Ranges:<br>Systolic<br>25-280mmHg,<br>Diastolic 10- 220mmHg<br>Pulse Range: 30- 240bpm<br>BP Accuracy:<br>±1.7mmHg Safety Limiters:<br>Over- inflation 300mmHg,<br>Duration 15s | | | |
| Ultrasound | a need to monitor the following<br>physiological applications:<br>• Single or twin fetal heart rates<br>by means of ultrasound<br>• Uterine activity – externally<br>sensed.<br>• Fetal movement – maternally<br>sensed and externally via<br>ultrasound.<br>• Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>• Maternal non- invasive<br>blood pressure Sonicaid Team3<br>Intrapartum is suitable for use<br>when there is a need to monitor<br>the following physiological<br>applications:<br>• Single or twin fetal heart rates<br>by means of ultrasound and/or<br>FECG.<br>• Maternal heart rate via<br>ECG electrodes<br>• Uterine activity - externally or<br>internally sensed<br>• Fetal movement – maternally<br>sensed and externally via<br>ultrasound.<br>• Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>• Maternal non- invasive<br>blood pressure | A MEMBER OF THE ARJO F<br>a need to monitor the following<br>physiological applications:<br>• Single or twin fetal heart rates<br>by means of ultrasound<br>• Uterine activity – externally<br>sensed.<br>• Fetal movement – maternally<br>sensed and externally via<br>ultrasound.<br>• Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>• Maternal non- invasive<br>blood pressure<br>• CTG analysis – advises<br>whether a number of defined<br>criteria indicative of a normal<br>cardiotocograph has been met<br>Sonicaid Team3 Intrapartum is<br>suitable for use when there is a<br>need to monitor the following<br>physiological applications:<br>• Single or twin fetal heart rates<br>by means of ultrasound and/or<br>FECG.<br>• Maternal heart rate via ECG<br>electrodes<br>• Uterine activity - externally or<br>internally sensed<br>• Fetal movement – maternally<br>sensed and externally via<br>ultrasound.<br>• Maternal heart rate and oxygen<br>saturation via pulse oximetry<br>• Maternal non- invasive<br>blood pressure | | | | | | |
| | Channels: 2 | Channels: 2 | | | | | | |
| | | | | | | | | |

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K241368

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A MEMBER OF THE ARJO FAMILY

| | Wireless Telemetry: Yes<br>USB: 2 channels | Wireless Telemetry: Yes<br>USB: 2 channels |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical | Size(WxDxH): 32x23x23.4cm<br>Weight (Net): 6kg | Size(WxDxH): 32x23x23.4cm<br>Weight (Net): 6kg |
| Mains Power Supply | Voltage: 85-264Vac<br>Frequency: 50 or 60 Hz<br>Consumption (max):<br><140VA | Voltage: 85-264Vac<br>Frequency: 50 or 60 Hz<br>Consumption (max):<br><140VA |
| Internal Battery | Rechargeable<br>5200mAh Li-ion Battery | Rechargeable<br>5200mAh Li-ion Battery |
| Environmental | Operating temp: +10- 40°C<br>Storage temp: -20- 50°C<br>Operating Press: 70- 106kPa<br>Storage Press: 70- 106kPa<br>Operating Humidity: 15-90%<br>RH<br>Storage Humidity: 10-<br>90% RH | Operating temp: +10- 40°C<br>Storage temp: -20- 50°C<br>Operating Press: 70- 106kPa<br>Storage Press: 70- 106kPa<br>Operating Humidity: 15-90%<br>RH<br>Storage Humidity: 10-<br>90% RH |
| EMC<br>and<br>Electrical Safety | 60601-1-2: Comply<br>60601-1: Comply | 60601-1-2: Comply<br>60601-1: Comply |

The Sonicaid Team3 subject device has the same intended use as the predicate - a system and accessories intended to perform perinatal monitoring. As noted in the table above, the subject device has identical technological characteristics as the predicate device, except for a new feature, the Dawes Redman CTG Analysis. The Dawes Redman CTG Analysis was cleared as a software algorithm in the reference device (K992607). This difference in technological features does not raise different questions of safety and effectiveness and can be addressed through performance testing.

#### Performance Data 6.

| Testing Conducted | Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Performance<br>Testing | Software verification and validation testing were<br>conducted, and documentation was provided as<br>recommended by FDA's Guidance for Industry and FDA<br>Staff, "Guidance for the Content for the Premarket<br>Submissions for Software Contained in Medical<br>Devices". The software for this device was considered as<br>a "major" level of concern. |

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A MEMBER OF THE ARJO FAMILY

| Cybersecurity Testing | Cybersecurity risk management and testing were<br>conducted following FDA's Guidance for Industry and<br>FDA Staff, "Content of Premarket Submissions for<br>Management of Cybersecurity in Medical Devices".<br>Documentation was provided to demonstrate compliance<br>with cybersecurity best practices, including threat<br>modeling, risk assessment, and mitigation strategies.<br>The device underwent verification and validation testing<br>to ensure protection against unauthorized access, data<br>breaches, and potential cyber threats. |
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#### 7. Conclusion

The non-clinical testing discussed above demonstrates that the Sonicaid Team3 is as safe and effective as the predicate device and supports a determination of substantial equivalence.