(265 days)
No
The document describes a fetal monitor with embedded software for CTG analysis (Dawes-Redman), but there is no mention of AI or ML technologies being used in this analysis or any other function of the device. The software is described as previously cleared and embedded, suggesting a more traditional algorithmic approach rather than adaptive or learning-based methods.
No
Justification: The device is described as a fetal monitoring device that monitors physiological parameters and provides analysis, but it does not claim to treat, mitigate, or cure any disease or condition.
Yes
The device monitors physiological parameters (fetal heart rates, uterine activity, maternal heart rate, blood pressure, etc.) and analyzes CTG traces to advise on criteria indicative of a normal cardiograph record and assist physicians in identifying normal and nonreassuring traces. This collection of physiological data and assistance in identifying normal/nonreassuring traces for diagnostic purposes fits the definition of a diagnostic device.
No
The device description explicitly states that the Sonicaid Team3 "includes systems and accessories intended to perform perinatal monitoring" and that the Dawes-Redman software is "embedded in the subject device, ensuring integration with the existing hardware." This indicates the device is a combination of hardware and software, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Sonicaid Team3 fetal monitor performs non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses. This involves using methods like ultrasound, external and internal sensing, pulse oximetry, and blood pressure measurement. These are all methods that directly measure physiological signals from the body, not analyze samples taken from the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, the Sonicaid Team3 fetal monitor falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
Yes
The "Predetermined Change Control Plan (PCCP) - All Relevant Information" section explicitly states: "The FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This directly indicates that the device has an authorized PCCP.
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
HGM, HEL, HGP, HFM, KXO, DRT, DQA, DXN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pregnant women from the 28th week of gestation, through to term and delivery.
Intended User / Care Setting
trained healthcare professionals in clinical and hospital-type facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Performance Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content for the Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "major" level of concern.
Cybersecurity Testing: Cybersecurity risk management and testing were conducted following FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". Documentation was provided to demonstrate compliance with cybersecurity best practices, including threat modeling, risk assessment, and mitigation strategies. The device underwent verification and validation testing to ensure protection against unauthorized access, data breaches, and potential cyber threats.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
§ 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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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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Image /page/4/Picture/0 description: The image shows the text "K241368 Page 1 of 8" on the left side. On the right side of the image is the word "HUNTLEIGH" in a large, bold, sans-serif font. Below the word "HUNTLEIGH" is the text "A MEMBER OF THE ARJO FAMILY" in a smaller font.
510(k) Summary — K241368 Sonicaid Team 3
| Name & Address: | Huntleigh Healthcare Limited
Unit 35, Portmanmoor Road
Cardiff
CF24 5HN
United Kingdom |
|-----------------|----------------------------------------------------------------------------------------------------|
| Telephone: | +44 (0)2920 485885 |
| Fax: | +44 (0)2920 492520 |
| 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 | |
| Codes: | HEL - Monitor, Heart Rate, Fetal, Ultrasonic |
| HGP – Electrode, Circular (spiral), Scalp and Applicator | |
| 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 |
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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Image /page/5/Picture/0 description: The image shows the text "K241368 Page 2 of 8" in the upper left corner. Below this text is the word "HUNTLEIGH" in a large, bold, sans-serif font. Underneath "HUNTLEIGH" is the text "A MEMBER OF THE ARJO FAMILY" in a smaller font. The overall impression is that this is a page from a document, possibly a report or manual, from the company Huntleigh, which is part of the Arjo family of companies.
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
| 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
Oximetry
(MSpO2) | Method: Differential optical
transmission Saturation Range:
1-
100% MSpO2
Accuracy: 70-100%
$\pm$ 1SD
Pulse Range: 30-240 bpm
Accuracy: $\pm$ 3 bpm | Method: Differential optical
transmission Saturation Range:
1-
100% MSpO2
Accuracy: 70-100%
$\pm$ 1SD
Pulse Range: 30-240 bpm
Accuracy: $\pm$ 3 bpm |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II | II | | Mode: Directional Pulsed
Doppler FHR Range: 30-240
bpm Frequency 1MHz
Safety: Type CF
Protection Type: Piezo 8 element
Ispta: