(265 days)
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
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.
The provided text indicates that the Sonicaid Team3 fetal monitor has incorporated the Dawes-Redman CTG Analysis software, which was previously cleared under K992607, into its hardware. The submission for K241368 aims to demonstrate substantial equivalence by addressing this integration.
However, the provided document does not contain the specific acceptance criteria or performance study details for the Dawes-Redman CTG Analysis software as requested in the prompt. The "Performance Data" section (page 10), under "Software Performance Testing," generically states: "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."
This statement confirms that software testing was performed and documentation provided, and that the software was considered "major" in terms of concern, but it does not include the acceptance criteria, reported performance, sample size, ground truth establishment, expert qualifications, or MRMC study details.
Therefore, I cannot fulfill all parts of your request based on the provided text. I can only infer what was stated:
Here's what can be extracted/inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
* Cannot be provided. The document states software V&V was performed, but does not specify the acceptance criteria for the Dawes-Redman CTG Analysis or the performance metrics achieved against those criteria.
2. Sample size used for the test set and the data provenance:
* Cannot be provided. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Cannot be provided. The document does not mention the number or qualifications of experts used for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Cannot be provided. The document does not describe any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Cannot be provided. The document specifically mentions the Dawes-Redman CTG Analysis assists physicians in "identifying normal and nonreassuring traces," which implies a human-in-the-loop scenario. However, it does not state whether an MRMC study was performed or any effect size related to human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Cannot be explicitly confirmed or denied. While the indication for use states it "assists physicians," the document does not detail individual study types (standalone vs. human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Cannot be provided. The document does not specify the type of ground truth used to evaluate the Dawes-Redman CTG Analysis.
8. The sample size for the training set:
* Cannot be provided. The document does not mention any details about a training set for the software.
9. How the ground truth for the training set was established:
* Cannot be provided. Since no training set details are given, how its ground truth was established is also not available.
In summary, the provided FDA premarket notification document for K241368 focuses on demonstrating substantial equivalence by integrating a previously cleared software (Dawes-Redman CTG Analysis) into new hardware. It confirms that general software verification and validation were conducted according to FDA guidance for "major" level of concern software and cybersecurity testing was performed. However, it does not include the detailed performance study results, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications for the Dawes-Redman CTG analysis itself. Such specific performance data would typically be found in more detailed test reports, which are not part of this summary document.
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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 (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
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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 LimitedUnit 35, Portmanmoor RoadCardiffCF24 5HNUnited 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 ProductCodes: | HEL - Monitor, Heart Rate, Fetal, UltrasonicHGP – Electrode, Circular (spiral), Scalp and ApplicatorHFM - Monitor, Uterine Contraction, External (For Use in Clinic)KXO - Monitor, Pressure, IntrauterineDRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DQA – OximeterDXN - 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 PredicateDevice(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. | MaternalOximetry(MSpO2) | Method: Differential opticaltransmission Saturation Range:1-100% MSpO2Accuracy: 70-100%$\pm$ 1SDPulse Range: 30-240 bpmAccuracy: $\pm$ 3 bpm | Method: Differential opticaltransmission Saturation Range:1-100% MSpO2Accuracy: 70-100%$\pm$ 1SDPulse Range: 30-240 bpmAccuracy: $\pm$ 3 bpm | |||
|---|---|---|---|---|---|---|---|---|
| Classification | II | II | Mode: Directional PulsedDoppler FHR Range: 30-240bpm Frequency 1MHzSafety: Type CFProtection Type: Piezo 8 elementIspta: <3mW/cm2 Material:Novodur P2H-AT | Mode: Directional PulsedDoppler FHR Range: 30-240bpm Frequency 1MHzSafety: Type CFProtection Type: Piezo 8 elementIspta: <3mW/cm2 Material:Novodur P2H-AT | Dawes RedmanSoftware Analysis | N/A | No. of criteria: 'Met or 'Not Met'Measurement Parameters: SignalLoss, Fetal Movements per hour,Basal Heart Rate, Accelerations,Decelerations, High and Lowvariation episodes, Short termvariationFirmware embedded in theTeam3 (fetal monitor | |
| Product Code | HGM | HGM | Toco | Type: TocodynamometerMaterial: Body – Novodur P2H-AT, Faceplate - Kraiburg TPETF6 FMAElastomer | Type: TocodynamometerMaterial: Body – Novodur P2H-AT, Faceplate – Kraiburg TPETF6 FMAElastomer | Patient Event Marker | Channels: 1 Indication: Audio,visual & printed | |
| Regulation | 21 CFR 884.2740 | 21 CFR 884.2740 | Fetal ECG | Channels: 1FHR Range: 30-240bpm | Channels: 1FHR Range: 30-240bpm | Display | Type: Colour TFT LCDSize: 17 x 12.8cm (6.7x 5") | |
| Intended Use | System and Accessories intendedto perform perinatal monitoring | System and Accessories intendedto perform perinatal monitoring | External UterineActivity | Channels: 1Range: 0-100 Relative UnitsSensitivity: 100%FSD=120gOffset range: ± 375g Alerts: TocoPersistence Alert | Channels: 1Range: 0-100 Relative UnitsSensitivity: 100%FSD=120gOffset range: ± 375g Alerts: TocoPersistence Alert | Printer | Print Head: 128mm Thick FilmThermal ArraySpeeds: 1, 2 or 3cm/min,20cm/min fast forward | |
| Configuration | Monitoring Hardware only | Monitoring Hardware and DawesRedman CTG Software | Internal UterineActivity | Channels: 1 Range: 0-100mmHg or 1-13.3kPaSensitivity: 5µV/V/mmHg | Channels: 1 Range: 0-100mmHg or 1-13.3kPaSensitivity: 5µV/V/mmHg | Controls and Indicators | Power on/off: On/standby touchswitch with indicator Audiovolume up/down: Volumeup/down touch screen 'button' | |
| Indications for Use | The Team3 fetal monitors areindicated for use by trainedhealthcare professionals in non-invasive and invasive monitoringof physiological parameters inpregnant women and fetuses,during the antepartum andintrapartum periods of pregnancy.The Team3 fetal monitors areintended for pregnant womenfrom the 28th week of gestation,through to term and delivery. Thedevices are intended for use inclinical and hospital-type facilities.Sonicaid Team3 Antepartum issuitable for use when there is | The Team3 fetal monitors areindicated for use by trainedhealthcare professionals in non-invasive and invasive monitoringof physiological parameters inpregnant women and fetuses,during the antepartum andintrapartum periods of pregnancy.The Team3 fetal monitors areintended for pregnant womenfrom the 28th week of gestation,through to term and delivery. Thedevices are intended for use inclinical and hospital-type facilities.Sonicaid Team3 Antepartum issuitable for use when there is. | Maternal eMHR | Reference: eMHR Channels:1 Electrode Type: StandardECGMHR Range: 30-240bpm | Reference: eMHR Channels:1 Electrode Type: StandardECGMHR Range: 30-240bpm | Interfaces | RS232-CRS: YesEthernet - CRS: Yes DVI: 1channel, DVI-I connector | |
| Maternal Non-Invasive BloodPressure | Method: Oscillometric OEM: PARMedizintechnik BP Ranges:Systolic25-280mmHg,Diastolic 10- 220mmHgPulse Range: 30- 240bpmBP Accuracy:±1.7mmHg Safety Limiters:Over- inflation 300mmHg,Duration 15s | Method: Oscillometric OEM: PARMedizintechnik BP Ranges:Systolic25-280mmHg,Diastolic 10- 220mmHgPulse Range: 30- 240bpmBP Accuracy:±1.7mmHg Safety Limiters:Over- inflation 300mmHg,Duration 15s | ||||||
| Ultrasound | a need to monitor the followingphysiological applications:• Single or twin fetal heart ratesby means of ultrasound• Uterine activity – externallysensed.• Fetal movement – maternallysensed and externally viaultrasound.• Maternal heart rate and oxygensaturation via pulse oximetry• Maternal non- invasiveblood pressure Sonicaid Team3Intrapartum is suitable for usewhen there is a need to monitorthe following physiologicalapplications:• Single or twin fetal heart ratesby means of ultrasound and/orFECG.• Maternal heart rate viaECG electrodes• Uterine activity - externally orinternally sensed• Fetal movement – maternallysensed and externally viaultrasound.• Maternal heart rate and oxygensaturation via pulse oximetry• Maternal non- invasiveblood pressure | A MEMBER OF THE ARJO Fa need to monitor the followingphysiological applications:• Single or twin fetal heart ratesby means of ultrasound• Uterine activity – externallysensed.• Fetal movement – maternallysensed and externally viaultrasound.• Maternal heart rate and oxygensaturation via pulse oximetry• Maternal non- invasiveblood pressure• CTG analysis – adviseswhether a number of definedcriteria indicative of a normalcardiotocograph has been metSonicaid Team3 Intrapartum issuitable for use when there is aneed to monitor the followingphysiological applications:• Single or twin fetal heart ratesby means of ultrasound and/orFECG.• Maternal heart rate via ECGelectrodes• Uterine activity - externally orinternally sensed• Fetal movement – maternallysensed and externally viaultrasound.• Maternal heart rate and oxygensaturation via pulse oximetry• Maternal non- invasiveblood pressure | ||||||
| Channels: 2 | Channels: 2 | |||||||
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A MEMBER OF THE ARJO FAMILY
| Wireless Telemetry: YesUSB: 2 channels | Wireless Telemetry: YesUSB: 2 channels | |
|---|---|---|
| Physical | Size(WxDxH): 32x23x23.4cmWeight (Net): 6kg | Size(WxDxH): 32x23x23.4cmWeight (Net): 6kg |
| Mains Power Supply | Voltage: 85-264VacFrequency: 50 or 60 HzConsumption (max):<140VA | Voltage: 85-264VacFrequency: 50 or 60 HzConsumption (max):<140VA |
| Internal Battery | Rechargeable5200mAh Li-ion Battery | Rechargeable5200mAh Li-ion Battery |
| Environmental | Operating temp: +10- 40°CStorage temp: -20- 50°COperating Press: 70- 106kPaStorage Press: 70- 106kPaOperating Humidity: 15-90%RHStorage Humidity: 10-90% RH | Operating temp: +10- 40°CStorage temp: -20- 50°COperating Press: 70- 106kPaStorage Press: 70- 106kPaOperating Humidity: 15-90%RHStorage Humidity: 10-90% RH |
| EMCandElectrical Safety | 60601-1-2: Comply60601-1: Comply | 60601-1-2: Comply60601-1: 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 PerformanceTesting | Software verification and validation testing wereconducted, and documentation was provided asrecommended by FDA's Guidance for Industry and FDAStaff, "Guidance for the Content for the PremarketSubmissions for Software Contained in MedicalDevices". The software for this device was considered asa "major" level of concern. |
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K241368 Page 8 of 8
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A MEMBER OF THE ARJO FAMILY
| Cybersecurity Testing | Cybersecurity risk management and testing wereconducted following FDA's Guidance for Industry andFDA Staff, "Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices".Documentation was provided to demonstrate compliancewith cybersecurity best practices, including threatmodeling, risk assessment, and mitigation strategies.The device underwent verification and validation testingto ensure protection against unauthorized access, databreaches, and potential cyber threats. |
|---|---|
| ----------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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.
§ 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).