(72 days)
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:
- 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
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 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).
- 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.
The provided text describes the acceptance criteria and study for a medical device (Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) in the context of an FDA 510(k) submission. However, it does not contain information about acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, or specificity targets for the physiological parameters being monitored). Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and various types of engineering and performance testing.
Therefore, the following information is extracted based on the provided text, and where specific details are not present, it will be noted.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the typical sense of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy targets. Instead, it demonstrates performance through compliance with recognized standards and various engineering and functional tests. The implied acceptance criterion is "demonstrating substantial equivalence to the predicate device" by meeting safety and performance standards and showing that technological differences do not raise new questions of safety or effectiveness.
| Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| General Device Comparison | Be substantially equivalent to the predicate device (Sonicaid FM820E and FM830E (K090285)) in intended use, safety, and effectiveness. | The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum have the same intended use as the predicate device – to monitor the progress of labor and fetal status. Although there are different technological characteristics, these do not raise different questions of safety and effectiveness. |
| Biocompatibility | Compliance with ISO 10993-1:2009 for skin-contacting devices (<30 days). | Biocompatibility evaluation conducted in accordance with ISO 10993-1:2009, considering the device and accessories as skin-contacting (intact) for <30 days. |
| Software Performance | Software verification and validation per FDA guidance. | 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. |
| Electronic Hardware Performance | Verification of PCB performance, functional testing of UUT, cooling fan controller, battery charging indication, switch ON feedback, and MASIMO/NELLCOR interface. | Testing confirmed these aspects of electronic hardware performance. |
| Mechanical Performance | Verification of general, physical, environment, product labeling, instructions for use, packaging, durability, and life testing. | Testing confirmed these aspects of mechanical performance. |
| Functional Performance | Verification of hardware-software interaction for all specified functions. | Functions tested include ultrasound, external devices, TOCO, SpO2, NIBP, alarms, FECG enhancements, eMHR, wireless, system, battery life, battery charge, and fetal movement detection. (Specific performance metrics for each function are not provided in the summary). |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1:2005/(R)2012 and amendments. | Electrical safety testing conducted by a third-party laboratory (UL) confirmed compliance with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. |
| EMC Testing | Compliance with AAMI/ANSI ES60601-1:2005/(R)2012 and amendments. | EMC testing conducted by a third-party laboratory confirmed compliance with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. |
| Environmental Performance | Verification of operating and storage temperature, humidity, atmospheric pressure, non-operational shock, and vibration. | Testing confirmed these environmental performance aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests (biocompatibility, software, electronic hardware, mechanical, functional, electrical safety, EMC, and environmental performance). It does not mention a "test set" in the context of patient data or clinical performance evaluation that would require a sample size or data provenance like country of origin, retrospective, or prospective. The "testing conducted" section describes verification and validation activities against engineering specifications and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document as the study described is not a clinical performance study involving expert ground truth for patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as the study described is not a clinical performance study involving expert adjudication.
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
There is no mention of an MRMC comparative effectiveness study or AI assistance in this submission. The device is a fetal monitor, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device described. The Sonicaid Team3 is a fetal monitor designed to directly measure physiological parameters, not an algorithm providing interpretations or diagnoses in isolation. Its performance is evaluated through its accuracy and reliability in measuring those parameters. The "Functional Performance Testing" section covers the interaction of hardware and software for its various functions, which could be considered a form of standalone performance evaluation for the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" would be established by:
- Engineering specifications and design requirements: For software, electronic hardware, and mechanical performance.
- Recognized consensus standards: For biocompatibility (ISO 10993-1), electrical safety (AAMI/ANSI ES60601-1), and EMC.
- Reference measurement instruments or established methods: For verifying the accuracy of physiological parameter measurements during functional testing (e.g., a calibrated pressure sensor for NIBP, a known heart rate generator for FHR). Specific details on the reference methods used for functional performance testing are not provided but implied by "verification of the hardware software interaction."
8. The sample size for the training set
This information is not applicable/provided. The document describes a traditional medical device submission (510(k)) that focuses on engineering and performance validation rather than machine learning or AI model development, which would typically involve training sets.
9. How the ground truth for the training set was established
This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:
-
- 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
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)
| ☑ 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 LimitedUnit 35, Portmanmoor RoadCardiffCF24 5HNUnited Kingdom |
| Telephone: | +44 (0)2920 485885 |
| Fax: | +44 (0)2920 492520 |
| 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, ultrasonicHGP, electrode, circular (spiral), scalp and applicatorHFM, 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 byHuntleigh Healthcare Ltd., Diagnostic Products Division. |
|---|---|
| The predicate device has not been subject to a design-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:
-
- 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
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
5.4 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.Sonicaid Team3 Antepartum andSonicaid Team3 Intrapartum | Huntleigh Healthcare Ltd.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 Antepartumand Sonicaid Team3 Intrapartumfetal monitors (Team3 fetal monitors)indicated for use by trainedhealthcare professionals in non-invasive and invasive monitoring ofphysiological parameters in pregnantwomen and fetuses, during theantepartum and intrapartum periodsof pregnancy. The Team3 fetalmonitors are intended for pregnantwomen from the 28th week ofgestation, through to term anddelivery. The devices are intendedfor use in clinical and hospital-typefacilities.Sonicaid Team3 Antepartum issuitable for use when there is a needto monitor the following physiologicalapplications:1) Single or twin fetal heart rates bymeans of ultrasound2) Uterine activity - externallysensed3) Fetal movement - maternallysensed and externally via ultrasound4) Maternal heart rate and oxygensaturation via pulse oximetry5) Maternal non-invasive bloodpressure | The Huntleigh Healthcare LtdSonicaid FM820 and FM830Encore fetal monitors areindicated for use by trainedhealhtcare professionals innon-invasive and invasivemonitoring of physiologicalparameters in pregnant adulthuman females, and fetuses,during the intrapartum andantepartum periods ofpregnancy. The devices areintended for use in clinicaland hospital-type facilities.They are not intended for usein intensive care units,operating room, or intransport monitoringapplications.Sonicaid FM820E is suitablefor use when there is a needto monitor the followingphysiological parameters:● single or twin fetal heartrates by means ofultrasound● fetal or maternal heartrate by ecg● uterine activity-externallyor internally sensed● fetal movement |
| Sonicaid Team3 Intrapartum issuitable for use when there is a needto monitor the following physiologicalapplications:1) Single or twin fetal heart rates bymeans of ultrasound and/or FECG2) Maternal heart rate via ECGelectrodes3) Uterine activity - externally orinternally sensed4) Fetal movement - maternallysensed and externally via ultrasound5) Maternal heart rate and oxygensaturation via pulse oximetry6) Maternal non-invasive bloodpressure | maternally sensedSonicaid FM830E is suitablefor use when there is a needto monitor the followingphysiological parameters:single or twin fetal heart●rates by means ofultrasoundfetal or maternal heart●rate by ecguterine activity-externally●or internally sensedfetal movement-●maternally sensedmaternal heart rate and●oxygen saturation viapulse oximetrymaternal non-invasive●blood pressure | |
| Electrical Safety – Device Classification | ||
| Protection against ingressof water and particulates | Main unit: IP30Main unit with protective cover: IP31Transducers: IPX7 (Ultrasound,TOCO) | Main unit: Not providedMain unit with protectivecover: Not providedTransducers: IPX4 (TOCO),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 rateSignal Loss | High and low heart rateSignal 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 rangeAlerts | + 375 gTOCO persistence alert (TPA) | + 100 gNone |
| 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(K955443) |
| Safety | Type CF | Type CF |
| Connector | Huntleigh 12-pole (pink) | Nikolay 12-pole (pink) |
| Fetal ECG | ||
| Technique | Peak-peak detection technique | Peak-peak detectiontechnique |
| HR range | 30 bpm - 240 bpm | 30 bpm – 240 bpm |
| HR resolution | ± 1 bpm over the range 100-180bpm± 2 bpm outside range | ± 1 bpm over the range 100-180 bpm± 2 bpm outside range |
| Input impedance | 10M Ohm | 10M Ohm |
| Input signal range | 30 – 500 µV peak-to-peak | 30 – 500 µV peak-to-peak |
| DC Offset | ± 2 V CM± 300 mV Differential | ± 2 V CM± 300 mV Differential |
| Noise | <10 µV peak-to-peak | <10 µV peak-to-peak |
| Defibrillator protection | Yes | Yes |
| Alerts | High & low heart rateLoss of contact* | High & low heart rateLoss of contact |
| Connector | Huntleigh 12-pole (green) | Nikolay 12-pole (white) |
| Safety | Type CF | Type CF |
| Fetal ECG Cables | Cable Safelinc (ACC-OBS-066)Cable Qwikconnect (ACC-OBS-068) | Cable Safelinc (ACC-OBS-022)Cable Qwikconnect (ACC-OBS-023)Cable Philips (ACC-OBS-007) |
| Sp02 | ||
| Saturation range | 0% - 99% | 0 - 100% |
| Saturation accuracy | 0-69%: Unspecified70-100%: ±2 digits displayed | 0% ~ 69%: Unspecified70-99%: ± 2 digits displayed |
| PR measurement range | 30 - 240 bpm | 20 – 250 bpm |
| Pulse Rate Accuracy | ±3 bpm | ±1 bpm |
| Connector | Huntleigh Mini 12-pole | Idu 12-pole |
| NIBP | ||
| Blood pressure range | Systolic pressure: 25mmHg ~280mmHgDiastolic pressure: 10mmHg ~220mmHg | Systolic pressure: 50mmHg |
| Measuring accuracy | ± 1.7 mmHg | ± 3 mmHg or ±2%, whicheveris greater |
| Cuff pressure protection | 300 mmHg15 sec duration | 310 mmHg160 sec max measurementtime |
| PR measurement range | 30 - 240 bpm | 40 – 200 bpm |
| PR measurement accuracy | Validated according to ISO 81060-2 | Meets requirements ofANSI/AAMI SP10: 1992 and2012 |
| Alerts | Systolic high/lowDiastolic high/lowCuff too looseCuff air leakMovement artefactexcessiveOver-pressureMeasurement timeexceeded | Air leakMovement, Overpressure |
| Safety | Type CF | Type CF |
| Maternal ECG / eMHR | ||
| Channel | 1 | 1 |
| Reference | eMHR | MECG |
| MHR Range | 30 - 240 bpm | 30 – 240 bpm |
| Alerts | High & low heart rateLoss of contact | DisconnectionSignal lossHeart rate goes above orbelow preset limits. |
| Safety | Type CF | Type CF |
| Connector | Huntleigh Mini 7-pole | Nikolay 12-pole (white) |
| Patient Event Marker | ||
| Safety | Type B | Type B |
| Connector | 6.35 mm Jack 3-pole | 6.35 mm Jack 3-pole |
| Part Number | 7775-6901 | 7775-6901 |
| Printer - unchanged from predicate | ||
| Paper width | 128mm thick film thermal array | 128mm thick film thermalarray |
| FHR scaling | 30-240 bpm or 50-210 bpm* | 30-240 bpm or 50-210 bpm* |
| Speeds | Standard: 1 cm/min, 2 cm/min, 3cm/min20 cm/min fast forward | Standard: 1 cm/min, 2cm/min, 3 cm/min10 cm/min rapid print |
| Resolution | 8 dots/mm | 8 dots/mm |
| Paper out buffer | 100 hours | Not provided |
| Paper | Plain thermal paper, z-fold, 45 mlength | Plain thermal paper, z-fold,45 m length |
| Physical Device Characteristics | ||
| Screen | LCD | LCD |
| Screen dimensions | 17 x 12.8cm (6.7 x 5") | 11.5 cm x 8.6 cm (4.5 x 3.4 ") |
| Resolution | 800 x 600 (SVGA) | 320 x 240 |
| Power supply | AC or battery | AC |
| Operating voltage | AC 85 - 246 V* | AC 90 - 240 V |
| Line frequency | 50/60 Hz | 50/60 Hz |
| Battery | Rechargeable Lithium-ion Battery | None |
| Dimensions | 32x23x23.4cm | 35.8 x 36.3 x 39.2 cm |
| Weight | 6 kg | 16 kg |
| Operating temperature | 10 °C ~ 40 °C | 10 ℃ ~ 35 ℃ |
| Transport/storagetemperature | -20 ℃ ~ 50 ℃ | -20 ℃ ~ 50 ℃ |
| Operating humidity | 15% ~ 90% (relative humidity) | 10% ~ 75% (relative humidity) |
| Transport/Storage humidity | 10% ~ 90% (relative humidity) | 10% ~ 90% (relative humidity) |
| Operating atmosphericpressure | 70 kPa ~ 106 kPa | 68 kPa ~ 106 kPa |
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{8}------------------------------------------------
The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum have the same intended use as the predicate device – to monitor the progress of labor and fetal status. As noted in the table above, the Sonicaid Team3 fetal monitors have different technological characteristics compared to the predicate device. However, these different technological characteristics do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Tests 5.6
{9}------------------------------------------------
The following performance data were provided in support of the substantial equivalence determination:
| Testing Conducted | Discussion |
|---|---|
| Biocompatibility Testing-Cytotoxicity-Sensitization-Irritation | The biocompatibility evaluation of the device wasconducted in accordance with ISO 10993-1:2009Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess. The subject device and accessories areconsidered a skin contacting device (intact) for a durationof <30 days. |
| 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. |
| Electronic HardwarePerformance Testing | Testing provided verification of the Sonicaid Team3 mainPrinted Circuit Board (PCB) performance includingAutomatic Test Equipment (ATE) testing, functional testingUnit Under Test (UUT), cooling fan speed controller,battery charging indication, switch ON feedback andMASIMO/NELLCOR interface. |
| MechanicalPerformance Testing | Testing provided verification of mechanical performanceincluding general, physical, environment, product labelling,instructions for use, packaging, durability and life testing. |
| Functional PerformanceTesting | Testing provided verification of the hardware softwareinteraction. Functions tested include ultrasound, externaldevices, TOCO, SpO2, NIBP, alarms, FECGenhancements, eMHR, wireless, system, battery life,battery charge and fetal movement detection. |
| Electrical SafetyTesting | Electrical safety testing was conducted on the product bya third-party laboratory, UL. Testing confirmed the devicecomplies with AAMI/ANSI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.Medical Electrical Equipment: Part 1: GeneralRequirements. |
| EMC Testing | EMC testing was conducted on the product by a third-party laboratory. Testing confirmed the device complieswith AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.Medical Electrical Equipment: Part 1: General |
| Requirements. | |
| EnvironmentalPerformance Testing | Testing provided verification of the operating and storagetemperature, humidity and atmospheric pressure, andnon-operational shock and vibration. |
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Conclusion 5.7
The results of the performance testing described above demonstrate that the Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors are as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.
§ 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).