(72 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance testing. The focus is on standard physiological monitoring and hardware/software functionality.
No
The device is described as a "fetal monitor" intended for "monitoring of physiological parameters." It does not mention treating, curing, or preventing disease, which are characteristics of a therapeutic device.
Yes
Explanation: The device is a fetal monitor that measures and presents physiological parameters (e.g., fetal heart rate, maternal heart rate, blood pressure, oxygen saturation, uterine activity) to trained healthcare professionals, which are then used in the process of diagnosis and clinical decision-making regarding the health of the pregnant woman and the fetus.
No
The device description explicitly states it is a "mains / battery powered multi-function fetal monitor" and lists numerous hardware components like an LCD display, touch screen, transducers, sensors, and an optional printer. It also details hardware performance testing.
Based on the provided information, 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 Sonicaid Team3 fetal monitor is a non-invasive device that monitors physiological parameters directly from the pregnant woman and fetus using methods like ultrasound, external sensors, pulse oximetry, and blood pressure measurement. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive monitoring of physiological parameters".
Therefore, the Sonicaid Team3 fetal monitor falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
HGM, HEL, HGP, HFM, KXO, DRT, DQA, DXN
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).
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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)
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 was conducted in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The subject device and accessories are considered a skin contacting device (intact) for a duration of |
§ 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).
0
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
2
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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3
510(k) Summary K200975
| Date Summary Prepared: | June 18, 2020 |
|---|---|
| Submitter/Applicant: | Huntleigh Healthcare Limited |
| Unit 35, Portmanmoor Road | |
| Cardiff | |
| CF24 5HN | |
| United 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, 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 | |
| Regulatory Class: | II |
| Review Panel: | Obstetrics/Gynecology |
5.2 Predicate Device Information
| Predicate Device: | Sonicaid FM820E and FM830E (K090285) manufactured by
Huntleigh Healthcare Ltd., Diagnostic Products Division. |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| | The predicate device has not been subject to a design-
related recall. |
4
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).
5
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 and | ||
| Sonicaid 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 Antepartum | |
| and Sonicaid Team3 Intrapartum | ||
| fetal monitors (Team3 fetal monitors) | ||
| 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 | The Huntleigh Healthcare Ltd
Sonicaid FM820 and FM830
Encore fetal monitors are
indicated for use by trained
healhtcare professionals in
non-invasive and invasive
monitoring of physiological
parameters in pregnant adult
human females, and fetuses,
during the intrapartum and
antepartum periods of
pregnancy. The devices are
intended for use in clinical
and hospital-type facilities.
They are not intended for use
in intensive care units,
operating room, or in
transport monitoring
applications.
Sonicaid FM820E is suitable
for use when there is a need
to monitor the following
physiological parameters:
● single or twin fetal heart
rates by means of
ultrasound
● fetal or maternal heart
rate by ecg
● uterine activity-externally
or internally sensed
● fetal movement |
| | 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 | maternally sensed
Sonicaid FM830E is suitable
for use when there is a need
to monitor the following
physiological parameters:
single or twin fetal heart
●
rates by means of
ultrasound
fetal or maternal heart
●
rate by ecg
uterine activity-externally
●
or internally sensed
fetal movement-
●
maternally sensed
maternal heart rate and
●
oxygen saturation via
pulse oximetry
maternal non-invasive
●
blood pressure |
| Electrical Safety – Device Classification | | |
| Protection against ingress
of water and particulates | Main unit: IP30
Main unit with protective cover: IP31
Transducers: IPX7 (Ultrasound,
TOCO) | Main unit: Not provided
Main unit with protective
cover: Not provided
Transducers: 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 rate
Signal Loss | High and low heart rate
Signal Loss |
| Safety | Type CF | Type CF |
| Connector | 3 x Huntleigh 12-pole socket | 2 x Nikolay 12-pole socket |
| Ultrasound Transducer | Sonicaid ACC-OBS-008 | Sonicaid ACC-OBS-008 |
| TOCO | | |
| TOCO Range | 0 - 100 relative units | 0 - 100 relative units |
| Channels | 1 | 1 |
| TOCO Resolution | 100% = 120 g | 100% = 120 g |
| Offset range
Alerts | + 375 g
TOCO persistence alert (TPA) | + 100 g
None |
| Safety | Type CF | Type CF |
| Connector | Huntleigh 12-pole (pink) | Nikolay 12-pole (pink) |
| Intrauterine Pressure Sensor | | |
| Channels | 1 | 1 |
| Sensor | Intran Plus IUP 400 (K955443) | Intran Plus IUP 400
(K955443) |
| Safety | Type CF | Type CF |
| Connector | Huntleigh 12-pole (pink) | Nikolay 12-pole (pink) |
| Fetal ECG | | |
| Technique | Peak-peak detection technique | Peak-peak detection
technique |
| HR range | 30 bpm - 240 bpm | 30 bpm – 240 bpm |
| HR resolution | ± 1 bpm over the range 100-180
bpm
± 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 |