(455 days)
Not Found
No
The document describes a device that measures electrical signals and converts them into a displayable format. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance study focuses on clinical interpretation and comparison to predicate devices, not on the performance of an AI/ML algorithm.
No
The device is used to measure and display uterine activity, providing diagnostic information for healthcare professionals, rather than directly treating a condition.
Yes
The device measures intrapartum uterine activity using electromyography (EMG) and displays it as a tocogram, which provides information about the physiological state of the patient (uterine contractions). This measurement helps healthcare professionals understand the labor progression.
No
The device description explicitly states that PUREtrace consists of a multi surface-electrode patch (Graphium patch) and a hardware module (PUREtrace module), indicating it includes physical hardware components for signal acquisition and processing.
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.
- PUREtrace Function: PUREtrace is described as an electromyography (EMG) device that non-invasively measures uterine activity by acquiring electrical signals from surface electrodes placed on the maternal abdomen. This is a measurement of physiological activity on the body, not a test performed on a sample taken from the body.
Therefore, PUREtrace falls under the category of a medical device that measures physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.
Product codes
OSP
Device Description
PUREtrace is a device for registering the electrical activity of the uterine muscle (myometrium) of laboring patients. PUREtrace consists of a multi surface-electrode patch (Graphium patch) and a hardware module (PUREtrace module). The Graphium patch is applied to the abdomen of the patient and acquires the electromyography (EMG) signal of the uterine muscle (electrohysterography, EHG). During a contraction, a large number of uterine muscle cells contract in a controlled manner and the changes in potential can be measured as changes in electrical on the skin of the pregnant woman's abdomen. This signal is sent to the PUREtrace module, converted into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram. PUREtrace is available in multiple variants with different output connectors to facilitate interfacing with various fetal monitors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
maternal abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An observational clinical study has been conducted with an enrollment of 42 women at term and in active labor, who were simultaneously monitored on uterine activity (UA) with PUREtrace, tocodynamometry (TOCO) and intrauterine pressure catheter (IUPC). 40 UA registrations that consisted of sufficient useable data were assessed to evaluate the performance of PUREtrace. The tracings were reviewed by three individual clinical investigators, who were blinded to the technology used and the study subjects corresponding with the tracings. The clinical investigators assessed the interpretability of the tracings. In addition, they annotated the tracings by marking all deflections they assessed to be uterine contractions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An observational clinical study has been conducted with an enrollment of 42 women at term and in active labor, who were simultaneously monitored on uterine activity (UA) with PUREtrace, tocodynamometry (TOCO) and intrauterine pressure catheter (IUPC). 40 UA registrations that consisted of sufficient useable data were assessed to evaluate the performance of PUREtrace. The tracings were reviewed by three individual clinical investigators, who were blinded to the technology used and the study subjects corresponding with the tracings. The clinical investigators assessed the interpretability of the tracings. In addition, they annotated the tracings by marking all deflections they assessed to be uterine contractions. The study demonstrated that PUREtrace performed substantially equivalent to the predicate device for displaying uterine activity of term pregnant women in active labor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2017
Nemo Healthcare BV Aron Wierts Project Leader De Run 4630 5504 DB, Veldhoven The Netherlands
Re: K153262
Trade/Device Name: PUREtrace TM Regulation Number: 21 CFR§ 884.2720 Regulation Name: External Uterine Contraction Monitor and Accessories Regulatory Class: II Product Code: OSP Dated: January 26, 2017 Received: January 30, 2017
Dear Aron Wierts:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153262
Device Name PUREtrace™
Indications for Use (Describe)
PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥7 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K153262
| Submitter | Nemo Healthcare B.V.
De Run 4630
5504 DB, Veldhoven
The Netherlands
Phone: +31 40 751 6150
Fax: +31 40 751 6159 | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Aron Wierts | |
| Date Prepared: | 03-Feb-17 | |
| Proprietary or Trade Name: | PUREtrace™ | |
| Common/Usual Name: | External uterine contraction monitor | |
| Classification: | 21 CFR 884.2720 | |
| Classification Name: | External uterine contraction monitor and accessories | |
| Regulatory Class: | II | |
| Product code: | OSP, uterine electromyographic monitor | |
| | Subject Device: | Predicate Device: |
| | PUREtrace | Monica AN24 |
| | K153262 | K112390 |
| Indications for
Use | PUREtrace™ is an
electromyography (EMG) device
that non- invasively measures
intrapartum uterine activity.
PUREtrace™ is indicated for use on
women who are at term (≥37
completed weeks), in labor, with
singleton pregnancies. The signal is
acquired from surface electrodes
that are placed on the maternal
abdomen. PUREtrace™ is intended
for use by healthcare professionals
in a clinical setting. | The Monica AN24 is an intrapartum
maternal-fetal monitor that non-
invasively measures and displays fetal
heart rate (FHR), uterine activity (UA),
and maternal heart rate (MHR). The
AN24 acquires and displays the FHR
tracing from abdominal surface
electrodes that pick up the fetal ECG
(fECG) signal. Using the same surface
electrodes, the AN24 also acquires and
displays the UA tracing from the uterine
electromyography (EMG) signal and the
MHR tracing from the maternal ECG
signal (mECG). The AN24 maternal-fetal
monitor is intended for use by
healthcare professionals in a clinical
setting. |
| Operating
principle (for UA
measurement) | Transabdominal electromyography | Transabdominal electromyography |
| System
components /
parts | • PUREtrace module (hardware
module)
• Patch cable
• Graphium patch (sensor) | • Monica AN24 recorder/ monitor
(hardware module)
• Electrode cable connector
• Electrodes (sensor)
• Battery charger AN24 |
| Patient interface
(materials) | Surface electrodes incorporated in
single electrode patch | Surface electrodes |
| Patient interface
(use
characteristics) | Single patient use, disposable | Single patient use, disposable |
| Power source | AC Mains power (50/60Hz)
Class II medical grade power supply
unit | Battery operated |
| Display of
(uterine activity)
information | Information to be displayed
on an
external fetal monitor | Information to be displayed on an
external device, such as a fetal monitor |
Predicate Device:
Monica Healthcare AN24 (K112390)
Device Description:
PUREtrace is a device for registering the electrical activity of the uterine muscle (myometrium) of laboring patients. PUREtrace consists of a multi surface-electrode patch (Graphium patch) and a hardware module (PUREtrace module). The Graphium patch is applied to the abdomen of the patient and acquires the electromyography (EMG) signal of the uterine muscle (electrohysterography, EHG). During a contraction, a large number of uterine muscle cells contract in a controlled manner and the changes in potential can be measured as changes in electrical on the skin of the pregnant woman's abdomen. This signal is sent to the PUREtrace module, converted into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram. PUREtrace is available in multiple variants with different output connectors to facilitate interfacing with various fetal monitors.
Indications for use:
PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.
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Predicate Comparison
The following table compares PUREtrace to the predicate device with respect to indications for use and technological characteristics:
5
PUREtrace has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.
Summary of non-clinical performance testing
Non-clinical tests were conducted to verify that PUREtrace met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards:
- . Biocompatibility testing per ISO 10993-1:2009 including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010)
- . Electrical Safety testing per IEC 60601-1:2005 + CORR. 1 (2006) + CORR.2 (2007) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012
- Electromagnetic Compatibility testing per IEC 60601-1-2:2007
Software verification and validation testing was also conducted as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Summary of clinical performance testing
An observational clinical study has been conducted with an enrollment of 42 women at term and in active labor, who were simultaneously monitored on uterine activity (UA) with PUREtrace, tocodynamometry (TOCO) and intrauterine pressure catheter (IUPC). 40 UA registrations that consisted of sufficient useable data were assessed to evaluate the performance of PUREtrace. The tracings were reviewed by three individual clinical investigators, who were blinded to the technology used and the study subjects corresponding with the tracings. The clinical investigators assessed the interpretability of the tracings. In addition, they annotated the tracings by marking all deflections they assessed to be uterine contractions. The study demonstrated that PUREtrace performed substantially equivalent to the predicate device for displaying uterine activity of term pregnant women in active labor.
Substantial Equivalence Conclusion
Based on the comparison and analysis above, PUREtrace is substantially equivalent to the predicate device.