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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study conducted for the PUREtrace™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, it implicitly uses the concept of "substantial equivalence" to a predicate device as the primary acceptance criterion. The performance is reported in terms of the device's ability to display uterine activity comparably to existing methods.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness: Complies with relevant standards	Non-clinical tests demonstrated compliance with ISO 10993-1:2009 (biocompatibility), IEC 60601-1:2005 (electrical safety), and IEC 60601-1-2:2007 (EMC). Software V&V also conducted.
Clinical Performance: Substantially equivalent to predicate	Clinical study demonstrated that PUREtrace™ performed substantially equivalent to the predicate device (Monica AN24) for displaying uterine activity of term pregnant women in active labor.
Interpretability of Tracings: (Implicit)	Clinical investigators assessed the interpretability of the tracings, and annotated deflections they assessed to be uterine contractions. The study's conclusion implies good interpretability.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 42 women initially enrolled. 40 uterine activity (UA) registrations with sufficient usable data were assessed for performance evaluation.
Data Provenance: The document does not specify the country of origin of the data. The study was an "observational clinical study," suggesting prospective data collection for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Three individual clinical investigators.
Qualifications of Experts: They are referred to as "clinical investigators." No specific qualifications like "radiologist with 10 years of experience" are provided.

4. Adjudication Method for the Test Set

The adjudication method appears to be individual blinded assessment and annotation. The text states: "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." This implies each expert independently reviewed and marked contractions, and the overall "performance" was assessed based on these individual assessments, likely compared against a gold standard (TOCO and IUPC data). It does not explicitly mention a consensus or arbitration process among the three experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly described. The clinical study was designed to compare the PUREtrace™ device (which uses electromyography and processes the signal to display uterine activity) against established methods (tocodynamometry and intrauterine pressure catheter) and to assess its interpretability by human readers. The PUREtrace™ device itself is an "electromyography (EMG) device" that "converts [the EMG signal] into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram." It's not presented as an AI-assisted human reading tool in this context, but rather a direct measurement and display device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment of the PUREtrace™ device was done in the clinical study. The device's output (the displayed tocogram derived from EMG) was directly compared against TOCO and IUPC readings, and its interpretability was assessed by clinical investigators. The device is intended to non-invasively measure and display uterine activity, and its "performance" in doing so was evaluated independently.

7. The Type of Ground Truth Used

The ground truth used for comparison in the clinical study was:

Tocodynamometry (TOCO): An external method for monitoring uterine contractions.
Intrauterine Pressure Catheter (IUPC): An invasive, more direct and typically considered gold standard method for measuring uterine contraction strength and frequency.

The study simultaneously monitored uterine activity with PUREtrace™, TOCO, and IUPC.

8. The Sample Size for the Training Set

The provided document does not specify a training set sample size. The description focuses on the clinical performance testing of the device rather than its development or machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided in this document.

Summary

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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.

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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 46305504 DB, VeldhovenThe NetherlandsPhone: +31 40 751 6150Fax: +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 forUse	PUREtrace™ is anelectromyography (EMG) devicethat non- invasively measuresintrapartum uterine activity.PUREtrace™ is indicated for use onwomen who are at term (≥37completed weeks), in labor, withsingleton pregnancies. The signal isacquired from surface electrodesthat are placed on the maternalabdomen. PUREtrace™ is intendedfor use by healthcare professionalsin a clinical setting.	The Monica AN24 is an intrapartummaternal-fetal monitor that non-invasively measures and displays fetalheart rate (FHR), uterine activity (UA),and maternal heart rate (MHR). TheAN24 acquires and displays the FHRtracing from abdominal surfaceelectrodes that pick up the fetal ECG(fECG) signal. Using the same surfaceelectrodes, the AN24 also acquires anddisplays the UA tracing from the uterineelectromyography (EMG) signal and theMHR tracing from the maternal ECGsignal (mECG). The AN24 maternal-fetalmonitor is intended for use byhealthcare professionals in a clinicalsetting.
Operatingprinciple (for UAmeasurement)	Transabdominal electromyography	Transabdominal electromyography
Systemcomponents /parts	• PUREtrace module (hardwaremodule)• 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 insingle electrode patch	Surface electrodes
Patient interface(usecharacteristics)	Single patient use, disposable	Single patient use, disposable
Power source	AC Mains power (50/60Hz)Class II medical grade power supplyunit	Battery operated
Display of(uterine activity)information	Information to be displayedon anexternal fetal monitor	Information to be displayed on anexternal device, such as a fetal monitor

Predicate Device:

Monica Healthcare AN24 (K112390)

Device Description:

Indications for use:

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Predicate Comparison

The following table compares PUREtrace to the predicate device with respect to indications for use and technological characteristics:

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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.

Regulation Number and Section

§ 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).