The SureCALL® EMG Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure intrapartum uterine activity. It is intended for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

Device Description

The SureCALL® EMG Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect. filter, and amplify the electromyographical (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device records and displays the input from standard FDA-cleared maternal heart rate sensor, fetal, heart rate sensor, intrauterine pressure catheter and tocodynamometer transducer devices, along side the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCl surface electrodes placed on the subject's abdomen and amplify and filter the signal. The heart rate, intrauterine pressure, and/or tocodynamometer signals originating and collected from FDA-cleared devices pass through the Signal Conditioning Module without modification. The Control System consists of an off-the-shelf laptop computer with a LabVIEW based program designed to collect, record and display electrical signals in a meaningful and quantifiable format.

AI/ML Overview

This document unfortunately does not contain explicit acceptance criteria for the SureCALL® EMG Labor Monitor®. It describes the device, its intended use, and the studies conducted, but it does not provide specific quantitative thresholds (e.g., "sensitivity must be >90%") that the device needed to meet to be considered effective.

Therefore, I cannot populate the "Acceptance Criteria" column in the table below. However, I can still provide the reported device performance and other requested information based on the provided text.

Acceptance Criteria and Study Details for SureCALL® EMG Labor Monitor®

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided document. The study aims to demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry.	The three-way clinical study and the follow-up MRMC study demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry. The document notes that the technology infrequently presents low amplitude deflections that may appear to be contractions but do not correspond to uterine contractions. It states that this difference is unlikely to have an adverse impact on clinical outcomes in full term laboring patients, implicitly suggesting the performance is acceptable for its intended use despite some false positives.

Acceptance Criteria

Reported Device Performance

Not explicitly stated in the provided document. The study aims to demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry.

The three-way clinical study and the follow-up MRMC study demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry. The document notes that the technology infrequently presents low amplitude deflections that may appear to be contractions but do not correspond to uterine contractions. It states that this difference is unlikely to have an adverse impact on clinical outcomes in full term laboring patients, implicitly suggesting the performance is acceptable for its intended use despite some false positives.

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

Sample Size for Test Set: 20 women
Data Provenance: The study was conducted at "three clinical sites," implying a prospective clinical study in an unspecified country (likely the US, given the FDA submission).

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth or evaluate tracings in the initial "three-way clinical study." However, for the follow-up Multi-Reader Multi-Case (MRMC) study, it refers to "clinician judgment" and "readers" but does not specify the number or their qualifications.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for establishing ground truth or resolving discrepancies among readers in either the initial three-way study or the MRMC study. It mentions the "varied" nature of "clinician judgment on individual deflections," indicating a lack of formal adjudication method for those specific deflections and highlighting the subjectivity.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? Yes, a "second study" was conducted using "multi-reader-multi-case (MRMC) methodology where each reader read all three tracings."
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This was a comparative study between SureCALL® EMG, tocodynamometry, and IUPC, not a study to evaluate human reader improvement with AI assistance. The MRMC study evaluated the relative False Positive (FP) rate for SureCALL® and tocodynamometry but concluded that clinician judgment varied too widely to generalize the comparison of FP rates.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly detail a separate standalone (algorithm only without human-in-the-loop) performance study. The studies described involve the device's output (tracings) which are then interpreted. The device implicitly performs the "detection of uterine myoelectric activity" and "analysis" (via the Control System's LabVIEW program), but its performance is always discussed in the context of interpretation by clinicians or comparison to other monitoring methods.

7. Type of Ground Truth Used

Ground Truth Type: Intrauterine Pressure Catheter (IUPC) was used as the 'gold standard' for measuring uterine activity.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The description focuses solely on the clinical studies used for validation.

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

As no training set is mentioned, this information is not provided.

Summary

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K090145
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REPRODUCTIVE RESEARCH TECHNOLOGIES, LP

JAN 2 5 2011

1770 St James Place, Suite 600 Houston, Texas 77056-3433 (713) 680-0200 Telephone (713) 680-0299 Fax E-Mail: jmc@innovalp.com

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SureCALL® EMG Labor Monitor®

1. Company making the submission:

Name	Reproductive Research Technologies, LP
Address	1770 St James Place, Suite 600Houston TX 77056-3433
TelephoneFax	713-680-0200713-680-0299
ContactE-mail	Jack N. McCraryjmc@innovalp.com

2. Device Name

Trade/Proprietary Name:	SureCALL® EMG Labor Monitor®
Common/Usual Name:	EMG Labor Monitor
Classification Name:	Uterine electromyographic monitor
Regulation Number:	884.2720
Product Code:	OSP

3. Predicate Devices:

Toco Lite Model TD-01 [K013477] Fetalgard 3000 Fetal Monitor [K983395]

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4. Indications for Use:

5. Description of Device:

6. Summary of the technological characteristics of the device compared to predicate devices:

The difference from the predicate device is the type of input sensors. Predicate devices utilize strain gauges held in place with a belt. The SureCALL® EMG Labor Monitor utilizes paste-on Ag/AgCl electrodes.

The SureCALL® EMG monitors contractions through the noninvasive detection of uterine myoelectric activity recorded from the abdominal surface, while the Tocodynamometer monitors contraction through the detection of pressure changes on the abdominal surface. Both of these physiological signals have the same origin event, i.e. electrical activity by the uterus; therefore either one can be measured to detect the presence of contractions.

7. Testing:

Testing of the SureCALL® EMG Labor Monitor® included functional performance, electrical safety, and clinical studies as outlined in FDA Guidance Documents, regulations, and by FDA reviewers. The SureCALL® EMG Labor Monitor® has successfully completed all required testing.

8. Clinical Studies

The primary study supporting the effectiveness of the SureCALL® monitor involved

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20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:

(1) a tocodynamometer (toco) attached to the maternal abdomen
(2) a set of abdominal surface electrodes for uterine electromyography (SureCALL®), and
(3) an intrauterine pressure catheter (IUPC).

Using IUPC as the 'gold standard', this study methodology allowed a three-way comparison for evaluating how well the SureCALL® system performed vis-a-vis the toco technology.

After completion of this study, in a second study the three different monitor tracings were evaluated using multi-reader-multi-case (MRMC) methodology where each reader read all three tracings.

False Positives

When SureCALL® or tocodynamometry tracings exhibit a deflection above baseline that does not have a corresponding deflection on the gold standard IUPC, that deflection may be considered a false positive (FP). The MRMC Study evaluated the relative FP rate for SureCALL® and tocodynamometry. The results of this analysis demonstrated that clinician judgment on individual deflections varied so widely that it is unclear whether the comparison of the FP rate for SureCALL® versus toco in the MRMC Study is generalizable.

To illustrate how individual clinical judgment may vary, the following example displays a SureCALL® tracing with at least two discernable deflections above baseline which do not correspond to deflections on the IUPC tracing.

Image /page/2/Figure/10 description: The image shows two graphs, one labeled "SureCALL" and the other labeled "IUP". Both graphs show a cyclical pattern, with peaks and valleys. There are arrows pointing to specific points on the "SureCALL" graph. The graphs are printed on a grid-like background.

Figure 1: Aligned Tracings, SureCALL® and IUP

If most or all of the types of SureCALL® deflections in Figure 1 (above) are counted as contractions, then SureCALL® may display more FP contractions compared to tocodynamometry. This difference, however, is unlikely to have an adverse impact on clinical outcomes in full term laboring patients.

Summary

In summary, the three-way clinical study and the follow-up MRMC study demonstrate that the SureCALL® uterine EMG technology detects uterine contractions as well as conventional tocodynamometry. However, the technology infrequently presents low

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amplitude deflections that may appear to be contractions but do not correspond to uterine contractions. These deflections may represent electrical activity in the myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract.

9. Rx or OTC

The SureCALL® EMG Labor Monitor® is a Rx prescription device per 21 CFR Subpart D. The indication for use is for clinical settings only.

10. Conclusions:

Based on testing and comparison to the predicate devices, the SureCALL® EMG Labor Monitor® has the same intended use, and is substantially equivalent to the predicate devices. The device performs as intended and does not raise any new safety or effectiveness issues.

Reproductive Research Technologies, LP

Jack N. McCrary Managing Director

Date: January 10, 2011

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring. MD 20993-0002

Reproductive Research Technologies, LP c/o Mr. J. Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071

JAN 2 5 2911

Re: K090145

Trade/Device Name: SureCALL EMG Labor Monitor Regulation Number: 21 CFR §884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: OSP · Dated: January 6, 2011 Received: January 7, 2011

Dear Mr. Knauss:

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. 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) 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 Statement

510(k) Number

SureCALL® EMG Labor Monitor® Device Name:

(090)

The device is intended for use by healthcare professionals in a clinical setting.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jeff Weninger

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K090145

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).