The SureCALL® Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure uterine activity. It is intended for use on pregnant women who are at term (>36 completed weeks), 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® Labor Monitor® is a transabdominal electromyography monitor. The device consists of a Signal Conditioning Module specifically designed to collect, filter, and amplify the electromyographic (EMG) signal and a separate Control System to analyze, record, and display the EMG signal. In addition, the device has the option to record and display the input from standard FDA-cleared fetal heart rate sensor, intrauterine pressure catheter, and maternal heart rate sensor or tocodynamometers transducer device, alongside the EMG signal traces. The Signal Conditioning Module contains electronic components designed to receive a physiological signal from a set of Ag/AgCI surface electrodes placed on the subject's abdomen and amplify and filter the signal. The optional fetal heart rate, intrauterine pressure catheter, and maternal heart rate or tocodynamometer's 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 easily quantifiable format.

AI/ML Overview

Here is the information describing the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Clinical Study (Uterine Contraction Detection):
- High agreement between SureCALL® RMS and TOCO devices for uterine contraction detection.	- Bootstrap agreement estimates for TOCO vs. SureCALL® RMS show above 95% agreement.
- Minimal and non-significant peak difference between SureCALL® RMS and TOCO.	- Overall mean peak difference between RMS and TOCO is 0.99 seconds (SE = 1.41), which is not significantly different from 0 at a = 0.05 level (P = 0.4901).
- High within-patient correlation for uterine contraction detection.	- Between-patient variance is 5.65 and within-patient variance is 72.89 with ICC of 0.96, suggesting that 96% of the variance is due to within-patient correlation and 4% variance is due to device to device variation.
Multi-Reader Study (Preterm Patients):
Due to the device's intended use for "term (>36 completed weeks)" pregnancies, the reported performance for "preterm patients" in the multi-reader study is noted, but it's important to recognize that the device is not indicated for this group.	- The sensitivity ranged from 75.6% to 90.1%.
	- The extra SureCALL® event rate ranged from 3.30 to 6.12 per hour among the readers.
	- The estimated individual agreement was 0.964 (>0.8).

Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the "comprehensive clinical study" or the "multi-reader study."
- The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the "new indications for use were substantiated by a comprehensive clinical study and a follow-up multi-reader study."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions a "multi-reader study" but does not specify the number of readers (experts) or their qualifications.
Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the "multi-reader study."
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:
- A "multi-reader study" was conducted.
- However, the document does not describe a comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The multi-reader study results report sensitivity, extra event rate, and individual agreement among readers in "preterm patients" – implying evaluation of the device output itself by readers, not the device's assistance to readers in interpretation of other data. It does not provide an effect size for human reader improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "comprehensive clinical study" compares the SureCALL® Labor Monitor® (implicitly, its algorithm's output) against a tocodynamometer (TOCO), suggesting a standalone evaluation of the device's ability to detect uterine contractions. The results (e.g., 95% agreement with TOCO, peak difference) reflect the device's performance directly.
The type of ground truth used:
- For the "comprehensive clinical study," the ground truth for uterine contraction detection appears to be established via comparison with the tocodynamometer (TOCO). The study directly compares the SureCALL® measurements (RMS) to those from a TOCO device.
- For the "multi-reader study," the ground truth against which reader performance (sensitivity, extra event rate, agreement) was judged is not explicitly stated but is implicitly the interpretation of the SureCALL® event detections, possibly against some established clinical standard or another reference. The document refers to "SureCALL® event rate" and "individual agreement" which suggests readers are evaluating events identified by the device.
The sample size for the training set:
- The document does not provide any information on the sample size used for a training set. The context suggests that the SureCALL® Labor Monitor® [K090145] was an existing device, and K130002 is for new indications, rather than a completely new algorithm requiring new training.
How the ground truth for the training set was established:
- The document does not provide any information on how ground truth for a training set was established.

Summary

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K130002 pg 1 of 3

REPRODUCTIVE RESEARCH TECHNOLOGIES, LP

JUN 2 8 2013

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® Labor Monitor®

1. Company making the submission:

Name	Reproductive Research Technologies, LP
Address	1770 St James Place, Suite 600Houston TX 77056-3433
Telephone	713-680-0200
Fax	713-680-0299
Contact	Jack N. McCrary
E-mail	jmc@innovalp.com

2. Device Name

Trade/Proprietary Name:	SureCALL® Labor Monitor®
Common/Usual Name:	Transabdominal UterineElectromyography Labor Monitor
Classification Name:	Monitor, Uterine Contraction
Regulation Number:	884.2720 and 884.2740
Product Code:	OSP

3. Predicate Device:

The SureCALL® Labor Monitor® is substantially equivalent to other Uterine Contraction Monitors in the market such as the SureCALL™ EMG Labor Monitor [K090145].

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4. Intended Use Statement:

K130002 page 2 of 2

5. Description of Device:

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

There is no change in device from the predicate SureCALL™ EMG Labor Monitor [K090145].

7. Testing:

Non clinical testing:

No new non-clinical testing was done since the SureCALL ™ EMG Labor Monitor [K090145].

Clinical testing:

The new indications for use were substantiated by a comprehensive clinical study and a follow-up multi-reader study with the SureCALL® Labor Monitor® and the tocodynamometer.

Results from the clinical comparative study show that:

1. With regard to uterine contraction detection, between-patient variance is 5.65 and within-patient variance is 72.89 with ICC of 0.96, suggesting that 96% of the variance is due to within-patient correlation and 4% variance is due to device to device variation.
1. The bootstrap agreement estimates for TOCO vs. SureCALL® RMS show that there was above 95% agreement between RMS and TOCO devices.
1. Overall mean peak difference between RMS and TOCO is 0.99 seconds (SE = 1.41), which is not significantly different from 0 at a = 0.05 level (P = 0.4901)

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K130002 pg 3 of 3

Results from the multi-reader study show that:

1. The sensitivity ranged from 75.6% to 90.1% and the extra SureCALL® event rate ranged from 3.30 to 6.12 per hour among the readers in preterm patient.
1. The estimated individual agreement was 0.964 (>0.8) in preterm patients.

8. Rx or OTC

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

9. Conclusions:

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

Reproductive Research Technologies, LP

signature

Jack N. McCrary Managing Director

Date: June 27, 2013

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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2013

Reproductive Research Technologies, LP % Mr. J. Harvey Knauss Delphi Consulting Group 1770 St. James Place, Suite 600 HOUSTON TX 77056

Re: K130002

Trade/Device Name: SureCALL® Labor Monitor® Regulation Number: 21 CFR 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: Class II Product Code: OSP Dated: May 20, 2013 Received: May 29, 2013

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 cither 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

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Page 2 - Mr. Knauss

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDcvices/Safety/ReportalProblem/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.

Sincercly yours,

Herbert P. Lerner -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 Statement

K130002 510(k) Number

SureCALL® Labor Monitor® Device Name:

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)

Herbert P. Lerner -S

K130002

02012 Reproductive Research Technologies, LP - AI Rights Reserved Sec 004 Indications for Use Resised 6 27 2013.000

Section 4 510(k) Submission Page #

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).