The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

Device Description

The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.

AI/ML Overview

The provided text describes a 510(k) summary for the Koala TOCO and Koala IUP/TOCO Reusable Cable. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing. Crucially, it explicitly states "Not Applicable" for clinical testing. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Available. The provided document does not specify quantitative acceptance criteria or performance metrics for the device in a clinical context. The non-clinical testing focused on establishing substantial equivalence in terms of design, materials, and specific physical/electrical characteristics compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. Since no clinical study was performed, there is no test set or data provenance from a clinical perspective. The non-clinical tests would have involved specific test samples (e.g., of materials, components), but the sample sizes for these are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical test set or ground truth established by experts is mentioned, as no clinical study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set was used.

5. 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

Not Applicable. This device is a physical medical device (tocodynamometer and cable), not an AI-powered diagnostic system. No MRMC study or AI-related effectiveness is discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable for clinical ground truth. The substantial equivalence claim is based on non-clinical testing, comparing technological characteristics (e.g., physical dimensions, materials, sensing technology) to a predicate device. The "ground truth" for these tests would be established engineering standards, material specifications, and performance against defined test parameters for the device itself, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable.

Summary of available information:

The 510(k) summary explicitly states "Not Applicable" for clinical testing. The device's acceptance is based on demonstrating substantial equivalence to an existing predicate device (FeatherLite™ Tocodynamometer - K013477) through non-clinical performance testing.

The non-clinical testing included:

Predicate comparison testing
Simulated use testing
Hardware testing
Electrical performance testing
Biocompatibility testing according to ISO 10993-1
Intrauterine pressure catheter (IUPC) compatibility testing

The conclusion is that the differences between the proposed device and the predicate device (minor differences in visual appearance, weight, sensing technology, and transducer location) are minor and do not impact safety and effectiveness, thus supporting substantial equivalence.

Summary

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MAY 2 9 2014

510(K) SUMMARY FOR THE CLINICAL INNOVATIONS, LLC Koala TOCO and Koala IUP/TOCO Reusable Cable

(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

Clinical Innovations, LLC 747 West 4170 South Murray, UT 84123 Phone: 1-801-268-8200 Internet: www.clinicalinnovations.com Establishment Registration No: 1722684

Contact: Tom Haueter Contact's Phone: 1-801-268-8200 Contact's Fax: 1-801-263-7373 Contact's Email: T.Haueter@clinicalinnovations.com

2. DEVICE NAME

Proprietary Name:	Koala TOCO and Koala IUP/TOCO Reusable Cable
Common/Usual Name:	Tocodynamometer and cable
Classification Name:	external uterine contraction monitor and accessories
Classification Panel:	Obstetrics/Gynecology
Device Class:	Class II
Classification Number:	21 CFR 884.2720
Product Code:	HFM, HFN

3. PREDICATE DEVICE

The following device is a legally marketed device to which equivalence is being claimed:

. FeatherLite™ Tocodynamometer (Ventrex, Inc., K013477)

4. DEVICE DESCRIPTION

The Koala TOCO is a single-use tocodynamometer that is a transducer pressuresensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guardring with a thin elastic membrane stretched across a shallow depression in the center

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of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

INDICATIONS FOR USE / INTENDED USE 5.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICE

A summary comparison of the technological characteristics, including design and materials, is provided in the table below:

Parameter	Koala TOCO and Koala IUP/TOCOReusable Cable(Clinical Innovations)	FeatherLite™ Tocodynamometer(Ventrex Inc.)
510(k) Number	K140163	K013477
Indications for Use	For use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting.	For use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting.
Target Patient Population	Pregnant patients, especially during labor	Pregnant patients, especially during labor

Clinical Innovations, LLC

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Parameter	Koala TOCO and Koala IUP/TOCOReusable Cable(Clinical Innovations)	FeatherLite™ Tocodynamometer(Ventrex Inc.)
Water environment use	No	No
Anatomical sites	Surface of abdomen over fundal area ofthe uterus	Surface of abdomen over fundal area ofthe uterus
Size	Body diameter: 7.0cmBody thickness: 0.8cm	Body diameter (sensing dome): 3.6cmBody thickness: .10cmSensing dome thickness: .79cm
Weight (with cable)	0.35 Ibs (159 g)	0.11 lbs (51g)
Material	Housing material: thermoplasticpolyurethaneCable: Thermoplastic polyurethane	Housing material: thermoplasticSensing nipple: flexible polymerCable: vinyl clad
Technology	Sensing diaphragm connected to apressure transducer centrally located in acircular (guard ring) body	Sensing nipple attached to a strain gauge
Sensor	Wheatstone resistive bridge sensor	Wheatstone resistive bridge sensor
Location of electronics	Housed in the reusable cable	Housed in the TOCO device
Serviceable	No	No
Patient attachment	Elastics belt included.Compatible with standard elastic belts.	Elastic belt included.Compatible with standard elastic belts.
Cable length	10 feet	8 feet
Single Use/Disposable	Yes	Yes
Biocompatible	Yes	Yes
Sterile	Non-sterile	Non-sterile

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Non-clinical testing performed to support the performance and safety claims for the Koala TOCO and the Koala IUP/TOCO Reusable Cable includes, but is not limited to, the following:

Predicate comparison testing .
Simulated use testing .
Hardware testing .
Electrical performance testing .
Biocompatibility testing according to ISO 10993-1 .
. Intrauterine pressure catheter (IUPC) compatibility testing

The evidence resulting from the non-clinical testing supports the substantial equivalence of the proposed and predicate devices.

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8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Not Applicable.

9. SUMMARY OF OTHER INFORMATION

This submission included proposed product labeling and packaging specifications.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The indications for use, principles of operation, and technological characteristics of the proposed Koala TOCO with the Koala IUP/TOCO Reusable Cable are substantially equivalent to the predicate device FeatherLite™ Tocodynamometer (subject of K013477). Differences between the proposed and predicate device are limited to minor differences in visual appearance, weight, sensing technology, and transducer location. These differences are minor and do not impact the safety and effectiveness of the device.

The safety, performance, and effectiveness of the Koala TOCO for its intended use are demonstrated by non-clinical testing. Based on the evidence provided, Clinical Innovations believes that the proposed Koala TOCO and Koala IUP/TOCO Reusable Cable are substantially equivalent to the predicate.

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Public Health Service

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

May 29, 2014

Clinical Innovations, LLC % JoAnne L. Bronikowski Consultant Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K140163

Trade/Device Name: Koala TOCO and Koala IUP/TOCO Reusable Cable Regulation Number: 21 CFR§ 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: HFM, HFN Dated: April 29, 2014 Received: April 30, 2014

Dear JoAnne L. Bronikowski,

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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Page 2 - JoAnne L. Bronikowski

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on fast page.

510(k) Number (if known) K140163

Device Name

Koala TOCO and Koala IUP/TOCO Reusable Cable

Indications for Use (Describe)

The single-use disposable, non-sterile Koala TOCO is in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Kosla TUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

: : FOR FDA USE ONLY :: 、人民和人民族、据明确的人才和用品。

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

2014

FORM FDA 3881 (1/14)

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).