The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

Device Description

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.

The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

AI/ML Overview

This document is a 510(k) premarket notification for the UTAH CVX-RIPE™ cervical ripening balloon catheter. It asserts substantial equivalence to a predicate device, the Cook® Cervical Ripening Balloon (K131206).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical or performance targets in a tabular format that is typically expected for, say, diagnostic accuracy or predictive power. Instead, it lists mechanical performance tests and states that the device successfully met the requirements of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Balloon Deflation Reliability	Balloons deflate properly after use.
Balloon Integrity	Balloons do not burst at maximum recommended inflation volume and duration under simulated use conditions.
Balloon Overuse	Balloons do not leak and properly deflate when using an inflation volume and duration greater than maximum recommendations.
Balloon Volume Maintenance	Balloons do not leak.
Balloon Response to Traction	Distal balloon does not pull out from the patient under simulated use conditions.
Bond Strength	Bonded connections do not fail during simulated use conditions.
Stylet Puncture	Stylet does not puncture through the catheter during simulated use.
Biocompatibility	Meets the requirements of ISO 10993-1.
Shelf Life	Established based on results of an accelerated aging study.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance tests mentioned are mechanical/bench tests. For these mechanical tests, the sample sizes are not explicitly stated. The document does not refer to any human-patient data collection (retrospective or prospective) for this 510(k) submission, as it relies on substantial equivalence to a predicate device based on similar intended use and technological characteristics, supported by bench testing. Therefore, there is no information on data provenance (e.g., country of origin).

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

This information is not applicable and not provided. The "test set" here refers to mechanical performance tests, not clinical data requiring expert human assessment for ground truth.

4. Adjudication Method for the Test Set:

This is not applicable as the "test set" refers to mechanical performance tests, not a clinical study involving human readers or adjudicators.

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:

This type of study was not done. The submission is for a mechanical medical device (a balloon catheter), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical medical device, not a software algorithm.

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

For the mechanical performance tests, the "ground truth" would be the engineering specifications and expected physical behavior validated through laboratory testing. For example, for "Balloon Deflation Reliability," the ground truth is simply whether the balloons did, in fact, deflate properly according to specified parameters. There is no biological or patient-related "ground truth" in this context.

8. The sample size for the training set:

This is not applicable. There is no machine learning or AI component to this device that would require a "training set." The training referenced in the document would be for healthcare professionals on how to use the device, not a dataset for an algorithm.

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

This is not applicable for the reasons stated in point 8.

Summary

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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three interconnected shapes.

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

August 28, 2015

Utah Medical Products, Inc. Ben Shirley VP of Quality Assurance & Product Development 7043 South 300 West Midvale, UT 84047

K143424 Re: Trade/Device Name: UTAH CVX-RIPE Regulation Number: 21 CFR 884.4260 Regulation Name: Hygroscopic Laminaria cervical dilator Regulatory Class: II Product Code: PFJ Dated: July 27, 2015 Received: July 29, 2015

Dear Ben Shirley,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 yours,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for 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 6.0

510(k) Number:	K143424
Device Name:	UTAH CVX-RIPE™; UTMD Cervical Ripening Balloon Catheter
	Indications for Use: The UTAH CVX-RIPE™ is intended to mechanically improve thefavorability of the cervix of pregnant patients at term gestation, in whichinduction of labor is medically indicated.

Prescription Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

Submitter Information

510(k) Owner:	Utah Medical Products, Inc
Address:	7043 South 300 West
	Midvale, UT 84047
	USA
Telephone No.:	(801) 566-1200
Fax No.:	(801) 566-2062
Contact:	Ben Shirley
Contact Phone No.:	(801) 569-4039
Contact E-mail:	bshirley@utahmed.com
Date Prepared:	August 27, 2015

Device Information

Trade Name:	UTAH CVX-RIPE™, UTMD Cervical Ripening BalloonCatheter
Common Name:	Catheter, Balloon, Dilation of Cervix
Classification:	Class II
Regulation:	21 CFR § 884.4260
Description:	Hygroscopic Laminaria cervical dilator
Product Code:	PFJ (catheter, balloon, dilation of cervical canal)

Predicate Device

The predicate device is the Cook® Cervical Ripening Balloon cleared September 27, 2013 under 510(k) number K131206.

Device Description

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Intended Use

The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

Predicate Device Comparison

The UTAH CVX-RIPE™ has the same intended use and technological characteristics as the Cook® Cervical Ripening Balloon cleared under K131206.

Performance Testing

To demonstrate substantial equivalence, the following mechanical performance tests were conducted:

Balloon Deflation Reliability Testing to demonstrate that the balloons ● deflate properly after use.
Balloon Integrity Testing to demonstrate that the balloons do not burst at ● the maximum recommended inflation volume and duration under simulated use conditions.
Balloon Overuse - Testing to demonstrate that balloons do not leak and properly deflate when using an inflation volume and duration greater than maximum recommendations.
Balloon Volume Maintenance Testing to demonstrate that the balloons ● do not leak.
Balloon Response to Traction - Testing to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions.
Bond Strength - Testing to demonstrate that bonded connections do not fail during simulated use conditions.
Stylet Puncture - Testing to demonstrate that the stylet does not puncture through the catheter during simulated use.

The UTAH CVX-RIPE™ is biocompatible per the requirements of ISO 10993-1.

The shelf life of the UTAH CVX-RIPE™ was established based on the results of an accelerated aging study.

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Conclusion

The UTAH CVX-RIPE™ is substantially equivalent to the Cook® Cervical Ripening Balloon cleared under K131206.

Regulation Number and Section

§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).