The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

Device Description

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

AI/ML Overview

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device. It is a 510(k) premarket notification for a urological catheter, a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these concepts apply to the evaluation of AI/ML algorithms.

The document discusses:

Device Name: Cure Dextra® and Cure Catheter® Closed System
Device Type: Intermittent urinary catheter
Regulation Number: 21 CFR 876.5130 (Urological Catheter and Accessories)
Predicate Device: Cure Catheter® Closed System (K080881)
Non-Clinical Performance Testing: A summary of tests performed to demonstrate substantial equivalence, including sterilization validation, biocompatibility, sterile packaging, shelf-life, packaging integrity, diameter/shaft length, flow rate, tensile strength, and kink stability testing. These are standard tests for physical medical devices and not related to AI/ML performance.

The submission concludes that the subject devices are substantially equivalent to the predicate device based on these non-clinical performance tests.

Summary

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November 7, 2023

ConvaTec, Inc. % Dawn Norman Partner MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial, CO 80112

Re: K230400

Trade/Device Name: Cure Dextra® and Cure Catheter® Closed System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: October 11, 2023 Received: October 11, 2023

Dear Dawn Norman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica K. Nguyen -S

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230400

Device Name

Cure Dextra® and Cure Catheter® Closed System

Indications for Use (Describe)

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 Cure Dextra® and Cure Catheter® Closed System November 7, 2023

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Company:	ConvaTec, Inc.7815 National Service Road, Suite 600Greensboro, NC 27409
Primary Contact:	Dawn NormanPartner, MRC GlobalPhone: 618-604-3064Dawn.Norman@askmrcglobal.com
Company/SecondaryContact:	Courtney SmithDirector, Regulatory AffairsPhone: 239-776-2947Courtney.Smith@ConvaTec.com
Trade Name:	Cure Dextra® and Cure Catheter® Closed System
Common Name:	Catheter, Urological
Classification:	Class II
Regulation Number:	21 CFR 876.5130
Regulation Name:	Urological Catheter and Accessories
Product Code:	EZD
Primary Predicate:	Cure Catheter® Closed System. K080881

Device Description:

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The target population for the Closed System and Dextra is both males and females. The selection of the French size (Ch) of the catheter is based on the size of the patient and is prescribed by a health care professional. The effective shaft length of the catheter (i.e., Dextra 286 mm and Closed System 290 mm) meets the requirements of ISO 20696:2018 for the minimum effective shaft length (275mm) for males and minimum effective shaft length (60 mm) for females.

Indications for Use:

Comparison of Technological Characteristics:

The subject catheters are a modified version of the predicate Cure Catheter® Closed System (K080881). The subject device modifications do not raise different questions about safety and effectiveness. A detailed comparison between the subject devices and the predicate and reference devices is provided in the table below.

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Comparison of Technological Characteristics Table:

Information	Subject Device	Primary Predicate Device	Reference Device	Substantial Equivalence
Device	Cure Catheter® Closed System® andCure Dextra® Closed System®	Cure Catheter® Closed SystemK080881	Cure Ultra®K221593	N/A
Indications for Use	The Cure Catheter® Closed System is anintermittent urinary catheter attachedto a collection bag that is insertedthrough the urethra and indicated forthe purpose of bladder drainage formales and females. The urinary cathetercomes in a variety of sizes and ispackaged sterile for single-use.The Cure Dextra® Closed System is anintermittent urinary catheter attachedto a collection bag that is insertedthrough the urethra and indicated forthe purpose of bladder drainage formales and females. The urinary cathetercomes in a variety of sizes and ispackaged sterile for single-use.	The Cure Catheter™ Closed System isan intermittent urinary catheterattached to a collection bag that isinserted through the urethra andindicated for the purpose of bladderdrainage for males and females. Theurinary catheter comes in a variety ofsizes packaged sterile for single-use.	The Cure Ultra® is an intermittenturinary catheter that is insertedthrough the urethra and indicated forthe purpose of bladder drainage formales and females. The urinarycatheter comes in a variety of sizes andis packaged sterile for single-use.	Identical to the primary predicate
Patient Population	For male and female adults	For male and female adults	For male and female adults	Identical to the primary predicate
Regulation	21 CFR 876.5130	21 CFR 876.5130	21 CFR 876.5130	Identical to the primary predicate
Product Code	EZD	KOD/FCM	EZD	Similar to the predicate, identicalto reference device
Tube Size Range(Effective Length/ODFrench)	Closed System: 310mm (+/- 5) effectivelength 8-16 FrDextra: 310 mm (+/- 5) effective length12-16 Fr	Male: 310 mm effective length 8-16FrFemale: 165mm (6.5 inch) length 8-16Fr	Male Ultra: 375 mm (14.76 inch)length, 8-18 FrFemale Ultra: 97 mm (3.82 inch)length, 8-16 FrFemale Ultra Plus: 175 mm (6.88) inchlength, 8-18 Fr	The effective length of both thesubject devices and the predicatedevices is identical
Information	Subject Device	Primary Predicate Device	Reference Device	Substantial Equivalence
Device	Cure Catheter® Closed System® andCure Dextra® Closed System®	Cure Catheter® Closed SystemK080881	Cure Ultra®K221593	N/A
Technological Features	Straight or Coude Tip CatheterPVCSmooth TipPolished EyeletsMultiple sizes for both male and femaleuseSterile Packaged for singlePre-lubricated: Water Based HydrophilicCoatingDrainage Bag for collecting urineGripper for ease of indexing tubeModified the interface tube to increasesurface area of the bag weld	Straight Tip CatheterPVCSmooth TipPolished EyeletsMultiple sizes for both male andfemale useSterile Packaged for single usePre-lubricated: Water BasedHydrophilic CoatingDrainage Bag for collecting urine	Straight or Coude Tip CatheterPVCSmooth TipPolished EyeletsMultiple sizes for both male andfemale useSterile Packaged for single useHandling gripper for male cathetersPre-lubricated: Water BasedHydrophilic CoatingOpen end for convenient use withoutcollection bag	The Closed System modified theinterface tube to increase surfacearea of the bag weld and theDextra has a gripper for ease ofindexing the tubing. Theseadditions do not create differentquestions of safety oreffectiveness.
Sterilization	Ethylene OxideSAL: 10-6	Ethylene OxideSAL: 10-6	Ethylene OxideSAL: 10-6	Identical to primary predicate
Biocompatibility	Evaluation and testing as applicablewithin the risk management process, theFDA Biocompatibility GuidanceDocument (September 2023) and ISO	All tests were performed inaccordance with US FDA GeneralProgram Memorandum #G95-1 andPart- 10993-1 of the InternationalStandard Organization (ISO) Standard(Biological Evaluation of MedicalDevices). The test articles wereconsidered biocompatible under theconditions tested.	All tests were performed in accordancewith US FDA General ProgramMemorandum #G95-1 and Part-10993-1 of the International StandardOrganization (ISO) Standard (BiologicalEvaluation of Medical Devices). Thetest articles were consideredbiocompatible under the conditionstested.	Biological equivalency betweenthe subject device and thepredicate was established bybiological testing or justification.
Catheter Tube Material	PVCCoudé tipped tubing contains a bluestripe comprised of <1% of colorantPhthalocyanine Blue (CAS No. 147-14-8)	PVCCoudé tipped tubing contains a bluestripe comprised of <1% of colorantPhthalocyanine Blue (CAS No. 147-14-8)	PVCCoudé tipped tubing contains a bluestripe comprised of <1% of colorantPhthalocyanine Blue (CAS No. 147-14-8)	Identical to primary predicatefor regular tip devices andidentical to reference device forCoudé tip devices
Information	Subject Device	Primary Predicate Device	Reference Device	Substantial Equivalence
Device	Cure Catheter® Closed System® andCure Dextra® Closed System®	Cure Catheter® Closed SystemK080881	Cure Ultra®K221593	N/A
Catheter Collection BagMaterial	LDPE	LDPE	N/A	Identical to primary predicate
Collection Bag Size	Closed System: 1500mLDextra:1000 mL	1500 mL	N/A	Dextra has a smaller collection bagthan the predicate device forportability. This does not createdifferent questions of safety oreffectiveness.
Catheter Lubrication	Lubrajel MG	Lubrajel MG	Lubrajel MG	Identical to primary predicate

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Summary of Non-Clinical Performance Testing:

Performance testing for the Cure Dextra® and Cure Closed System® were conducted per applicable sections of voluntary and FDA consensus standards:

Sterilization validation was adopted into an existing terminal cycle validation per AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008
. Biocompatibility testing (cytotoxicity, irritation, sensitization, and subacute systemic toxicity) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
Sterile packaging in accordance with ISO 11607-1:2006 and ISO 11607-2:2019
Real Time aged shelf-life testing according to ISO 11607-1:2019
Packaging integrity testing according to ASTM F2096-11 (2019)
Diameter and Effective Shaft Length testing performed according to ISO 20696:2018
Flow rate, Tensile, Strength, and Kink Stability testing performed in accordance with ISO 20696:2018

Conclusion:

The data and information provided in this submission support the conclusion that the Cure Dextra® and Cure Closed System (subject devices) are substantially equivalent to the predicate device (K080881).

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.