The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.

Device Description

The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.

AI/ML Overview

The provided text is a 510(k) summary for the Cure Catheter® Hydrophilic Coated. It predominantly focuses on demonstrating substantial equivalence to predicate devices based on device features, materials, and intended use, rather than on detailed performance criteria suitable for AI/ML devices. Therefore, much of the requested information (acceptance criteria for performance metrics, details of studies with test sets, ground truth establishment, sample sizes for training/test sets, expert qualifications, MRMC studies, and standalone performance) is not applicable or not provided in the document.

The document states that performance testing was conducted through "design verification and design validation activities," and these support the device's functionality and safety/effectiveness. However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility and Safety	"Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use."
Functionality	"Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness."
Substantial Equivalence	The device is found "substantially equivalent to the currently marketed predicate devices." This is the primary "performance" metric for a 510(k).

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

Not provided. The document does not detail specific "test sets" in the context of typical AI/ML performance studies. It refers to "design verification and design validation activities," which are general engineering and quality assurance processes, but doesn't quantify samples or data provenance in this submission.

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 / Not provided. The device is a physical medical device (urinary catheter), not an AI/ML diagnostic tool requiring expert-established ground truth on a test set of data.

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

Not applicable / Not provided. See point 3.

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 / Not done. This is a physical device, not an AI system designed to aid human readers.

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

Not applicable / Not done. This is a physical device.

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

Not applicable. For a physical device like a catheter, "ground truth" typically refers to engineering specifications, material properties, and clinical performance in terms of safety and efficacy (e.g., ability to drain bladder without complications). The document states biocompatibility and functional performance were verified, implying such engineering and potentially in-vitro/in-vivo testing was done, but specific "ground truth" establishment methods as one would define them for an AI/ML device are not relevant or detailed.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/ML device.

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

Not applicable / Not provided. This is not an AI/ML device.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly states that:

"Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use."
"Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness."

These statements imply a series of standard medical device testing, likely including:

Biocompatibility testing: To ensure the materials (PVC, hydrophilic coating) are safe for contact with the human body, following standards like ISO 10993.
Physical and Mechanical Testing: To verify properties like tensile strength, catheter tip integrity, coating durability, flow rates, and lubricity.
Sterilization Validation: To ensure the sterilization process is effective.
Packaging Validation: To ensure sterility is maintained until use.
Potentially, simulated use or in-vitro performance testing: To confirm the hydrophilic coating's activation and low friction properties under simulated physiological conditions.

However, the 510(k) summary does not provide specific details on the methodologies, sample sizes, or quantitative results of these "studies," as its primary purpose is to demonstrate substantial equivalence to existing predicate devices, rather than a detailed report of novel performance data. The FDA's clearance (K132500) confirms that based on the provided information, the device was deemed substantially equivalent to already legally marketed devices.

Summary

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Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission

510(k) SUMMARY
Submitted by:	Ann Kenowsky, PresidentCure Medical, LLC3700 Newport Blvd., #301Newport Beach, CA 92663949 673 8474 (Phone)949 723 0564 (Fax)email: akenowsky@curemedical.com
Contact person:	John Beasley, MS, RAC (US)MedTech Review, LLC257 Garnet Garden StreetHenderson, NV 89015612 889 5168 (Phone)email: john@medtechreview.com
Date Prepared:	10 November 2013
Trade Name:	Cure Catheter ™ Hydrophilic Coated
Common Name:	Urinary catheter for intermittent use
Classification Name:	Urological catheter
Device Class:	II
Procode:	EZD (catheter, straight)
CFR Reference:	876.5130
Predicate Device(s):	Cure Medical Cure Catheter K072539Cure Pediatric Catheter K110653
Reference Devices(s):	Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter K050874Coloplast SpeediCath K023254
Device Description:	The Cure Catheter ™ Hydrophilic Coated is an intermittenturinary catheter intended to be used by adult and pediatricmales and females for the purpose of bladder drainage. Thecatheter is manufactured with conventional medical gradePVC. The surface is coated with a hydrophilic low-frictioncoating (polyvinyl pyrrolidone, or PVP) and, when activated

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Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission

Intended Use:	with water it becomes slippery and ready to use. The straightand Coudè tip configurations have been designed to eliminatetrauma to the urethra and are offered in a variety of sizes.Each catheter is provided in sterile, single-use packages.
	The Cure Catheter ™ Hydrophilic Coated is an intermittenturinary catheter that is inserted through the urethra andindicated for the purpose of bladder drainage for males andfemales.

The Cure Catheter ™ Hydrophilic Coated and listed predicate devices are all similar in device function, features, Technology Comparison: composition, and intended use as listed in the following table:

Characteristics	Proposed Device	Predicate Devices		Reference Devices
	Cure Catheter ™Hydrophilic Coated	Cure MedicalCureCatheter™	Cure MedicalCurePediatricCatheter™	Astra Tech ABLoFric®Primo™ SingleUse UrinaryCatheter	ColoplastSpeediCath
510(k)	/	K072539	K110653	K050874	K023254
Device Features	Hydrophilic coated,with water sachet.Low friction betweencatheter and urethralmucosa. Ready touse.	No coating	No coating	Hydrophiliccoated, withwaterintegrated inthe package.Low frictionbetweencatheter andurethralmucosa.	Hydrophiliccoated. Lowfrictionbetweencatheter andurethralmucosa. Readyto use.
Sizes¹	Female 6 inchStraight TipCh 6, 8, 10, 12, 14,16, 18	FemaleStraight Tip 6inch Ch 8, 10,12, 14, 16, 18	Pediatric, 10inch StraightTip, Ch 8, 10,12, 14	Female 150mmCh 8, 10, 12, 14	FemaleCh 6, 8, 10, 12,14, 16
	Male 16 inch Straightand Coudè TipCh 8, 10, 12, 14, 16,18	Male StraightTip 16 inch Ch8, 10, 12, 14,16, 18		Female 200mmCh 8, 10, 12, 14,16, 18	MaleCh 8, 10, 12, 14,16, 18
	Pediatric 10 inchStraight Tip Ch 6, 8,10, 12, 14			MaleCh 8, 10, 12, 14,16, 18, 20, 22,24	TiemannCh 10, 12, 14
				TiemannCh 10, 12, 14,16, 18	PediatricCh 6, 8, 10
				Pediatric200mmCh 6, 8, 10	BoyCh 6, 8, 10, 12
				BoyCh 6, 8, 10

1 The name and the symbol "Ch" refer to the Charrière gauge scale, which is often called the French scale.

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Characteristics	Proposed Device	Predicate Devices		Reference Devices
	Cure Catheter™Hydrophilic Coated	Cure MedicalCureCatheter™	Cure MedicalCurePediatricCatheter™	Astra Tech ABLoFric®Primo™ SingleUse UrinaryCatheter	ColoplastSpeediCath
510(k)	/	K072539	K110653	K050874	K023254
Sterility	STERILE	STERILE	STERILE	STERILE	STERILE
Packaging	Peel Pack	Peel Pack	Peel Pack	Peel Pack	Peel Pack
Devicecomposition	Polyvinyl Chloride(PVC) Catheter withDSM Comfort Coat -polyvinylpyrrolidone- HydrophilicMaterial Coating -and sterile watersachet	PolyvinylChlorineCatheterwithouthydrophiliccoating	PolyvinylChlorineCatheterwithouthydrophiliccoating	Polyvinylchloride cathetercoated withpolyvinylpyrrolidone and salt.Packaged withwater sachet.	Polyurethanecatheter coatedwithpolyvinylpyrrolidone, placed ina salinesolutioncontainingpolyvinylpyrrolidone.
Intended Use	Intermittentcatheterization,through the urethra,for the purpose ofbladder drainage formales and females.	Intermittentcatheterization,through theurethra, for thepurpose ofbladderdrainage formales andfemales.	Intermittentcatheterization through theurethra forthe purpose ofbladderdrainage forpediatricmales andfemales.	Intermittentcatheterizationof the urethra.	Chronic urineretention.Post-voidresidualvolume (PVR).Voidingdysfunctions.

Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission

Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use.

Performance Testing:

Moreover, product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness.

The Cure Catheter ™ Hydrophilic Coated is substantially Conclusion of Comparison: equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

December 23, 2013

Cure Medical LLC c/o John Beasley, MS, RAC Founder and Senior consultant Medtech Review, LLC 257 Garnet Garden Street Henderson, NV 89015

Re: K132500

Trade/Device Name: Cure Catheter® Hydrophilic Coated Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: November 25, 2013 Received: November 26, 2013

Dear Mr. John Beasley:

We have reviewed vour 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

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Page 2 - Mr. John Beasley

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/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/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,

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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Cure Medical - Cure Catheter ® Hydrophilic Coated Special 510(k) Submission

Indications for Use

510(k) Number (if known): K132500

Device Name: Cure Catheter ® Hydrophilic Coated

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

and/or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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 2013.12.23 09:57:47 -05'00'

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Cure Medical, LLC

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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.