The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Device Description

The Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Sleeved IC," which is an intermittent catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "VaPro2 Intermittent Catheter" by Hollister Incorporated (K180824).

The document details the device's characteristics and compares them to the predicate device, along with the non-clinical testing performed. However, it does not provide explicit acceptance criteria in the form of numerical performance thresholds or a specific study that measures device performance against these criteria as typically seen for AI/ML devices.

Instead, the document focuses on demonstrating substantial equivalence through a series of engineering, biocompatibility, and sterilization tests. The "acceptance criteria" are implied to be the successful completion of these standard tests and conformity to relevant ISO and industry standards for medical devices of this type. The "study" proving acceptance criteria is the sum of these non-clinical tests.

Let's break down the information based on your requested points, highlighting what is present and what is absent in the document regarding performance criteria specific to an AI/ML device.

Missing Information/Not Applicable for this Device Type:

This device is a physical medical device (intermittent catheter), not an AI/ML device. Therefore, many of your specific questions related to AI/ML performance, such as sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, training set details, and adjudication methods for ground truth in an AI context, are not applicable to this 510(k) submission.

Information Extracted from the Document:

A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria and device performance in the format typically used for AI/ML devices (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" are implied by successful completion of various non-clinical tests and conformity to standards. The "reported device performance" is that it met all applicable requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Conformity to BS EN ISO 20696:2018 (Sterile urethral catheters for single use)	Met all applicable requirements.
Equivalence of lubricity to predicate device	Substantial equivalency of catheter lubricity demonstrated via testing.
Catheter strength and security of drainage funnel fit	Testing conducted showed it met requirements.
Flow rate through catheter	Testing conducted showed it met requirements.
Catheter kink stability and peak tensile force	Testing conducted showed it met requirements.
Biocompatibility (ISO 10993 series)	All requirements met for biological endpoints (cytotoxicity, irritation, sensitization, systemic toxicity).
Sterilization (ISO 11137 series, ANSI/AAMI/ISO 11737 series)	Met all requirements of the listed FDA recognized standards. The required Sterility Assurance Level (SAL) has been validated.
Packaging integrity (maintenance of sterile barrier)	Verified through shelf life.
Transportation testing (no impact on safety/efficacy)	Verified no impact from transportation hazards.

Sample size used for the test set and the data provenance

This information is not provided for the non-clinical tests. Medical device performance testing often uses a statistically relevant number of samples for each specific test (e.g., a batch of catheters for tensile strength, a certain number of test animals for biocompatibility), but these specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not detailed in this 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert interpretation as ground truth.
Adjudication method for the test set

This is not applicable for the same reasons as above.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as this is a physical medical device, not an AI-assisted diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this is a physical medical device.
The type of ground truth used

The "ground truth" for this device's non-clinical testing refers to established scientific principles, physical measurements (e.g., force, flow rate), chemical analysis, and biological responses as defined by the referenced ISO standards and industry best practices. It's not "expert consensus" or "pathology" in the context of diagnostic performance.
The sample size for the training set

This is not applicable as this is a physical medical device and does not involve AI/ML training.
How the ground truth for the training set was established

This is not applicable for the same reasons as above.

In summary, the provided document describes a traditional medical device 510(k) submission, not an AI/ML device. Therefore, the questions tailored to AI/ML device performance validation are not addressed, as they are not relevant to this type of product. The "acceptance criteria" are implied by regulatory compliance and successful completion of standard non-clinical tests demonstrating substantial equivalence to a predicate device.

Summary

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December 8, 2022

Hollister Incorporated Sandra Mullen Regulatory Affairs Manager 2000 Hollister Drive Libertyville, Illinois 60048

Re: K220667 Trade/Device Name: Sleeved IC Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter And Accessories Regulatory Class: II Product Code: EZD Dated: November 17, 2022 Received: November 17, 2022

Dear Sandra Mullen:

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. 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

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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,

Negeen Haghighi -S

For

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220667

Device Name Sleeved IC (not finalized)

Indications for Use (Describe)

The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K220667 Page 1 of 5

510(k) Summary

Applicant:	Hollister Incorporated2000 Hollister DriveLibertyville, IL 60048
Contact Person:	Sandra MullenHollister Incorporated2000 Hollister DriveLibertyville, IL 60018(t) +00 353 86 301 1706

Date Prepared:	7 December 2022
Trade Name :	Sleeved IC (not finalized)
Common Name:	Catheter, Straight
Classification Number	21 CFR 876.5130
Classification Name	Urological catheter and accessories
Product Code	EZD
Product Code Name	Gastroenterology-Urology
Regulatory Class	Class II

Predicate Device:

VaPro2 Intermittent Catheter by Hollister Incorporated. (K180824)

The predicate has not been subject to a design- related recall.

Indications for Use:

This Sleeved IC is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Description of Applicant Device:

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Comparison of Technological Characteristics

The table below summarizes the technological characteristics of the Sleeved IC as compared to the predicate device.

	PredicateVaPro 2IntermittentCatheter(K180824)	Sleeved IC	Rationale for no impact to safety andefficacy
Indication for Use	This intermittent catheter is a flexible tubular device thatis inserted through the urethra by male, female andpediatric patients who need to drain urine from thebladder.		There is no change toIndications for Use includingintended patient population.Testing provided in relation toproduct differencesdemonstrate no impact todevice safety, effectiveness orfunctionality per the intendeduse when compared topredicate device.
Condition of Use	Single Use		No change
Ready to use	Yes		No change
Hydration Method	Water vapor hydration	Direct Hydration	Testing provided showsdifferences do not affect the safetyand effectiveness compared topredicate and reference devices.Although a different method ofhydration is utilized between thepredicate device and the Sleeved IC,substantial equivalency of catheterlubricity is demonstrated via testing.
Hydration Fluid	DI Water	Hydration Fluid	Testing provided showsdifferences do not affect safety andeffectiveness compared to the predicatedevice.
Catheter HydrophilicCoating	PVP Based (polyvinylpyrollidone) Coating		The hydrophilic coating onthe predicate and SleevedIC is PVP based.Testing provided showsdifferences do not affect the safetyand effectiveness compared topredicate and reference devices.
Catheter Material	Polyvinyl Chloride (PVC);(Not manufactured withPhthalates)	ThermoplasticElastomer (TPE);(Not manufacturedwith Phthalates orwith PVC)	Testing shows differences in materialsdo not affect safety and effectivenesscompared to the predicate device.Both Sleeved IC and representativedevice conform to BS EN 20696
	PredicateVaPro 2IntermittentCatheter(K180824)	Sleeved IC	Rationale for no impact to safety andefficacy
			'Sterile Urethral Catheters for SingleUse'.
			Biocompatibility has been assessed andall requirements met.
Catheter length/ Fr.sizes	Diameter (Fr) - 8, 10, 12, 14and 16 Length - 16 inches	Diameter (Fr) 12 and 14Length - 16 inches	The sleeved IC diameter sizes arewithin the range of the predicateproduct familyNo change in catheter length
End of catheterdesign	Rounded tip		No change
End Design	Color coded funnel		No change
Catheter Eyelets	2 smooth catheter eyelets		No change
Catheter Color	Opaque	Clear	The appearance of thecatheter tubing does not impactfunctionality
Not Made withNatural RubberLatex	Yes		No change
Packaging Material	OPA/ALU/PE Foil laminate	PET/ALU/PE Foillaminate	Testing shows differencesdo not affect safety and effectivenesscompared to the predicate device.
SterilizationMethod	Gamma Irradiation Dose 25-40kGy SAL 10-6	e-beam Irradiation Dose25-65kGy	The difference inSterilization method does not affect thesafety and effectiveness compared tothe predicate device.Gamma and E-beam sterilizationmethods are both forms of radiationsterilization.The required Sterility Assurance Level(SAL) has been validated for bothmethods.
Storage Conditions	15-30°C / 59-86°F		No change
Environment of Use	HospitalHome SettingPublic Places		No Change

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Brief Description of Non-Clinical Testing:

The physical performance properties of the Sleeved IC met all applicable requirements of BS EN ISO 20696:2018: Sterile urethral catheters for single use.

Testing was conducted to support size designation, show equivalence of lubricity and determination of the strength of the catheter, security of fit of the drainage funnel, flow rate through catheter, catheter kink stability and peak tensile force.

Biocompatibility testing met the following requirements:

ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-12:2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18:2020. Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

The following biological endpoints were addressed: cytotoxicity, intracutaneous irritation, vaginal irritation, sensitization, acute systemic toxicity and subacute systemic toxicity.

Sterilization met all requirements of the following FDA recognized standards:

ISO 11137-1:2006. Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ANSI/AAMI/ISO 11737-1:2018, Sterilization of health care products - Microbiological methods -Part 1: Determination of a population of microorganisms on products

ANSI/AAMI/ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part

2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted in order to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment.

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Conclusion:

It is concluded that the information supplied in this submission has demonstrated that the Sleeved IC is substantially equivalent to the legally marketed predicate device.

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.