Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): This 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.
Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

Device Description

The Sleeved IC 2 (not finalized) catheters are:

E-beam sterilized.
Hydrophilic-coated, single use catheter.
Have two drainage eyelets that is used to manage urinary incontinence.
The Sleeved IC is inserted into the urethra to drain urine from the bladder.
Available in 16 inch and 8 inch lengths.
Available in various Fr sizes ranging from Fr 08 through Fr 16.
Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
Lubricated by direct contact with the hydration fluid.
Available with and without integrated urine collection bag.
Available in pocket and straight packaging configurations.
Environment of use: hospital, home setting, public places.

AI/ML Overview

The provided document describes the FDA clearance for the "Sleeved IC 2 Family" of intermittent catheters (K233524). It details the device's characteristics, indications for use, and a comparison to a predicate device ("Sleeved IC" K220667). It also summarizes the non-clinical testing conducted to support the substantial equivalence claim.

However, the document does not contain the specific information required to complete a table of acceptance criteria with reported device performance from a clinical study, nor does it detail a study that demonstrates the device meets specific acceptance criteria in the way described in the prompt.

Here's an explanation of why the requested information cannot be fully provided based on the input:

Type of Submission: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device. For many moderate-risk devices (Class II), clinical studies are not always required if non-clinical performance testing can demonstrate substantial equivalence.
Focus of the Document: The document focuses primarily on the technical characteristics and non-clinical testing (e.g., physical performance, biocompatibility, sterilization, packaging) to show that the new device performs as safely and effectively as the predicate device. It explicitly states, "Brief Description of Non-Clinical Testing".

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes for test sets (as no clinical test set is described), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for a clinical study because this information is not present in the provided text.

The document does include details on the non-clinical testing performed, which serves as the "study" demonstrating the device meets the requirements for clearance.

Below is a partial response based on the information available, noting where specific requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing against recognized standards rather than specific acceptance criteria from a clinical study. The "reported device performance" is that the device "met all applicable requirements" of these standards.

Acceptance Criteria (Standard Requirement)	Reported Device Performance (Result)
BS EN ISO 20696:2018 (Sterile urethral catheters for single use):	Met all applicable requirements
Size designation	Equivalence to predicate
Lubricity	Equivalence to predicate
Strength of the catheter	Equivalence to predicate
Security of fit of the drainage funnel	Equivalence to predicate
Flow rate through catheter	Equivalence to predicate
Catheter kink stability	Equivalence to predicate
Peak tensile force	Equivalence to predicate
Urine collection bag flowrate (~1 min)	Sufficient flow within 1 minute
Biocompatibility (ISO 10993 series)	Met all requirements
Sterilization (ISO 11137 series, ANSI/AAMI/ISO 11737 series)	Met all requirements
Shelf life (by package integrity & bench performance)	Supported shelf life
Packaging (ISO 11607 series, ASTM F2096, ASTM F88/F88M)	Met all requirements

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the non-clinical tests. Non-clinical bench testing often uses small, representative samples.
Data Provenance: Not specified, but generally, such testing is conducted in controlled laboratory environments by the manufacturer or contract labs. It is non-clinical (i.e., not from human subjects).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The testing described is non-clinical and does not involve expert review or "ground truth" establishment in the context of clinical expert consensus. Performance is measured against engineering and biological standards.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human interpretation or adjudication.

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 urological catheter, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device does not incorporate an algorithm.

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

For non-clinical performance, the "ground truth" is established by the specifications and measurable parameters defined in the referenced international and national standards (e.g., ISO 20696 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. (See #8)

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2024

Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, Illinois 60048

Re: K233524

Trade/Device Name: Sleeved IC 2 Family: Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Received: April 2, 2024

Dear Michelle Schiltz-Taing:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Sharon M. Andrews -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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)	K233524/S001
Device Name	Sleeved IC 2 Family
	Sleeved IC 2 SWT (Name not Finalized)
	Sleeved IC 2 Plus (Name not Finalized)
	Sleeved IC 2 Pocket (Name not Finalized)
	Sleeved IC 2 Plus Pocket (Name not Finalized)
Indications for Use (Describe)	Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), &Sleeved IC 2 Plus Pocket (16" and 8"):
	This 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.
	Sleeved IC 2 Pocket (8"):
	This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/4/Picture/1 description: The image contains the Hollister logo. The logo consists of a red, geometric symbol resembling a stylized cross or asterisk on the left. To the right of the symbol is the word "Hollister" in a gray, sans-serif font. The overall design is clean and corporate.

510(k) Summary

Applicant:	Hollister Incorporated2000 Hollister DriveLibertyville, IL 60048
Contact Person:	Michelle Schiltz-TaingHollister Incorporated2000 Hollister DriveLibertyville, IL 60048(t) 224-864-0431
Date Prepared:Trade Name:Common Name:Product Code/ Class:	22 April 2024Sleeved IC 2 (Not finalized)Catheter, UrethralEZD (catheter, straight)/Class II

Classification Name: CFR:

Predicate Device:

Sleeved IC by Hollister Incorporated. (K220667)

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

Indications for Use:

Sleeved IC 2	Sleeved IC 2 Plus	Sleeved IC 2 Pocket	Sleeved IC 2 Plus Pocket
This intermittent catheter is aflexible tubular device that isinserted through the urethra bymale, female and pediatricpatients who need to drainurine from the bladder.		16 InchThis intermittent catheter is aflexible tubular device that isinserted through the urethraby male, female andpaediatric (pediatric) patientswho need to drain urine fromthe bladder.	This intermittent catheter is aflexible tubular device that isinserted through the urethra bymale, female and pediatricpatients who need to drain urinefrom the bladder.
		8 inchThis intermittent catheter is aflexible tubular device that isinserted through the urethraby female and femalepaediatric (pediatric) patientswho need to drain urine fromthe bladder.

Urological catheter and accessories

21 CFR 876.5130

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Description of Applicant Device:

The Sleeved IC 2 (not finalized) catheters are:

E-beam sterilized. ●
Hydrophilic-coated, single use catheter. .
Have two drainage eyelets that is used to manage urinary incontinence. ●
The Sleeved IC is inserted into the urethra to drain urine from the bladder. ●
. Available in 16 inch and 8 inch lengths.
Available in various Fr sizes ranging from Fr 08 through Fr 16.
Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
Lubricated by direct contact with the hydration fluid. ●
Available with and without integrated urine collection bag. ●
Available in pocket and straight packaging configurations.
. Environment of use: hospital, home setting, public places.

Comparison of Technological Characteristics:

The table below summarizes the technological characteristics of the Sleeved IC 2 as compared to the predicate device.

	Sleeved ICPredicate K220667	Sleeved IC 2	Same or Different/Rationale for noimpact to safety orefficacy
Indication forUse	This intermittent catheter is a flexible tubular device that is inserted throughthe urethra by male, female and pediatric patients who need to drain urinefrom the bladder.8-inch Sleeved IC 2 Pocket:This intermittent catheter is a flexible tubular device that is inserted throughthe urethra by female and female paediatric (pediatric) patients who need todrain urine from the bladder.		No changeThe 8-inch Sleeved IC2Pocket has the sameindication for use butfocuses on a subset ofthe population.There is no effect to thesafety or efficacy or tothe intended use.
Condition ofUse		Single Use	No change
Ready to use		Yes	No change
HydrationMethod		Direct hydration	No change
HydrationFluid		Hydration Fluid	No change
Catheterhydrophiliccoating		PVP Based (polyvinylpyrollidone) Coating	No change
CatheterMaterial		Thermoplastic Elastomer (TPE); not made with phthalates, not made withPVC	No change
	Sleeved ICPredicate K220667	Sleeved IC 2	Same or Different/Rationale for noimpact to safety orefficacy
Catheterlength/ Fr. sizes	Diameter (Fr) 12 and 14Length - 16 inches	Diameter (Fr) 08-16Length - 16 inches and 8 Inches	DifferentThe additional Fr sizesand catheter length meetthe same requirementsas the predicate device.(ISO 20696)There is no effect tosafety or efficacy or tothe intended use.
End of catheterdesign		Rounded tip	No change
End Design(Straight)		Color coded funnel	No change
End Design(Plus)	N/A	Urine collection bag	DifferentThe urine collection bagwas added for userconvenience. Thematerials used in thecollection bag havebeen assessed forbiocompatibility andtested to verifysufficient flowrate ofurine into the collectionbag.There is no effect tosafety or efficacy or tothe intended use.
CatheterEyelets		2 smooth catheter eyelets	No change
Catheter Color		Clear	No change
Not Made withNatural RubberLatex		Yes	No change
PackagingMaterial		Aluminium Foil Laminate	No change
SterilizationMethod		e-beam Irradiation Dose 25-65kGy SAL 10-6	No change
StorageConditions		15-30°C / 59-86°F	No Change
	Sleeved ICPredicate K220667	Sleeved IC 2	Same or Different/Rationale for noimpact to safety orefficacy
Environment ofUse		HospitalHome SettingPublic Places	No Change

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K220667 Page 4 of 5

Brief Description of Non-Clinical Testing:

The physical performance properties of the Sleeved IC 2 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. Testing of the urine collection bag was conducted to verify that the liquid would flow into the collection bag within 1 minute and to confirm sufficient flowrate.

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 10993-23, Biological evaluation of medical devices - Part 23 Tests for irritation

The following biological endpoints were addressed: cytotoxicity, 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

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Both package integrity testing and bench performance testing were completed to support shelf life.

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.

Packaging met all requirements of the following FDA recognized standards:

ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: Requirements for ● materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation ● requirements for forming, sealing and assembly process
ASTM F2096-11(2019) Standard test method for detecting gross leaks in packaging internal ● pressurization (bubble test)
ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials ●

Conclusion:

It is concluded that the information supplied in this submission has demonstrated that the safety and effectiveness of the Sleeved IC 2 is substantially equivalent to the cleared 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.