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)

Q: Who is the manufacturer of 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)?

Hollister Incorporated filed the 510(k) submission for 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) (K233524).

Q: What is the FDA product code for 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)?

EZD. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for 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)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like 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)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K233524 · Hollister Incorporated · EZD · May 3, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K233524
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)
Applicant	Hollister Incorporated
Product Code	EZD · Gastroenterology, Urology
Decision Date	May 3, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

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.

Device Story

Sleeved IC 2 is a hydrophilic-coated, single-use intermittent urinary catheter; available in 8-inch and 16-inch lengths and Fr 08-16 sizes. Device features two drainage eyelets, rounded tip, and color-coded funnel; some configurations include an integrated urine collection bag. Constructed from thermoplastic elastomer (TPE); free of phthalates and PVC. Used in hospitals, homes, and public settings by patients or caregivers. Catheter is lubricated via direct contact with hydration fluid. E-beam sterilized. Device facilitates bladder drainage for patients with urinary incontinence. Healthcare providers use the device to manage urinary retention; output is the physical drainage of urine from the bladder, which provides immediate relief and prevents complications associated with bladder distension.

Clinical Evidence

Bench testing only. Performance testing verified size designation, lubricity, catheter strength, drainage funnel security, flow rate, kink stability, and peak tensile force per ISO 20696. Biocompatibility testing addressed cytotoxicity, sensitization, and systemic toxicity per ISO 10993 series. Packaging integrity and shelf-life validated per ISO 11607 and ASTM standards.

Technological Characteristics

Materials: Thermoplastic Elastomer (TPE), PVP-based hydrophilic coating. Dimensions: 8-16 Fr, 8-16 inch lengths. Sensing/Actuation: Passive drainage. Energy: None. Connectivity: None. Sterilization: E-beam irradiation (25-65kGy, SAL 10^-6). Packaging: Aluminum foil laminate. Standards: ISO 20696 (catheter performance), ISO 10993 (biocompatibility), ISO 11137 (sterilization), ISO 11607 (packaging).

Indications for Use

Indicated for male, female, and pediatric patients requiring urinary bladder drainage via urethral catheterization.

Regulatory Classification

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).

Predicate Devices

Sleeved IC (K220667)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) | <svg height="12" width="12"> <rect fill="black" height="12" width="12" x="0" y="0"></rect> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 Incorporated 2000 Hollister Drive Libertyville, IL 60048 | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Michelle Schiltz-Taing Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (t) 224-864-0431 | | Date Prepared: Trade Name: Common Name: Product Code/ Class: | 22 April 2024 Sleeved IC 2 (Not finalized) Catheter, Urethral EZD (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 a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. | | 16 Inch This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and paediatric (pediatric) patients who need to drain urine from the bladder. | 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. | | | | 8 inch 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. | | Urological catheter and accessories 21 CFR 876.5130 {5}------------------------------------------------ #### 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 IC Predicate K220667 | Sleeved IC 2 | Same or Different/ Rationale for no impact to safety or efficacy | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | 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. 8-inch Sleeved IC 2 Pocket: 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. | | No change The 8-inch Sleeved IC2 Pocket has the same indication for use but focuses on a subset of the population. There is no effect to the safety or efficacy or to the intended use. | | Condition of Use | | Single Use | No change | | Ready to use | | Yes | No change | | Hydration Method | | Direct hydration | No change | | Hydration Fluid | | Hydration Fluid | No change | | Catheter hydrophilic coating | | PVP Based (polyvinylpyrollidone) Coating | No change | | Catheter Material | | Thermoplastic Elastomer (TPE); not made with phthalates, not made with PVC | No change | | | Sleeved IC Predicate K220667 | Sleeved IC 2 | Same or Different/ Rationale for no impact to safety or efficacy | | Catheter length/ Fr. sizes | Diameter (Fr) 12 and 14 Length - 16 inches | Diameter (Fr) 08-16 Length - 16 inches and 8 Inches | Different The additional Fr sizes and catheter length meet the same requirements as the predicate device. (ISO 20696) There is no effect to safety or efficacy or to the intended use. | | End of catheter design | | Rounded tip | No change | | End Design (Straight) | | Color coded funnel | No change | | End Design (Plus) | N/A | Urine collection bag | Different The urine collection bag was added for user convenience. The materials used in the collection bag have been assessed for biocompatibility and tested to verify sufficient flowrate of urine into the collection bag. There is no effect to safety or efficacy or to the intended use. | | Catheter Eyelets | | 2 smooth catheter eyelets | No change | | Catheter Color | | Clear | No change | | Not Made with Natural Rubber Latex | | Yes | No change | | Packaging Material | | Aluminium Foil Laminate | No change | | Sterilization Method | | e-beam Irradiation Dose 25-65kGy SAL 10-6 | No change | | Storage Conditions | | 15-30°C / 59-86°F | No Change | | | Sleeved IC Predicate K220667 | Sleeved IC 2 | Same or Different/ Rationale for no impact to safety or efficacy | | Environment of Use | | Hospital Home Setting Public Places | No Change | {6}------------------------------------------------ {7}------------------------------------------------ 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 {8}------------------------------------------------ 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.

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)

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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)

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