Sleeved IC

K220667 · Hollister Incorporated · EZD · Dec 8, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220667
• Device Name: Sleeved IC
• Applicant: Hollister Incorporated
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Dec 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Sleeved IC is a sterile, single-use, hydrophilic-coated intermittent catheter for urinary incontinence management. Device consists of a 16-inch thermoplastic elastomer (TPE) tube with drainage eyelets, available in 12 and 14 Fr sizes. Unlike the predicate's water vapor hydration, this device uses direct hydration via an integrated fluid pouch within the foil packaging to lubricate the PVP-based coating. Used in hospitals, homes, or public settings; operated by patients or caregivers. Insertion into the urethra allows urine drainage from the bladder. Benefits include ease of use and effective bladder management. Device is phthalate-free and PVC-free.

Clinical Evidence

Bench testing only. Performance testing included size designation, lubricity, catheter strength, drainage funnel security, flow rate, kink stability, and peak tensile force. Biocompatibility testing (ISO 10993 series) addressed cytotoxicity, irritation, sensitization, and systemic toxicity. Sterilization and packaging integrity were validated per ISO 11137 and ISO 11737 standards.

Technological Characteristics

Materials: Thermoplastic Elastomer (TPE), PVP-based hydrophilic coating. Dimensions: 16-inch length, 12-14 Fr diameters. Principle: Direct hydration of hydrophilic coating via integrated fluid. Sterilization: e-beam irradiation (25-65kGy). Packaging: PET/ALU/PE foil laminate. Conforms to BS EN ISO 20696:2018.

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

• VaPro2 Intermittent Catheter (K180824)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

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 Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60048 |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sandra Mullen<br>Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60018<br>(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:

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.

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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.

| | Predicate<br>VaPro 2<br>Intermittent<br>Catheter<br>(K180824) | Sleeved IC | Rationale for no impact to safety and<br>efficacy |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | This intermittent catheter is a flexible tubular device that<br>is inserted through the urethra by male, female and<br>pediatric patients who need to drain urine from the<br>bladder. | | There is no change to<br>Indications for Use including<br>intended patient population.<br><br>Testing provided in relation to<br>product differences<br>demonstrate no impact to<br>device safety, effectiveness or<br>functionality per the intended<br>use when compared to<br>predicate device. |
| Condition of Use | Single Use | | No change |
| Ready to use | Yes | | No change |
| Hydration Method | Water vapor hydration | Direct Hydration | Testing provided shows<br>differences do not affect the safety<br>and effectiveness compared to<br>predicate and reference devices.<br><br>Although a different method of<br>hydration is utilized between the<br>predicate device and the Sleeved IC,<br>substantial equivalency of catheter<br>lubricity is demonstrated via testing. |
| Hydration Fluid | DI Water | Hydration Fluid | Testing provided shows<br>differences do not affect safety and<br>effectiveness compared to the predicate<br>device. |
| Catheter Hydrophilic<br>Coating | PVP Based (polyvinylpyrollidone) Coating | | The hydrophilic coating on<br>the predicate and Sleeved<br>IC is PVP based.<br><br>Testing provided shows<br>differences do not affect the safety<br>and effectiveness compared to<br>predicate and reference devices. |
| Catheter Material | Polyvinyl Chloride (PVC);<br>(Not manufactured with<br>Phthalates) | Thermoplastic<br>Elastomer (TPE);<br>(Not manufactured<br>with Phthalates or<br>with PVC) | Testing shows differences in materials<br>do not affect safety and effectiveness<br>compared to the predicate device.<br><br>Both Sleeved IC and representative<br>device conform to BS EN 20696 |
| | Predicate<br>VaPro 2<br>Intermittent<br>Catheter<br>(K180824) | Sleeved IC | Rationale for no impact to safety and<br>efficacy |
| | | | 'Sterile Urethral Catheters for Single<br>Use'. |
| | | | Biocompatibility has been assessed and<br>all requirements met. |
| Catheter length/ Fr.<br>sizes | Diameter (Fr) - 8, 10, 12, 14<br>and 16 Length - 16 inches | Diameter (Fr) 12 and 14<br><br>Length - 16 inches | The sleeved IC diameter sizes are<br>within the range of the predicate<br>product family<br><br>No change in catheter length |
| End of catheter<br>design | 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 the<br>catheter tubing does not impact<br>functionality |
| Not Made with<br>Natural Rubber<br>Latex | Yes | | No change |
| Packaging Material | OPA/ALU/PE Foil laminate | PET/ALU/PE Foil<br>laminate | Testing shows differences<br>do not affect safety and effectiveness<br>compared to the predicate device. |
| Sterilization<br>Method | Gamma Irradiation Dose 25-<br>40kGy SAL 10-6 | e-beam Irradiation Dose<br>25-65kGy | The difference in<br>Sterilization method does not affect the<br>safety and effectiveness compared to<br>the predicate device.<br><br>Gamma and E-beam sterilization<br>methods are both forms of radiation<br>sterilization.<br><br>The required Sterility Assurance Level<br>(SAL) has been validated for both<br>methods. |
| Storage Conditions | 15-30°C / 59-86°F | | No change |
| Environment of Use | Hospital<br>Home Setting<br>Public 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.