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 Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided 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 in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.

AI/ML Overview

Based on the provided text, the device in question is an Intermittent Catheter, and the submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. The document does not describe an AI/ML-based medical device. Therefore, many of the requested elements pertaining to AI/ML device testing (e.g., training set, test set, ground truth establishment for AI, MRMC studies, standalone algorithm performance, number of experts for AI ground truth, adjudication methods) are not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing of physical performance, biocompatibility, sterilization, and packaging integrity, comparing the new device to its predicate.

Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present for this type of device submission.

Acceptance Criteria and Device Performance for an Intermittent Catheter

1. A table of acceptance criteria and the reported device performance

The document states: "The physical performance properties of the Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single use." and "Biocompatibility testing met the requirements of the following standards..." and "Sterilization met all requirements of the following FDA-recognized standards:".

Since this is a substantial equivalence submission for a traditional medical device (not AI/ML), the "acceptance criteria" are compliance with established performance and safety standards, and the "reported device performance" is that it "met all applicable requirements" or "met all requirements." Specific numerical accept/fail criteria or performance metrics are not explicitly tabulated in the summary provided.

Acceptance Criteria Category	Applicable Standard(s) / Requirement	Reported Device Performance
Physical Performance	BS EN ISO 20696:2018 (Sterile urethral catheters for single use)	Met all applicable requirements
Biocompatibility	ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-17:2002, ISO 10993-18:2020	Met the requirements of the listed standards. Biological endpoints addressed: cytotoxicity, intracutaneous irritation, vaginal irritation, sensitization, acute systemic toxicity, and subacute systemic toxicity.
Sterilization	ISO 11137-1:2006, ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI/ISO 11737-2:2019	Met all requirements of the listed FDA-recognized standards.
Packaging Integrity	Not explicitly listed, but implied by "Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life."	Tested and verified maintenance of sterile barrier through shelf life.
Transportation Testing	Not explicitly listed, but implied by "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."	Tested and verified no impact to device safety or efficacy due to transportation.

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

Sample Size: Not explicitly provided. The text mentions "Testing was conducted to support size designation..." but does not give the number of catheters or samples tested for each criteria (e.g., "size designation," "lubricity," "security of fit," "flow rate," "kink stability," "tensile force").
Data Provenance: Not specified. Standard medical device testing for regulatory clearance is generally conducted under controlled laboratory conditions, not typically involving patient data in the same way as AI/ML or clinical trials. It's safe to assume the testing facilities are in the country of the applicant (USA) or a compliant jurisdiction, but this is not stated. The data would be prospective in the sense that the tests were conducted specifically for 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. This is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image/data interpretation. Testing involves physical and biological assays against established standards.

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

Not Applicable. As above, this is not an AI/ML diagnostic study involving human interpretation and adjudication. Testing involves objective measurements and adherence to specified performance limits within standards.

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 is not an AI/ML device, and no MRMC study was conducted or required. The "effectiveness" is demonstrated by meeting performance standards and equivalence to the predicate device.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable in the AI/ML sense. The "ground truth" for this device's testing is adherence to the specified requirements in the referenced international and FDA-recognized standards (e.g., BS EN ISO 20696:2018 for physical properties, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization). For example, "ground truth" for lubricity would be a quantitative measurement meeting a predefined specification within the standard.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not Applicable. This is a physical medical device, not an AI/ML model.

Summary

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January 27, 2022

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

Re: K211436

Trade/Device Name: Intermittent Catheter (not finalized) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: December 29, 2021 Received: December 30, 2021

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 (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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,

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

510(k) Number (if known)

K211436

Device Name Intermittent Catheter (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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Applicant:	Hollister Incorporated2000 Hollister DriveLibertyville, IL 60048
Contact Person:	Michelle Schiltz-TaingHollister Incorporated2000 Hollister DriveLibertyville, IL 60018(t) 224-864-0431
Date Prepared:	January 25, 2022
Trade Name:	Intermittent Catheter (not finalized
Common Name:	Catheter, Urethral
Product Code/Class:	GBM/Class II
Classification Name:	Urological catheter and accessories
Classification Number:	21 CFR 876.5130

Predicate Device:

Onli Intermittent Catheter by Hollister Incorporated (K163179)

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

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 Description:

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Comparison of Technological Characteristics:

The table below summarizes the technological characteristics of the Intermittent Catheter as compared to the predicate and reference devices.

	Predicate OnliK163179	Intermittent Catheter	Same or Different/Rational for noimpact to efficacy or safety
Indications forUse	The intermittent catheter is a flexible tubular device that isinserted through the urethra by male, female and pediatricpatients who need to drain urine from the bladder.		No change
Condition of Use		Single Use	No change
Device Material	Polyvinyl Chloride (PVC);phthalate free funnel andcatheterThermo-plastic Elastomer(TPE); phthalate free,PVC free gripper	Thermo-plastic Elastomer(TPE); phthalate free,PVC free funnel, catheter,and gripper	Testing shows differences do notaffect safety and effectivenesscompared to the predicate device.
Length/Fr Sizes	7 inches: Fr 8, 10, 12, 1416 inches: Fr 8, 10, 12, 14, 16		No change
Gripper on 16 in.Catheter	Yes		No change
Attachment ofFunnel toCatheter Tube	Solvent Bonded	Insert molded funnel(created by a thermalbond)	Although the attachment of thefunnel to the catheter tube isdifferent, the differences do notaffect safety and effectivenesscompared to the predicate device.
End of CatheterDesign	Rounded tip		No change
End Design	Color-coded funnel		No change
Number ofEyelets	2		No change
Catheter Color	Opaque	Clear	The appearance of the catheter doesnot impact functionality.
Coating	PVP Based Coating(polyvinylpyrollidone)		The Hydrophilic coating on thepredicate and the Intermittent Catheteris PVP based. Testing showsdifferences do not affect safety andeffectiveness compared to thepredicate device.
Fluid	DI water	Hydration fluid	Although the hydration fluid isdifferent between the predicate and theIntermittent Catheter, testing showsdifferences do not affect safety andeffectiveness compared to thepredicate device.
HydrationMethod	Vapor Hydration	Direct Hydration	Although a different method ofhydration is utilized between thepredicate device and the IntermittentCatheter, substantial equivalency ofcatheter lubricity is demonstratedvia testing.
PackagingMaterial	OrientedPolyamide/Aluminum/Polyethylene (OPA/ALU/PE) foil(foil laminate)	PolyethlyeneTerephthalate/Aluminum/Polyethylene(PET/ALU/PE) foil(foil laminate)	Testing shows differences do notaffect safety and effectivenesscompared to the predicate device.
SterilizationMethod	Gamma IrradiationDose 25-40kGySAL 10-6	e-beam IrradiationDose 25-65kGySAL 10-6	The difference in sterilization methoddoes not affect the safety andeffectiveness compared to thepredicate device.
ExpirationDating	2 years		No change
StorageConditions	15-30°C / 59-86°F		No change

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Brief Description of Non-Clinical Testing:

The physical performance properties of the Intermittent Catheter 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 catheter, the security of fit of the drainage funnel, flow rate through catheter, kink stability and peak tensile force of urethral catheter.

Biocompatibility testing met the requirements of the following standards:

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

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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.

Conclusion:

It is concluded that the information supplied in this submission has demonstrated that the Intermittent Catheter 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.