This intermittent catheter is a flexible tubular device that is inserted through the urethra by female pediatic patients who need to drain urine from the bladder.

Device Description

The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Female IC intermittent catheter) and primarily discusses its substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It does not include information about AI/ML algorithm performance, clinical studies involving human readers, or specific performance metrics like sensitivity, specificity, and AUC that would be expected for an AI/ML medical device.

Therefore, I cannot fulfill the request for information related to acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence, not AI/ML performance.

If you have a document describing an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

Summary

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September 13, 2022

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

Re: K213575

Trade/Device Name: Female IC (not Finalized) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: August 9, 2022 Received: August 9, 2022

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 (OS) 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,

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

510(k) Number (if known) K213575

Device Name

Female IC (not finalized)

Indications for Use (Describe)

This internittent catheter is a flexible tubular device that is inserted through the urethra by female pediatic 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:	13 September 2022
Trade Name:	Female IC (Not Finalized)
Common Name:	Catheter, Urethral
Product Code/Class:	EZD/Class II
Classification Name:	Catheter, Straight
Regulation Number:	21 CFR 876.5130

Predicate Device:

Infyna Chic K191633 by Hollister Incorporated. The predicate 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 female and female pediatric patients who need to drain urine from the bladder.

Description of Applicant Device:

Technological Characteristics:

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

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	Predicate DeviceInfyna Chic(K191633)	Female IC	Same or Different/Rationalefor No impact to Efficacy or Safety
Indication for Use	This intermittent catheter is aflexible tubular device that isinserted through the urethra byfemale patients who need todrain urine from the bladder.	This intermittent catheter is aflexible tubular device that isinserted through the urethra byfemale and female pediatricpatients who need to drainurine from the bladder	No change-additionalverbiage was used to clarifythat "female" includes femalepediatric patients. No impactto the existing Female IC riskfile was identified and noadditional safety concernswere added due to theclarification of the patientpopulation.
Condition of Use	Single Use		No Change
Pre-lubricated	Water vapor hydration	Direct Hydration	Although a different methodof hydration is utilizedbetween the predicate andsubject device; equivalency ofcatheter lubricity isdemonstrated within thissubmission
Ready to use	Yes		No Change
End Design	Color coded Funnel		No Change
Sterile	Gamma Radiation	E-Beam Radiation	Gamma and E-Beamsterilization methods are bothforms of radiationsterilization. The requiredSterility Assurance Level(SAL) has been validated forboth methods.
Hydrophilic Coating	PVP Based (polyvinylpyrrolidone) Coating		No Change
Catheter Eyelets	2 smooth catheter eyelets		No Change
Not Made withNatural Rubber Latex	Yes		No Change
Catheter Material	Polyvinyl Chloride (PVC);phthalate free	Thermo-plastic Elastomer(TPE); phthalate free, PVCfree)	Catheter material changes hasno impact as both thepredicate and subject deviceconform to BS EN 20696.
			"Sterile urethral catheters forsingle use". Biocompatibilityhas been assessed and allrequirements have been met
Catheter Length	5 inches	5.5 inches	The subject device has alength of 0.5 inches morethan the predicate. No impactas both the predicate andsubject device conform to BSEN 20696- "Sterile urethralcatheters for single use"effective shaft length.
Fr Size	Fr 8, 10, 12, 14		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 Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single Use.

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.
10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
10993-12:2021, Biological evaluation of medical devices Part 12: Sample preparation and ● reference materials.
10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances.
10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.

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.

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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 Female 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.