The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.

Device Description

The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.

The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Rusch® Intermittent Urethral Catheters". The document primarily focuses on demonstrating substantial equivalence to a predicate device (K033023). It does not contain information about acceptance criteria and a study proving device meeting acceptance criteria in the way these terms are typically used for AI/ML device evaluations (i.e., performance metrics, ground truth, expert adjudication, MRMC studies, etc.).

Instead, it details the non-clinical performance testing performed to demonstrate substantial equivalence to the predicate device. For this type of medical device (a catheter), "acceptance criteria" would typically refer to meeting industry standards and performance benchmarks for physical and functional characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information from the provided text, framed as closely as possible to your request, but highlighting what is not present:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the format typically seen for AI/ML diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it lists non-clinical performance tests that were conducted to establish substantial equivalence.

Acceptance Criteria (Implied from tests)	Reported Device Performance (Implied from conclusion)
Meets standards for Flow Rate	Verifies performance is substantially equivalent to predicate device
Meets standards for Catheter Tensile properties	Verifies performance is substantially equivalent to predicate device
Meets standards for Break Strength	Verifies performance is substantially equivalent to predicate device
Meets Cytotoxicity ISO 10993-5	Biocompatibility studies conclude materials are safe for intended use
Meets Sensitization ISO 10993-10	Biocompatibility studies conclude materials are safe for intended use
Meets Skin Irritation ISO 10993-10	Biocompatibility studies conclude materials are safe for intended use
Performs as well as or better than predicate device in critical performance characteristics	Performance test results demonstrate the subject device meets its intended use and is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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

This information is not provided in the document. The document describes non-clinical (bench) testing, not a clinical study involving a test set of patient data.

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)

This information is not applicable/provided. The evaluation is based on non-clinical engineering and biocompatibility tests, not expert interpretation of diagnostic images or patient cases.

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

This information is not applicable/provided. There is no "test set" in the context of diagnostic interpretation that would require 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

This information is not applicable/provided. The device is an intermittent urethral catheter, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

This information is not applicable/provided. The device is a physical medical device (catheter), not an algorithm.

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

For the non-clinical performance tests, the 'ground truth' is effectively established by standardized laboratory testing procedures and ISO standards (e.g., ISO 10993 for biocompatibility), and comparison to the characteristics of the legally marketed predicate device.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

This information is not applicable/provided.

Summary

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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.

January 29, 2018

Teleflex Medical, Inc. Amanda Webb Manager, Regulatory Affairs 3015 Carrington Mill Blvd. Morrisville, NC 27560

Re: K173596

Trade/Device Name: Rusch® Intermittent Urethral Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZC, EZD Dated: November 28, 2017 Received: November 29, 2017

Dear Amanda Webb:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-491-8960 Fax: 919-443-4996

Contact Person

Amanda Webb Manager, Regulatory Affairs

Date Prepared

1/23/2018

Device Name

Trade Name:	Rusch® Intermittent Urethral Catheter
Common/Usual Name:	Urological Catheter
Regulation Number:	21 CFR 876.5130
Regulation Name:	Urological catheter and accessories
Regulation Class:	II
Product Code:	EZC - catheter, coudeEZD - catheter, straight
Panel:	Gastroenterology/Urology

Predicate Device Rusch® Intermittent Urethral Catheters -K033023

Device Description

Indications for Use

The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.

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Contraindications

Insuperable obstruction of the urethra. However, the suitability of each patient must be individually assessed by a physician or other suitably qualified personnel.

Substantial Equivalence

The subject device is substantially equivalent to the predicate device:

Features	Teleflex MedicalRuschIntermittentUrethralCatheters (SubjectDevice)	Rusch UrethralIntermittentCatheters(Predicate Device-K033023)	Comparison
			Similarities	Differences
ClassificationName	Catheter,Urological	Catheter,Urological	Devices are thesame	None
RegulationNumber	876.5130	876.5130	Devices are thesame	None
Class	II	II	Devices are thesame	None
DeviceDescription	The IntermittentUrethral Cathetersconsists of atubular shaft withattached funnelas connectingdevice. PVCmaterial used inthe catheter.The product sizesrange from 10Ch. to 24 Ch.The device shaft isuncoated.	The IntermittentUrethral Cathetersconsists of atubular shaft withattached funnelas connectingdevice. The PVCmaterial used inthe catheter.The product sizesrange from 6 Ch.to 24 Ch.The device shaftmay be uncoatedor hydrophiliccoated.	Both devices areintended forintermittentcatheterization.	Thepredicate,IntermittentUrethralCatheters,are offeredwith orwithouthydrophiliccoating andhave a widerange ofsizes.The subjectdevice shaftdoes nothave ahydrophiliccoating, it isuncoated.
Indication for Use	The IntermittentUrethralCatheters areindicated forroutine drainageof fluids from thebladder. Thesecatheters are notintended ordesigned forindwelling use.	The IntermittentUrethral Cathetersare sterile, single-use, flexible tubulardevices that areinserted through theurethra and used topass fluids to orfrom urinary tracts.	Both thepredicates andsubject cathetersare sterile, single-use devices thatpass fluids fromthebladder/urinarytract.	The predicatedevicesintended useincludespassage offluids to orfrom theurinary tract.The subjectIntermittentUrethralCatheters donot includethe intendeduse ofadministrationof fluids to theurinary tract.
Contraindications	Insuperableobstruction of theurethra. However,the suitability ofeach patient mustbe individuallyassessed by aphysician or othersuitably qualifiedpersonnel.	None known	There are noknowncontraindicationsfor the predicatedevices.	The subjectIntermittentUrethralCatheters hasacontraindication.
Single Use	Yes	Yes	Devices are thesame	None
Size Range	10 Ch. - 24 Ch.	6 Ch. - 24 Ch.	The subjectIntermittentUrethral catheterssizes are includedwithin the rangeof the predicatedevices.	The predicatedevices have alarger sizerange.
Overall Length	Nominal 40 cm	Nominal 40 cm	Devices are thesame	None
Shaft	Tubular	Tubular	Devices are thesame	None
Shaft Material			Both devices are	The subject
	PVC	PVC	made with PVC	device is made with different plasticizer
Funnel Material	PVC	PVC	Both devices are made with PVC	The subject device is made with different plasticizer
Coating	Uncoated	Uncoated or Hydrophilic Coated	Both the predicate and subject Intermittent Urethral Catheters have uncoated catheters.	The predicate, Intermittent Urethral Catheters, also has coated catheters.
Biocompatibility	Evaluation and testing within the risk management process ISO 10993-1	Evaluation and testing within the risk management process ISO 10993-1	Biocompatibility studies of the devices conclude that the materials are safe for the intended use	None
Principal of Operation - Short Description of Use	Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device	Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device	Devices are the same	None
Catheter Tip Configurations	Tiemann and Nelaton- Robinson	Tiemann, Nelaton-Robinson, and Olive	The Tiemann and Nelaton-Robison configurations are offered for the predicate and subject devices.	The Olive tip configuration is offered for the predicate device.
Eyelets	Yes	Yes	Devices are the same	None
Primary Packaging	Paper and film peel back	Paper and film peel back	Devices are the same	None
Secondary Packaging	Corrugated box, quantity 50	Corrugated box, quantity 100		The unit quantities in the secondary
			Secondarypackagingmaterial is thesame	packaging aredifferent forthe predicatethan for thesubject device.
Shipper Case	Corrugated board	Corrugated board	Devices are thesame	None
Sterile	Yes	Yes	Devices are thesame	None
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Devices are thesame	None
Shelf-life	5 Years	3 Years	Both deviceshave a shelf-lifeof at least 3 years	The subjectdevice,IntermittentUrethralCatheters,have a shelf-life of 5 years.

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Non-clinical Performance testing

The bench testing performed verifies that the performance of the subject Intermittent Urethral Catheters are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Flow Rate
Catheter Tensile properties
. Break Strength
Cytotoxicity ISO 10993-5 ●
Sensitization ISO 10993-10
Skin Irritation ISO 10993-10

Conclusion

The Intermittent Urethral Catheters have demonstrated through comparison of design features and performance testing that the proposed device and the predicate device are substantially equivalent. Performance test results demonstrate that the subject device meets its intended use and is as safe, as effective, and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject device can be found substantially equivalent.

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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.