The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics in a clinical context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical outcomes are not applicable or cannot be extracted from this document, as it primarily details bench testing and a comparison to a predicate device for regulatory clearance.

However, I can extract the relevant bench testing performance data which serves as the "study" for this type of submission and interpret the "pass" results as meeting implicit acceptance criteria for substantial equivalence.

Here's the information that can be extracted, with explanations for what is not applicable:

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

For a 510(k) submission, the "acceptance criteria" for bench testing are generally that the device performs comparably to the predicate or meets established standards, and in all reported cases, the device "Passed". Specific numerical acceptance thresholds are not explicitly detailed in this summary for each test, but "Pass" indicates they were met.

Test Performed	Reported Device Performance	Implicit Acceptance Criteria (based on "Pass")
Visual Inspection	Pass	Meets visual quality standards
Connector Security	Pass	Meets EN 1616:1997 standard requirements
Instron Pull Test	Pass	Meets EN 1617:1997 & EN 1618:1997 standards
Flow Rate	Pass	Meets EN 1618:1997 & ASTM F623:2013 standards
Coating Presence	Pass	Hydrophilic coating is present and effective
Friction Test	Pass	Meets internal or recognized friction standards
Biocompatibility	Pass	Meets ISO 10993-1:2009, -5:2009, -10:2010 standards
Sterilization	Pass	Meets ISO 11135-1:2014 & ISO 11137-1:2006 standards

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: The document does not specify the sample size for any of the bench tests conducted.
Data Provenance: The document does not specify the country of origin of the data. The testing described is bench testing, not clinical data, so terms like "retrospective or prospective" do not directly apply.

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 section is Not Applicable (N/A). The "ground truth" concept is usually associated with clinical or image-based studies where expert consensus or diagnostic outcomes are used. This submission focuses on engineering bench tests and material biocompatibility, which do not typically involve experts establishing "ground truth" in this manner. The evaluations are based on compliance with international standards and internal protocols.

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

This section is Not Applicable (N/A). Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for objective bench testing of device performance parameters.

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 section is Not Applicable (N/A). This device is a urological catheter, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

This section is Not Applicable (N/A). As stated above, this is a physical medical device, not an algorithm.

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

This section is Not Applicable (N/A) in the traditional sense. For the bench tests, the "ground truth" or reference for assessment is established by the specified international and industry standards (e.g., EN 1616:1997, ASTM F623:2013, ISO 10993 series, ISO 11135-1:2014). Passing these standards serves as verification that the device meets defined engineering and safety specifications.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This section is Not Applicable (N/A). As this is not an AI/ML device, there is no training set or ground truth in that context.

Summary

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Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 24, 2019

Teleflex Medical, Inc. Sirisha Kommana Regulatory Affairs Specialist 3015 Carrington Mill Blvd., Suite 600 North Morrisville, NC 27560

Re: K181979

Trade/Device Name: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 24, 2019 Received: April 26, 2019

Dear Sirisha Kommana:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

for Glenn B. Bell, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181979

Device Name

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

Indications for Use (Describe)

The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)

ption Use (Part 21 CFR 601 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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510(k) SUMMARY

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 919-361-3939 Fax:

B. Contact Person

Sirisha Kommana Requlatory Affairs Specialist, Respiratory Division

C. Date Prepared

May 23, 2019

D. Device Name

Trade Name:	Rusch FloCath Quick™ 18 Fr. Coudé Hydrophilic IntermittentCatheter
Common Name:	Catheter, Urethral
Product Code:	GBM
Regulation Number:	CFR 876.5130
Regulation Name:	Urological Catheter and Accessories
Classification:	II
Classification Panel:	Gastroenterology/Urology

E. Predicate Device

This submission demonstrates substantial equivalence to the predicate device

Rusch® FloCath - K000070

F. Device Description

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The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter.

The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

G. Indications for Use

The Subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

H. Contraindications

Insurmountable urethral obstructions
Urethral injuries
Urethral inflammation

l. Substantial Equivalence

The proposed Teleflex Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent to the predicate devices with respect to intended use, technology and construction. The differences between the predicates and the proposed devices are minor and any risks have been mitigated through testing. Table 036-1 summarizes the differences between the proposed and predicate devices.

The proposed device is substantially equivalent to the predicate device:

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Features	Teleflex MedicalRusch FloCath QuickUrological Catheter(Subject Device)	Rusch FloCath(Predicate Device-K000070)
ClassificationName	Catheter Urethral	Catheter Urological
Product Code	GBM	KOD
Class	II	II
RegulationNumber	876.5130	876.5130
Single Use	Yes	Yes
Patient Populationfor 18 Fr.	Adult	Adult
Size Range	18 Fr.	5-30 Fr.
18 Fr. OverallLength	40 cm	40 cm
Color IndicatingSize for 18 Fr.	Red	Red
Sterile	Yes	Yes
SterilizationMethod	Ethylene Oxide	Ethylene Oxide orGamma irradiation.
Device Description	The FloCath Quick isa sterile, ready-to-use,flexible PVC catheterfor intermittentcatheterization. Thecatheter is hydrophiliccoated and has anintegrated pouchcontaining a 0.9%sterile saline solutionand a handlingsheath. The FloCathQuick is a Coudé, 18Fr. Catheter.	The Rusch FloCathCatheter consists ofa tubular PVC shaftwith attacheddrainage funnel.The catheters isdesigned with eitherNelaton, Olive orTiemann tip. Thisdevice shaft may beuncoated orHydrogel/ Hydrophiliccoated.

Shaft	Tubular	Tubular
Shaft Material	PVC	PVC
Funnel Material	PVC	PVC
Intended Use	The FloCath Quickcatheter is a tubulardevice that is insertedthrough the urethraand is used to passfluids from urinarytract.	FloCath catheter is atubular device that isinserted through theurethra and is usedto pass fluids to orfrom urinary tracts.
Indication for Use	The subject device isa tubular device that isinserted through theurethra to pass urinefrom the bladder.	FloCath catheter is atubular device that isinserted through theurethra and is usedto pass fluids to orfrom urinary tracts.
Contraindications	Insurmountableurethral obstructions Urethral injuries Urethralinflammation	None
Coating	Hydrophilic	Uncoated orHydrogel/Hydrophilic Coating
MaterialsEvaluation	The materials used inthe construction of	The materials used inthe construction of
	Section 036 – Updated 510(k) Summary		Hydrophilic Intermittent Catheter
	FloCath Quick wereevaluated per ISO10993-1:2009	predicate wereevaluated per ISO10993-5:1993,10993-10:1995
Principle ofOperation - ShortDescription of Use	Squeeze salinesachet.Move packaging upand down 2 or 3 timesto ensure coating ofthe catheter.Hang and let soak for30 seconds.Peel package open.Insert catheter usingblue protectivecatheter sleeve.	Tear peel backwrapper about 5cm.Pour water intocatheter funnel.Takes about 30seconds for catheterto activate.Remove catheterfrom the package bythe funnel and insertthe catheter.
Eyelets	Yes	Yes
Liquid for Wetting	0.9% Sterile salinesolution	Tap water
Primary Packaging	Paper and film peelback	Paper and film peelback
SecondaryPackaging	Corrugated board	Corrugated board
Shipper Case	Corrugated board	Corrugated board
Shelf-life	5 Years	5 Years
PerformanceStandards	ASTM F623:2013EN 1616:1997,EN 1617:1997,	ASTM F623-89

Table 36-1. Comparison of Predicate vs. Proposed Device

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Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

Section 036 – Updated 510(k) Summary

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Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

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J. Comparison to the Predicate

Table 36-1 illustrates the similarities and differences between the subject and predicate device (K000070). The basic technological and operating principles are the same for both devices. Both the predicate and subject device have same intended use.

Both the subject and predicate device are intended for similar patient populations, adult. Both the subject and predicate devices are disposable, sterile, single use devices. As evidenced by comparison Table 7-1, above, the proposed FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy.

K. Performance Data

The bench testing performed verifies that the performance of the subject device FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Testing Performed	Reference to Standard	Results
Visual Inspection	NA	Pass
Connector Security Test	EN 1616:1997	Pass
Instron Pull Test	EN 1617:1997EN 1618:1997	Pass
Flow Rate	EN 1618:1997ASTM F623:2013	Pass
Coating Presence	NA	Pass
Friction Test	NA	Pass
Biocompatibility Testing	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010	Pass
Sterilization	ISO 11135-1: 2014ISO 11137-1: 2006	Pass

The proposed devices were tested to the requirements of EN 1616:1997, EN1617:1997, EN 1618:1997. In addition, testing was performed to ensure compliance to ASTM F623:2013.

Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials.

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The proposed device is sterilized using Ethylene Oxide method and the saline sachet is sterilized using Gamma Irradiation method. The respective sterilization validations performed are ETO overkill method and the dose audit study.

Overall, the results are comparable to the predicate and support a determination of substantial equivalence.

L. Conclusion

The FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter has the same intended use and technological characteristics as its predicates. Test results demonstrate that the proposed 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.

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.