The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

Device Description

The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.

AI/ML Overview

This document describes the Teleflex Rusch Hydrophilic Intermittent catheters (comprising Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, and Rusch MMG H2O Singles). This submission is for a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a claim of superiority or novel performance requiring extensive clinical studies typically associated with AI/ML devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of medical device submission.

The submission focuses on establishing substantial equivalence through "bench testing" and biocompatibility studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical "acceptance criteria" for each performance characteristic with corresponding reported values in a table format that would be typical for an AI/ML device. Instead, it states that "The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." and "The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." It also adds, "Overall, the results are comparable to the predicate and support a determination of substantial equivalence."

Here's a summary of the performance characteristics evaluated and the reported outcome:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Visual Inspection	Meets predefined visual quality standards.	Performance verified to be substantially equivalent to the predicate device.
Flow Rate	Achieves flow rates comparable to the predicate device.	Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate.
Friction Test	Exhibits friction characteristics comparable to the predicate device.	Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate.
Coating Presence	Presence of a functional hydrophilic coating as designed.	Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate.
Biocompatibility	Meets ISO 10993-1, -5, -10 standards.	Cytotoxicity, Sensitization, and Irritation tests were performed, demonstrating biocompatibility. Results are comparable to the predicate and support substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify exact sample sizes for each bench test performed. For physical tests like flow rate and friction, standard engineering practices would involve testing a statistically representative sample from multiple production lots. For biocompatibility, testing is typically performed on material extracts according to ISO standards, which define the sample sizes and controls.

As this is a physical device, not an AI/ML system, concepts like "data provenance" (country of origin of data, retrospective/prospective) are not applicable in the same way. The testing would have been conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. For a physical medical device submission like this, "ground truth" as it relates to expert consensus or labeling of images/data for AI training/testing is not relevant. The performance is assessed against engineering specifications, industry standards (e.g., ASTM F623, ISO 10993), and direct comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. This concept is typically relevant to AI/ML where human reviewers might adjudicate disagreements in interpretations. For physical device testing, the methods are typically standardized and objective (e.g., measuring flow rate, instrumental assessment of friction).

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. An MRMC study is designed for evaluating diagnostic or interpretive AI systems in a clinical setting by comparing human performance with and without AI assistance. This submission is for a physical urological catheter, not an AI-enabled diagnostic tool.

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

Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.

7. The Type of Ground Truth Used:

For the physical and biocompatibility testing, the "ground truth" is derived from:

Engineering Specifications: The design specifications of the device.
Predicate Device Performance: The known and established performance of the legally marketed predicate device (Rusch® FloCath - K000070). The subject device aims to be "substantially equivalent."
International Standards: Adherence to standards such as ASTM F623 for physical properties and ISO 10993 series (1, 5, 10) for biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not an AI/ML device that requires a training set or ground truth in that context.

Summary

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May 8, 2019

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd., Suite 600 North Morrisville, NC 27560

Re: K183461

Trade/Device Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 5, 2019 Received: April 8, 2019

Dear Lori Pfohl:

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.

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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 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.htm); 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 medical devices and radiation-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.

Purva Pandya Acting, Assistant Division 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) K183461

Device Name

Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles).

Indications for Use (Describe)

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

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

Lori Pfohl Senior Regulatory Affairs Specialist

C. Date Prepared

May 7, 2019

D. Device Name

Trade Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles)

Common Name:	Catheter, Urethral
Product Code:	GBM
Regulation Number:	CFR 876.5130
Classification 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

Teleflex Medical, Inc.

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polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.

G. Indications for Use

H. Contraindications

Insurmountable urethral obstructions
Urethral injuries
Urethral inflammation

I. Substantial Equivalence

The subject device Teleflex Rusch FloCath Quick 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 subject devices are minor and any risks have been mitigated through testing. Table 07.1 summarizes the differences between the subject and predicate device.

The subject devices are substantially equivalent to the predicate device:

Features	Teleflex MedicalRusch FloCath QuickUrological Catheter(Subject Devices 1)	Teleflex MedicalRusch MMGUrological Catheter(Subject Device 2)	Rusch FloCath - Uncoated orCoated Urological Catheter(Predicate Device-K000070)
ClassificationName	Urological Catheterand Accessories	Same	Same
RegulationNumber	876.5130	876.5130	Same
FDA Procode	GBM	GBM	KOD
Class	II	II	Same
Indication for Use	The RuschHydrophilicIntermittent	The Rusch HydrophilicIntermittentcatheters (Rusch	The FloCath catheter is atubular device that isinserted through the urethra

	catheters (RuschFloCath Quick, RuschFloCath Quick Kit,Rusch FloCathIntermittentCatheter, RuschMMG H2O PVCCatheter Kit, RuschMMG H2O Singles)are tubular devicesthat are insertedthrough the urethrato pass urine fromthe bladder.	FloCath Quick, RuschFloCath Quick Kit,Rusch FloCathIntermittent Catheter,Rusch MMG H2O PVCCatheter Kit, RuschMMG H2O Singles)are tubular devicesthat are insertedthrough the urethrato pass urine from thebladder.	and is used to pass fluids toor from urinary tracts.
Contraindications	- Insurmountableurethralobstructions-Urethral injuries-Urethralinflammation	None	None
Single Use	Yes	Yes	Same
Population	Adult and Pediatric,Male and Female	Adult and Pediatric,Male and Female	Same
Size Range	6-20 Fr.	6-20 Fr.	5-30 Fr.
Overall Length	40 cm	40cm	Same
Shaft	Tubular	Tubular	Same
Shaft Material	PVC (Mucosal andskin, limited contact<24hr)	PVC (Mucosal andskin, limited contact<24hr)	Same
Coating	Hydrophilic	Hydrophilic	Uncoated or Hydrogel/Hydrophilic Coating
Biocompatibility	Evaluation andtesting within therisk managementprocess ISO 10993-1:Cytotoxicity ISO10993-5Sensitization ISO10993-10Skin Irritation ISO10993-10	Evaluation and testingwithin the riskmanagement processISO 10993-1:Cytotoxicity ISO10993-5Sensitization ISO10993-10Skin Irritation ISO10993-10	Same
Tip	Nelaton, Olive, orTiemann tip	Split introducer,introducer tip, andcap	Nelaton, Olive, or Tiemanntip
Eyelets	Yes	Yes	Yes
	solution	solution
Primary Packaging	Paper and film peelback	Paper and film peelback	Same
Sterile	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Shelf-life	5 Years	5 Years	Same

Table 07.1 - Comparison of Predicate vs. Subject Devices

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Teleflex Medical, Inc.

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J. Comparison to the Predicate

Table 7.1 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 devices have same intended use.

Both the subject and predicate devices are intended for similar patient populations adult and pediatric, male and female. Both the subject and predicate devices are disposable, non-sterile, single patient use devices. As evidenced by comparison Table 7.1, above, the subject FloCath Quick 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 devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Visual Inspection
Flow Rate
Friction Test
Coating Presence
Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization

The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device.

The subject devices were tested to the requirements of ASTM F623.

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Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials. Overall, the results are comparable to the predicate and support a determination of substantial equivalence.

L. Conclusion

The Rusch Hydrophilic Intermittent Catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

The Rusch Hydrophilic Intermittent Catheters have the same intended use and technological characteristics as the predicate. Test results demonstrate that the subject devices meet their intended use and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject devices 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.