These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.

Device Description

The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

AI/ML Overview

This document is a 510(k) summary for the Rusch Simplastic Foley Catheters (K162989). It focuses on establishing substantial equivalence to predicate devices through a comparison of features and non-clinical performance testing. It does not describe a study in the typical sense of evaluating AI performance or human reader improvement.

Therefore, the requested information, which is largely geared towards evaluating an AI/CADe device's performance, cannot be extracted from this document. This document concerns a medical device (foley catheters), not an AI system. The "acceptance criteria" here refers to the device meeting specific engineering and performance standards, not diagnostic accuracy metrics.

However, I can extract the relevant non-clinical performance testing information as an analogy to acceptance criteria and the study that proves it, interpreting "device performance" in the context of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Outcome)
Balloon Peel Strength	Verified to meet performance
Balloon Security	Verified to meet performance
Deflation Reliability	Verified to meet performance
Shaft Pull Test	Verified to meet performance
Funnel Detachment	Verified to meet performance
Biocompatibility	Materials tested per ISO 10993
Sterility	Verified (Sterile)
Sterilization Method	Ethylene Oxide (Verified)

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "bench testing" was performed, but does not detail the sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for physical device bench testing in the same way it would be for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment (e.g., image interpretation). These are physical device performance tests.

4. Adjudication method for the test set:
This information is not applicable as this is not a study requiring adjudication of expert interpretations.

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 as this document does not describe a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this document does not describe an algorithm or AI system.

7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" would be established engineering specifications and regulatory standards. For example, a "Balloon Peel Strength" test would have an a priori defined minimum force requirement for the balloon to remain attached. For biocompatibility, the ground truth is compliance with ISO 10993 standards.

8. The sample size for the training set:
This information is not applicable as this document does not describe a machine learning model or training set.

9. How the ground truth for the training set was established:
This information is not applicable as this document does not describe a machine learning model or training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2017

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mills Blvd Morrisville, North Carolina 27560

Re: K162989 Trade/Device Name: Rusch Simplastic Foley Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZL Dated: February 1, 2017 Received: February 6, 2017

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. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Charles Viviano -S

For 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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Indications for Use

510(k) Number (if known) K162989

Device Name Rusch Simplastic Foley Catheters

Indications for Use (Describe)

These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of 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

Rusch Simplastic Foley Catheters

Name, Address, Phone and Fax Number of Applicant

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

Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

Date Prepared

1/23/2017

Device Name

Trade Name: Rusch Simplastic Foley Catheters

Common Name: Disposable Balloon-Retention Catheter

Classification Name: Catheter, Retention Type, Balloon (Class II per 21 CFR 876.5130, Product Code EZL)

Predicate Devices

Rusch Simplastic Foley Catheterization Set - K963996 Amsino International Amsure Hydrophilic Latex Foley Catheter (K091699)

Device Description

Indications for Use

These catheters are indicated for routine transurethral drainage of the bladder or for routine postoperative transurethral drainage and irrigation of the bladder.

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Rusch Simplastic Foley Catheters

Substantial Equivalence

The subject device is substantially equivalent to the predicate devices:

Features	Teleflex MedicalRusch Simplastic FoleyCatheters(Subject Device)	Rusch Simplastic FoleyCatheterization Set(Predicate Device-K963993)	Amsino InternationalAmsure Hydrophilic LatexFoley Catheter (K091699)
ClassificationName	Catheter, Retention Type,Balloon	Tray, Catheterization,Sterile urethral, With OrWithout Catheter	Catheter, Retention Type,Balloon
Product Code	EZL	FCM	EZL
RegulationNumber	876.5130	Same	Same
Class	II	Same	Same
Indications forUse	These catheters areindicated for routinetransurethral drainage of thebladder or for routine post-operative transurethraldrainage and irrigation of thebladder.	The Rusch Simplastic FoleyCatheter is intended to beused to pass fluid to andfrom the urinary tract. Apack of lubricating jelly isintended to assist insertionof the catheter through theurethra.	The Amsure HydrophilicLatex Foley Catheter, isintended for use in thedrainage of fluids from,and to the urinarytract/bladder
Population	Adult and Pediatric	Not Specified	Adult and Pediatric
Lumen	Two way and three way	Same	Not specified
Single Use	Yes	Same	Same
Size Range	12-28Fr	12-26Fr	12-28
Radiopaque	Yes	Same	Not Specified
Balloon Sizes	30 and 75 ml	10, 30 and 75ml	5 and 30 ml
BalloonMaterial	Latex	same	Same
Shaft Material	PVC	PVC	Silicone coated naturallatex
Coated orUncoated	Uncoated	Uncoated	Coated
Connections	Luer Taper/Funnel	Same	Same
Biocompatibility	Materials have been testedper ISO 10993	Same	Not Specified
Sterile	Yes	Same	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide or Gamma	Same

The subject device is substantially equivalent to the subject device and nonclinical test data demonstrates substantial equivalence.

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510(k) SUMMARY

Rusch Simplastic Foley Catheters

Non-clinical Performance testing

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include Balloon Peel Strength, Balloon Security, Deflation Reliability, Shaft Pull Test, and Funnel Detachment.

Conclusion

The Rusch Simplastic Foley Catheter has the same indications for use, technological characteristics and construction as its predicates. Performance test results demonstrate that the subject device meets its intended use. 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.