The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.

AI/ML Overview

The provided document is a 510(k) Summary for the Rusch Silicone Foley Catheter, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific efficacy or diagnostic performance acceptance criteria through clinical studies. Therefore, much of the information requested about acceptance criteria and detailed study design for diagnostic performance is not present in this document.

However, I can extract information related to the non-clinical performance testing which served to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., a specific peel strength in Newtons) or reported numerical performance data for the subject device. It states what was tested and the conclusion that the subject device is substantially equivalent.

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Balloon Peel Strength	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Balloon Security	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Deflation Reliability	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Shaft Pull Test	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Tip Detachment	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Funnel Detachment	Not explicitly stated (implied to be equivalent to predicate)	Not explicitly stated (implied to meet equivalence)
Biocompatibility	Per ISO 10993	Materials tested per ISO 10993

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any of the individual non-clinical performance tests.
Data Provenance: The tests are "bench testing" which are conducted in a laboratory setting. No country of origin is specified for these tests, but the applicant is Teleflex Medical, Inc. in the USA. The data is retrospective in the sense that the tests were performed and analyzed to support this 510(k) submission.

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

This type of information is not applicable to the non-clinical performance (bench testing) described. Bench tests do not involve expert interpretation or ground truth establishment in the way a clinical diagnostic study would.

4. Adjudication Method for the Test Set

This is not applicable as there were no expert interpretations requiring adjudication for these bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This document describes a medical device (catheter) for drainage, not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a physical medical device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards, internal company standards) for measuring properties like peel strength, security, and reliability. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. For biocompatibility, the ground truth is established by the successful completion of tests adhering to ISO 10993.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no 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

May 5, 2017

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K161770

Trade/Device Name: Rusch Silicone Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: April 6, 2017 Received: April 7, 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.

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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 (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.

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/ResourcesforYou/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,

Benjamin R. Fisher -S

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)

K161770

Device Name Rusch Silicone Foley Catheter

Indications for Use (Describe)

The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage 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 Silicone Foley Catheter

Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 919-433-4996 Fax:

Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

Date Prepared

4/5/2017

Device Name

Trade Name: Rusch Silicone Foley Catheter

Common Name: Disposable Balloon-Retention Catheter

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

Predicate Device

Guangdong Baihe Medical Technology Co., Ltd. - K130908

Device Description

Indications for Use

The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder

Intended Population: Pediatric

Teleflex Medical

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510(k) SUMMARY

Rusch Silicone Foley Catheter

Contraindications

-Insurmountable urethral passages -Excessive urethral stricture via falsa

Substantial Equivalence

The subject device is substantially equivalent to the predicate devices:

Features	Teleflex MedicalRusch Silicone Foley Catheter(Subject Device)	Guangdong Baihe Medical Technology Co., Ltd.(Predicate Device-K130908)
ClassificationName	Catheter, Retention Type,Balloon	Same
Product Code	EZL	Same
RegulationNumber	876.5130	Same
Class	ll	Same
Indications for Use	The Rusch Brilliant BalloonCatheter is indicated forroutine transurethral drainageof the bladder	Two-way Disposable Silicone Foley Catheter: Urethralcatheterization for bladder drainage for urologicaluse only: indwelling time of the proposed device is nomore than 30 daysThree-way Disposable Silicone Foley Catheter: Urethralcatheterization for bladder drainage and bladderirrigation for urological use only; indwelling time of theproposed device is no more than 30 days
Population	Pediatric, Male and female	Same
Lumen	Two-Way	Two way and three way
Indwell Time	Maximum indwell time of29 days	No more than 30 days
Single Use	Yes	Same
Size Range	6Fr	6-26Fr
Length	300 ±10mm	310mm and 400mm
Balloon	Yes	Same
Balloon size	1.5ml	Same
Sterile	Yes	Same
Method ofSterilization	Ethylene Oxide 106 SAL	Same
Biocompatibility	Materials have been testedper ISO 10993	Same
Main ShaftMaterial	Silicone	Same
Eyes in Tip	Yes	Same
Standard Funnel	Yes	Same
Tip Shape	Rounded	Same

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510(k) SUMMARY

Rusch Silicone Foley Catheter

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

Non-clinical Performance testing

The bench testing performed verifies that the performance of the subject Rusch Silicone Foley Catheter 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, Tip Detachment, and Funnel Detachment.

Conclusion

The Rusch Silicone 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.