Rusch Silicone Foley Catheter

K161770 · Teleflexmedical, Inc. · EZL · May 5, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161770
• Device Name: Rusch Silicone Foley Catheter
• Applicant: Teleflexmedical, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: May 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Rusch Silicone Foley Catheter is a single-use, sterile, balloon-retention catheter. Device features a two-lumen silicone shaft; one lumen for bladder drainage via distal eye holes, one for inflation/deflation of a retention balloon using sterile water. Proximal end includes a connective funnel and Luer-activated valve. Used in clinical settings for transurethral bladder drainage. Physician or nurse inserts catheter into bladder; balloon is inflated to secure position. Output is continuous urine drainage. Device facilitates bladder emptying, benefiting patients requiring urinary management.

Clinical Evidence

Bench testing only. Performance characteristics verified via testing including Balloon Peel Strength, Balloon Security, Deflation Reliability, Shaft Pull Test, Tip Detachment, and Funnel Detachment. Biocompatibility tested per ISO 10993.

Technological Characteristics

Materials: Silicone. Design: Two-lumen balloon-retention catheter with rounded tip and two eye holes. Dimensions: 6Fr size, 300mm length, 1.5ml balloon. Sterilization: Ethylene Oxide (106 SAL). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for routine transurethral drainage of the bladder in pediatric, male, and female patients. Contraindicated in patients with insurmountable urethral passages or excessive urethral stricture via falsa.

Regulatory Classification

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).

Predicate Devices

• Guangdong Baihe Medical Technology Co., Ltd. (K130908)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] 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

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.

#### 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 Medical<br>Rusch Silicone Foley Catheter<br>(Subject Device) | Guangdong Baihe Medical Technology Co., Ltd.<br>(Predicate Device-K130908) |
|----------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Catheter, Retention Type,<br>Balloon | Same |
| Product Code | EZL | Same |
| Regulation<br>Number | 876.5130 | Same |
| Class | ll | Same |
| Indications for Use | The Rusch Brilliant Balloon<br>Catheter is indicated for<br>routine transurethral drainage<br>of the bladder | Two-way Disposable Silicone Foley Catheter: Urethral<br>catheterization for bladder drainage for urological<br>use only: indwelling time of the proposed device is no<br>more than 30 days<br>Three-way Disposable Silicone Foley Catheter: Urethral<br>catheterization for bladder drainage and bladder<br>irrigation for urological use only; indwelling time of the<br>proposed 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 of<br>29 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 of<br>Sterilization | Ethylene Oxide 106 SAL | Same |
| Biocompatibility | Materials have been tested<br>per ISO 10993 | Same |
| Main Shaft<br>Material | 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.