Rusch Simplastic Foley Catheters

K162989 · Teleflexmedical, Inc. · EZL · Feb 24, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162989
• Device Name: Rusch Simplastic Foley Catheters
• Applicant: Teleflexmedical, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Rusch Simplastic Foley Catheter is a single-use, sterile, balloon-retention catheter. Device consists of a transparent PVC shaft (12-28Fr) with 2 or 3 lumens, a proximal funnel, an inflation valve, and a distal latex retaining balloon (30 or 75 ml). Used in clinical settings for transurethral bladder drainage or post-operative irrigation. Operated by healthcare professionals. Device facilitates fluid passage to/from the urinary tract; balloon secures catheter position within the bladder. Benefits include effective bladder management and post-operative care.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including balloon peel strength, balloon security, deflation reliability, shaft pull test, and funnel detachment.

Technological Characteristics

Materials: PVC shaft, latex balloon. Design: 2 or 3 lumen, 12-28Fr, radiopaque. Sterilization: Ethylene Oxide. Biocompatibility: Tested per ISO 10993. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for routine transurethral bladder drainage or post-operative drainage and irrigation in adult and pediatric patients.

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

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

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

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

#### 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

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.

#### 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 Medical<br>Rusch Simplastic Foley<br>Catheters<br>(Subject Device) | Rusch Simplastic Foley<br>Catheterization Set<br>(Predicate Device-<br>K963993) | Amsino International<br>Amsure Hydrophilic Latex<br>Foley Catheter (K091699) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Catheter, Retention Type,<br>Balloon | Tray, Catheterization,<br>Sterile urethral, With Or<br>Without Catheter | Catheter, Retention Type,<br>Balloon |
| Product Code | EZL | FCM | EZL |
| Regulation<br>Number | 876.5130 | Same | Same |
| Class | II | Same | Same |
| Indications for<br>Use | These catheters are<br>indicated for routine<br>transurethral drainage of the<br>bladder or for routine post-<br>operative transurethral<br>drainage and irrigation of the<br>bladder. | The Rusch Simplastic Foley<br>Catheter is intended to be<br>used to pass fluid to and<br>from the urinary tract. A<br>pack of lubricating jelly is<br>intended to assist insertion<br>of the catheter through the<br>urethra. | The Amsure Hydrophilic<br>Latex Foley Catheter, is<br>intended for use in the<br>drainage of fluids from,<br>and to the urinary<br>tract/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 |
| Balloon<br>Material | Latex | same | Same |
| Shaft Material | PVC | PVC | Silicone coated natural<br>latex |
| Coated or<br>Uncoated | Uncoated | Uncoated | Coated |
| Connections | Luer Taper/Funnel | Same | Same |
| Biocompatibility | Materials have been tested<br>per ISO 10993 | Same | Not Specified |
| Sterile | Yes | Same | Same |
| Sterilization<br>Method | 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.