GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER

K140953 · Convatec, Ltd. · KOD · Aug 1, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140953
• Device Name: GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
• Applicant: Convatec, Ltd.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

Device Story

GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter is a single-use, thin, hollow tube designed for transient bladder drainage. It features a connector at one end and an olive-shaped tip at the other, with two lateral eyelets and an angled tip to facilitate insertion through the male urethra. The device is operated by a clinician or the patient for self-catheterization. It functions by providing a conduit for urine to drain from the bladder. The device is supplied sterile and is available in various French sizes (FR08-FR18).

Clinical Evidence

Bench testing only. Comparison tests performed on catheter flow rate, strength of tube and connector attachment, angle of coudé tip, and diameter of ball demonstrated performance parameters similar or superior to predicate devices.

Technological Characteristics

Materials: Plastic components bonded with cyclohexanone. Design: Thin hollow tube with connector, olive tip, and two lateral eyelets. Sizes: 8-18 FR. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for routine short-term bladder drainage in patients requiring intermittent catheterization via the urethra.

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

• GentleCath Male Tiemann Intermittent Urinary Catheter (K896729)
• Self-Cath Olive Tip Coudé Male Intermittent Urinary Catheter (K100878)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.

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

August 1, 2014

ConvaTec Ltd. Clare Williamson Senior Regulatory Affairs Executive Unit 20, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU UK

Re: K140953

> Trade/Device Name: GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: June 24, 2014 Received: June 27, 2014

Dear Clare Williamson,

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Herbert P. Lerner -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) K140953

Device Name

GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter

Indications for Use (Describe)

Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Herbert P. Lerner -S 2014.08.01 15:42:53 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Image /page/3/Picture/0 description: The image shows the logo for ConvaTec. The logo consists of the word "ConvaTec" in a sans-serif font, followed by a circular emblem. The emblem contains a stylized image of a building with three columns, enclosed within a circle.

Unit 20, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU Telephone: [phone] Facsimile: 01244 584011

Section 5

# 510(k) Summary

Applicant: ConvaTec Ltd.

Applicant Address: Unit 20, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU nK

Contact: Clare Williamson Senior Regulatory Affairs Executive

> ConvaTec Ltd. Unit 20, First Avenue, Deeside Industrial Park Deeside Flintshire CH5 2NU nK

Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: April 07, 2014

# Device Identification:

Trade Name: GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter

Common Name: Urological Catheter

Requlation Number: 21 CFR §876.5130

Classification Panel: Gastroenterology and Urology

Classification Name: Urological catheter and accessories

Regulatory Class: II

Product Code: KOD

Product Reference: 508979, 508980, 508981, 508982, 508983, 508984

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# Predicate Devices:

| 510(k) number: K896729 | GentleCath Male Tiemann Intermittent Urinary<br>Catheter<br>(formerly known as Unoplast Nelaton-, Female- or<br>Tiemann Catheter) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product reference: 501011, 501012, 501013, 501014,<br>501015, 501016 |
| 510(k) number: K100878 | Self-Cath Olive Tip Coudé Male Intermittent Urinary<br>Catheter<br>Product reference: 504710/808, 504720/810,<br>504730/812, 504740/814, 504750/816, 504760/818 |

### Device Description

The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter.

The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide.

The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.

### Intended Use

The GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter is a single use device indicated for the routine short term drainage of the bladder. The catheter is inserted through the urethra.

### Performance Testing - Bench

Details relating to performance testing of the subject device and the 2 predicate devices can be found in section 18 of this submission. The following comparison tests were performed to demonstrate substantial equivalence:

- 1) Catheter Flow Rate
- 2) Strength of Tube and Connector Attachment
- 3) Angle of Coudé Tip
- 4) Diameter of Ball

The laboratory testing shows no differences that would indicate the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for

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the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter. Therefore, the testing has demonstrated substantial equivalence of the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter to the predicate devices.

# Substantial Equivalence Conclusion

.

It has been demonstrated through comparison of design and features and performance testing, that the proposed device and its predicates have been found to be substantially equivalent; see following pages.