SELF CATH CATHETER

K100878 · Coloplast Manufacturing Us, LLC · EZD · May 26, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100878
• Device Name: SELF CATH CATHETER
• Applicant: Coloplast Manufacturing Us, LLC
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: May 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Self Cath Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Device Story

Self Cath Catheter is a urological device for bladder drainage. Device consists of flexible PVC tube with two distal eyelets for urine entry and proximal PVC connector tubing (drain funnel). Used by patients or clinicians to facilitate urine flow in individuals unable to void naturally or with significant residual urine. Device is a passive mechanical catheter; no electronic or software components. Benefits include relief of urinary retention and management of bladder emptying.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence supported by design, material, and functional performance comparisons.

Technological Characteristics

Flexible PVC tube with two distal eyelets and proximal PVC connector (drain funnel). Passive mechanical device. No energy source, connectivity, or software.

Indications for Use

Indicated for male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage due to inability to promote natural urine flow or presence of significant residual urine volume post-voiding.

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

• Self Cath Plus (K003784)

Submission Summary (Full Text)

{0}------------------------------------------------

K100878
Page 1 of 2

# 3. 510(K) SUMMARY

| 510(K) Owner's Name: | Coloplast A/S | MAY 2 6 2010 |
|-------------------------|-----------------------------------------------------------------------|--------------|
| Address: | Holtedam 1 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | | |
| | Office: [phone] | |
| | Mobile: [phone] | |
| | Fax: [phone] | |
| | e-mail: [e-mail] | |
| Name of Contact Person: | Brian E. Schmidt | |
| Address/Contact: | Regulatory Affairs Manager 1601 West River Road Minneapolis, MN 55411 | |
| Date Prepared: | March 29, 2010 | |
| Trade Name: | Self Cath | |
| Common Name: | Catheter, Urological | |
| Classification Name: | 21 CFR 876.5130 Gastroenterology-Urology Devices Class II | |
| Product Code: | EZD | |

Legally Marketed Devices to Which Your Firm Is Claiming Equivalence:

The Self Cath Catheter is substantially equivalent in performance, indications, design and materials to Self Cath Plus cleared on March 5, 2001 under premarket notification 510(k) number K003784.

{1}------------------------------------------------

K100878
Page 2 of 2

#### Description of the Device:

The Self Cath Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector tubing (drain funnel) is attached to the opposite end of the PVC tube.

### Intended Use Of The Device:

The Self Cath Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Technological Characteristics Compared To Predicate Device:

The Self Cath Catheter is substantially equivalent to the Self Cath Plus catheter.

Summary and Conclusions from the Nonclinical Tests Submitted:

Substantial equivalence of the Self Cath Catheter is supported by a comparison of the design, materials, and intended use compared to the predicates, as well as acceptable results from functional performance and biocompatibility testing.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a stylized logo of what appears to be a bird in flight. The bird is represented by three thick, curved lines that suggest the shape of wings and a head. The lines are black against a white background, creating a simple yet dynamic design. The word "BEHAVIORAL" is written vertically along the left side of the image, in a smaller font size.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Brian Schmidt Regulatory Affairs Manager Coloplast A/S 1601 West River Road North MINNEAPOLIS MN 55411

MAY 2 5 2010

Re: K100878

Trade/Device Name: Self Cath® Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: May 18, 2010 Received: May 20, 2010

Dear Mr. Schmidt:

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.

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

{3}------------------------------------------------

Page 2 -

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### 2. STATEMENT OF INDICATIONS FOR USE

## Indications for Use

100878 510(k) Number (if known):

Device Name:

Self Cath® Catheter

Indications for Use:

The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Remen
(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K100878