SPEEDICATH COMPACT SET (12 FR)

K121457 · Coloplast Corp. · GBM · Oct 2, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121457
• Device Name: SPEEDICATH COMPACT SET (12 FR)
• Applicant: Coloplast Corp.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Oct 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The device is intended for females only.

Device Story

Sterile, single-use, disposable polyurethane catheter for females; pre-lubricated with hydrophilic coating; immersed in saline solution. Includes pre-attached urine collection bag. Operation: remove cover, unfold bag, pull catheter from packaging; insert into urethra to drain bladder. Used by patients for intermittent catheterization. Provides easy drainage and collection of urine; improves ease of use compared to predicate.

Clinical Evidence

Bench testing only. Compliance with ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, ISO 8669-2, and ISO 10993 (biological evaluation).

Technological Characteristics

Polyurethane catheter; hydrophilic coating; saline solution immersion. Integrated urine collection bag. Complies with ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, ISO 8669-2, and ISO 10993. Sterile, single-use, disposable.

Indications for Use

Indicated for female patients with chronic urine retention and post void residual volume (PVR) due to neurogenic or non-neurogenic voiding dysfunction.

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

• SpeediCath Compact (K072808)

Reference Devices

• Conveen EasiCath Set (K973070)

Submission Summary (Full Text)

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## 510(k) Summary

ーシー

# SpeediCath Compact Set

(as required per 21 CFR § 807.92)

The assigned 510(k) number is: K121457

| Submitter. | Coloplast Corp<br>1601 West River Road North<br>Minneapolis, MN 55411 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian E. Schmidt<br>Regulatory Affairs Manager<br>Coloplast Corp<br>1601 West River Road<br>Minneapolis, MN 55411<br>USA<br>Office: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |

Date Prepared:

September 28, 2012

Device Name and Classification

| Trade Name: | SpeediCath Compact Set |
|----------------------|---------------------------------------|
| Common Name: | Urinary Catheter for Intermittent Use |
| Classification Name: | Gastroenterology-Urology Devices |
| Product Code: | GBM |

Legal Manufacturer / Manufacturing Site

Coloplast A/S Holtedam 1 DK-3050 Humlebaek Denmark

2 2012

OCT

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#### Device Description

The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

#### Substantial Equivalence Claim

Coloplast believes the proposed SpeediCath Compact Set is substantially equivalent in form and function to Coloplast's SpeediCath Compact, which was cleared under 510(k) K072808 on November 9, 2007.

SpeediCath Compact Set and the predicate device are sterile, single use catheters for intermittent use with hydrophilic coatings.

Both SpeediCath Compact Set and SpeediCath Compact are ready to use catheters with hydrophilic coatings made of the same materials and are both immersed in the same saline solution.

The difference between SpeediCath Compact Set and SpeediCath Compact is the packaging configuration and packaging material, a 2 cm longer catheter as well as the addition of an attached urine collection bag. These modifications are made for ease of use improvements. The SpeediCath Compact Set packaging configuration has the same ready to use features as the predicate, SpeediCath Compact, and is packaged in discrete containers.

SpeediCath Compact Set is similar to other catheters, e.g. Conveen EasiCath Set (K973070), in that they both have a pre-attached bag for urine collection.

SpeediCath Compact Set and the predicate, SpeediCath Compact, are for females only.

#### Indications for Use

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The device is intended for females only.

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### Summary of Testing

SpeediCath Compact Set has been tested and complies with relevance sections of ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618 and ISO 8669-2.

SpeediCath Compact Set has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

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

OCT

2012

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

Re: K121457

Trade/Device Name: SpeediCath Compact Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: August 31, 2012 Received: September 5, 2012

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. 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

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Page 2-

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin K. Evanko

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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# Statement of Indications for Use

510(k) Number (if known): K121457

Device Name: SpeediCath Compact Set

Indications for Use:

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and opeculoutir Oompact Ooks includione (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The device is intended for females only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use_ × (Per 21 CFR 801.109

Over-The-Counter Use

(Optional Format 1-2-96)

Division'Sign-Off) vision of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number