LOFRIC SINGLE USE URINARY CATHETER

K113424 · Astra Tech AB · EZD · Apr 17, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113424
• Device Name: LOFRIC SINGLE USE URINARY CATHETER
• Applicant: Astra Tech AB
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Apr 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

Device Story

LoFric® Single Use Urinary Catheter is a single-use, disposable device designed to provide an intermittent pathway for bladder drainage. The device consists of a plastic catheter coated with polyvinyl pyrrolidone to facilitate insertion. It is available in various lengths and configurations, including Nelaton (straight tip) and Tiemann (curved tip) designs, to accommodate individual patient anatomy. The device is packaged in a thermoformed tray with a heat-sealed paper lid. It is intended for use by patients or clinicians to manage urinary retention or bladder emptying. The device functions as a mechanical conduit; it does not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and biocompatibility testing.

Technological Characteristics

Single-use, disposable urinary catheter. Materials include plastic tubing coated with polyvinyl pyrrolidone. Available in Nelaton (straight) and Tiemann (curved) tip configurations. Sterilized using established processes. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for intermittent urinary catheterization in male and female patients requiring bladder drainage.

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

• Astra Tech LoFric® Single Use Urinary Catheter (K896750)

Submission Summary (Full Text)

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LoFric® Single Use Urinary Catheter
K113424

## 510(k) Summary

APR 1 7 2012

## Astra Tech AB

# LoFric® Single Use Urinary Catheter

April 17, 2012

Head of Regulatory Affairs

#### ADMINISTRATIVE INFORMATION

Manufacturer Name: Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431 21 Telephone: [phone] Fax: [phone] Official Contact: Christina Lewing

Representative/Consultant:

Floyd G. Larson Kevin A. Thomas, Ph.D. Allison C. Komiyama, Ph.D. PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | LoFric® Single Use Urinary Catheter |
|-----------------------------|--------------------------------------------|
| Classification Name: | Urological catheter and accessories |
| Classification Regulations: | 21 CFR Part 876.5130, Class II |
| Product Code: | EZD |
| Classification Panel: | Gastroenterology and Urology Devices Panel |
| Reviewing Branch: | Urology and Lithotripsy Devices Branch |

#### INTENDED USE

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

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### 510(k) Summary

#### DEVICE DESCRIPTION

The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.

#### EQUIVALENCE TO MARKETED DEVICE

Astra Tech AB submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the LoFric® Single Use Urinary Catheter is substantially equivalent in indications and design principles to the following legally marketed predicate device, which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:

Astra Tech LoFric® Single Use Urinary Catheter - K896750

The subject device and the predicate device both have the same intended use, which is for intermittent urinary catheterization. Both are single-use plastic catheters coated with polyvinyl pyrrolidone. Both are made using the same basic manufacturing technology, and both have the same performance characteristics. Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device.

Overall, LoFric® Single Use Urinary Catheter has the following similarities to the predicate devices:

- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design. .
- incorporates the same or very similar materials, and .
- . has similar packaging and is sterilized using the same materials and processes

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is in a sans-serif font.

#### Public Health Service

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

Astra Tech AB % Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 SAN DIEGO CA 92130

APR 17 2012

Re: K113424

> Trade/Device Name: LoFric® Single Use Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: March 30, 2012 Received: April 2, 2012

Dear Mr. Larson:

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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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,

Benjamin R. Fisher, Ph.D.

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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## 510(k) Premarket Notification

LoFric® Single Use Urinary Catheter
K113424

## Indications for Use

510(k) Number:

113424

Device Name:

LoFric® Single Use Urinary Catheter

Indications for Use:

LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

Prescription Use X ______________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D).

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

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

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| (Division Sign-Off) | |
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| Division of Reproductive, Gastrointestinal, and<br>Urological Devices | |
| 510(k) Number | K113424 |