LOFRIC SENSE

K123751 · Wellspect Healthcare · EZD · Feb 28, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123751
• Device Name: LOFRIC SENSE
• Applicant: Wellspect Healthcare
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Feb 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intermittent urinary catheterization.

Device Story

LoFric® Sense™ is a single-use, intermittent urinary catheter for bladder drainage. Device features a Nelaton (straight) tip and various diameters to accommodate patient anatomy. Packaged with an integrated water packet; user breaks packet immediately before use to hydrate the hydrophilic coating on the tubing. Used in clinical or home settings to facilitate urine drainage. Benefits include reduced friction during insertion and removal due to the hydrophilic coating. Healthcare providers or patients perform the procedure.

Clinical Evidence

Bench testing only. Evidence includes dimensional analysis, biocompatibility testing, and performance testing conducted in accordance with ASTM F623 standards.

Technological Characteristics

Single-use intermittent catheter; Nelaton (straight) tip; polyvinyl pyrrolidone hydrophilic coating; plastic construction. Performance testing per ASTM F623. Sterilized using same processes as predicate.

Indications for Use

Indicated for patients requiring intermittent urinary catheterization for 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® Primo™ (K122078)

Submission Summary (Full Text)

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K123751
Page 1 of 2

LoFric® Sense™

FEB 2 8 2013

## 510(k) Summary

## Wellspect HealthCare

LoFric® Sense™

December 27, 2012

## ADMINISTRATIVE INFORMATION

| Manufacturer Name | Wellspect HealthCare<br>Aminogatan 1, P. O. Box 14<br>Mölndal, Sweden SE-431 21 | |
|---------------------------|---------------------------------------------------------------------------------|--------------------------------------------|
| | Telephone: | [phone] |
| | Fax: | [phone] |
| Official Contact | Herman Fahlström | |
| | Head of Quality Systems and Regulatory Affairs | |
| Representative/Consultant | Allison C. Komiyama, Ph.D. | |
| | Floyd G. Larson | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| | Email: | [e-mail]<br>[e-mail] |

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | LoFric® Sense™ |
|------------------------------------------|--------------------------------------------------------------------------------------|
| Classification Name | Urological catheter and accessories |
| Classification Regulations | 21 CFR Part 876.5130, Class II |
| Product Code | EZD |
| Classification Panel<br>Reviewing Branch | Gastroenterology and Urology Devices Panel<br>Urology and Lithotripsy Devices Branch |

510(k) Summary

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510(k) Summary

K123751
Page 2 of 2

#### INTENDED USE

Intermittent urinary catheterization.

#### DEVICE DESCRIPTION

LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.

#### EQUIVALENCE TO MARKETED DEVICE

Wellspect HealthCare submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, LoFric® Sense " is substantially equivalent in indications and design principles to the following legally marketed predicate device:

Astra Tech, LoFric® Primo™ - K122078

The subject device and the predicate device have the same intended use for intermittent urinary catheterization. All are single-use plastic catheters coated with polyvinyl pyrrolidone. They are made using the same basic manufacturing technology, and all have similar 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. Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy.

Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included: dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623.

The data included in this submission demonstrate substantial equivalence to the predicate device listed above.

Overall, LoFric® Sense" has the following similarities to the predicate device:

- . 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

February 28, 2013

Wellspect HealthCare % Allison C. Komiyama, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K123751

Trade/Device Name: LoFric® Sense™ Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: December 5, 2012 Received: December 6, 2012

Dear Dr. Komiyama:

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. Ilsting 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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Page 2 - Allison C. Komiyama, Ph.D.

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,

Image /page/3/Picture/6 description: The image shows the name "Benjamin B. Fisher -S" in a stylized font. The first name, Benjamin, is written in a simple, bold font. The middle initial and last name are written in a more complex, geometric font that appears to be made up of lines and shapes. The "-S" at the end is written in the same simple, bold font as the first name.

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

K123751 510(k) Number:

LoFric® Sense™ Device Name:

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

# Benjamin 2013.02.28

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Jrological Devices 510(k) Number _ KIZ375