CURE CATHETER

K110653 · Cure Medical, LLC · EZD · Aug 1, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110653
• Device Name: CURE CATHETER
• Applicant: Cure Medical, LLC
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Device Story

Cure Pediatric Catheter is an intermittent urinary catheter for bladder drainage in pediatric patients. Device is inserted through urethra; used for single-use sterile drainage. Manufactured from medical-grade, latex-free, biocompatible materials. Tip design minimizes urethral trauma. Available in multiple sizes. Device is a mechanical tool; no electronic or software components.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 standards to establish safety.

Technological Characteristics

Intermittent urinary catheter; medical-grade, latex-free, biocompatible materials; sterile, single-use packaging; various sizes; mechanical operation; no energy source; no software.

Indications for Use

Indicated for bladder drainage in pediatric males and females requiring intermittent catheterization.

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

• Cure Catheter (K072539)
• Cure Catheter Closed System (K080881)

Submission Summary (Full Text)

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

K1106.53
page 1 of 2

AUG - 1 2011

## 5. 510(k) Summary

## SUMMARY

Cure Medical, LLC

Submitter's name:

Address:

2113 Seville Avenue Newport Beach, CA 92661

Phone: Fax number: 949-673-5117 949 723-4818

Name of contact person:

Robyn Scopis Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone]

Date the summary was prepared: July 28, 2011

Name of the device: Trade or proprietary name: Common or usual name: Classification name: Classification Product Code

Cure Pediatric Catheter Cure Pediatric Catheter Intermittent Urinary Catheter Catheter, Straight 2 EZD

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|------------------------------------|--------------|
| K072539 | Cure Catheter | Cure Medical |
| K080881 | Cure Catheter Closed System | Cure Medical |

Description of the device:

The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to open, sterile, single-use packages.

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

K110 653
page 2 of 2

Indications:

An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Summary of the technological characteristics of our device compared to the predicate device:

The Cure Pediatric Catheter is substantially equivalent to the predicate devices. The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881.

Summary of Nonclinical Testing:

Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices). The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use.

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

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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

Cure Medical. LLC % Ms. Robyn Scopis Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606

AUG - 1 2011

Re: K110653

Trade/Device Name: Cure Pediatric Catheter by Cure Medical, LLC Regulation Number: 21 CFR\$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 25, 2011 Received: July26, 2011

Dear Ms. Scopis:

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 of medical device-related

{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/ucm11.5809.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.

v.tua.gov/medicaldevices/recallssection.cfm/industry/declaration.htm

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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

# 4. Indications for Use Statement

## Indications for Use

510(k) Number (if known): K110653

Device Name: Cure Pediatric Catheter by Cure Medical, LLC

Indications for Use:

An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for singleuse.

× AND/OR 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 ANOTHER PAGE OF NEEDED)

해양도출장샵ロューヨン

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

icion Sion-Of of Reproductive, Gastro-Renal, and

.....

Page 1 of