CURE CATHETER

K072539 · Cure Medical, LLC · EZD · Sep 13, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072539
• Device Name: CURE CATHETER
• Applicant: Cure Medical, LLC
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Sep 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females.

Device Story

Cure Catheter is an intermittent urinary catheter for bladder drainage; inserted through urethra by patients or clinicians. Device features specialized tip design to minimize urethral trauma; manufactured from medical-grade, latex-free, biocompatible materials. Provided in sterile, single-use packaging in various sizes. Used in clinical or home settings to facilitate bladder emptying.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 and FDA General Program Memorandum #G95-1 by NAmSA confirmed the device is biocompatible and safe.

Technological Characteristics

Intermittent urinary catheter; medical-grade, latex-free, biocompatible materials; sterile, single-use; various sizes; non-powered, manual device.

Indications for Use

Indicated for bladder drainage in male and female patients requiring intermittent catheterization. Provided sterile for single-use in various sizes.

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

• Rusch Easy Cath Intermittent Catheters (K033023)

Submission Summary (Full Text)

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# SEP 1 3 2007

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# 510(k) SUMMARY

| Submitted by: | Ann Kenowsky<br>Cure Medical, LLC<br>2113 Seville Avenue<br>Newport Beach, CA 92661<br>805-928-0109 (Phone)<br>949 723-4818 (Fax)<br>E-mail: [e-mail] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Smith, Ph.D., RAC<br>Bentley Biomedical Consulting, LLC<br>28241 Crown Valley Parkway, Suite 510<br>Laguna Niguel, CA 92677<br>949-340-7261 (phone)<br>949-340-7141 (fax)<br>E-mail: [e-mail] |
| Date Prepared: | August 11, 2007 |
| Device Name: | Cure Catheter ^TM |
| Trade Name: | Cure Catheter ^TM |
| Common Name: | Intermittent Urinary Catheter |
| Classification Name: | Catheter, Urological |
| Device Class: | II |
| Procode: | KOD |
| CFR Reference: | 876.5130 |
| Predicate Device: | Rusch Easy Cath Intermittent Catheters |
| Predicate 510(k) #: | K033023 (Rusch) |
| Device Description: | The Cure Catheter ^TM device is an intermittent urinary<br>catheter intended to be used by males and females for the<br>purpose of bladder drainage. It is manufactured with<br>conventional medical grade, latex-free, biocompatible<br>materials. The tip has been designed to eliminate trauma to<br>the urethra and is provided in a variety of sizes in easy-to-<br>open, sterile, single-use packages. |
| Intended Use: | The Cure Catheter ^TM is an intermittent urinary catheter that<br>is inserted through the urethra and indicated for the purpose<br>of bladder drainage for males and females. |

CURE MEDICAL • 2113 Seville Ave. • Newport Beach, CA 92661 • 800 570-1778 • www.curemedical.com

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K072534
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| Technology Comparison: | The Cure Catheter™ is substantially equivalent to the<br>predicate device. The two devices are similar in function,<br>composition, and intended use. |
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| Nonclinical Testing: | Standard biocompatibility tests were performed on the Cure<br>Catheter™ to establish device safety. The tests and assays<br>performed are typically performed for these medical<br>devices. All tests were performed in accordance with US<br>FDA General Program Memorandum #G95-1 and Part-<br>10993-1 of the International Standard Organization (ISO)<br>Standard (Biological Evaluation of Medical Devices) by<br>North America Science Associates, Inc. (NAmSA). The<br>studies indicated that the Cure Catheter™ is biocompatible<br>and safe for its intended use. |
| Conclusion of Comparison: | The Cure Catheter™ is substantially equivalent to the<br>currently-marketed predicate device, the Rusch Easy Cath<br>Intermediate Catheter. |

.

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SEP 1 3 2007

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Cure Medical, LLC c/o Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

Re: K072539

> Trade/Device Name: Cure Catheter™ Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and GBM Dated: September 7, 2007 Received: September 10, 2007

#### Dear Mr. Conry:

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 individe for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commence 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 ano rice. The general 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 (Premarket Approval), it may be subject to such 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.

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Protecting and Promoting Public Health.

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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 not 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gal/y marketed predicate device results in a classification for your device and thus, persons your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_ Cure Catheter

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulen Lemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number

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نيت

CURE MEDICAL • 2113 Seville Ave. • Newport Beach, CA 92661 • 800 570-1778 • www.curemedical.com