CURE CATHETER CLOSED SYSTEM

K080881 · Cure Medical, LLC · KOD · Jun 11, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080881
• Device Name: CURE CATHETER CLOSED SYSTEM
• Applicant: Cure Medical, LLC
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Cure CatheterTM Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Device Story

Intermittent urinary catheter attached to collection bag; used for bladder drainage. Inserted through urethra. Manufactured from medical-grade, latex-free, biocompatible materials. Tip design minimizes urethral trauma. Provided in various sizes; sterile, single-use packaging. Offered as standalone catheter or complete kit. Used in clinical or home settings by patients or caregivers. Facilitates bladder emptying; reduces risk of urinary retention.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with FDA General Program Memorandum #G95-1 and ISO 10993-1. Device met all acceptance criteria.

Technological Characteristics

Intermittent urinary catheter with collection bag. Materials: medical-grade, latex-free, biocompatible polymers. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for bladder drainage in male and female patients 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

• Rusch MMG/O'Neil Catheter (K010420)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a logo with the word "CURE" in bold, sans-serif font. The word is positioned within a circular shape. A stylized checkmark extends from the right side of the circle, adding a dynamic element to the design. The logo has a textured, possibly distressed appearance, with a grainy effect surrounding the central elements.

K080881

Page 1 of 2

## 510(k) SUMMARY

JUN 1 1 2008

Submitted by:

Ann Kenowsky Cure Medical, LLC 2113 Seville Avenue Newport Beach, CA 92661 949 673-8474 (Phone) 949 723-4818 (Fax) E-mail: [e-mail]

Contact Person:

James Smith, Ph.D., RAC DeFerris, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 949-340-7261 (phone) 949-340-7141 (fax) E-mail: [e-mail]

Date Prepared: February 7, 2008 Trade Name: Cure Catheter™ Closed System Common Name: Urological Catheter Classification Name: Catheter, Urological Device Class: II Procode: KOD/FCM CFR Reference: 876.5130 Predicate Device: Rusch MMG/O'Neil Catheter (K010420) Predicate 510(k) #: K010420 (Rusch) Device Description: The Cure Catheter™ Closed System is an intermittent

urinary catheter attached to a collection bag and intended to be used by 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 sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.

Page 5 of 21

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

K080881

Page 2 of 2

Image /page/1/Picture/1 description: The image shows a logo with the word "CURE" in bold, stylized letters. Below the word, there is a white silhouette of a bird in flight. The logo is set against a textured, oval-shaped background that fades into a grainy, dark border, giving the image a vintage or hand-drawn appearance.

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Intended Use: | The Cure CatheterTM Closed System is an intermittent<br>urinary catheter attached to a collection bag that is inserted<br>through the urethra and indicated for the purpose of bladder<br>drainage for males and females. The urinary catheter<br>comes in a variety of sizes packaged sterile for single-use. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology Comparison: | The Cure CatheterTM Closed System is substantially<br>equivalent to the predicate device. The devices are similar<br>in function, composition, and intended use. |
| Nonclinical Testing: | Standard biocompatibility tests were performed on the Cure<br>CatheterTM Closed System to establish device safety. The<br>tests and assays performed are typically performed for<br>these medical devices. All tests were performed in<br>accordance with US FDA General Program Memorandum<br>#G95-1 and Part-10993-1 of the International Standard<br>Organization (ISO) Standard (Biological Evaluation of<br>Medical Devices) by North America Science Associates,<br>Inc. (NAmSA). The Cure CatheterTM Closed System met<br>the acceptance criteria for all tests conducted and is<br>considered biocompatible under the conditions tested. |
| Conclusion of Comparison: | The Cure CatheterTM Closed System is substantially<br>equivalent to the currently-marketed predicate device, the<br>Rusch MMG/O'Neil Catheter. |

Lage 6 of 21

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

## 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2008

Cure Medical, LLC c/o James Smith, Ph.D., RAC Consultant, Regulatory Affairs DeFerris, Inc. 29442 Pointe Rovale LAGUNA NIGUEL CA 92677

K080881 Re:

Trade/Device Name: Cure Catheter" Closed System Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: KOD and FCM Dated: May 22, 2008 Received: May 27, 2008

Dear Dr. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

{3}------------------------------------------------

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); 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 a legally marketed predicate device results in a classification for your device and thus, permits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy C. Brogdon

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

Enclosure

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

Image /page/4/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K080881". The characters are written in a cursive style, with some connections between the letters and numbers. The writing is in black ink on a white background.

Image /page/4/Picture/1 description: The image shows a logo with the word "CURE" in bold, stylized letters. The letters are arranged in a slightly curved manner, with the "C" and "E" being more prominent. A wing-like shape extends from the bottom right of the "U", adding a sense of movement or aspiration to the design. The logo is set against a textured, circular background that appears to be shaded or distressed, giving it a vintage or slightly worn appearance.

## INDICATIONS FOR USE

9080881 510(k) Number (if known):_

Device Name: Cure Catheter Closed System

Indications for Use:

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

Prescription Use × (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)

Herbert Hoover

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

Page 1 of 1

Cure Medical, LLC 2113 Seville Avenue, Newport Beach, CA 92661 Page 4 of 21