NEXUS IRRIGATION TUBING SET

K062551 · Nexus Medical, LLC · LJH · Dec 15, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062551
• Device Name: NEXUS IRRIGATION TUBING SET
• Applicant: Nexus Medical, LLC
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Device Story

Nexus Irrigation Tubing Set facilitates fluid delivery from a container to an irrigation site. Used during bladder irrigation, cystoscopy, transurethral resection (TUR), and arthroscopic procedures. Operated by clinicians in clinical settings. Device acts as a conduit for irrigating solutions; ensures controlled flow to the surgical or diagnostic site. Benefits patient by maintaining clear visualization and irrigation during endoscopic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tubing set for fluid delivery. No specific materials, dimensions, or software components described. Device functions as a passive conduit for irrigation solutions.

Indications for Use

Indicated for delivery of irrigating solutions to an irrigation site during bladder irrigation, cystoscopy, transurethral resection (TUR), and arthroscopic procedures. No specific patient population or contraindications provided.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## DEC 1 5 2006

Ms. Anita Smith Quality Manager Nexus Medical LLC 11315 Strang Line Road LENEXA KS 66215

Re: K062551

Trade/Device Name: Nexus Irrigation Tubing Set Regulation Number: 21 CFR §888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: LJH and HRX Dated: November 7, 2006 Received: November 9, 2006

Dear Ms. 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 (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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ting and Promoting Du

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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 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 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/cdrl/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): K062551

Device Name: Nexus Irrigation Tubing Set

Indications for Use:

The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hanson

August 2006 Nexus Medical, LLC: NITS

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

6-1