IRRIGATION SETS

K023808 · International Medsurg Connection · LJH · Mar 10, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023808
• Device Name: IRRIGATION SETS
• Applicant: International Medsurg Connection
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Mar 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

Device Story

Irrigation set consisting of tubing segments, connectors, and flow regulators; facilitates delivery of irrigation solutions from fluid containers to surgical sites during endoscopic procedures (cystoscopy, TUR, arthroscopy). Used in clinical settings by healthcare professionals. Device connects to endoscopes to provide continuous fluid flow to the bladder or knee joint. Benefits include maintaining clear visualization and irrigation during minimally invasive surgery. No electronic or software components.

Clinical Evidence

Bench testing only. Evaluation included physical and chemical testing: oxidizable matter, acidity/alkalinity, UV absorbancy, metallic ions, evaporated residual, connection integrity, flow rate, and mechanical properties of fittings and tubing.

Technological Characteristics

Tubing-based irrigation system. Components include tubing, drip chambers, flow regulators, and conical fittings. Evaluated for chemical properties (oxidizable matter, metallic ions) and mechanical integrity (connection strength, flow rate, fitting taper/dimensions).

Indications for Use

Indicated for patients undergoing bladder irrigation or endoscopic procedures, including cystoscopy, transurethral resection (TUR), and arthroscopic procedures, requiring delivery of irrigation solutions to sites such as the bladder or knee.

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

• Baxter Healthcare Corporation Irrigation Sets

Submission Summary (Full Text)

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Ko23808

## SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

INTERNATIONAL MEDSURG CONNECTIONS IRRIGATION SETS

| Manufacturer: | International Medsurg Connections, Inc.<br>935 N. Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|--|
| Regulatory Affairs Contact: | Michele Vovolka<br>P.O. Box 848<br>Grayslake, Illinois 60030 | |
| Telephone: | [phone] | |
| Date Summary Prepared: | November 5, 2002 | |
| Product Trade Name: | TUR, Arthroscopic, Cystoscopy Irrigation Sets | |
| Common Name: | Irrigation Sets | |
| Classification: | Class II | |
| Predicate Devices: | | |

Description: The International Medsurg Connections Irrigation Sets.

Intended Use:

This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

Substantial Equivalence:

The International Medsurg Connections Irrigation Sets are substantially equivalent to the Baxter Healthcare Corporation Irrigation Sets in that they provide the following characteristics:

- Intended use is the same
- Similar configurations
- Similar materials

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Ko23808

Summary of Testing: All materials used in the fabrication of the International Medsurg Connections Irrigation Sets were evaluated for:

| Joined Tubing 5" and 20" | Irrigation Sets* |
|-----------------------------------------|-------------------------------|
| Oxidizable Matter | Oxidizable Matter |
| Acidity and Alkalinity | Acidity and Alkalinity |
| UV Absorbancy | UV Absorbancy |
| Metallic ions | Metallic ions |
| Evaporated Residual | Evaporated Residual |
| Diameter of the end conical fitting | Integrity |
| Length of conical fitting | Connection between components |
| Taper of conical fitting | Closure-piecing device |
| Separate force of conical fitting | Tubing |
| Tightness of conical fitting | Drip chamber and drip tubing |
| Force of split the conical fitting | Flow rate of infusion |
| Diameter of conical aperature | Flow regulator |
| Depth of conical aperature | Self-sealing injection site |
| Taper of conical aperature | Protective caps |
| Separate force of conical aperature | Symbol |
| Tightness of conical aperature | Packing |
| Force of split the conical aperature | Chemical property |
| Outer diameter of conical fitting on | |
| outstanding position | |
| Angle of conical fitting on outstanding | |
| postion | |
| Length of tubing | |
| Connection Strength | |
| Integrity | |

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2003

International Medsurg Connection % Ms. Michele H. Vovolka Regulatory Consultant Vantage Consulting International, Ltd. P.O. Box 848 GRAYSLAKE IL 60030

Re: K023808

Trade/Device Name: Irrigation Sets Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: 87 HRX Dated: February 18, 2003 Received: February 19, 2003

Dear Ms. Vovolka:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

International Medsurg Connections Irrigation Sets Device Name:

Indications For Use:

This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)