CATHETER CONNECTOR

K023690 · World Metals, Inc. · KNY · Feb 28, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023690
• Device Name: CATHETER CONNECTOR
• Applicant: World Metals, Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Feb 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physiclan's prescription.

Device Story

Quick Disconnect Plug facilitates patient mobility during urinary catheterization; allows temporary disconnection of catheter from drainage bag. Device consists of body and insert with integrated shut-off valve; inserted into catheter end to seal urine flow during disconnection. Used in clinical or home settings by patients, nurses, or physicians. Enables patient to perform rehabilitative exercises without drainage bag obstruction. Benefits include increased patient comfort and safety. Single-use, sterile device.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility confirmed via USP Class VI material testing. Packaging and shelf-life (5 years) validated through transportation testing.

Technological Characteristics

Components: body and insert with shut-off valve, plus vinyl tubing coupler. Materials: USP Class VI non-toxic. Dimensions: one size fits catheters up to size 26. Sterilization: ETO gas. Connectivity: None.

Indications for Use

Indicated for patients requiring urinary catheterization to facilitate bladder drainage. Used to temporarily disconnect the catheter from the drainage bag for up to 2 hours. Intended for short-term use (up to 14 days). Prescription use only.

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

• Simple urinary catheter plug (preamendment device)

Submission Summary (Full Text)

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Ko23690

Page 1 of 2

# 510 (K) SUMMARY:

FEB 2 8 2003

The 510 (k) summary of Quick Disconnect Plug connector:

- . Predicate Device:
The Quick Disconnect Plug is substantially equivalent, but an improvement over the predicate preamendment device, which is a simple urinary catheter plug that stops the flow of urine from leaving the catheter.

- Device Description:
The Quick Disconnect Plug is designed to facilitate a speedy, comfortable, and safe rehabilitation for patients requiring use of a urinary catheter. The use of a urinary catheter to facilitate drainage from the bladder is usual and customary following most surgery. In using a catheter, it is connected to a collection bag, which becomes a potential physical hazard and a source of discomfort to the patient in attempting to do rehabilitative exercise. The Quick Disconnect Plug allows the patient and/or attending nurse or physician to quickly disconnect the catheter from the drainage bag, leaving one half of the Quick Disconnect Device, which has a shut-off valve built in, in the open end of the catheter and seals off the flow of urine until such time as it is reconnected and the flow is once again resumed between the catheter and the collection bag.

- Technical Characteristics:
The device is made up of two main components: (1) the body; and (2) the insert with the valve. Also included in the sterilized package is a vinyl tubing coupler.

All components included above are made of non-toxic ingredients that meet USP Class VI requirements. Diagrams, drawings, and photographs of the above components are included and attached to this statement.

One size is adequate to handle catheters up to and including size 26.

Intended use of the device is for one-time use only for short durations of 2 weeks (14 days) or less with a 2-hour disconnection time interval from the bag before reconnection to evacuate the bladder. This is to be sold as a sterile product with a 5-year shelf-life. Corresponding paperwork to substantiate statement is enclosed.

This device is sold with a restriction by order of a physician in accordance with 21 CFR 801.109.

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KOJ3890
Page 2 of 2

### 510 (k) Summary (Continued):

- . Performance Standards:
None established.

- Sterilization
.

♥

Sterilization will be ETO (ethylene oxide) gas.

Medsource Packaging Concepts is the company who will be packaging the product. Sterilization Services is the sterilization facility who will be processing the product.

Medsource Packaging Concepts (FDA Registration #1125782) is a Manufacturer/ Repacker/Relabeler of finished devices which may be received nonsterile or sterile from the original manufacturer. Sterilization Services of Virginia (FDA Registration #1123137) is a contract sterilization facility located in Richmond, Virginia.

The packaging method has been tested and proven to have a shelf-life of 5 years, and has been transportation tested over the past 15 years, and has shown no damage or deterioration caused by transportation of this product after sterilization.

Labeling and Instruction Sheet.

Labeling and instruction sheet to conform to device labeling guidance (Blue Book Memo G91-1). Picture of label and copy of instruction sheet to be included with this statement.

- Biocompatibility:
Device is made of all USP Class VI material. Bioincompatibility and/or toxicity in using this device is virtually zero. Refer to biocompatibility statement enclosed.

Safety and Effectiveness:

This product is being manufactured and sterilized under government regulated guidelines and should cause no harmful effects to any patient.

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Image /page/2/Picture/1 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 perimeter. Inside the circle is an abstract image of an eagle.

### Public Health Service

FEB 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Martin Mitchell World Metals Inc. 1020 NE 27th Avenue Pompano Beach, FL 33062 Re: K023690 Trade/Device Name: Catheter Connector Quick Disconnect Plug Regulation Number: 21 CFR§ 876. 5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: February 13, 2003 Received: February 14, 2003

Dear Mr. Mitchell:

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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#### KO23690 510 (k) Number:

Quick Disconnect Plug Device Name:

## Indications for Use:

The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physiclan's prescription.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kirill A. Lazann

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023690

OR

**Prescription Use**
(Per 21 CFR 801.109)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________