K.E.P. CONNECTOR AND CLIP

K042900 · K.E.P., LLC · KDJ · Nov 5, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042900
• Device Name: K.E.P. CONNECTOR AND CLIP
• Applicant: K.E.P., LLC
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2

Indications for Use

The K.E.P. Connector and Clip is a non-sterile, right-angle barbed connector and retaining clip that is used to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.

Device Story

Device comprises right-angle barbed tubing connector, wire frame, and suction cup; provided as assembled unit. Used in peritoneal dialysis to secure outlet tubing to non-porous surfaces (e.g., ceramic). Design incorporates air gap between connector distal end and drain site to prevent fluid backflow or restriction, consistent with ASME plumbing standards. Enables free flow of waste dialysate in hygienic manner. Operated by patient or caregiver in home or clinical setting. Output is physical stabilization of drainage tubing; facilitates safe waste disposal.

Clinical Evidence

Bench testing only; device complies with design and performance specifications.

Technological Characteristics

Non-sterile, right-angle barbed connector with wire frame and suction cup. Mechanical design features integrated air gap for backflow prevention. No electronic components or software.

Indications for Use

Indicated for securing the position of outlet tubing for single-use peritoneal dialysis sets on solid surfaces.

Regulatory Classification

Identification

(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

Special Controls

*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

Submission Summary (Full Text)

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

# 510(k) Summary K.E.P., LLC, K.E.P. Connector and Clip

#### SPONSOR 1.

K.E.P., LLC 45060 Substation Road Hammond, Louisiana 70401

Contact Person: Kevin Pollard 504-834-7889 Telephone:

Date Prepared: October 18, 2004

#### 2. DEVICE NAME

Proprietary Name: K.E.P. Connector and Clip Common/Usual Name: Connector Classification Name: Accessory to peritoneal dialysis set

#### 3. PREDICATE DEVICES

Similar connectors are exempt from premarket notification. This premarket notification is submitted because this device is unclassified and is used for a new intended use / indication for use.

#### DEVICE DESCRIPTION 4.

The K.E.P. Connector and Clip comprises three major components: (1) the rightangle barbed tubing connector (outlet), (2) the wire frame, and (3) the suction cup. This device is provided to the user as an assembled device. The K.E.P Connector and Clip enables free flow of waste dialysate in a safe and hygienic manner. The suction cup is designed to adhere to ceramic or any other non-porous surface, unless intentionally released by the "A tab." The K.E.P. Connector and Clip has been designed with an air gap between the distal end of the connector and the discharge site (drain), thereby making it impossible for any fluid to back flow or to be restricted; this air gap is consistent with ASME designs for plumbing fixtures.

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

#### INTENDED USE 5.

The K.E.P. Connector and Clip is a non-sterile, right-angle barbed connector and retaining clip that is used to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.

### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The K.E.P. Connector and Clip is substantially equivalent in design to commercially available connectors and tube holders that are exempt from premarket notification. This premarket notification is submitted because the K.E.P. Connector and Clip have a new intended use and indications for use.

## 7. PERFORMANCE TESTING

Testing of the K.E.P. Connector and Clip demonstrates that it complies with design and performance specifications.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

NOV - 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K.E.P., LLC c/o Ms. Rosina Robinson, RN, MEd, RAC Senior Staff Consultant Regulatory Services Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K042900 Trade/Device Name: K.E.P. Connector and Clip Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: October 18, 2004 Received: October 19, 2004

Dear Ms. Robinson:

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 do not require 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 n Jour at), 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.

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 Four and butters and light (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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.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" (21 CFR 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/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

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

# Indications for Use

510(k) Number (if known):

Device Name: ___ K.E.P. Connector and Clip_

Indications for Use:

The K.E.P. Connector and Clip is intended to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.

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)

Nancy C. Broadon

(Division Sien-Off) Division of Reproductive, Abdomi and Radiological Devi 510(k) Number