FLEX-NECK PD CATHETER, INFANT

K031351 · Medigroup, Inc. · FJS · Sep 17, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031351
• Device Name: FLEX-NECK PD CATHETER, INFANT
• Applicant: Medigroup, Inc.
• Product Code: FJS · Gastroenterology, Urology
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

Device Story

Flex-Neck™ PD Catheter, Infant is a long-term, indwelling peritoneal catheter designed for infants. Device consists of silicone tubing (3.7 mm OD, 2.5 mm ID) with radiopaque strip, 1 or 2 polyester cuffs, and 4 rows of distal side holes for dialysate inflow/outflow. Kit includes tunnel marking stencils, surgical marking pen, plastic connector, plastic cap, and lubricating gel. Implanted by physician (surgically, peritoneoscopically, or percutaneously) to provide peritoneal access for dialysis. Facilitates fluid exchange in infants too small for adult/pediatric models.

Clinical Evidence

Bench testing only; functional testing performed to demonstrate mechanical integrity and retention.

Technological Characteristics

Implantable grade silicone tubing; radiopaque strip; polyester cuffs; plastic connector/cap. Dimensions: 42 cm length, 3.7 mm OD, 2.5 mm ID. Distal end features 4 rows of side holes. Non-electronic, mechanical device.

Indications for Use

Indicated for infants requiring peritoneal dialysis (PD) therapy who are too small for standard Flex-Neck catheters. Contraindicated if patient is not a candidate for PD.

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.

Predicate Devices

• Flex-NeckTM Peritoneal Catheter (K970159)

Submission Summary (Full Text)

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K031357

Page 1 of 2

# SEP 1 7 2003

#### SMDA Information 6.

#### 510(k) Summary of Safety and Effectiveness 6.1.

- 6.1.1. Basic Data

| Date Prepared: | April 24, 2003 |
|----------------|--------------------------|
| Company: | MEDIGROUP, Inc. |
| Contact: | John A. Navis, President |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### 6.1.2. Device Information:

Classification Name: Peritoneal Catheter; long-term, indwelling Common Name: Peritoneal Catheter

- 6.1.3. Predicate Device
Flex-NeckTM Peritoneal Catheter, 510 (k) 970159.

- 6.1.4. Intended Use & Device Description
- 6.1.4.1. The current Flex-Neck™ catheters (510 (k) 970176) are designed for the typical adult or infant patient who needs peritoneal dialysis (PD) therapy. To facilitate different patient sizes and physiques, there currently are 2 styles (internally coiled and straight) and 5 different adult sizes at 62 cm long and 2 pediatric sizes at 42 cm long. All these catheters share the same outside diameter (OD, 5.1 mm) and the same inside diameter (ID, 3.5 mm). The actual lengths and the location of the polyester cuffs are the primary variables. (See Appendix B.)

The Flex-Neck™ Catheter, Infant (part number CF-4240 and CF-4245) is intended for infants. (The overall length remains at 42 cm, but the OD and ID are smaller -- 3.7 mm and 2.5 mm, respectively. (See Appendix B.)

6.1.4.2. This device consists of the following components:

- 1-Flex-Neck™ Catheter, Infant, made of long-term, a. implantable grade silicone tubing with radiopaque strip and 1 or 2 polyester cuffs. All components are made of the same materials as the Flex-Neck™ Catheter, Adult and Pediatric. The Infant catheter also has 4 rows of side holes punched into the tubing at the distal end to facilitate inflow and outflow of dialysate. (See Appendix B for additional details.)

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031351

Page 2 of 2

- b. 1-Right hand and 1-left hand tunnel marking stencils to mark and guide and thereby assist the implanting doctor to make a sound subcutaneous tunnel for the catheter.
- 1-Surgical grade marking pen C.
- 1-Catheter connector, plastic d.
- e. 1-Catheter cap, plastic
- 1-Tube (20 cc) of water-soluble lubricating gel f.

## 6.1.5. Testing

Functional testing has been performed to demonstrate mechanical integrity and retention.

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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 depiction of an eagle or bird with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

### Public Health Service

SEP 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John A. Navis President MEDIGROUP, Inc. 505 Weston Ridge Drive NAPERVILLE IL 60563-3932

Re: K031351

Trade/Device Name: Flex-Neck™ PD Catheter, Infant; Part #CF-4240 and CF-4245 Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FJS Dated: June 23, 2003 Received: June 24, 2003

Dear Mr. Navis:

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 (OS) 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 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 the 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" (21CFR Part 807.97) you may obtain. 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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KO 31357

#### 7. Indications for Usc

510(k) Number:

K031351

Device Name:

Flex-Neck™ PD Catheter, Infant

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy and is too small for the current Flex-Neck™ catheters, the Flex-Neck™ Catheter, Infant, can be implanted either surgically, peritoneoscopically or percutaneously. The only contraindication to implantation of the Flex-Neck™ PD Catheter, Infant, is if the patient is not a candidate for peritoneal dialysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)

David R. Flynn

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