FLEX-NECK ARC CATHETER

K070730 · Medigroup, Inc. · FJS · Jul 3, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070730
• Device Name: FLEX-NECK ARC CATHETER
• Applicant: Medigroup, Inc.
• Product Code: FJS · Gastroenterology, Urology
• Decision Date: Jul 3, 2007
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Flex-Neck® ARC™ catheter is designed for adults, children, and infants for whom peritoneal dialysis has been decided to be the mode of treatment by a physician. This catheter will be chosen by the physician who desires the faster flowrates of the Flex-Neck® conventional PD catheter as well as the uniformity of the permanent bend provided by the Swan-Neck™ catheter. The addition of accessories packaged with the catheter will enhance the implantation and use of the catheter.

Device Story

Flex-Neck® ARC™ PD catheter provides access for peritoneal dialysis fluid infusion and drainage. Device consists of long-term implantable silicone tubing with radiopaque strip and polyester felt cuffs; features permanent 30° bend and coiled distal end. Accessories include surgical stencils for incision site planning, surgical marking pen, plastic connector/cap, and lubricating gel. Used in clinical settings by physicians to establish peritoneal access. Combines larger internal diameter of Flex-Neck® 'classic' (for faster flow) with permanent arcuate tunnel/exit site geometry of Swan-Neck™ design. Benefits include improved flow rates and maintenance of tunnel/exit site architecture, facilitating long-term dialysis therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by the twenty-year clinical history of the Swan-Neck™ catheter and ten-year history of the Flex-Neck® 'classic' catheter, alongside referenced literature (1985, 1995, 1996) confirming the benefits of permanently bent PD catheters.

Technological Characteristics

Silicone tubing (long-term implantable grade) with radiopaque strip; polyester felt cuffs. Coiled distal end with 30° permanent bend. Available in adult, pediatric/adolescent, and infant sizes. Non-powered, mechanical device.

Indications for Use

Indicated for adults, children, and infants requiring acute or chronic peritoneal dialysis (PD) therapy, where the patient is a suitable candidate for PD as determined by a physician. Implantation may be performed surgically, laparoscopically, or peritoneoscopically.

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

• Swan-Neck™ PD Catheter (862046)
• Flex-Neck® PD Catheter (970159)
• Flex-Neck® PD Catheter, Infant (031351)

Submission Summary (Full Text)

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## 510(k) Summary

Medigroup, Inc.

JUL - 3 2007

## Basic Information

Submitter:

14 A Stonehill Road Oswego, IL 60543 Establishment Registration Number: #1450420 Contact: John A. Navis, President Telephone: [phone] Fax: [phone] E-mail [e-mail] Date of Submission March 13, 2007

### Device Information

Trade Name: Flex-Neck® ARCTM PD Catheter & Accessories Common Name: Peritoneal Dialysis Catheter & Accessories Classification Name: 78 FJS, accessory. Class: II

## Predicate Devices

510(k) 862046 Swan-Neck™ PD Catheter issued June 19, 1986 510(k) 970159 Flex-Neck® PD Catheter issued September 5, 1997 510(k) 031351 Flex-Neck® PD Catheter, Infant, issued September 17, 2003

## Product Description

This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.

## Intended Use

The Flex-Neck® ARC™ catheter is designed for adults, children, and infants for whom peritoneal dialysis has been decided to be the mode of treatment by a physician. This catheter will be chosen by the physician who desires the faster flowrates of the Flex-Neck® conventional PD catheter as well as the uniformity of the permanent bend provided by the Swan-Neck™ catheter. The addition of accessories packaged with the catheter will enhance the implantation and use of the catheter.

MEDIGROUP. Inc. (Division of Janin Group, Inc.) 7-1

Image /page/0/Picture/18 description: The image shows three logos related to quality assurance. The first logo on the left is a circular seal with the letters 'R' and 'Q' inside, surrounded by the text 'LLOYD'S REGISTER QUALITY ASSURANCE' and 'ISO 13485'. The middle logo features a crown above a checkmark, with the text 'UKAS QUALITY MANAGEMENT' and the number '001' below. The third logo on the right mirrors the first, but with 'ISO9001' at the bottom, indicating different ISO standards.

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#### Substantial Equivalence

The new Flex-Neck® ARC™ catheter has the same indications for use as the two predicate devices, the Flex-Neck® "classic" catheter and the Swan-Neck™ catheter. All three catheters are to be implanted in a patient needing peritoneal dialysis in order to provide access for peritoneal dialysis fluid infusion and drainage. All three are a silicone tube, with one or two cuffs for anchoring in the rectus muscle, ending in a coil. The Flex-Neck® catheters (both the "classic" style and the new ARC™ design) have a larger internal diameter than the Swan-Neck™ catheter which provides a faster flow rate for the fluid. The Flex-Neck® "classic" style is bendable into variable caudally directed exit sites, whereas the Flex-Neck® ARCTM and the Swan-Neck™ catheters have a 30° permanent bend. The Flex-Neck® ARCTM catheter therefore combines advantages of both predicate devices.

pg. 2of2

K070730

## Testing

The twenty-year history of the Swan-Neck™ catheter with its permanent bend, and the ten-year history of the Flex-Neck® "classic" catheter with its larger internal diameter and variable bend have validated the design. High usage of catheters with this design further validates that a coiled silicone tube with a permanent bend is the catheter of choice for many physicians. See also three articles/ studies from 1985, 1995, and 1996 in Appendices F.1, F.2, F.3 which confirm the benefit of a permanently bent peritoneal dialysis catheter. Additional studies are referenced in F.4. Because of the longevity and success of the two predicate devices, no further studies have been done for this submission.

#### Conclusions

The Flex-Neck® ACR™ peritoneal dialysis catheter will function as designed and intended. It will provide a faster flowing access for peritoneal dialysis fluid and give the physician a bent tunnel portion to maintain a permanent arcuate tunnel/exit site.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL - 3 2007

Mr. John A. Navis President Medigroup, Inc. 14 A Stonehill Road OSWEGO IL 60543-9400

Re: K070730

Trade/Device Name: Flex-Neck® ARC™ Catheter and Accessories Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: June 1, 2007 Received: June 4, 2007

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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Page 2 - Mr. John Navis

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 (21 CFR Part 807); 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 the labeling regulation, 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). 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/industry/support/index.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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K070730

# Indications for Use

510(k) Number (if known):

Device Name: Flex-Neck® ARC™ Peritoneal Dialysis Catheter & Accessories

Indications For Use:

If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.

Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 801 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 Brogdon
(Division Sign-Off)

Division of Reproduct and Radiological De 510(k) Number

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