FLEX-NECK PD CATHETER

K970159 · Janin Group, Inc. · FJS · Sep 5, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970159
• Device Name: FLEX-NECK PD CATHETER
• Applicant: Janin Group, Inc.
• Product Code: FJS · Gastroenterology, Urology
• Decision Date: Sep 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

Device Story

Flex-Neck™ PD Catheter provides long-term peritoneal access for fluid infusion and drainage in patients undergoing peritoneal dialysis. Device consists of medical-grade silicone tube with one or two Dacron® cuffs for tissue ingrowth and bacterial barrier; features multiple 0.75mm side holes to prevent omental entrapment. Implanted surgically or peritoneoscopically (via Y-TEC® system). During infusion, fluid flows through catheter; during outflow, side holes ensure drainage even if tip is obstructed by peritoneum or bowel. Benefits include reduced risk of omental entrapment compared to larger-holed catheters and flexibility in exit site positioning.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Medical-grade long-term implantable silicone; Dacron® felt cuffs. 1-2 cuffs. 3.5-5.0mm OD; 2.0-3.5mm ID. 0.75mm inflow/outflow holes. 50 durometer. Blue radiopaque stripe. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring peritoneal dialysis (PD) therapy. Contraindicated in patients not suitable for PD. Relative contraindications include prior surgeries or intraperitoneal adhesions, though peritoneoscopic implantation may mitigate these risks.

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 Peritoneal Dialysis Catheter
• Tenckhoff Catheter

Reference Devices

• Y-TEC® peritoneoscopic system

Submission Summary (Full Text)

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K970159

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is ___________________________ SEP - 5 1997

## Applicant Information

| Date Prepared | January 6, 1997 |
| --- | --- |
| Name | MEDIGROUP, Inc. (Division of Janin Group, Inc.) |
| Address | 615 Enterprise Street, Aurora, IL 60504-8138 |
| Contact Person | Pamela L. Swatkowski |
| Phone Number | [phone] |
| Fax Number | [phone] |

## Device Information

| Trade Name | Flex-Neck™ PD Catheter |
| --- | --- |
| Common Name | Peritoneal Catheter |
| Classification Name | Peritoneal Catheter; long-term, indwelling |

## Equivalent Device

| Name | Peritoneal Dialysis Catheter |
| --- | --- |
| | Swan Neck Peritoneal Dialysis Catheter |
| | Tenckhoff Catheter |

## Device Description

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the “deep” cuff in the abdominal musculature and the “superficial” cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.

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K970159

The Flex-Neck™ PD Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system.

## Intended Use

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

## Comparison to Predicate Device

The following table displays the similarities and differences of the new device to the legally marketed device to which equivalency is claimed.

| Characteristics Compared | Subject Device Flex-Neck™ PD Catheter | Predicate Device Swan Neck™ Coiled | Predicate Device Tenckhoff |
| --- | --- | --- | --- |
| 1. Material: Catheter | Silicone | Silicone | Silicone |
| 2. Material: Cuff | Dacron® Felt | Dacron® Felt | Dacron® Felt |
| 3. # of Cuffs | 1-2 | 1-2 | 1-2 |
| 4. Outside Diameter (OD) | 3.5 - 5.0 mm | 5.0 mm | 5.0 mm |
| 5. Inside Diameter (ID) | 2.0 - 3.5 mm | 2.7 mm | 2.7 mm |
| 6. Length | Varies 43-62 | Varies 43-62 | Varies 43-62 |
| 7. Radiopaque stripe | Blue | White | White |
| 8. Distal (deep) cuff location | within the rectus | within the rectus | within the rectus |
| 9. Diameter of inflow/ outflow holes | 0.75 mm | 1.00 mm | 1.00 mm |
| 10. Proximal (superficial) cuff location relative to distal cuff | Varies | Varies | Varies |
| 11. Exit site direction (location) choices relative to implantation site | Any place between lateral and caudal 30° - 90° bend | Caudal 60° nominal | 0-15° straight to slight lateral |
| 12. Durometer | 50 | 65 | 70 - 65 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 5 1997

Ms. Pamela L. Swatkowski
Quality Assurance & Regulatory Affairs Manager
MEDIGROUP, Inc.
(Division of Janin Group, Inc.)
615 Enterprises Street
Aurora, Illinois 60504-8138

Re: K970159
Flex-Neck™ PD Catheter
Dated: June 6, 1997
Received: June 9, 1997
Regulatory class: II
21 CFR §876.5630/Product code: 78 FJS

Dear Ms. Swatkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): K970159

Device Name: Flex-Neck™ PD Catheter

Indications for Use:

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970159
K970159

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1/2/96)