PD CATH

K053123 · Med-Conduit, Inc. · FJS · Mar 29, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053123
• Device Name: PD CATH
• Applicant: Med-Conduit, Inc.
• Product Code: FJS · Gastroenterology, Urology
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.

Device Story

PD Cath is a radiopaque silicone, single-lumen catheter designed for long-term peritoneal dialysis access. It features a fixed Dacron cuff to facilitate tissue ingrowth for secure placement and a permanently bonded flexible silicone overtube to insulate the cuff from mechanical forces. The device is implanted to allow for the insertion and removal of peritoneal fluid. It is intended for use by clinicians in a healthcare setting for patients requiring chronic dialysis access.

Clinical Evidence

Bench testing only. In vitro performance data, including flow rate and tensile strength, was provided to demonstrate substantial equivalence. No clinical data was deemed necessary.

Technological Characteristics

Radiopaque silicone, single-lumen catheter; includes a fixed Dacron cuff for tissue ingrowth and a flexible silicone overtube for strain relief. Device is non-electronic and mechanical in nature.

Indications for Use

Indicated for patients requiring long-term peritoneal access for peritoneal dialysis via the peritoneum, with an intended implantation dwell time exceeding 30 days.

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

• Dermaport™ Access Device (K894131)
• Missouri Catheter (K874650)

Submission Summary (Full Text)

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K053123

MAR 29 2006

510(k) Summary

- 1. SPONSOR
Med-Conduit Inc. 18 Derby Lane Tyngsboro, MA 01879

Contact: Gerald G. Bousquet, M.D.

Date Prepared:

- 2. DEVICE NAME

| Proprietary Name: | PD Cath |
|----------------------|-----------------------|
| Common/Usual Name: | Skin Port Catheter |
| Classification Name: | Long-Term PD Catheter |
| Classification: | |

- 3. PREDICATE DEVICES
Dermaport™ Access Device -- K894131

Missouri Catheter-K874650

- 4. DEVICE DESCRIPTION
The PD Cath is a radiopaque silicone, single lumen catheter used to insert and The fixed Dacron cuff allows for tissue ingrowth for remove peritoneal fluid. long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.

- INTENDED USE ડ.
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.

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K053123 Pzg

## SUBSTANTIAL EQUIVALENCE 6.

The PD Cath is substantially equivalent to a combination of its predicate devices in terms of intended use, design, material type, performance, and method of sterilization.

- Performance Testing 7.
Information submitted in this premarket notification includes in vitro performance data for the PD Cath including flow rate and tensile strength that is substantially equivalent to the legally marketed devices.

Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for peritoneal dialysis.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Gerald G. Bousquet, M.D. Med-Conduit, Inc. 18 Derby Lane TYNGSBORO MA 01879

Re: K053123

Trade/Device Name: PD Cath/Skin Port Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: February 7, 2006 Received: February 16, 2006

Dear Dr. Bousquet:

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 (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 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 clectronic 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 Scetion 510(k) This leter will anow you to begin harketing your manence of your device of your device to a legally premarket nothleation. The I DA muning of our 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 If you desire specific advice for your do roo 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 Also, prease note the regulation entitled, "Association on your responsibilities under the Act from the 807.97). I ou may obtain outce general michel 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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## KOS 3123

## Indications for Use

510(k) Number (if known): K053123

PD Cath/Skin port Device Name:

Indications For Use: The PD Cath is indicated for use in attaining long term peritoneal The I D Oath 15 Indivated a your and ener is intended for access for porkonous and greater than 30 days.

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)

Daniel A. Slagman

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

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