VETA PERITONEAL DIALYSIS CATHETER

K113354 · Pfm Medical, Inc. · FJS · Mar 13, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113354
• Device Name: VETA PERITONEAL DIALYSIS CATHETER
• Applicant: Pfm Medical, Inc.
• Product Code: FJS · Gastroenterology, Urology
• Decision Date: Mar 13, 2012
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Device Story

Veta Peritoneal Dialysis Catheter is a side-ported silicone catheter; features single or double retention cuff; available in various lengths, French sizes, and straight or spiral tip configurations. Device provides access to peritoneal cavity for fluid drainage and infusion during peritoneal dialysis. Used by clinicians in clinical settings. Safety and effectiveness established via in vitro testing (leakage, flow rate, tensile strength, corrosion) and biocompatibility assessment per ISO 10993.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via in vitro bench testing including leakage, flow rate, tensile strength, and corrosion per BS EN 1618-1997, and biocompatibility testing per ISO 10993.

Technological Characteristics

Silicone catheter; side-ported; single or double retention cuff; straight or spiral tip. Materials meet ISO 10993. Performance testing per BS EN 1618-1997.

Indications for Use

Indicated for patients requiring acute or chronic access to the peritoneal cavity for fluid drainage and infusion during peritoneal dialysis procedures.

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

• Quinton Tenckhoff Peritoneal Catheter (K812607)
• ASEPT Peritoneal Drainage System (K093796)
• Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711)

Submission Summary (Full Text)

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K113354 fgz-1gl

MAR 1 3 2012

# 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

November 8, 2011 Date Prepared: Name: PFM Medical, Inc Address: 1815 Aston Ave Ste 106. Carlsbad, CA 92008 SALVADORE F. PALOMARES, RAC Contact Person: Phone: [phone]

### 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:

Trade Name: Veta Peritoneal Dialysis Catheter Common Name: Catheter, Peritoneal Dialysis, Single-Use Classification Name: Peritoneal Dialysis System and Accessories

Equivalent Devices: Manufacturer: Quinton, Inc. (now Covidien) Name: Quinton Tenckhoff Peritoneal Catheter 510(k) #: K812607

Manufacturer: PFM Medical, Inc. Name: ASEPT Peritoneal Drainage System 510(k) #: K093796

Manufacturer: Denver Biomedical (now Cardinal Health) Name: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits 510(k) #: K051711

Device Description:

Veta™ Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention cuff, available in a range of lengths and French sizes and in either a straight or spiral tip configuration.

Intended Use:

The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

#### Performance Data:

In vitro testing was performed on the Veta Peritoneal Dialysis Catheter to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.

#### Biocompatibility:

Materials used in the Veta Peritoneal Dialysis Catheter meet the requirements of ISO 10993 or identical to legally marketed devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the wings and body of the bird.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Salvadore Palomares, RAC Director of Regulatory Affairs PFM Medical, Inc. 1815 Aston Ave. Suite 106 CARLSBAD CA 92008

MAR 1 3 2012

Re: K113354

Trade/Device Name: Veta Peritoneal Dialysis Catheter Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: January 26, 2012 Received: January 27, 2012

Dear Mr. Palomares:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 r lease be as now a a determination that your device complies with other requirements of the Act that I D. Fire internations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing eonipty "Hill and 807); labeling (21 CFR Part 801); medical device reporting of medical

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Page 2.

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Evans

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K113354

510(k):

K113354

Device Name:

Veta Peritoneal Dialysis Catheter

Indications for Use:

The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.

Over the Counter Use × AND/OR Prescription Use (Per 21 CFR 801 Subpart D) (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)

Haber Remi

(Division Sign-Off) Division of Reproductive, Gastro-Renal, Urological Devices 113354 510(k) Number