VETA PERITONEAL DIALYSIS CATHETER

{0}------------------------------------------------ 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: (760) 758-8749 ### 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. {1}------------------------------------------------ ## 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 {2}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 {3}------------------------------------------------ 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