BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER

{0}------------------------------------------------ K\u03b142491 left 2 BD Medical Systems 9450 South State Street andv Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com NOV 2 2 2004 # Attachment D Image /page/0/Picture/4 description: The image shows the BD logo. The logo consists of a circular emblem on the left and the letters "BD" on the right. The emblem features a stylized image of a person with arms raised, with rays emanating from above. The letters "BD" are in a bold, sans-serif font. Helping all people live healthy lives #### Premarket Notification [510(k)] Summary | Submitter: | Becton Dickinson Infusion Therapy Systems Inc. | |------------------------|------------------------------------------------| | Address: | 9450 South State Street<br>Sandy, UT 84070 | | Contact Person: | Leslie Wood<br>Manager, Regulatory Affairs | | Telephone Number: | (801) 565-2504 | | FAX Number: | (801) 565-2749 | | Date Summary Prepared: | August 30, 2004 | | Trade Name: | BD OneCath™™ | | Common Name: | Peripherally Inserted Central Catheter or PICC | | Classification Name: | Intravascular, therapeutic, long-term catheter | | Classification: | Class II<br>880.5970 - LJS | | Predicate Device: | BD L-Cath PICC | # Description of the BD OneCath Peripherally Inserted Central Catheter: Device selection is an important component of intravenous therapy. Some of the patient considerations that are included in this decision are the: (1) length and type of therapy, (3) adequacy of venous access, (4) lifestyle and activity, and (5) setting in which therapy will be administered. Peripherally inserted central catheters (PICC) are selected for intermediate length therapy, while tunneled percutaneous catheters and subcutaneous ports are selected for long-term central venous access. A PICC is a central venous catheter that is inserted into a peripheral vein and advanced to the superior vena cava. The basilic, cephalic and median cubital veins of the arm are the preferred locations for PICC insertion in adults; scalp veins such as the posterior auricular and temporal veins may be used for neonatal patients. For pediatric patients, the saphenous, popliteal, and femoral veins of the leg may be used, with the tip location in the inferior vena cava. The PICC is generally selected for IV therapy that is prescribed for less than 6 to 8 weeks. Although a PICC may indwell for a shorter period, the average indwelling time for a PICC is 2-6 months. {1}------------------------------------------------ The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer. 7.47 ### Intended Use of the BD OneCath Peripherally Inserted Central Catheter: The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medications, fluids, nutrients, blood and blood products. #### Technological Characteristics Comparison: The polyurethane used for the BD OneCath product has improved radiopacity and resistance to alcohol than the polyurethane used for the current L-Cath product. These improved characteristics will make the BD OneCath PICC more competitive in this market. #### Nonclinical Tests Support Substantial Equivalence: Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted. ## Conclusions from Nonclinical Tests: The BD OneCath PICC is substantially equivalent to the BD L-Cath PICC. The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white. NOV 2 2 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070 Re: K042491 Trade/Device Name: BD OneCath™ Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 13, 2004 Received: September 14, 2004 Dear Ms. Wood: 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 (PMA), 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. {3}------------------------------------------------ Page 2 - Ms. Wood 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 (OS) 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications For Use 510(k) Number (if known): K042491 BD OneCath™ Peripherally Inserted Central Catheter Device Name: Indications For Use: The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) 1 of 1 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Tuan Dima (Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: _ K P Y 2 40) Page 1 of ____________________________________________________________________________________________________________________________________________________________________