INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS

{0}------------------------------------------------ BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com # KO13073 ## NOV 0 8 2001 Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun and a figure with outstretched arms. To the right of the logo are the words "Indispensable to human health". The text is in a simple, sans-serif font and is arranged in two lines. ### Premarket Notification [510(k)] Summary of Safety and Effectiveness for Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, moyo - | | htima™, and Saf-T-Intima™, and Saf-T-Intima™ IV Catheters | Submitter: | Becton Dickinson Infusion Therapy Systems Inc. | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 9450 South State Street<br>Sandy, UT 84070 | | Contact Person: | Leslie Wood, Manager, Regulatory Affairs | | Telephone Number: | (801) 565-2504 | | FAX Number: | (801) 565-2749 | | Date Summary Prepared: | August 9, 2001 | | Trade Names: | Insyte™ IV Catheter; Angiocath™ IV Catheter;<br>Insyte™ Autoguard™ IV Catheter; Angiocath™<br>Autoguard™ IV Catheter; Autoguard™ Pro IV<br>Catheter; Intima™ IV Catheter; and Saf-T-Intima™<br>IV Catheter | | Common Name: | Peripheral Intravascular Catheter or<br>IV Catheter | | Classification Name: | Intravascular Catheter | #### Product Descriptions: The products identified in this 510(k) notification include both standard catheters and catheters with a needle-shielding feature. The catheters listed have either a FEP polymer or Vialon material catheter. All have a luerlocking adapters to which an IV line or accessories may be attached. #### Intended Use: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. {1}------------------------------------------------ #### Technological Characteristics Comparison: The catheter design and technological characteristics have not changed. The lubrication systems used have been modified to make the manufacturing process 'ozone friendly.' #### Nonclinical Tests Support Substantial Equivalence: Side-by-side testing of modified and unmodified devices was conducted to compare the following attributes: penetration, tip adhesion and catheter / adapter separation force. #### Conclusions from Nonclinical Tests: Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices. 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 82001 Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070 Re: K013073 Trade/Device Name: Insyte™, Intravascular Catheter Angiocath™, Intravascular Catheter Insyte™, Autoguard™, Intravascular Catheter Angiocath™, Autoguard™, Intravascular Catheter Autoguard™, Pro Intravascular Catheter Intima™, Intravascular Catheter Saf-T-Intima™, Intravascular Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 12, 2001 Received: September 14, 2001 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}------------------------------------------------ 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ NOV 0 8,2001 ## INDICATIONS FOR USE Device Name: Insyte™ Intravascular Catheter Angiocath™ Intravascular Catheter Insyte TM Autoguard TM Intravascular Catheter Angiocath™ Autoguard ™ Intravascular Catheter Autoquard™ Pro Intravascular Catheter Intima™ Intravascular Catheter Saf-T-Intima™ Intravascular Catheter As provided in 21 CFR 880.5200, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: _ X (per 21 CFR 801.109) OR Over-The Counter Use: __________ Patricia Cucurullo Division Sign-Off) ivision of Dental, Infection Control, and General Hospital De 11 (k) Number ________________________________________________________________________________________________________________________________________________________________ 510(k) Lubrication System Indications for Use 8/1/01