MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER

{0}------------------------------------------------ ## JUN 7 - 2005 ### SUMMARY OF SAFETY AND EFFECTIVENESS ### GENERAL INFORMATION I. Angiographic Catheter Device Generic Name: MEDRAD Vanguard Dx™ Angiographic Catheter Device Trade Name: K050371 510(k) Number: Name/Address of Applicant: MEDRAD, Inc. One Medrad Drive Indianola, PA 15051 #### II. Indications The Vanguard Dx™ catheter is intended for use in the delivery of radiopaque contrast media and common flushing agents to the vascular system. #### III. Contraindications The Vanguard DxTM is not intended for multi-patient use. Vanguard DxTM is single patient use only. Vanguard DxTM is not for use in the MRI environment. Vanguard Dx™ is not to be used for drug infusion, chemotherapy, or any other use for which the device is not intended. #### Warnings and Precautions IV. A list of warnings and precautions can be found in the device labeling. #### Device Description V. The Vanguard Dx™ is a sterile, single patient use diagnostic catheter for use in cardiology and radiology during angiography. Vanguard Dx™ is the proprietary name for a family of 30 angiographic catheters. The Vanguard Dx™ is similar to other diagnostic catheters on the market in that it delivers radiopaque fluids and common flushing agents to a specific artery in the cardiovascular system for the purpose of differentiating the vessel from the surrounding anatomy during diagnostic imaging procedures. Vanguard Dx™ is available in 4 French and 5 French sizes. It is offered in both flush and selective styles. The Vanguard Dx™ catheter was designed to enable the effective use of power injection using smaller diameter catheters while reducing the negative effects seen with many {1}------------------------------------------------ similar catheters such as jetting, whip, and endovascular damage. The differentiating elements of the of Vanguard Dx™ lies in the combination of small holes near the stem/tip interface and a soft tip with an incorporated restrictor that combine to produce clinically beneficial effects. These effects include the creation of a "cloud" of contrast gently exiting through the side holes, which envelops the tip, rather than a single stream of contrast exiting the tip. This reduces the likelihood of vascular injury and has the potential to enhance image quality. Another effect is that a restrictor is incorporated into the tip that limits the flow through the catheter tip thereby encouraging flow through the catheter side holes. The reduction of forward flow through the tip and resulting dispersion of fluid through the side holes produces more balanced hydraulic forces on the catheter during injections so that random oscillations of the tip and rearward motion of the catheter are effectively reduced or eliminated. The result is a more uniform distribution of fluid around the catheter, reduced trauma to the catheterized artery, increased catheter tip stability during a procedure, and potential for enhanced image quality. Vanguard DxTM catheters are designed to mate with commercially available fluid delivery products. The finished catheter is compatible with common contrast agents such as Omnipaque 350. Isovue 370. Optiray 350. Ultravist 370, Renografin 76, and Visipaque 320. Vanguard Dx™ is fully biocompatible including compatibility with human blood, saline, and heparinized saline. ### VI. Marketing History The Vanguard Dx™ catheter has not been marketed in the United States or in any other country. {2}------------------------------------------------ ### Biocompatibility Testing VII. The biocompatibility study was undertaken to verify that the 4 French and 5 French Vanguard Dx™ catheters meet the requirements of ISO 109933-1 through 11 | Tests Performed | Pass / Fail | |------------------------------------------------------------------------|-------------| | Cytotoxicity: L929-MEM Elution Test | Pass | | Irritation or Intracutaneous Reactivity: Intracutaneous Injection Test | Pass | | Systemic Toxicity: System Injection Test | Pass | | Material Mediated Pyrogens: Rabbit Pyrogen Test | Pass | | Sensitization: Kligman Maximization Test | Pass | | Hemocompatibility: In-Vitro Hemocompatibility Assay | Pass | | Hemocompatibility: Hemolysis - Rabbit Blood | Pass | | Hemocompatibility: Prothrombin Time Assay | Pass | | Hemocompatibility: Lee & White Clotting Test | Pass | | In-Vivo Thrombogenicity: Thrombogenicity Assay in Dogs | Pass | ### Vanguard Dx Biocompatibility Tests | Vanguard Dx Biocompatibility Chemical Tests | | |---------------------------------------------|----------------| | Tests Performed | Pass / Fail | | Infra Red Spectroscopic Analysis (IR Scan) | Pass | | USP Physical/Chemical Tests: | | | *Non-Volatile Residual | Pass | | *Residue on Ignition | Not applicable | | *Heavy Metals | Pass | | *Buffering Capacity | Pass | # Vanquard Dy Riocompatibility Chemical Tests As evidenced by the charts above, the Vanguard Dx passed all Biocompatibility tests demonstrating its acceptability for use. {3}------------------------------------------------ ### VIII. In-Vitro Testing An in-vitro study of Vanguard Dx™ catheters was undertaken to assess the functionality, safety, and conformance of Vanguard Dx™ catheter to design requirements and compare its performance to currently manufactured and distributed diagnostic angiographic catheters (Cordis). Tests were conducted December 1, 2004 through December 15, 2004 at Teleflex Medical in Limerick, Ireland. The following Vanguard Dx™ and control catheter (Cordis) styles were tested: 4 French (Fr) Judkins Right 4.0, 4 Fr Judkins Left 4.0, 4 Fr Pigtail, 5 Fr Judkins Right 4.0, 5 Fr Judkins Left 4.0, and 5 Fr Pigtail. | Vanguard Dx In-Vitro Verification | | |-----------------------------------|-------------| | Tests Performed | Pass / Fail | | Dimensional Analysis | Pass | | Hub Durability & Compatibility: | | | Liquid Leakage | Pass | | Air Leakage During Aspiration | Pass | | Unscrewing Torque | Pass | | Ease of Assembly | Pass | | Resistance to Overriding | Pass | | Stress Cracking | Pass | | Catheter Joint Strength | Pass | | Catheter Seal Integrity | Pass | | Catheter Burst Pressure | Pass | | Flow Characterization | Pass | | Catheter Tip Stability | Pass | | Restrictor Deformation | Pass | | Restrictor Durability | Pass | | Guidewire Insertion Force | Pass | | Catheter Insertion Force | Pass | | Stiffness | Pass | | Torquability | Pass | | Radiopacity | Pass | As evidenced above, the Vanguard Dx passed all In-Vitro Verification tests demonstrating its acceptability for use. {4}------------------------------------------------ ### IX. Shelf Life & Packaging Tests A study was undertaken to assess the shelf life and packaging validation of Vanguard DxTM catheters. The tests were also performed to confirm the safety and efficacy of Vanguard DxTM catheters and its packaging. Testing included accelerated aging, distribution simulation, and catheter performance testing. A currently manufactured and distributed diagnostic angiographic catheter (Cordis) was used as a control. Preconditioning and distribution simulation was conducted at DDL, Inc from October 15 thru December 22, 2004. Catheter performance testing was conducted at Teleflex Medical in Limerick, Ireland from January 15 thru January 20, 2005. The following Vanguard Dx™ and control catheter styles were tested: 4 French (Fr) Judkins Right 4.0, 4 Fr Judkins Left 4.0, 4 Fr Pigtail, 5 Fr Judkins Right 4.0, 5 Fr Judkins Left 4.0, and 5 Fr Pigtail. | Vanguard Dx Two-Year Shelf Life & Packaging | | |---------------------------------------------------|-------------| | Tests Performed | Pass / Fail | | Pouch Seal Strength | Pass | | Pouch Integrity | Pass | | Hub Durability & Compatibility:<br>Liquid Leakage | Pass | | Air Leakage During Aspiration | Pass | | Unscrewing Torque | Pass | | Ease of Assembly | Pass | | Resistance to Overriding | Pass | | Stress Cracking | Pass | | Catheter Joint Strength | Pass | | Catheter Seal Integrity | Pass | | Guidewire Insertion Force | Pass | | Catheter Burst Pressure | Pass | | Catheter Tip Stability | Pass | | Restrictor Durability | Pass | | Stiffness | Pass | | Torquability | Pass | As evidenced above, the Vanguard Dx passed all in-vitro shelf life and packaging tests demonstrating its acceptability for use. {5}------------------------------------------------ # X. PRODUCT COMPARISON CHART | MODEL | MEDRAD<br>VANGUARD Dx | CORDIS<br>INFINITI | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | WHERE MARKETED | Intended for Worldwide | Worldwide | | TYPE | Angiographic catheter | Angiographic<br>catheter | | DISPOSABLE | Yes | Yes | | CE MARK (MDD) | Yes | Yes | | INDICATIONS | Vanguard Dx is intended for<br>use in the delivery of<br>radiopaque contrast media to<br>selected sites in the vascular<br>system | INFINITI is intended<br>for use in the<br>delivery of<br>radiopaque contrast<br>media to selected<br>sites in the vascular<br>system | | DIMENSIONAL | | | | Catheter Diameter (Fr) | 4 & 5 | 4 & 5 | | Catheter Usable Lengths | Selective -100cm<br>Flush -110cm | Selective -100cm,<br>Flush -110cm | | Catheter Hub | Female Luer | Female Luer | | Catheter Shapes | Judkins Left- 3.5, 4.0, 5.0<br>Judkins Right- 3.5, 4.0<br>Amplatz Left- 1,2,3<br>Amplatz Right 1<br>Internal Mammary<br>Left Coronary Bypass<br>Right Coronary Bypass<br>Multi-purpose A2<br>Pigtail<br>Angled Pigtail | Judkins Left- 3.5,<br>4.0, 5.0<br>Judkins Right- 3.5,<br>4.0<br>Amplatz Left- 1,2,3<br>Amplatz Right 1<br>Internal Mammary<br>Left Coronary<br>Bypass<br>Right Coronary<br>Bypass<br>Multi-purpose A2<br>Pigtail<br>Angled Pigtail | | Catheter Distal Tip Endhole | 4Fr- 0.009"<br>5Fr- 0.010" | 4Fr- 0.040"<br>5Fr- 0.044" | | Maximum allowable Guidewire Size (inches) | 4Fr- 0.035"<br>5Fr- 0.038" | 4Fr- 0.038"<br>5Fr- 0.038" | | MODEL | MEDRAD<br>VANGUARD Dx | CORDIS<br>INFINITI | | PERFORMANCE | | | | Catheter Rated Burst Pressures | 1200 psi (8274 KPA) | 1200 psi (8274 KPA) | | Catheter Joint Strengths: | | | | Hub to Shaft | 4Fr- 10.9 lbs<br>5Fr- 12.6 lbs | 4Fr- 11.4 lbs<br>5Fr- 14.7 lbs | | Shaft to Soft-Tip | 4Fr- 4.7 lbs<br>5Fr- 7.0 lbs | 4Fr- 3.5 lbs<br>5Fr- 5.4 lbs | | Soft-Tip to Atraumatic-Tip | 4Fr- 1.7 lbs<br>5Fr- 2.8 lbs | 4Fr- 2.3 lbs<br>5Fr- 3.0 lbs | | Catheter Flow Rates | 4Fr Selectives- 13 ml/sec<br>4Fr Flush- 12.4 ml/sec<br>5Fr Selectives- 20ml/sec<br>5Fr Flush- 20ml/sec | 4Fr Selectives- 14 ml/sec<br>4Fr Flush- 4 ml/sec<br>5Fr Selectives- 20 ml/sec<br>5Fr Flush- 20 ml/sec | | Catheter Tip Stability Selectives<br>(9 centipoise contrast @ 6ml/sec) | 4Fr- 1.9 mm<br>5Fr- 5.4 mm | Greater than 2 cm | | Catheter Tip Stability Flush<br>(9 centipoise contrast @ 14ml/sec for 4Fr and 18ml/sec for 5Fr) | 4Fr- 1.7 mm<br>5Fr- 1.7 mm | Not Applicable | | Catheter Stiffness | 4Fr- 0.173 lbs<br>5Fr- 0.153 lbs | 4Fr- 0.099 lbs<br>5Fr- 0.139 lbs | | Catheter Radiopacity | The tubing is radiopaque for<br>proper visualization under<br>flouroscopy. | The tubing is<br>radiopaque for proper<br>visualization under<br>flouroscopy. | | MATERIAL | | | | Strain Relief Colors | 4Fr- Red<br>5Fr- Grey | 4Fr- Blue<br>5Fr- Blue | | Shaft Material | Nylon | Nylon | | Soft-Tip Material | Nylon | Nylon | | Atraumatic-Tip Material | Nylon | Nylon | continued on the next page . {6}------------------------------------------------ # PRODUCT COMPARISON CHART (continued from previous page) NOTE: A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only NOT L. A statement or dabothidated without prior reclassification or clinical approval. The present submission whether the presont product our of many patent, and is not to be interpreted as an admission or used as evidence is thororor not rollation to the Commissioner of the FDA, " .. a determination of substantial in a patch. Inningoment lawsull Prod., Drug, and Cosmetic Act relates to the fact that the product can lawfully be equivalence andor the Pour a reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suit." 42 Fed. Reg. 42, 520 et set. (1977) {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human form. JUN 7 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medrad, Inc. c/o Mr. Geoff M. Fatzinger Manager Regulatory & Compliance Cardiovascular Strategic Business Unit One Medrad Drive Indianola, PA 15051-0780 K050371 Re: Trade/Device Name: Vanguard Dx™ Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: May 18, 2005 Received: May 19, 2005 Dear Mr. Fatzinger: 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. 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 {8}------------------------------------------------ Page 2 -- Mr. Geoff M. Fatzinger forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radianon control provisions (Declients of a vice as described in your Section 510(k) I his letter will anow you to begin manies. In a substantial equivalence of your device to a legally prematket notheation: "The PDF missification 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 If you desire specific acvice 101 your at (240) 276-0120. Also, please note the regulation entitled, Contact and office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oct.ss http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Dwna R. Vochner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # INDICATIONS FOR USE K050371 Company: MEDRAD, Inc Device Name: Vanguard Dx™ angiographic catheter Indications for Use: The Vanguard Dx™ catheter is intended for use in the delivery of radiopaque contrast media and common flushing agents to the vascular system. ### Contraindications The Vanguard Dx™ is not intended for multi-patient use. Vanguard Dx™ is single patient use only. Vanguard Dx™ is not for use in the MRI environment. Vanguard Dx™ is not to be used for drug infusion, chemotherapy, or any other use for which the device is not intended. X Prescription Usc-(Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 807 Subpart C) Duna P. Vachner (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K05037/