JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...

{0}------------------------------------------------ #### 510 (K) Summary Submitter: Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany - Contact Person: Kathleen Johnson Phone: (610) 932-7738 (610) 932-7366 Fax: Date Prepared: June 21, 2001 Jostra Pediatric Arterial Cannulae Device Trade Name: Common/Usual Name: Pediatric Arterial Cannulae - Classification Names: Cardiopulmonary Bypass Vascular Cannula Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting #### Predicate Device: Medtronic DLP Pediatric Arterial Cannulae Device Description: The Jostra Pediatric Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use. Indications for use: The Jostra Pediatric Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less. Statement of Technical Characteristics Comparison: The Jostra Pediatric Cannulae have the same intended use as the Medtronic DLP Pediatric Cannulae. The wire-wound 8fr. to 16fr. Sizes from Medtronic are not available with a curved tip, and come with a "Flow-Guard" Style introducer. The Jostra Pediatric Cannulae provide the user with the option of a curved tip, and a vent plug for safe de-airing. Comparative testing has demonstrated that these differences do not affect safety and effectiveness. {1}------------------------------------------------ Non-Clinical Testing: Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device. Performance testing included: Flow-Pressure curves Kink Resistance Bond Strength Leakage Test Additionally, in-vitro testing was performed to determine the effects on cellular components. Conclusion: Performance, and in-vitro testing demonstrate that the Jostra Peditorial vac Penomiance, and in viro cosing active the predicate devices in intended use, Ourinaliae are overation, materials, design, and performance. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 6 2001 Ms. Kathleen Johnson Regulatory Affairs, Submission Manager Jostra AG c/o Jostra-Bentley Corporation 478 Media Road Oxford, PA 19363 Re: K012617 Trade Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: June 29, 2001 Received: August 13, 2001 Dear Ms. Johnson: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreours) is trgansjal the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de noos mat ha re been 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 1 ou may, morelore, market of the Act include requirements for annual registration, listing of general controls pro vision 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 If your device is classinod (600 as controls. Existing major regulations affecting your device can may oe subject to basil acceral 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 tease be actised alla i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {3}------------------------------------------------ ### Page 2 - Ms. Kathleen Johnson forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quinn 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) I mis letter will and in you is ought tinding of substantial equivalence of your device to a legally prematication - No 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 additionally 21 (301) 594-4646. Additionally, for questions on the promotion and advertising of Compilance at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on the responsibilities under the Act may be obtained from the Other general mistmation of Small 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, Lh James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ NOV 0 6 2001 K012617 Page 1 of 1 510(k) Number: Device Name: Arterial Cannulae (paediatric) ## Indications for Use indications for Soc The Jostia Fediatio Anonal Samulations are a circuit to the patient during cardiopulmonary bypass up to 6 hours or less. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) Division of Cardiovasc... 510(k) Number K0/2617