PIVOT STEERABLE MICROCATHETER

{0}------------------------------------------------ K050630 ## Summary of Safety and Effectiveness Prepared 8 March 2005 | General<br>Provisions | Submitter of 510(k)<br>Premarket Notification: | Boston Scientific - Precision Vascular<br>2405 West Orton Circle<br>West Valley City, UT 84119<br>Phone: 801.974.1700<br>Fax: 801.974.1740 | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | | Contact Person: | Rick Gaykowski<br>Vice President, Regulatory/Clinical<br>Affairs & Quality Systems | | | | Device Trade Name: | "PivotTM" Steerable Microcatheter | | | | Device Generic Name: | Infusion Catheter | | | | The predicate devices are listed below. | | | | Predicate<br>Devices | Device | Manufacturer | 510(k) Number/Date<br>Pro Code | | | <i>SDS</i> 0.018" | PVS, Inc. | K020733, 21 March 2002<br>KRA | | | <i>SDS</i> 0.010" | PVS, Inc. | K032494, 05 Sep 2003<br>KRA | | | <i>Pivot</i> "SDS" | PVS, Inc. | K033726, 16 Jan 2004<br>KRA | | Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA | | | | Performance<br>Standards | Performance standards have not been established by FDA under section 514 of the<br>Federal Food, Drug and Cosmetic Act. | | | | Intended Use | The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous<br>vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and<br>therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for<br>guide wire exchange/support during diagnostic or interventional procedures. | | | | Device<br>Description | The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular<br>device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or<br>embolics. The lumen is constructed from a polymeric material and has an inside<br>diameter of 0.017". The device is coated on the outer diameter with a lubricious<br>coating over the distal segment of the device. Two radiopaque markers are positioned<br>at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of<br>the device has a standard luer adapter for attachment of accessories and can be used<br>to flush the lumen. The subject device has the ability to access distal, tortuous<br>vasculature over a guide wire, deliver embolics and agents, and has the ability to be<br>steered like a guide wire as needed. | | | {1}------------------------------------------------ | Technological<br>Characteristics | Technological similarities between the "Pivot™" Steerable Microcatheter and predicate devices include the basal tubular design and dimensions, polymeric materials and construction, and hydrophilic coating. In instances where the technological characteristics may differ slightly, it has been demonstrated that there are no new questions raised regarding safety and efficacy of the "Pivot™" Steerable Microcatheter. | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Safety and<br>Performance<br>Tests | Performance testing of the "Pivot™" Steerable Microcatheter was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters -- Part 1. Verification testing for the subject device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable results.<br>In addition, torsional strength, torqueability, and corrosion resistance tests have also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the "Pivot™" Steerable Microcatheter is substantial equivalent to the cited predicate devices. | | Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and performance testing, the subject "Pivot™" Steerable Microcatheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 of three horizontal lines curving upwards, resembling a human figure with outstretched arms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 2 2005 Mr. Rick Gaykowski Mice President, Regulatory/Clinical Affairs & Quality Systems Boston Scientific - Precision Vascular 2405 West Orton Circle West Valley City, UT 84119 K050630 Re: Trade/Device Name: Pivor™ Steerable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: March 10, 2005 Received: March 11, 2005 Dear Mr. Gaykowski: 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 for assessment 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 {3}------------------------------------------------ Page 2 – Mr. Rick Gaykowski Fage 2 - "htt read as a proposion (21 CFR Part 820); and if applicable, the electronic forth in the quality systems in and inco (Sections 531-542 of the Act); 21 CFR 1000-105 forth in the quality systems (QS) regulation (2) CFR Pat 620); and 11 CFF product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 101 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -This letter will allow you to begin marketing your device of your device to a legally premarket notification. The FDA finding of subscification for your device to a legally remarket notification. The FDA finding of substantial on 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 s and the results of the support (240) 276.0120 . Also, please note the r If you desire specific advice for your device on our labeling nease not the regulation entitled, contact the Office of Compliance at (240) 276-0120. Also, please not 97). contact the Office of Compliance at (240) 270-01-20. Proxet 807.97). You may obtain "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misbranding by reference to premarket notification "(21 cf 1 cr from the Division of Small other general information on your responsibilities under the Act from the Division other general information on your responsibilities under (800) 638-204) or 2001) Manufacturers, International and Consumer Assistance at its todalfred wordindex.html. Manufacturers, International and Consumer Assistance at les to restor in over index.html. (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/i Sincerely yours, Durna R. Kirchner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known): ¥650630_ Device Name: "Pivot™" Steerable Microcatheter Indications for Use: The "Pivot™" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-The "Pivot™" Steerable Microcather is intended to activer and therapeutic agents into the distal, selective controlled infusion of diagnosic, emblic, and therapeupport during selective controlled infusion or delivery of diagnostic, endonic, and therebels agence of the counter of the county, or interventional procedures. : . . . PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <span></span> ✓ | OR | Over-the-Counter Use | | |----------------------|-----------------|----|----------------------|--| | (Per 21 CFR 801.109) | | | | | | | <div style="text-align:left;">Donna P. Vechinel</div> <div style="text-align:left;">(Division Sign-Off)</div> <div style="text-align:left;">Division of Cardiovascular Devices</div> | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K050630 |