SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM

{0}------------------------------------------------ Page 1 of 5 K121404 # 510(k) Summary # Onset Medical Corporation, SoloPath® Re-Collapsible Access System This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807, section 807.92. #### General Information | Sponsor's Name and Address: | Onset Medical Corporation<br>13900 Alton Parkway, Suite 120<br>Irvine, CA 92618 | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Joseph Bishop<br>Vice President and Chief Operating Officer<br>Onset Medical Corporation<br>13900 Alton Parkway, Suite 120<br>Irvine, CA 92618<br>(949) 716-1100 | | Date Summary Prepared: | April 19, 2013 | | Device Trade Name: | <i>SoloPath</i> ®Re-Collapsible Access System | | Product Code: | DYB | | Regulation Number: | 21 CFR 870.1340 | | Classification: | Class II | | Common Name: | Catheter Introducer | | Predicate Devices | • Onset Medical <i>SoloPath</i> ® Balloon Expandable TransFemoral<br>Introducer (K092014 and K100819)<br>• GORE® DrySeal Sheath (K093791) | - Cook® Extra Large Check-Flo® Introducer (Pre-Amendment device) ## Description The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Testing was performed to demonstrate the SoloPath® Re-Collapsible Access System device is substantially equivalent to the predicate devices. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices {1}------------------------------------------------ K121404 Page 2 of 5 introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The SoloPath® Re-Collapsible Access System is equivalent to approved predicate devices currently available as vascular introducers such as the Cook® Extra Large Check-Flo® Introducer which is available in 20F, 22F and 24F configurations with a variable usable lengths and Onset Medical Corporation's SoloPath® Balloon Expandable TransFemoral Introducer which utilizes the same material and balloon expandable dilation feature for vascular introduction. These devices are designed to be advanced over a guidewire, under fluoroscopic or ultrasound guidance. The dilator portion of the introducer assembly is advanced gently into the vasculature and facilitates a clinical conduit through which interventional tools and prostheses can be safely delivered. The devices may contain various hemostasis valve assemblies and hydrophilic-coated surfaces for improved lubricity. The SoloPath® Re-Collapsible Access System is equivalent in regards to materials, indications for use and overall clinical utility. However, like the approved SoloPath® TransFemoral Introducer, the SoloPath® Re-Collapsible Access System consists of a flexible sheath with a specially folded distal segment pre-mounted over a central balloon dilatation catheter (the Expander). The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath® Re-Collapsible Access System is inserted percutaneously into the femoral artery, over a guidewire. Once the device is positioned, the Expander balloon is inflated with liquid and exerts controlled radial dilation, enlarging the folded distal segment of the Sheath to a unidiameter configuration. The Expander balloon is deflated and is removed leaving a large central lumen extending from the proximal end to the distal end of the SoloPath® Re-Collapsible Access System performs the same as previously approved predicate devices and raises no new issues of safety or effectiveness. The sheath is capable of expanding and actively collapsing. In Vitro bench studies were conducted to demonstrate that the SoloPath® Re-Collapsible Access System performed as intended in simulated use conditions. Biocompatibility testing was conducted to demonstrate conformance to ISO 10993-1 requirements. #### Intended Use/Indications For Use The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously into the femoral artery, over a guidewire and once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. {2}------------------------------------------------ | Device Name | SoloPath®<br>Re-Collapsible<br>Access System | SoloPath®<br>Balloon<br>Expandable<br>TransFemoral<br>Introducer | GORE® DrySeal<br>Sheath | Extra Large<br>Check-Flo®<br>Introducer | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K# | K121404 | K092014 and<br>K100819 | K093791 | Pre-Amendment<br>device | | Manufacturer | Onset Medical<br>Corporation | Onset Medical<br>Corporation | Gore Medical | Cook<br>Incorporated | | Indication for use | The SoloPath®<br>Re-Collapsible<br>Access System is<br>intended to be<br>inserted<br>percutaneously<br>into the femoral<br>artery, over a<br>guidewire and<br>once expanded,<br>to be used as a<br>guide for<br>catheters and/or<br>devices<br>introduced into<br>the femoral<br>artery. | The SoloPath®<br>Balloon<br>Expandable<br>TransFemoral<br>Introducer is<br>intended to be<br>inserted<br>percutaneously<br>into the femoral<br>artery, over a<br>guidewire, and<br>once expanded,<br>to provide a<br>guide for<br>catheters and/or<br>devices<br>introduced into<br>the femoral iliac<br>arteries. | The GORE<br>DrySeal Sheath is<br>intended to be<br>inserted in the<br>vasculature to<br>provide a<br>conduit for the<br>insertion of<br>endovascular<br>devices while<br>minimizing blood<br>loss associated<br>with such<br>insertions. | Introducers are<br>intended for<br>introduction of<br>balloons, closed<br>and non-tapered<br>end catheters or<br>other diagnostic<br>or interventional<br>devices. The<br>product is<br>intended for use<br>by physicians<br>trained and<br>experienced in<br>diagnostic and<br>interventional<br>techniques.<br>Standard<br>techniques for<br>placement of<br>vascular access<br>sheaths should<br>be employed | | Device Name | New Device:<br>SoloPath® Re-<br>Collapsible<br>Access System | Predicate Device:<br>SoloPath®<br>TransFemoral<br>Introducer | Predicate Device:<br>GORE® DrySeal<br>Sheath | Predicate Device:<br>Extra Large<br>Check-Flo®<br>Introducer | | Placement | Standard<br>techniques for<br>placement of<br>vascular access<br>sheaths | Standard<br>techniques for<br>placement of<br>vascular access<br>sheaths | Standard<br>techniques for<br>placement of<br>vascular access<br>sheaths | Standard<br>techniques for<br>placement of<br>vascular access<br>sheaths | | | | | | | | Device Name | SoloPath®<br>Re-Collapsible<br>Access System | SoloPath®<br>Balloon<br>Expandable<br>TransFemoral<br>Introducer | GORE® DrySeal<br>Sheath | Extra Large<br>Check-Flo®<br>Introducer | | Guidewire<br>compatibility | Can be navigated<br>over a .035" or<br>.038"compatible<br>guidewire | Can be navigated<br>over a .035" or<br>.038" compatible<br>guidewire | Recommended<br>to be navigated<br>over a .035" or<br>smaller<br>guidewire. | Recommended<br>to be navigated<br>over a .035"<br>guidewire. | | Radiographic markers | Sheath tip =<br>Radiopaque Gold<br>Distal Marker | Sheath tip =<br>Radiopaque Gold<br>Distal Marker | Sheath tip =<br>distal marker<br>band | Optional | | Shaft Materials | • Medical grade<br>plastic shaft<br>reinforced<br>with stainless<br>steel ribbon<br>• PET Outer<br>Jacket<br>• Coated with<br>hydrophilic<br>coating | • Medical grade<br>plastic shaft<br>reinforced<br>with stainless<br>steel ribbon<br>• Coated with<br>hydrophilic<br>coating | • Medical grade<br>plastic shaft<br>• Physical<br>characteristics<br>are similar to<br>other<br>predicate<br>devices. | • Medical grade<br>plastic shaft | | Device length | 25cm - 35cm | 25cm - 35cm | 28cm | 25cm - 55 cm | | Available sheath ID's<br>(pre-expansion) | 19F - 24F | 11F - 21F | 12F - 26F | 18F - 24F | | Available sheath OD's<br>(post-expansion) | 23F - 28.5F | 14 F - 24 F | NA | NA | | Fixed OD (guidewire<br>lumen) | Yes | Yes | Yes | Yes | | Variable OD (Capable<br>of expansion) | Yes — via<br>injecting fluid<br>though the<br>applicable port | Yes — via<br>injecting fluid<br>though the<br>applicable port | No | No | | Capable of OD<br>collapsation | Yes — by<br>injecting fluid<br>into the<br>applicable port | Yes - passively;<br>the sheath<br>collapses during<br>removal | No | No | | Sterilized by | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | # Comparison of the Technological Characteristics of the New Device and Predicate Devices {3}------------------------------------------------ K121404 Page 4 of 5 . · {4}------------------------------------------------ K121404 Page 5 of 5 # Performance Testing Results of bench studies conducted on both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System demonstrated the System to be as safe and effective as the predicate device based on the biocompatibility of the materials used, sterilization, bench testing. Testing was performed on both EO processed and EO equivalent product, and product accelerated aged to 6 months. The following studies were conducted and acceptance criteria were met: ### Functional Verification - . Bend - . Coating integrity - . Coating particulate - . Collapsation - . Dilator burst - . Dilator cycle - . Expansion - . Hemostasis valve leakage . - . Sheath jacket burst - . Sheath jacket cycle - . Tensile - . Torque - . Trackability #### Materials tested per ISO 10993-1 - . Cytotoxicity - . Complement Activation - . Partial Thromboplastin Time (PTT) - . Sensitization - . Intracutaneous Reactivity - . Acute Systemic Toxicity - . Pyrogenicity, and - . Hemolysis #### Conclusion - . The SoloPoth® Re-Collapsible Access System is substantially equivalent to the predicate devices. - . The indication for use for the devices is substantially equivalent. - . The technological design and functional characteristics of the sterile disposable access devices are all substantially equivalent to the predicate devices. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 3, 2013 Onset Medical Corporation Mr. Joseph Bishop Vice President and Chief Operating Officer 13900 Alton Parkway, Suite 120 Irvine, CA 92618 Re: K121404 Trade/Device Name: SoloPath® Re-Collapsible Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 19, 2013 Received: April 24, 2013 Dear Mr. Bishop: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Joseph Bishop 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Bram D厚uckerman Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K121404 Device Name: SoloPath® Re-Collapsible Access System Indications for Use: The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously into the femoral artery, over a guidewire and once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Bram D. Zuckerman 2013.05.03 11:52:54 -04'00' Concurrence of CDRH, Office of Device Evaluation (ODE)