TSP Crosser Transseptal Access System

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September 28, 2018 Transseptal Solutions Ltd. % Mary LeGraw Consultant to Transseptal Solutions Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752 Re: K181088 Trade/Device Name: TSP Crosser Transseptal Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: August 23, 2018 Received: August 24, 2018 Dear Mary LeGraw: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Rachel E. Neubrander -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT 5 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|--| | Food and Drug Administration | | | Indications for Use | | orm Approved: OMB No. 0910-0120 xpiration Date: 06/30/2020 ee PRA Statement below. 510(k) Number (if known) K181088 Device Name TSP CrosserTM Transseptal Access System Indications for Use (Describe) The TSP Crosser Transseptal Access System is intended to both puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-674) {3}------------------------------------------------ ### 6 510(K) SUMMARY This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date is April 4, 2018 [21 CFR 807.92(a)(1)]. #### Submitter 6.1 | Name: | Transseptal Solutions Ltd. | |----------|----------------------------------------------------------------| | Address: | 10 HaGavish St.<br>P.O. Box 4060<br>Netanya, 4250708<br>Israel | | Phone: | +972 9 8914217 | | Contact Person: | Mary P. LeGraw | |-----------------|------------------------------| | | Boston Biomedical Associates | | | 100 Crowley Drive, Suite 216 | | | Marlborough, MA 01752 | | | mlegraw@bbacro.com | | | Phone: (508) 691-7038 | | | Fax: (508) 351-8637 | #### 6.2 Device | Name of Device: | TSP Crosser™ Transseptal Access System (Model Number TSUS001) | |--------------------------------|---------------------------------------------------------------| | Common Name: | Introducer Catheter | | Classification Name: | Catheter, Introducer | | Regulatory Class: | Class II | | Product Code:<br>Device Panel: | DYB, 21 CFR 870.1340<br>Division of Cardiovascular Devices | #### Predicate Device 6.3 | Primary Predicate Name<br>and 510(k) Number: | St. Jude ACross™ Transseptal Access System (K070417) | |----------------------------------------------|------------------------------------------------------| | Reference Device: | St. Jude Agilis™ NxT Steerable Introducer (K081645) | #### Device Description 6.4 The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. The main components of the TSP Crosser System are: {4}------------------------------------------------ - . Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F - . Dilator that is compatible with guidewires up to a maximum diameter of 0.035" - Transseptal needle with Stylet ● The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet. # Indications for Use 6.5 The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. # Comparison of Technological Characteristics with the Predicate Device 6.6 The proposed device is substantially equivalent to the design and materials in the predicate device. The table below summarizes the comparisons between the predicate device and the TSP Crosser System | Technical<br>Characteristic | Proposed Device<br>TSP Crosser System<br>(Pending) | Predicate Device<br>ACross System<br>(K070417) | Predicate Device<br>Agilis NxT System<br>(K081645) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Integrated System | | | | | Indications for Use | The TSP Crosser<br>Transseptal Access System<br>is intended to both to<br>puncture the interatrial | The St. Jude Medical<br>ACross Transseptal<br>Access System is<br>used both to puncture | The Agilis NxT Steerable<br>Introducer is indicated for<br>introducing various<br>cardiovascular catheters | | Technical | Proposed Device<br>TSP Crosser System | Predicate Device<br>ACross System | Predicate Device<br>Agilis NxT System | | Characteristic | (Pending) | (K070417) | (K081645) | | | septum during a transseptal<br>catheterization procedure<br>and to introduce various<br>cardiovascular catheters into<br>the left side of the heart. | the interatrial septum<br>during a transseptal<br>catheterization<br>procedure and to<br>introduce various<br>cardiovascular<br>catheters into the left<br>side of the heart. | into the heart, including the<br>left side of the heart<br>through the interatrial<br>space. | | Regulatory Class | Class II | Class II | Class II | | Product Code | DYB | DYB | DYB | | Regulation Name | Catheter Introducer | Catheter Introducer | Catheter Introducer | | Regulation Number | 21 CFR 870.1340 | 21 CFR 870.1340 | 21 CFR 870.1340 | | Common Name | Transseptal Catheter<br>Introducer | Transseptal Catheter<br>Introducer | Transseptal Catheter<br>Introducer | | | Introducer / Sheath | | | | Sheath Characteristics | TSP Crosser Steerable<br>Introducer | ACross<br>Swartz™ Guiding<br>Introducer | Agilis Steerable<br>Introducer | | Shaft Deflection | Pull Wire | Stable braided (fixed<br>curve) | Pull Wire | | Deflection Mechanism | Rotating knob on handle | Not steerable | Rotating knob on handle | | Labeled Internal<br>Diameter | 8.7F | 8F | 8.5F | | Labeled Outer Diameter | 14 F | Unavailable | 11.5F | | Catheter Compatibility | 8F OD or less | 8F OD or less | 8F OD or less | | Shaft Usable Length | 68.5cm | 63cm and 81cm | 61cm, 71cm, 82cm | | Maximum Deflection | 180°<br>Bi-directional | 45°, 60°, 90°, 135°,<br>180°<br>(Fixed Curves) | 90° Clockwise<br>180° Counter Clockwise<br>Bi-directional | | Radiopaque Tip | YES | YES | YES | | Hemostasis | Internal valve | Internal valve | Internal valve | | Shaft Construction | Laminated, SS braided<br>shaft, inner PTFE liner,<br>deflectable sheath | Braided Sheath | Laminated, SS braided<br>shaft, inner PTFE liner,<br>deflectable sheath | | Sheath Primary<br>Materials | Stainless steel and PTFE<br>inner liner, outer Pebax<br>jacket | Unavailable | PE, polycarbonate, ABS,<br>PVC and silicone rubber<br>(IFU) | | | System Dilator | | | | Dilator Characteristics | TSP Crosser Dilator | ACross Dilator | Agilis Dilator | | Purpose | To provide support to the<br>sheath and ensure smooth<br>advancement into the vessel | To provide support to<br>the sheath and ensure<br>smooth advancement<br>into the vessel | To provide support to the<br>sheath and ensure smooth<br>advancement into the<br>vessel | | Outer Diameter | 8.5F | 8F, 8.5F | 8.5F | | Guidewire Compatibility | 0.035" | 0.032" | 0.032" | | Effective Length | 94.9cm | 71cm, 89cm | 98cm | | Tip Length | 10.5mm | Unavailable | 9mm | | Material | High Density Polyethylene<br>(HDPE) | Unavailable | Unavailable | | Transseptal Needle / Stylet | | | | | Technical<br>Characteristic | Proposed Device<br>TSP Crosser System<br>(Pending) | Predicate Device<br>ACross System<br>(K070417) | Predicate Device<br>Agilis NxT System<br>(K081645) | | Transseptal<br>Needle/Stylet<br>Characteristics | TSP Crosser Needle | TSP Crosser Stylet | ACross BRK Transseptal<br>Needle | | Overall Length | 105.5 cm | 107.8 cm | 71cm, 89cm, 98cm | | Working Length | 100 cm | 120.5 cm | Unknown | | Internal Diameter | 0.6 mm | N/A | Unknown | | Outer Diameter | 0.9 mm | 0.45 mm | 1.02 mm | | Curve Angle | Straight with flexible tip<br>(passive steering using<br>sheath deflection) | Straight | BRK: Standard curve, 19°<br>angle between curved<br>segment and need shaft<br>BRK-1: Accentuated<br>curve, 53° angle | | Material | 304 Stainless Steel | 304 Stainless Steel | Stainless Steel | | System Performance | | | | | Bench Testing<br>Demonstrate<br>Equivalence | YES | YES | YES | | Biocompatible | YES | YES | YES | | Sterilization | EO | EO | EO | # Table 6-1: Substantial Equivalence {5}------------------------------------------------ {6}------------------------------------------------ #### 6.7 Performance Data and Substantial Equivalence The technical characteristics between the subject device and the predicate devices have been evaluated through design, material and dimensional comparison, bench and biocompatibility tests to provide evidence of substantial equivalence. The TSP Crosser Transseptal Access System is substantially equivalent to the predicate devices based on comparison of the devices functionality, compatibility, technological characteristics and indications for use. In vitro bench testing was performed on the TSP Crosser System to assure reliable design and performance. The non-clinical tests performed include Visual and Dimensional Verification, Steerability, Air Leakage, Liquid Leakage, Pushability, Torqueability, Simulated Use, Tensile Strength, and Corrosion. Biocompatibility testing consisted of Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, ASTM Hemolysis (Direct and Indirect), SC5b-9 Complement Activation and In Vivo Thrombogenicity. In vivo animal studies were performed to confirm the safety and performance of the TSP Crosser System in a left heart catheterization and to demonstrate the ability of the System to successfully introduce commercial percutaneous catheters into the left chambers of the heart. Clinical data was also collected outside the United States that supports the safety and performance of the TSP Crosser System for its labeled indications for use. {7}------------------------------------------------ #### 6.8 Conclusions Transseptal Solutions believes the proposed TSP Crosser System is substantially equivalent to the legally marketed predicate devices. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate products. In addition, performance testing, in addition to in vivo animal studies and clinical data supports substantial equivalence of the proposed and predicate devices.