Xtractor device

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February 17, 2022 Xcardia Innovation Ltd. % Orly Maor Regulatory Consultant 25 Sirkin Street Kfar Saba, 4442156 Israel Re: K211679 Trade/Device Name: Xtractor device Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: January 17, 2022 Received: January 21, 2022 Dear Orly Maor: 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/cfpmn/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. K211679 Device Name Xtractor™ device Indications for Use (Describe) The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. | Type of Use (Select one or both, as applicable) | <table><tr><td><div> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |------------------------------------------------------------------------------|--| |------------------------------------------------------------------------------|--| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conductor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 ER {3}------------------------------------------------ # Traditional Premarket Notification Submission - 510(k) Xtractor™ device 510(k) Number K211679 ## Date Prepared: February 15, 2022 ### I. SUBMITTER Xcardia Innovation Ltd. 1 Hamada St. Rehovot 7670301, Israel E-mail: info@xcardia.com Tel: +97286321175 ## Contact Person Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com ### II. DEVICE Name of Device: Xtractor™ device Common or Usual Name: Xtractor™ device Classification Name: 21 CFR 870.1310; Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE. ### III. PREDICATE DEVICE Xcardia Innovation Ltd. believes that the Xtractor™ device is substantially equivalent to the following predicate device: - Spectranetics TightRail™ Mechanical Dilator Sheath Set cleared under K140047 . (product code DRE Regulation No. 21 CFR 870.1310) and in subsequent submission under K142546 TightRail and TightRail Mini Rotating Dilator Sheaths. ### DEVICE DESCRIPTION IV. The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead. The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle. {4}------------------------------------------------ The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements). The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip. The Xtractor™ device is visible under fluoroscopy during the procedure. ## V. INDICATIONS FOR USE The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Xtractor™ device has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device. | | Xtractor™ | TightRail™ | SE JUSTIFICATION | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K211679 | K140047 | — | | Manufacturer | Xcardia Innovation Ltd. | Spectranetics, Inc. | — | | Product Code | DRE | DRE | Same | | CFR | 21 CFR 870.1310 | 21 CFR 870.1310 | Same | | Intended Use | The Xtractor™ device is<br>intended for use in patients<br>requiring the percutaneous<br>dilation of tissue to<br>facilitate removal of<br>cardiac leads, indwelling<br>catheters, and foreign<br>objects. | The TightRail™ Rotating<br>Dilator Sheaths are<br>intended for use in<br>patients requiring the<br>percutaneous dilation of<br>tissue to facilitate<br>removal of cardiac leads,<br>indwelling catheters, and<br>foreign objects. | Same | | Nominal Outer<br>Diameter | 7.75mm | 6.6mm without sheath<br>and is designed to be used<br>with a 8.1mm sheath | Similar<br>The nominal outer<br>diameter is similar. | | | Xtractor™ | TightRail™ | SE JUSTIFICATION | | Nominal Inner<br>Diameter | 13Fr | 9,11,13 Fr | Similar<br>The nominal inner<br>diameter is similar. | | Nominal<br>effective length | 540mm | 475mm | Similar<br>The nominal effective<br>length is similar. | | Radiopacity<br>Markers | Device: Radio-detectable<br>materials source is the dense<br>layers of stainless steel coils<br>Sheath: Radio-detectable<br>materials source is Teflon<br>compounded with 10-12%<br>bismuth | Device: Radio-detectable<br>materials source is the dense<br>layers of stainless steel coils<br>Sheath: Radio-detectable<br>materials source is Teflon<br>compounded with bismuth<br>trioxide | Similar<br>The radiopacity markers<br>are similar. | | Blade design | Two circular rings: a rotating<br>blade for dilation, and a blunt<br>impact ring for axial<br>dilatation | Serrated / Interrupted<br>Beveled Edge<br>Blade includes an axial<br>translation during rotation. | Similar<br>Both designs are suitable<br>for dilation of<br>surrounding tissue. | | Blade feature | Shielded<br>Blade is covered by the blunt<br>ring. | Shielded<br>Blade is retracted into the<br>shaft. | Similar.<br>Achieved by different but<br>substantially equivalent<br>mechanism. | | Materials | Stainless Steel, Pebax Jacket<br>PTFE Teflon with bismuth for<br>radiopacity<br>Hydrophilic coating | Stainless Steel, Pebax Jacket<br>PTFE Teflon with bismuth<br>trioxide for radiopacity | Similar | | Shaft Design | Shaft is designed to provide<br>a flexible means of aligning<br>the shaft and tip assembly<br>parallel to<br>the vessel wall in the<br>expected curvature of<br>the anatomy. | Shaft is designed to<br>provide a flexible means<br>of aligning the shaft and<br>tip assembly parallel to the<br>vessel wall in the expected<br>curvature of the anatomy. | Same | | | Xtractor™ | TightRail™ | SE JUSTIFICATION | | Outer Sheath /<br>External Sheath<br>design | Outer Sheath / Teflon (radio-<br>detectable)<br>Beveled distal end (to<br>navigate the expected<br>curvature of the anatomy)<br>The Xtractor™ external<br>sheath has flare proximal end<br>for convenient grip.<br>The Xtractor™ device (not<br>the sheath) already has a<br>blunt proximal end, thus<br>supports counter traction to<br>release of the lead from the<br>myocardium | Outer Sheath / Teflon<br>(radio-detectable)<br>Beveled distal (to<br>navigate the expected<br>curvature of the anatomy)<br>Blunt straight proximal<br>end when flipped around<br>(to provide a blunt surface<br>for counter-traction at the<br>release of the lead from the<br>myocardium) | Both devices have same<br>purpose and similar<br>performance for<br>supporting the procedure<br>and entry into the vessel. | | Anatomical Site<br>used | From pacemaker pocket,<br>through the veins, along the<br>path towards the heart | From pacemaker pocket,<br>through the veins, along the<br>path towards the heart | Same | | Environments of<br>Use | Physicians knowledge in the<br>techniques and devices for<br>lead or catheter removal | Physicians knowledge in the<br>techniques and devices for<br>lead or catheter removal | Same | | Sterilization | Sterile for single use (EtO) | Sterile for single use (EtO) | Same | | Device Life | Disposable | Disposable | Same | | Prescription Use | The device should be used by<br>a physician who is familiar<br>with the intended procedures. | The device should be used<br>by a physician who is<br>familiar with the intended<br>procedures. | Same | | Operation | Battery operated | Mechanical | Testing demonstrated<br>substantial equivalence<br>with respect to safe<br>operation | | Haptic feel | The user advances the device<br>and pulls the lead manually.<br>The user activates the<br>motorized rotation of the shaft<br>using the handle's button or<br>pedal. | The user advances the device<br>and pulls the lead manually.<br>The user rotates the shaft by<br>manual squeezing of the<br> | The user advances the<br>device and pulls the lead<br>in exact same way.<br>Rotation is achieved by<br>different but substantially<br>equivalent mechanisms. | | | Xtractor™ | TightRail™ | SE JUSTIFICATION | | Mechanisms of<br>action/tissue<br>interaction | The Xtractor™ has a rotating<br>dilation blade that rotates to<br>assists the user in separating<br>the tissue that is bound around<br>the lead. The blade has sharp<br>teeth that when pushed<br>against the fibrotic tissue are<br>used to assist in separating it.<br>The Xtractor™ has a<br>"combined" mode | The TightRail™ device has a<br>rotating dilation blade that<br>rotates to assist the user in<br>separating the tissue that is<br>bound around the lead. The<br>blade has sharp teeth that<br>when pushed against the<br>fibrotic tissue are used to<br>assist in separating it.<br>The TightRail™ device is<br>actually working in a similar<br>"combined" mode. | The mechanism of action,<br>tissue interaction, and full<br>control by the user is<br>similar for both devices.<br>For the Extractor™, the<br>total amount of rotary<br>dilation is controlled by<br>the duration of button<br>press and in the predicate<br>device by number of<br>squeezes.<br>The Xtractor™ enables<br>the user to select modes<br>in which only sub-set of<br>the actions would be<br>performed.<br>The activation is fully<br>controlled by the user in<br>both devices.<br>The user can start and<br>stop the shaft rotation at<br>any time and change<br>mode as desired in the<br>Xtractor™. | | Pedal | The Xtractor has a pedal that<br>includes the battery and<br>electrical circuitry to drive the<br>handle's motor, LED display<br>and buttons.<br>The pedal can be used to<br>select modes and for device<br>activation. | NA | The Xtractor™ pedal<br>provides battery power,<br>mode selection and for<br>convenient use by user.<br>The Xtractor™ can be<br>used to release the hand<br>of the user from manually<br>squeezing the trigger as<br>in the predicate device.<br>The activation is fully<br>controlled by the user in<br>both devices.<br>The user can start and<br>stop the shaft rotation at<br>any time and change<br>mode as desired in<br>Xtractor™.<br>Electrical safety, EMC<br>and software testing were | The Xtractor™ device has similar technological characteristics as the predicate device as demonstrated in the table below: {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination: ## Biocompatibility - Biocompatibility evaluation in compliance with ISO 10993-1 was performed. The following tests were conducted: Cytotoxicity Study Xtractor™ -Device Cytotoxicity Study- Handle Cytotoxicity- pooling rod ISO Intracutaneous /irritation Study Sensitization Test Acute Systemic toxicity SC5b-9 Complement Activation Assay ASTM Hemolysis Pyrogen Study - Material Mediated ASTM Partial Thromboplastin Time with Sponsor Provided Control NAVI The device was found biocompatible. ## Sterilization, Packaging and Shelf Life Testing - Sterilization validation was performed to demonstrate compliance with ISO 11135-1. In addition, transportation simulation and environmental tests prior shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed. ## Performance Testing - Performance testing included the following: | Name of test | Test description | |--------------------------|------------------------------------------------------------------------------------------------------------------------| | Bending Test | The test was done to verify that the XtractorTM device<br>is functional after working in an extreme bending<br>radius. | | Corrosion Resistance | Corrosion resistance was tested per ASTM<br>A967/A967M | | Device radiopacity | The test was done to verify that the XtractorTM device<br>is visible under fluoroscopy. | | Dimensional Verification | Measurements following sterilization of the<br>XtractorTM device critical dimensions were taken. | | Tensile strength | The test was done to define the tensile strength of the<br>XtractorTM device and the External Sheath. | | Extended use | Test was done to verify that the XtractorTM device is<br>not damaged by the procedure and remains without | {9}------------------------------------------------ | Name of test | Test description | | |-----------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | | signs of defects, wear or deformations in substantially<br>extended and/or extreme use | | | | Torque test | Torque transmission from the handle to the distal tip<br>both inner and outer shaft was tested. | | | Simulated use | Simulated use of the device in anatomical model<br>simulator was done in time T0 and time Tx (shelf<br>life) | | Hydrophilic coating testing | | 3 tests (particles, visual, and pinch test) that<br>demonstrated that the device coating performs as<br>intended. | | | | Xtractor™ vs. Predicate comparison<br>test | All tests passed and met the predefined acceptance criteria. ## Software Validation - The Xtractor™ device level of concern is moderate. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". ## -Electrical Safety and EMC Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 were conducted on the Xtractor™ Lead Extraction device. # VIII. CONCLUSION The Xtractor™ device was determined to be substantially equivalent to the predicate devices.