IMPEDE-FX Embolization Plug

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May 23, 2019 Shape Memory Medical Meghan Reu Ouality and Regulatory Manager 807 Aldo Avenue, Suite 109 Santa Clara, California 95054 Re: K182390 Trade/Device Name: IMPEDE-FX Embolization Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: April 25, 2019 Received: April 26, 2019 # Dear Meghan Reu: 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). 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Sincerely, For Kenneth Cavanaugh Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182390 Device Name IMPEDE-FX Embolization Plug Indications for Use (Describe) The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) SUMMARY #### SUBMITTER Shape Memory Medical Inc 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054 Contact Person: Meghan Reu, Quality and Regulatory Sr. Manager Phone: 408-649-5175 x 711 Fax: 669-230-5932 Date Prepared: March 29, 2019 #### DEVICE Name of Device: IMPEDE-FX Embolization Plug Common Name: Vascular Embolization Device Classification Name: Device, embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD PREDICATE DEVICE IMPEDE Embolization Plug (K181051) REFERENCE DEVICE Vascular Solutions Gel Block Embolization Pledgets (K113266) #### DEVICE DESCRIPTION The IMPEDE-FX Embolization Plug is a permanent implant, pushable embolization device comprised of a porous, degradable polyurethane thermoset foam plug and a proximal platinumiridium alloy marker band. The foam plug is crimped into a secondary shape to allow delivery through a catheter to the target vessel using a guidewire. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to its primary shape to embolize the target vessel. The IMPEDE-FX device may only be used in conjunction with the IMPEDE® Embolization Plug System to further enhance vessel occlusion or increase the length of occlusion within the target vessel. It is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX polyurethane foam undergoes slow oxidative degradation with the majority (> 90%) of the foam remaining at 30 days in a swine intravascular model. The amount of foam degradation was also assessed in vivo in 180-day rat subcutaneous implants and 26-week rabbit intramuscular implants. Analysis of the histology slides from both studies revealed near complete degradation of the polymer foam at the majority of the implant sites in each study. The device is pre-loaded into an introducer sheath which is made of a PEEK tube bonded to a polycarbonate luer hub to facilitate the transfer of the device into the catheter. The device implant is categorized as a permanent implant, blood contacting device, and the introducer is categorized as an external communicating device, limited (< 24 hour) circulating blood {4}------------------------------------------------ contacting device. The assembled unit is supplied to the user e-beam sterile for single use. ### INDICATIONS FOR USE The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. ### COMPARSON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICE Transcatheter embolization of the peripheral vasculature is the technological principle for both the subject and predicate devices. It is based on the method of delivering an implant device through a catheter and deploying it into and filling the target site thereby obstructing or reducing blood flow to the vasculature. The following table shows the technological similarities and differences between the subject and predicate device: | | IMPEDE-FX Embolization Plug | IMPEDE™ Embolization Plug | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K182390 | K181051 | | Indications for Use | The IMPEDE-FX Embolization Plug is<br>indicated for use with the IMPEDE<br>Embolization Plug to obstruct or reduce<br>the rate of blood flow in the peripheral<br>vasculature | The IMPEDE Embolization Plug is<br>indicated to obstruct or reduce the rate of<br>blood flow in the peripheral vasculature | | Implant Dimensions<br>OD (mm) x L (mm) | IMP-FX-06: 6 x 10<br>IMP-FX-08: 8 x 10<br>IMP-FX-12: 12 x 15 | IMP-05: 6 x 10<br>IMP-07: 8 x 10<br>IMP-12: 12 x 15 | | Vessel Indication | Not stated in the IFU | 2-10mm (3 models) | | Product Code | 21 CFR 870.330 (KRD) | 21 CFR 870.330 (KRD) | | Classification | Class II | Class II | | Delivery/Deployment<br>Method | Pushable by guidewire through an 0.038"<br>(IMP-FX-06), 0.055' (IMP-FX-08) or<br>0.070" (IMP-FX-12) Min Catheter ID | Pushable by guidewire through an 0.038"<br>(IMP-05), 0.055' (IMP-07) or 0.070"<br>(IMP-10) Min Catheter ID | | How transferred to<br>catheter | The plug implant is pre-loaded in PEEK<br>Introducer Sheath with polycarbonate luer<br>hub; transferred to the catheter by<br>advancing an off the shelf guidewire | The plug implant is pre-loaded in PEEK<br>Introducer Sheath with polycarbonate luer<br>hub; transferred to the catheter by<br>advancing an off the shelf guidewire | | Detachment | No - Pushable | No - Pushable | | Implant Materials | Polyurethane (polymer foam), Pt/Ir<br>markerband, Adhesive | Polyurethane (polymer foam), Nitinol<br>Core Wire, Pt/Ir Coil, Pt/Ir markerband,<br>Adhesive | | Anchoring Mechanism | N/A | Pt/Ir and Nitinol Anchor Coil | | How Provided | Sterile, single-use, pre-loaded in<br>introducer | Sterile, single-use, pre-loaded in introducer | | Sterilization Method | E-Beam | E-Beam | | Biodegradable | Yes - slow degradation with the majority<br>(>90%) of the foam remaining after 30<br>days in a swine intravascular occlusion<br>animal model. Near complete degradation<br>in 180-day rat subcutaneous implants and<br>26-week rabbit intramuscular implants | Yes - slow degradation with the majority<br>(>90%) of the foam remaining after 30<br>days in a swine intravascular occlusion<br>animal model. Near complete degradation<br>in 180-day rat subcutaneous implants and<br>26-week rabbit intramuscular implants | | Radiopacity | Proximal Pt/Ir Marker Band | Proximal Pt/Ir Marker Band and distal<br>Pt/Ir and Nitinol Anchor Coil | #### TABLE 1: PREDICATE DEVICE COMPARISON CHART {5}------------------------------------------------ ### PERFORMANCE DATA - NEW The following performance data were provided in support of the substantial equivalence determination. ### Mechanical, Visual and Characterization testing - Simulated use testing ● - o Accessory Compatibility (Guidewire, Catheter and Introducer) - Delivery Performance (Deliverability, Migration) O - Implantation Performance (Plug Expansion, Migration, Bond Integrity) о - Radial Force ● - Dimensional Inspection ● - Visual Inspection ### Animal Study The IMPEDE-FX Embolization Plug was evaluated acutely (i.e. 4 hour sacrifice) in a porcine large animal study to evaluate usability, performance, and vessel response. # PERFORMANCE DATA - LEVERAGED The following performance data was leveraged from the predicate IMPEDE device, due to similarities between the devices. ### Biocompatibility testing The biocompatibility evaluation for the IMPEDE device was conducted in accordance with ISO10993-1 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests. The implant is considered a permanent implant, blood contacting device, and the introducer is considered an external communicating device, limited (<24hour) circulating blood contacting device. The battery of testing for the implant portion of the device included the following tests: - Cytotoxicity ● - Sensitization - Irritation ● - Genotoxicity - . Hemocompatibility - . Intramuscular Implantation - Materials Mediated Pyrogenicity - Systemic toxicity - Subchronic toxicity - Chronic toxicity ● {6}------------------------------------------------ The battery of testing for the Introducer Sheath included the following tests: - Cytotoxicity - Sensitization - . Irritation - Hemocompatibility - Materials Mediated Pyrogenicity - Systemic toxicity ● # Mechanical, Visual and Characterization testing - Radiopacity - Particulate Testing - MRI Compatibility ● - Packaging/Sterilization - Material Characterization ● # Animal Study The IMPEDE Embolization Plug was evaluated in a number of animal studies including multiple animal species and implantation sites. This analysis included the following studies: - 30, 60, and 90-day porcine large animal study - 90 day standard subcutaneous rat study - 90 and 180-day custom (foam only) subcutaneous rat study ● - 4. 13. and 26-week intramuscular implant rabbit study # BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE The IMPEDE-FX Embolization Plug shares technology and functionality with the predicate IMPEDE Embolization Plug (K181051) and reference Gel-Block Embolization Pledgets (K113266) as all are embolic devices that are intended to obstruct blood flow in the vasculature. The subject, predicate, and reference devices are delivered in a compressed shape to allow delivery through a catheter and each expands in a similar fashion once deployed to facilitate occlusion. Each are similar in geometry and consist of degradable materials of construction. While the specific device materials for the subject and Gel-Block predicate devices are not identical, the subject and IMPEDE Embolization Plug predicate devices share many of the same materials. The primary difference between the subject IMPEDE-FX and predicate IMPEDE devices is the lack of the anchor coil in the subject device design. The reference Gel Block Embolization Pledgets (K113266) device, similar to the subject device, lacks a separate anchoring mechanism. Since the migration resistance of the subject device without the anchor coil may be different as compared to the predicate IMPEDE device, it has been indicated for use as an accessory or adjunct to the IMPEDE device. Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the IMPEDE-FX Embolization Plug is substantially equivalent to the predicate device.