Stent Positioning Assistance System (SPAS)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. August 19, 2022 Seven Sons Ltd. Nancy Zhang Regulatory Affairs 65 Yigal Alon Street Tel Aviv. 67443 Israel Re: K221917 Trade/Device Name: Stent Positioning Assistance System (SPAS) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 17, 2022 Received: June 30, 2022 Dear Nancy Zhang: 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 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 {1}------------------------------------------------ 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/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 Lydia Glaw Assistant 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) K221917 #### Device Name Stent Positioning Assistance System (SPAS) Indications for Use (Describe) SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### 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 This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | August 15, 2021 | |----------------------------|-----------------------------------------------------------------------| | Manufacturer: | Seven Sons Ltd.,<br>65 Yigal Alon Street<br>Tel Aviv, 67443<br>Israel | | Primary Contact<br>Person: | Vladimir Trapeznikov<br>CEO<br>E-mail: vt@spas-system.com | | Device: | | | | | | | | | | | | | | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------|----------------------|---------------------|-------------------------------|----------------|-----------------------|----------------|---------------|----------|-----------------------|-----| | | <table><tr><td>Trade Name:</td><td>Stent Positioning Assistance System (SPAS)</td></tr><tr><td>Classification Name:</td><td>Catheter Guide Wire</td></tr><tr><td>Classification<br/>Regulation:</td><td>21CFR 870.1330</td></tr><tr><td>Classification Panel:</td><td>Cardiovascular</td></tr><tr><td>Device Class:</td><td>Class II</td></tr><tr><td>Primary Product Code:</td><td>DQX</td></tr></table> | Trade Name: | Stent Positioning Assistance System (SPAS) | Classification Name: | Catheter Guide Wire | Classification<br>Regulation: | 21CFR 870.1330 | Classification Panel: | Cardiovascular | Device Class: | Class II | Primary Product Code: | DQX | | Trade Name: | Stent Positioning Assistance System (SPAS) | | | | | | | | | | | | | | Classification Name: | Catheter Guide Wire | | | | | | | | | | | | | | Classification<br>Regulation: | 21CFR 870.1330 | | | | | | | | | | | | | | Classification Panel: | Cardiovascular | | | | | | | | | | | | | | Device Class: | Class II | | | | | | | | | | | | | | Primary Product Code: | DQX | | | | | | | | | | | | | | Primary Predicate<br>Device: | | | | | | | | | | | | | | | | | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------|---------------|--------------------|-------------------|---------|----------------------|---------------------|-------------------------------|-----------------|-----------------------|----------------|---------------|----------|---------------|-----| | | <table><tr><td>Trade Name:</td><td>Distal Access Torque Device or Controller<br/>(Predict or Spinr)</td></tr><tr><td>Manufacturer:</td><td>Distal Access, LLC</td></tr><tr><td>510(k) Clearance:</td><td>K141054</td></tr><tr><td>Classification Name:</td><td>Catheter Guide Wire</td></tr><tr><td>Classification<br/>Regulation:</td><td>21CFR §870.1330</td></tr><tr><td>Classification Panel:</td><td>Cardiovascular</td></tr><tr><td>Device Class:</td><td>Class II</td></tr><tr><td>Product Code:</td><td>DQX</td></tr></table> | Trade Name: | Distal Access Torque Device or Controller<br>(Predict or Spinr) | Manufacturer: | Distal Access, LLC | 510(k) Clearance: | K141054 | Classification Name: | Catheter Guide Wire | Classification<br>Regulation: | 21CFR §870.1330 | Classification Panel: | Cardiovascular | Device Class: | Class II | Product Code: | DQX | | Trade Name: | Distal Access Torque Device or Controller<br>(Predict or Spinr) | | | | | | | | | | | | | | | | | | Manufacturer: | Distal Access, LLC | | | | | | | | | | | | | | | | | | 510(k) Clearance: | K141054 | | | | | | | | | | | | | | | | | | Classification Name: | Catheter Guide Wire | | | | | | | | | | | | | | | | | | Classification<br>Regulation: | 21CFR §870.1330 | | | | | | | | | | | | | | | | | | Classification Panel: | Cardiovascular | | | | | | | | | | | | | | | | | | Device Class: | Class II | | | | | | | | | | | | | | | | | | Product Code: | DQX | | | | | | | | | | | | | | | | | {4}------------------------------------------------ | Device description: | SPAS is a sterile disposable device, which serves as adjunct to<br>compatible coronary stent delivery systems. It interfaces with the<br>coronary stent delivery system and supports the positioning the coronary<br>stent on the delivery system. | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | | SPAS is made of biocompatible polycarbonate with an inner polymer<br>sleeve/hub, which interfaces with the distal outer diameter of the catheter<br>of stent delivery systems. It does not interfere with proximal catheter<br>handling until the stent target region is approximated. Then it is slid to<br>the most proximal outer part of the patient's vascular access and fixated<br>with its inner sleeve to the delivery catheter to allow its precise<br>advancement and positioning in the target region. | | | Indications for Use: | SPAS is an adjunct device intended to be used to manoeuvre endo-<br>vascular stent delivery systems and support their positioning in<br>Percutaneous Coronary Interventions (PCI). SPAS is not intended for use<br>in neurovascular interventional procedures. | | | Technological characteristics: | The subject device and the predicates share the same intended use and<br>compatibility with endovascular procedural devices. The subject device<br>and the predicate control the movement of the connected devices by<br>rotatory motions. Both devices share similar technological characteristics<br>(materials, sterilization method, single use and torque ability) as listed<br>detail in below table. | | | | Proposed Device | Predicate Device | | | SPAS | Distal Access torque<br>device (Predict or Spinr) | | Torque | The device can | The Distal Access torque | | | SPAS | Distal Access torque<br>device (Predict or Spinr) | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Torque<br>assist<br>provided<br>by | The device can<br>fix/release the coronary<br>stent delivery system and<br>move the fixed delivery<br>system in both forward<br>and backward directions.<br>The delivery system is<br>moved by rotatory<br>motions of the back of<br>the device. | The Distal Access torque<br>device manually rotates<br>devices between 3 and 5<br>times clockwise and counter<br>clockwise as per the labelled<br>number of rotations.<br>Rotation is manually<br>controlled by the user's<br>finger, thumb and hand. | | Sterility | Sterile, ethylene oxide<br>sterilization. Shelf life is<br>defined. | Sterile, ethylene oxide<br>sterilization. Shelf life is<br>defined. | {5}------------------------------------------------ | Material | Polycarbonate (body, cap, traveler, retainer)<br>Elastomer (insert) | Medical grade polycarbonate (sleeve, grip, body, screw, slider, and cap components)<br>Stainless steel spring | |----------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |----------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| The SPAS device is substantially equivalent to the predicate devices with regards to its intended use, design function, materials and sterilization method. | Summary of Non-<br>Clinical<br>Performance Data: | Non-clinical performance testing has been performed on the proposed<br>Stent Positioning Assistance System (SPAS) and demonstrates<br>compliance with the following FDA recognized consensus standards: | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| - . ISO 10993-1:2018. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - ISO 11135-1:2014, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices - ISO 11607-1: 2019. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - . ISO 11607-2: 2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - ISO 14971: 2019 Medical devices - Application of risk management to medical devices Non-clinical verification testing has been performed to demonstrate the torque ability, compatibility and usability of the proposed device. All these tests were used to support substantial equivalence of the subject device and demonstrate that Stent Positioning Assistance System (SPAS) - . complies with the aforementioned international and FDA-recognized consensus standards, and - meets the acceptance criteria and is adequate for its intended use. {6}------------------------------------------------ | Summary of<br>Clinical<br>Performance Data: | Clinical performance testing has been performed on the proposed Stent<br>Positioning Assistance System (SPAS) and included the performance of<br>an usability evaluation of the SPAS device in coronary stenting<br>procedures. | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The main study objective of this multi-center usability study was to evaluate<br>the usability of the SPAS device in stent positioning. In addition,<br>device-related adverse events and serious adverse events were investigated. | | | The SPAS device was deployed by seven cardiologists in 55 standard stenting<br>procedures. The usability evaluation using a 7-point device usability<br>questionnaire showed that operators were satisfied with the SPAS device.<br>Moreover, no (device-related) adverse events were reported in a wide<br>range of cardiac stenting procedures, from standard to complex. | | Substantial<br>Equivalence<br>Conclusion: | The Stent Positioning Assistance System (SPAS) is substantially<br>equivalent to the currently marketed predicate device Distal Access<br>Torque Device (K141054) in terms of indications for use,<br>technological characteristic, and safety and effectiveness. | | | Additionally, substantial equivalence was demonstrated by non-clinical<br>performance tests provided in this 510(k) premarket notification. These<br>tests demonstrate that the device complies with the requirements<br>specified in the international and FDA-recognized consensus standards<br>and is as safe and effective as its predicate device without raising any<br>new safety and/or effectiveness concerns. |