Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. November 16, 2018 LeMaitre Vascular John Bradsher Senior Regulatory Affairs Specialist 63 Second Avenue Burlington, Massachusetts 01803 ### Re: K182916 Trade/Device Name: Pruitt F3 Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN Dated: October 15, 2018 Received: October 18, 2018 ### Dear John Bradsher: 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/cdrl/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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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. # Brian D. Pullin -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 510(k) Number (if known) K182916 Device Name Pruitt F3 Carotid Shunt Indications for Use (Describe) The Pruitt F3 Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries. 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. 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Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter blue font. | SECTION 8: 510k Summary | K182916 | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | I. SUBMITTTER | LeMaitre Vascular, Inc.<br>63 Second Avenue<br>Burlington, MA 01803 | | Establishment Registration | 1220948 | | Phone: | 781-425-1685 | | Fax: | 781-425-5049 | | Contact Person: | John N. Bradsher<br>Senior Regulatory Affairs Specialist<br>Email: jbradsher@lemaitre.com | | Date Prepared | October 15, 2018 | | I. DEVICE | | | Device Name: | Pruitt F3 Carotid Shunt | | Trade Name: | Pruitt F3 Carotid Shunt | | Common Name: | Catheter, intravascular occluding, temporary | | Classification Panel: | Cardiovascular | | Regulation Number: | 21CFR §870.4450 | | Class: | II (2) | | Product Code: | MJN | | Prior Submissions: | No prior submissions have been made for the changes | | II. PREDICATE DEVICE | detailed in this special 510(k).<br>Pruitt F3 Carotid Shunt (K051067)<br>This predicate device has not been subject to a design-<br>related recall.<br>No reference devices were used in this submission. | | III.DEVICE DESCRIPTION: | The Pruitt F3 Carotid Shunt is used in patients with<br>carotid artery disease in instances where removal of<br>vascular occlusions is the therapeutic objective. The<br>Pruitt F3 Carotid Shunt is employed in Carotid<br>Endarterectomy (CEA), where the shunt is used as a<br>short-term conduit for blood flow between the common | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a blue square with a white swirl inside, followed by the words "LeMaitre" in a bold, blue font. Below "LeMaitre" is the word "VASCULAR" in a smaller, blue font. carotid and the internal carotid arteries. The Pruitt F3 Shunt is provided sterile for single use, and is provided with two 3 ml syringes used to inflate the balloons (accessory syringes have been previously cleared in K051067). The Pruitt F3 Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3 Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. #### IV. INDICATIONS FOR USE: The Pruitt F3 Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries. The indications for use and intended use of the modified device, as described in the labeling, have not changed as a result of the modifications described in this special 510(k). ## V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Pruitt F3 Carotid Shunt maintains the same technological characteristics as the predicate device. Skive holes in the shunt have increased on both arms and the angle of the cutting of the common inflation arm and the internal inflation arm, which connect to the shunt body, have changed from 45 to 70 degrees. In all other respects of design, chemical composition and material, the subject device and the predicate device are identical. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is the logo for LeMaitre Vascular. The logo features a stylized blue wave design on the left, followed by the words "LeMaitre" in a bold, blue font. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter blue font. #### Device Modifications and Rationales: There are 2 modifications to the design of the Pruitt F3 Carotid Shunt that are different between the predicate and the subject device: - 1. The previous design of the F3 Carotid Shunt featured 2 skive holes on each of the Common Carotid Artery Arm and the Internal Carotid Artery Arm. These skive holes are positioned under the occlusion balloon and are designed to facilitate inflation and deflation of the balloon as desired for completion of the CEA procedure. In the subject device, the number of skive holes in the Internal Arm of the device has been increased to 3, and the skive holes on the Common Arm of the device has been increased to 4. This change is being made to improve the characteristics of deflation of the arms of the shunt when the shunt is to be removed at completion of the endarterectomy procedure. - 2. The previous design of the F3 Carotid Shunt features inflation conduits that are cut at a 45-degree angle. In the subject device, this angle has been increased to 70-degrees. Engineering studies showed that in some cases, the inflation conduit tubing cut at 45-degrees was actually partially occluding the lumen and resulting in increased back-pressure during deflation. This change has been made to improve the airflow characteristics of the balloon in the interest to avoid turbulent flow. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a blue and white abstract shape on the left, followed by the words "LeMaitre" in a large, bold, blue font. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter blue font. The logo is clean and professional, and it conveys a sense of trust and reliability. Table: List and description of each device for which clearance is requested | Model | Description | Usable<br>Length | Diameter | |---------|------------------------------------------------------|------------------|----------| | 2011-10 | Pruitt F3 Carotid<br>Shunt with T-port<br>(Outlying) | 31 cm | 10 Fr | | 2011-12 | Pruitt F3 Carotid<br>Shunt with T-port<br>(Inlying) | 15 cm | 10 Fr | | 2012-10 | Pruitt F3 Carotid<br>Shunt with T-port<br>(Outlying) | 31 cm | 9 Fr | | 2012-11 | Pruitt F3 Carotid<br>Shunt (Outlying) | 31 cm | 9 Fr | | 2012-12 | Pruitt F3 Carotid<br>Shunt with T-port<br>(Inlying) | 15 cm | 9 Fr | | 2012-13 | Pruitt F3 Carotid<br>Shunt (Outlying) | 15 cm | 9 Fr | | 2013-10 | Pruitt F3 Carotid<br>Shunt with T-port<br>(Outlying) | 31 cm | 8 Fr | ### VI. PERFORMANCE DATA ## BENCH TEST DATA The following performance data are provided in support of the substantial equivalence determination. - Main Lumen Flow Test - Inflated Common Balloon Diameter - Inflated Internal Balloon Diameter: - Deflation Time, Common Balloon: - Deflation Time, Internal Balloon - Deflation Integrity - Balloon Location - Pressure Inspection for Backflow - Inflation Lumen to Shunt Body Adhesion: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a blue square with a white, stylized wave inside, followed by the words "LeMaitre" in a bold, teal font. Below "LeMaitre" is the word "VASCULAR" in a smaller, lighter teal font. Summary of non-clinical and clinical Studies: VII. CONCLUSION: N/A LeMaitre Vascular has demonstrated that the Pruitt F3 Carotid Shunt is substantially equivalent to the predicate device based on its intended use and fundamental scientific technology, and that the subject device is as safe, as effective, and performs as well as the predicate device.