(114 days)
The Pruitt F3-S Polyurethane Carotid Shunt is in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
The Pruitt F3-S Polyurethane 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. 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-S Polyurethane 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. The Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.
This document is a 510(k) premarket notification for a medical device (Pruitt F3-S Polyurethane Carotid Shunt) and does not contain information about the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted.
The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This involves comparing the new device's technological characteristics, indications for use, and performance data (e.g., sterilization, biocompatibility, functional testing) to those of the predicate device. The functional testing described is for the physical device itself (shunts and balloons), not an AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
LeMaitre Vascular, Inc. Anna Kasseris Senior Regulatory Affairs Specialist 63 Second Avenue Burlington, Massachusetts 01803
Re: K152833
Trade/Device Name: Pruitt F3-S Polyurethane Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Received: December 10, 2015
Dear Ms. Anna Kasseris:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152833
Device Name Pruitt F3-S Polyurethane Carotid Shunt
Indications for Use (Describe)
The Pruitt F3-S Polyurethane Carotid Shunt is 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
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510k Summary
Submitter's Information
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second AvenueBurlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Anna KasserisSenior Regulatory Affairs SpecialistEmail: akasseris @ lemaitre.com |
| Date Prepared: | January 8, 2016 |
| Device Name: | Pruitt F3-S Polyurethane Carotid Shunt |
| Trade Name: | Pruitt F3-S Polyurethane Carotid Shunt |
| Common Name: | Catheter, intravascular occluding, temporary |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21CFR §870.4450 |
| Class: | II (2) |
| Product Code: | MJN |
| EstablishmentRegistration Number: | 1220948 |
| Establishment Address: | 63 Second AvenueBurlington, MA 01803 |
| Predicate Device: | Pruitt F3-S Carotid Shunt K143454 |
| Reference Device: | Pruitt F3 Carotid Shunt K051067 |
| Device Description: | The Pruitt F3-S Polyurethane Carotid Shunt is designed toserve as an artificial passage connecting two blood vesselsallowing blood flow from one vessel to another. This isaccomplished by using a clear, plastic, sterile conduit thatis held in place by a stabilization technique (balloons) onboth ends of the conduit. |
| Intended Use: | devices with balloons on both the distal (internal carotid)and proximal (common carotid) ends of the shunt. Theballoons, when inflated independently, act as a stabilizationmechanism to maintain the position of the shunt when it isplaced within the common and internal carotid arteries.The Pruitt F3-S Polyurethane Carotid Shunt has features toaid 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 theblue stopcock, through the blue lumen and into the bluecommon carotid balloon.The Pruitt F3-S Polyurethane Carotid Shunt is not made ofnatural rubber latex.The Pruitt F3-S Polyurethane Carotid Shunt is indicated foruse in carotid endarterectomy as a temporary conduit toallow for blood flow between the common and internalcarotid arteries. |
| Summary of TechnologicalCharacteristics: | The Pruitt F3-S Polyurethane Carotid Shunt maintains thesame technological characteristics as the predicate device.The differences between the proposed Pruitt F3-SPolyurethane Carotid Shunt and the predicate Pruitt F3-Sshunt are:Balloon material. The balloons of the subjectdevices are made of polyurethane while theballoons of the predicate device are latex; Material of the balloon adhesive; Blue colorant used in the common balloon; Packaging |
| Sterilization: | The device is ethylene oxide (EO) sterilized according toANSI/AAMI/ISO 11135-1:2007, "Sterilization of MedicalDevices - Validation and Routine Control of EthyleneOxide Sterilization" |
| Biocompatibility: | Biocompatibility tests were performed for Pruitt F3-SPolyurethane Carotid Shunt per ISO 10993-1. Followingtests are performed:Cytotoxicity Material Mediated Pyrogen Test Sensitization Irritation Systemic Acute Test Hemolysis Hemolysis Direct Contact Thrombosis Complement Activation PTT |
| Summary of FunctionalTesting: | The following tests have been completed to evaluate thesafety and performance of the Pruitt F3-S PolyurethaneCarotid Shunt:Balloon volume vs. diameter Balloon deflation time Balloon burst volume Balloon pull force Balloon leak Balloon fatigue The verification activities conducted indicate that Pruitt F3-S Polyurethane Carotid Shunt meets the productperformance requirements of the device specifications anddoes not raise any additional safety issues. |
| Summary of Pre-clinicalStudy: | N/A |
| Conclusion: | LeMaitre Vascular has demonstrated that the Pruitt F3-SPolyurethane Carotid Shunt is substantially equivalent tothe predicate device based on its intended use andfundamental scientific technology. |
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§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).