Pruitt F3-S Polyurethane Carotid Shunt

K152833 · LeMaitre Vascular, Inc. · MJN · Jan 21, 2016 · Cardiovascular

Device Facts

• Record ID: K152833
• Device Name: Pruitt F3-S Polyurethane Carotid Shunt
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jan 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. The Pruitt F3-S Polyurethane 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.

Device Story

Temporary conduit for blood flow between common and internal carotid arteries during carotid endarterectomy; clear plastic sterile tube with inflatable balloons at both ends for stabilization; proximal balloon inflation path color-coded blue for identification; saline injected via blue stopcock to inflate proximal balloon; device maintains shunt position within arteries; used by surgeons in clinical settings; non-latex construction.

Clinical Evidence

Bench testing only. No clinical data provided. Functional testing included balloon volume vs. diameter, deflation time, burst volume, pull force, leak, and fatigue. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, pyrogenicity, sensitization, irritation, systemic acute toxicity, hemolysis, thrombosis, complement activation, and PTT.

Technological Characteristics

Temporary intravascular conduit; polyurethane balloons; blue colorant; ethylene oxide (EO) sterilization per ANSI/AAMI/ISO 11135-1:2007; biocompatibility per ISO 10993-1; non-latex materials.

Indications for Use

Indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Pruitt F3-S Carotid Shunt (K143454)

Reference Devices

• Pruitt F3 Carotid Shunt (K051067)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-------------------------------------------------------------|------------------------------------------------------------|
|-------------------------------------------------------------|------------------------------------------------------------|

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## 510k Summary

## Submitter's Information

| Name: | LeMaitre Vascular, Inc. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 63 Second Avenue<br>Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Anna Kasseris<br>Senior Regulatory Affairs Specialist<br>Email: 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 |
| Establishment<br>Registration Number: | 1220948 |
| Establishment Address: | 63 Second Avenue<br>Burlington, 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 to<br>serve as an artificial passage connecting two blood vessels<br>allowing blood flow from one vessel to another. This is<br>accomplished by using a clear, plastic, sterile conduit that<br>is held in place by a stabilization technique (balloons) on<br>both ends of the conduit. |
| | |
| <b>Intended Use:</b> | devices with balloons on both the distal (internal carotid)<br>and proximal (common carotid) ends of the shunt. The<br>balloons, when inflated independently, act as a stabilization<br>mechanism to maintain the position of the shunt when it is<br>placed within the common and internal carotid arteries.<br><br>The Pruitt F3-S Polyurethane Carotid Shunt has features to<br>aid the user during shunt insertion and balloon inflation.<br>The inflation path of the proximal (common carotid)<br>balloon is color-coded. Sterile saline is injected from the<br>blue stopcock, through the blue lumen and into the blue<br>common carotid balloon.<br><br>The Pruitt F3-S Polyurethane Carotid Shunt is not made of<br>natural rubber latex.<br><br>The Pruitt F3-S Polyurethane Carotid Shunt is indicated for<br>use in carotid endarterectomy as a temporary conduit to<br>allow for blood flow between the common and internal<br>carotid arteries. |
| <b>Summary of Technological<br/>Characteristics:</b> | The Pruitt F3-S Polyurethane Carotid Shunt maintains the<br>same technological characteristics as the predicate device.<br>The differences between the proposed Pruitt F3-S<br>Polyurethane Carotid Shunt and the predicate Pruitt F3-S<br>shunt are:<br>Balloon material. The balloons of the subject<br>devices are made of polyurethane while the<br>balloons of the predicate device are latex; Material of the balloon adhesive; Blue colorant used in the common balloon; Packaging |
| <b>Sterilization:</b> | The device is ethylene oxide (EO) sterilized according to<br>ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical<br>Devices - Validation and Routine Control of Ethylene<br>Oxide Sterilization" |
| <b>Biocompatibility:</b> | Biocompatibility tests were performed for Pruitt F3-S<br>Polyurethane Carotid Shunt per ISO 10993-1. Following<br>tests are performed:<br>Cytotoxicity Material Mediated Pyrogen Test Sensitization Irritation Systemic Acute Test Hemolysis Hemolysis Direct Contact Thrombosis Complement Activation PTT |
| Summary of Functional<br>Testing: | The following tests have been completed to evaluate the<br>safety and performance of the Pruitt F3-S Polyurethane<br>Carotid Shunt:<br>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-<br>S Polyurethane Carotid Shunt meets the product<br>performance requirements of the device specifications and<br>does not raise any additional safety issues. |
| Summary of Pre-clinical<br>Study: | N/A |
| Conclusion: | LeMaitre Vascular has demonstrated that the Pruitt F3-S<br>Polyurethane Carotid Shunt is substantially equivalent to<br>the predicate device based on its intended use and<br>fundamental scientific technology. |

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