Pruitt F3-S Carotid Shunt

K143454 · LeMaitre Vascular, Inc. · MJN · Aug 27, 2015 · Cardiovascular

Device Facts

• Record ID: K143454
• Device Name: Pruitt F3-S Carotid Shunt
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Aug 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pruitt F3-S 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

Pruitt F3-S Carotid Shunt is a multi-lumen, sterile, clear plastic conduit used during carotid endarterectomy. Device acts as a temporary bridge for blood flow between common and internal carotid arteries. Stabilization is achieved via two independently inflatable balloons at distal and proximal ends. Proximal balloon inflation path is color-coded (blue) to assist user during insertion. Device is operated by surgeons in an OR setting. By maintaining shunt position via balloon inflation, the device ensures continuous cerebral perfusion during surgery, reducing risk of ischemia. Output is the physical maintenance of blood flow; healthcare providers monitor the procedure and balloon inflation status to ensure proper shunt function.

Clinical Evidence

Bench testing only. Performance evaluated via shunt lumen diameter, balloon diameter, balloon deflation time, balloon radial force, kink testing, and balloon inflation curve analysis. Biocompatibility is established through identity with predicate device materials.

Technological Characteristics

Multi-lumen catheter with dual inflatable balloons for stabilization. Materials are identical to predicate. Sterilization via ethylene oxide per ANSI/AAMI/ISO 11135-1:2007. No software or electronic components.

Indications for Use

Indicated for patients undergoing carotid endarterectomy requiring a temporary conduit for blood flow between 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 Carotid Shunt (K051067)

Reference Devices

• Vascushunt Carotid Shunt (K861790)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 27, 2015

LeMaitre Vascular, Inc Xiang Zhang Director of Regulatory Affairs 63 Second Avenue Burlington, Massachusetts 01803

Re: K143454 Trade/Device Name: Pruitt F3-S Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 20, 2015 Received: July 27, 2015

Dear Xiang 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. 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

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K143454

Device Name Pruitt F3-S Carotid Shunt

Indications for Use (Describe)

The Pruitt F3-S 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)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <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 [e-mail]

"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}------------------------------------------------

## K143454

# 510k Summary

#### Submitter's Information

| Name: | LeMaitre Vascular, Inc. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 63 Second Avenue, Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Xiang (Vic) Zhang<br>Global Director of Regulatory Affairs<br>LeMaitre Vascular, Inc.<br>Email: [e-mail] |
| Date Prepared: | August 26, 2015 |
| Device Name: | Pruitt F3-S Carotid Shunt |
| Trade Name: | Pruitt F3-S Carotid Shunt |
| Common Name: | Catheter, intravascular occluding, temporary |
| Regulation Number: | 21CFR §870.4450 |
| Classification Panel: | Cardiovascular |
| Class: | II (2) |
| Product Code: | MJN |
| Establishment<br>Registration: | 1220948 |
| Establishment: | 63 Second Avenue<br>Burlington, MA 01803 |
| Predicate Device: | Pruitt F3 Carotid Shunt K051067 |
| Reference Device: | Vascushunt Carotid Shunt K861790 |
| Device Description: | The Pruitt F3-S Carotid Shunt is designed to serve as an<br>artificial passage connecting two blood vessels, allowing<br>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.<br><br>The Pruitt F3-S Shunts are multi-lumen devices with<br>balloons on both the distal (internal carotid) and proximal<br>(common carotid) ends of the shunt. The balloons, when<br>inflated independently, act as a stabilization mechanism to |
| | maintain the position of the shunt when it is placed within<br>the common and internal carotid arteries. |
| | The Pruitt F3-S Carotid Shunt has features to aid the user<br>during shunt insertion and balloon inflation. The inflation<br>path of the proximal (common carotid) balloon is color-<br>coded. Sterile saline is injected from the blue stopcock,<br>through the blue lumen and into the blue common carotid<br>balloon. |
| Intended Use: | The Pruitt F3-S Carotid Shunt is indicated for use in carotid<br>endarterectomy as a temporary conduit to allow for blood<br>flow between the common and internal carotid arteries. |
| Summary of Technological<br>Characteristics: | Comparisons of the Pruitt F3-S Shunt with the predicate<br>Pruitt F3 Shunt show that technological characteristics such<br>as materials, biocompatibility, performance, sterilization,<br>and packaging of the proposed device are substantially<br>equivalent to the predicate device. The design modification<br>of the proposed device compared to that of the predicate<br>device are:<br>• Removal of the pressure relief balloon on the<br>internal inflation arm;<br>• Provide balloon diameter vs. inflation volume data<br>in the IFU to guide the users |
| Functional/Safety Testing: | The verification activities conducted indicate that Pruitt F3-<br>S Carotid Shunt meets the product performance<br>requirements of the device specifications and does not raise<br>any additional safety issues. |
| Sterilization: | 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" |
| Biocompatibility: | The materials used in Pruitt F3-S Carotid Shunt are<br>identical to those in the predicate device which has<br>established biocompatibility. |
| Summary of Product<br>Testing: | The following tests have been completed to evaluate the<br>safety and performance of the Pruitt F3-S Carotid Shunt:<br>• Shunt lumen diameter<br>• Balloon diameter<br>• Balloon deflation time<br>• Balloon radial force<br>• Kink test<br>• Balloon inflation curve |

{4}------------------------------------------------

{5}------------------------------------------------

Summary of Pre-clinical N/A Study: Conclusion: LeMaitre Vascular has demonstrated that the Pruitt F3-S Carotid Shunt is substantially equivalent to the predicate devices based on its intended use and fundamental scientific technology.