PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

K051067 · LeMaitre Vascular, Inc. · MJN · May 27, 2005 · Cardiovascular

Device Facts

• Record ID: K051067
• Device Name: PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pruitt® F3 Carotid Shunts are 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 Carotid Shunts are temporary blood conduits used during carotid endarterectomy to maintain cerebral blood flow. The device is a tri-lumen catheter with inflatable balloons at distal (internal carotid) and proximal (common carotid) ends for stabilization. An external safety balloon on the inflation arm prevents over-inflation of the internal carotid balloon, reducing risk of vessel damage. Operated by surgeons in an OR setting. The device provides a physical bypass for blood; it does not involve electronic processing, software, or AI. Benefits include continuous cerebral perfusion during surgery and reduced risk of vessel trauma via the safety balloon mechanism.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tri-lumen catheter with inflatable stabilization balloons. Materials: clear plastic conduit. Dimensions: 10F French size. Features: external safety balloon for pressure relief. Sterilization: sterile.

Indications for Use

Indicated for patients undergoing carotid endarterectomy requiring temporary blood flow conduit between common and internal carotid arteries. Size 8 French shunt indicated for patients with vasculature too small for 9 French shunt.

Regulatory Classification

Identification

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

Predicate Devices

• Next Generation Pruitt-Inahara® Outlying Carotid Shunt (K043023)

Submission Summary (Full Text)

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# MAY 2 7 2005

### 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807.92.

| Submitter's Name: | LeMaitre Vascular, Inc. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 63 Second Avenue<br>Burlington, MA 01803 |
| Telephone: | 781/221-2266 |
| Fax: | 781/221-2223 |
| Contact Person: | Amy Watzke |
| Date Prepared: | 04/04/05 |
| Device Trade Names: | Pruitt® F3 Outlying Carotid Shunt<br>(without T-Port)<br>Pruitt® F3 Outlying Carotid Shunt (with T-Port)<br>Pruitt® F3 Inlying Carotid Shunt (with T-Port)<br>Pruitt® F3 Inlying Carotid Shunt<br>(without T-Port) |
| Device Common Name: | Carotid Shunt |
| Device Classification Name: | Catheter, Intravascular Occluding, Temporary |
| Device Classification: | Class II |

## Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of the Pruitt® F3 Outlying Carotid Shunt without T-port, the Pruitt® F3 Outlying Carotid Frant with T-port, the Pruitt® F3 Inlying Carotid Shunt with T-port and the Pruitt® Onlying Carotid Shunt without T-port (the Pruitt® F3 Shunts) are substantially equivalent with regard to these features in the predicate device, the Next Generation Pruitt-Inahara® Outlying Carotid Shunt (K043023, December 3, 2004).

## Device Description:

The proposed Pruitt® F3 Shunts are designed to serve as temporary blood conduits connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The device is manufactured using a clear, plastic,

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sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.

The Pruitt® F3 Shunts are tri-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. An external safety balloon, located on the inflation arm internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.

#### Intended Use:

The Pruitt® F3 Carotid Shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

## Technoloqical Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed devices are substantially equivalent ടterilization and pashaging of the new Pruitt® F3 Shunts compared to that of the predicate carotid shunt are:

- . Physical Changes
- Removal of the T-Port (for Outlying without T-Port and Inlying without o T-Port versions)
- o Reduction in the length of the shunt body (for Inlying versions)
- o Reduction in French size from 10.5F to 10F

## Performance Data:

The safety and effectiveness of the proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LeMaitre Vascular, Inc. c/o Ms. Amy Watzke International Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K051067

Pruitt® F3 Outlying and Inlying Carotid Shunts with and without T-Port Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (Two) Product Code: MJN Dated: April 4, 2005 Received: April 26, 2005

Dear Ms. Watzke:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it 11 your de ree to such additional controls. Existing major regulations affecting your device can may or bayers tode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Amy Watzke

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr a wean that your device complies with other requirements of the Act that I Dri has made a aond regulations administered by other Federal agencies. You must of any it cach statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Hot of CFR Part 801); good manufacturing practice requirements as set CI K Part 607); mooning (D. CFR Part 820); and if applicable. the electronic forul in the quant) by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 5 (0(k) 1 ms letter will and w yours of substantial equivalence of your device to a legally prematics notification: "The Britismation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please 11 you abon office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Duma R. Lochner

Image /page/3/Picture/5 description: The image shows a signature. The signature is composed of a series of curved and angular lines. The lines are dark and appear to be written with a pen or marker. The signature is illegible and does not resemble any recognizable letters or words.

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 Statement

| 510(k) Number (if known): | K051067 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pruitt® F3 Outlying Carotid Shunt (without T-Port)<br>Pruitt® F3 Outlying Carotid Shunt (with T-Port)<br>Pruitt® F3 Inlying Carotid Shunt (without T-Port)<br>Pruitt® F3 Inlying Carotid Shunt (with T-Port) |

Indications For Use:

- 1. The Pruitt-Inahara®, Inahara-Pruitt® and Pruitt® F3 carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
- 2. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.

| Prescription Use | X |
|------------------|---|
|------------------|---|

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vochner

'Division Sign-Off) Ivision of Cardiovascular Devices

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