SMITHWICK CAROTID SHUNT

K062474 · Mcpherson Enterprises, Inc. · DXC · Nov 9, 2006 · Cardiovascular

Device Facts

• Record ID: K062474
• Device Name: SMITHWICK CAROTID SHUNT
• Applicant: Mcpherson Enterprises, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.

Device Story

Tapered shunt; functions as temporary conduit during carotid endarterectomy; diverts blood flow between common and internal carotid arteries; used in surgical setting by vascular surgeons; maintains cerebral perfusion during procedure; prevents ischemia.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarity to predicate devices.

Technological Characteristics

Tapered shunt design; intended for temporary vascular bypass; mechanical conduit; no energy source; non-implantable (temporary use).

Indications for Use

Indicated for patients undergoing carotid endarterectomy requiring temporary blood flow diversion 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

• Sundt Shunt
• Pruitt-Inhara Shunt
• Smithwick Shunt
• Javid Shunt
• Vascuflo Shunt
• Modified Carotid Shunt (Uresil Corp.)

Submission Summary (Full Text)

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## 510(k) Safety and Effectiveness Summary

| Date: | Feb. 23, 2006 | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Prepared By: | Cheryl Curry | NOV - 9 2006 |
| Common/Usual Name: | Carotid Shunt | |
| Proprietary Name: | Implantable Devices Shunt | |
| Classification: | Class II 870.1200 | |
| Description: | A tapered shunt used to divert blood flow from the<br>common carotid artery to the internal carotid during carotid<br>endarterectomy. | |
| Indications for Use: | Carotid Endarterectomy | |
| Substantial Equivalence: | Sundt Shunt, Pruitt-Inhara Shunt, Smithwick Shunt, Javid<br>Shunt, Vascuflo Shunt and Modified Carotid Shunt by<br>Uresil Corp. | |
| Conclusion: | The Implantable Devices Shunt is safe and effective for<br>carotid endarterectomy. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2006

McPherson Enterprises, Inc. c/o Mr. William E. McPherson 3851 62nd Avenue N. Suite A Pinellas Park, EL 33781

Re: K062474

Smithwick Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: August 22, 2006 Received: August 29, 2006

Dear Mr. McPherson:

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 may be subject to such 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.

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Page 2 - Mr. William E. McPherson

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, perreits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note (24 Cr re an over), proc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ontain 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/cdrh/industry/support/index.html

Sincerely yours.

R. Wulner

Image /page/2/Picture/5 description: The image contains a handwritten letter 'S' in a cursive style. The letter is written in black ink on a white background. The 'S' has a flowing, elegant shape with a distinct curve at the top and a loop at the bottom.

\ 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): K062474

Device Name: Smithwick Carotid Shunt Models WR1409SB DWR1409SB Models WR1409DB DWR1409DB

Indications For Use:

This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma P. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number Ko62474