SMITHWICK CAROTID SHUNT

K021608 · Implantable Devices · DXC · Oct 22, 2002 · Cardiovascular

Device Facts

• Record ID: K021608
• Device Name: SMITHWICK CAROTID SHUNT
• Applicant: Implantable Devices
• Product Code: DXC · Cardiovascular
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Carotid Shunt is intended to be used in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

Device Story

The Carotid Shunt is a temporary conduit used during carotid endarterectomy procedures. It is inserted by a surgeon to maintain cerebral blood flow between the common and internal carotid arteries while the artery is clamped. The device acts as a bypass, preventing ischemia during the surgical repair of the carotid artery. It is a single-use, sterile, mechanical device operated by a vascular surgeon in an operating room setting. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical conduit for vascular bypass. Materials and dimensions are consistent with standard surgical shunt designs for carotid endarterectomy. Non-electronic, non-software device.

Indications for Use

Indicated for patients undergoing carotid endarterectomy requiring a temporary conduit to maintain 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Implantable Devices c/o Mr. Bill McPherson P.O. Box 270882 Tampa, FL 33688

Re: K021608

> Smithwick Carotid Shunt Regulation Number: 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: August 12, 2002 Received: August 13, 2002

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. Bill 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 (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.

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 legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

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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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KO21608 510(k) Number (if known):

Device Name: Carotid Shunt

Indications for use:

The Carotid Shunt is intended to be used in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

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Concurrent of CDRH, Office of Device Evaluation (ODE)

Cmflumagn fr BDZ
Division of Cardiovascular & Respiratory Devices
510(k) Number K024608

Prescription Use _ X (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________