FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05

K071367 · LeMaitre Vascular, Inc. · MJN · Aug 29, 2007 · Cardiovascular

Device Facts

• Record ID: K071367
• Device Name: FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Aug 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flexcel™ 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

Flexcel Carotid Shunt serves as temporary blood conduit during carotid endarterectomy; connects common and internal carotid arteries to maintain cerebral perfusion. Straight design; available in 8-14 French sizes. Used in surgical setting by vascular surgeons. Provides continuous blood flow to brain during vessel clamping; prevents ischemia. Benefits patient by maintaining cerebral oxygenation during endarterectomy procedure.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Straight design intravascular shunt; sizes 8-14 French. Temporary conduit for blood flow. 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)
• LeMaitre Vascular Straight Carotid Shunt (K033159)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a stylized, rounded square shape on the left, with a white, curved line running through it. To the right of the shape is the word "LeMaitre" in a bold, sans-serif font, with a registered trademark symbol next to it. Below "LeMaitre" is the word "VASCULAR" in a smaller, sans-serif font.

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KD71367
p. 1 of 1

AUG 2 9 2007

510(k) SUMMARY SAFETY and EFFECTIVENESS INFORMATION
as required by Safe Medical Devices Act of 1990 and codified in 21 CFR Part 807.92 upon which
substantial equivalence is based.

| Flexcel® Carotid Shunt (inlying) | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|
| Date Prepared: | 05/15/2007 |
| Submitter's Name: | LeMaitre Vascular, Inc. |
| Address: | 63 Second Avenue<br>Burlington, MA 01803 |
| Company Contact: | Minnie Mildwoff, RAC<br>Sr. Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax:[phone] |
| Device Name<br>Trade Name: | Flexcel® Carotid Shunt (inlying) |
| Device Common Name: | Carotid Shunt |
| Device Classification Name: | Catheter, Intravascular Occluding, Temporary |

#### Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of Flexcel™ Carotid Shunt (inlying) is substantially equivalent with regard to these features in the predicate device, the Pruitt F3 Carotid Shunt (K051067) and LeMaitre Vascular Straight Carotid Shunt (K033159)

## Device Description:

The Flexcel™ Carotid Shunt is designed to serve as a temporary blood conduit 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 Flexcel Carotid Shunt is a straight design shunt packaged in 5-unit packages providing a variety of sizes from 8-14 French.

#### Intended Use:

The Flexcel™ 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.

## Performance Data:

The safety and effectiveness of the Flexcel™ Carotid Shunt has been demonstrated through data collected from bench tests and analyses.

United States LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803

Germany LeMaitre Vascular GmbH Otto-Volger-Str. 5a/b 65843, Sulzbach/Ts

Tel: [phone] Fax: [phone]

Tel: [phone] Fax: [phone] Japan LeMaitre Vascular, KK 1F Kubodera Twin Tower Bldg. 2-9-4 Kudan-minami, Chiyoda-ku Tokyo, 102-0074

Tel: [phone] Fax: [phone] www.lemaitre.com

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2007

LeMaitre Vascular, Inc. c/o Ms. Minnie Mildwoff Senior Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K071367 Flexcel Carotid Shunt (Inlying) Regulation Number: 21 C.F.R. § 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN Dated: August 16, 2007 Received: August 22, 2007

Dear Ms. Mildwoff:

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 - Ms. Minnie Mildwoff

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); labcling (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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Dmina R. Vachnes

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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Image /page/3/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a stylized, abstract shape on the left, followed by the words "LeMaitre" in a bold, sans-serif font. Below "LeMaitre" is the word "VASCULAR" in a smaller, sans-serif font. A registered trademark symbol is present to the right of the word "LeMaitre".

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# Indications for Use

510(k) Number (if known): \$07_1367

Device Name: Flexcel Carotid Shunt (inlying)

Indications For Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

uma R. Vachner
Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K071367

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United States LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803

Tel: [phone] Fax: [phone]

1: [phone] Fax: [phone]