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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Flexcel™ Carotid Shunt:

The document is a 510(k) Summary for the Flexcel™ Carotid Shunt, submitted by LeMaitre Vascular, Inc. to the FDA. The core of this submission is to demonstrate substantial equivalence to previously marketed predicate devices, not to prove meeting specific, novel acceptance criteria through a clinical study. Therefore, many of the requested categories about acceptance criteria, detailed study design, and reader performance are not directly applicable or explicitly stated in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, the device's performance is demonstrated through bench tests and analyses to show it is comparable to predicate devices. The "reported device performance" is implicitly that it functions as a temporary blood conduit during carotid endarterectomy without introducing new safety or effectiveness concerns compared to the predicates.

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (from Bench Tests & Analyses)
Device functions as a temporary blood conduit.	Demonstrated through bench tests and analyses.
Device allows continuous blood flow to the brain.	Demonstrated through bench tests and analyses.
Device is safe for intended use.	Demonstrated through bench tests and analyses.
Device is effective for intended use.	Demonstrated through bench tests and analyses.
Device is substantially equivalent to predicate devices (Pruitt F3 Carotid Shunt (K051067) and LeMaitre Vascular Straight Carotid Shunt (K033159)).	The 510(k) submission concluded substantial equivalence based on design, materials, method of delivery, and intended use features, supported by bench tests and analyses.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. The document states "data collected from bench tests and analyses." This indicates laboratory or engineering testing, not a clinical study on patient samples.
Data Provenance: Not explicitly stated beyond "bench tests and analyses." It would be assumed these tests were conducted by LeMaitre Vascular, Inc., likely at their facilities in the US or Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" refers to engineering specifications, material properties, and functionality under simulated conditions, not expert interpretation of patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept applies to clinical studies where different experts interpret data. Bench tests would follow engineering and quality control protocols.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is not an AI/software device. The Flexcel™ Carotid Shunt is a physical medical device (a temporary blood conduit).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the "bench tests and analyses," the ground truth would be based on engineering specifications, material science standards, and functional performance metrics established prior to testing, and compared against the performance of the predicate devices. This is not biological ground truth from patient data.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/software device that undergoes machine learning training.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable.

Summary Conclusion:

The provided document describes a 510(k) submission for a physical medical device, the Flexcel™ Carotid Shunt. The primary method for demonstrating safety and effectiveness is through proving substantial equivalence to existing predicate devices. This is done via bench tests and analyses, not through human-in-the-loop clinical studies, AI performance evaluations, or extensive multi-reader studies with patient data. Therefore, many of the questions related to clinical study design, expert involvement, and AI performance are not relevant to this specific regulatory submission. The "study" proving the device meets the (inferred) acceptance criteria is the undisclosed set of bench tests and analyses that LeMaitre Vascular performed to support their claim of substantial equivalence.

Summary

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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 AvenueBurlington, MA 01803
Company Contact:	Minnie Mildwoff, RACSr. Regulatory Affairs SpecialistTel: (781) 221-2266Fax:(781) 425-5049
Device NameTrade 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:

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: 781 221-2266 Fax: 781 221-2223

Tel: +49-(0)6196-659230 Fax: +49-(0)6196-527072 Japan LeMaitre Vascular, KK 1F Kubodera Twin Tower Bldg. 2-9-4 Kudan-minami, Chiyoda-ku Tokyo, 102-0074

Tel: +81-(0)3-5215-5681 Fax: +81-(0)3-5215-5682 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Page 1 of 1

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

Tel: 781 221-2266 Fax: 781 221-2223

1: +81-(0)3-5215-568 Fax: +81-(0)3-5215-5682

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).