The 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.
The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.

Device Description

The Next Generation Pruitt 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 device is manufactured using a clear, plastic, sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.

The Next Generation Pruitt Carotid Shunt is a multi-lumen device 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 that is inserted into the internal carotid artery, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it is inflated above a predetermined pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Next Generation Pruitt-Inahara Outlying Carotid Shunt." This submission focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance evaluations against a set of complex acceptance criteria typically associated with AI/ML devices. Therefore, much of the requested information regarding AI/ML-specific study design (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable to this 510(k) summary.

However, I can extract the relevant information regarding performance data and acceptance criteria as presented for this specific type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "The safety and effectiveness of the Next Generation Pruitt-Inahara Outlying Carotid Shunt has been demonstrated through data collected from bench tests and analyses." While specific quantitative acceptance criteria or detailed performance metrics are not explicitly listed in this summary, the core acceptance criterion for a 510(k) device is substantial equivalence to an existing predicate device. This is assessed across various characteristics.

Acceptance Criterion (Implicit for 510(k) Equivalence)	Reported Device Performance
Intended Use Equivalence	"The Pruitt-Inahara Outlying 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." This matches the predicate device's intended use.
Design, Materials, Method of Delivery Equivalence	"The design, materials, method of delivery and intended use features of Next Generation Pruitt-Inahara Outlying Carotid with 10.5F diameter is substantially equivalent with reqard to these features in the predicate device, the Pruitt-Inahara Outlying Carotid Shunt (K960715, September 9, 1996)."
Technological Characteristics Equivalence	"Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed device are substantially equivalent to the currently marketed predicate devices." This is supported by "bench tests and analyses."
Safety (Demonstrated via Bench Tests & Analyses)	The device includes an "external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage." This design element addresses potential safety concerns. General safety is affirmed by "bench tests and analyses" establishing substantial equivalence.
Effectiveness (Demonstrated via Bench Tests & Analyses)	Effectiveness, in the context of a temporary conduit for blood flow, is supported by "bench tests and analyses" demonstrating that the device functions as intended and is substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for specific bench tests in this summary. The "tests and analyses" would typically involve a certain number of units or simulated conditions, but these details are not provided.
Data Provenance: The data is from "bench tests and analyses." This implies laboratory-based testing conducted by the manufacturer, LeMaitre Vascular, Inc., in the USA (their address is Burlington, MA). The data would be retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) summary does not involve human expert ground truth for evaluating AI/ML results. The "ground truth" for this device's performance would be established by engineering specifications, validated test methods, and comparison against the known performance of the predicate device.

4. Adjudication method for the test set

Not applicable. There is no human expert adjudication process described, as this is not an AI/ML device evaluating complex medical images or data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI/ML systems on human reader performance, which is not relevant for this device.

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

Not applicable. This is not an algorithm or AI/ML device. The "performance" refers to the physical device's characteristics.

7. The type of ground truth used

The "ground truth" for this device's performance relies on:

Engineering Specifications: Adherence of the device to its physical, mechanical, and material specifications.
Validated Test Methods: Results from standardized or validated bench tests (e.g., pressure resistance, flow rates, material compatibility, balloon inflation/deflation characteristics, dimensional accuracy).
Predicate Device Performance: The established performance and safety profile of the legally marketed predicate device (Pruitt-Inahara Outlying Carotid Shunt, K960715) serves as the benchmark against which substantial equivalence is claimed.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as this is not an AI/ML device.

Summary

{0}------------------------------------------------

Ko43023
34

DEC - 3 2004

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 AvenueBurlington, MA 01803
Telephone:Fax:	781/221-2266781/221-2223
Contact Person:Date Prepared:	Saba Modjarrad10/29/04
Device Trade Name:	Pruitt-Inahara Outlying Carotid Shunt
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 Next Generation Pruitt-Inahara Outlying Carotid with 10.5F diameter is substantially equivalent with reqard to these features in the predicate device, the Pruitt-Inahara Outlying Carotid Shunt (K960715, September 9, 1996).

Device Description:

{1}------------------------------------------------

to relieve pressure on the internal carotid balloon in the event it is inflated above a predetermined pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.

Intended Use:

The Pruitt-Inahara Outlying 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.

Technological Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed device are substantially equivalent to the currently marketed predicate devices. The design modifications of the new carotid shunt compared to that of the predicate carotid shunts are:

Blue tint added to the Common Carotid Inflation Arm .
Black locating stripes on the stopcock and shunt body were removed .
Yellow tint added to the safety sleeve .
For the Pellethane shunt body: .
- · Decrease in durometer
- · Increase in French size
- · Change from circular to triangular cross section of shunt body tubing
For the Tecoflex shunt body: .
- · Additional Material
- · Decrease in durometer
- · Increase in French size
- · Change from circular to triangular cross section of shunt body tubing

Performance Data:

The safety and effectiveness of the Next Generation Pruitt-Inahara Outlying Carotid Shunt has been demonstrated through data collected from bench tests and analyses.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

LeMaitre Vascular, Inc. c/o Ms. Sara Modjarrad Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K043023

Pruitt-Inahara Outlying Carotid Shunt and the Inahara-Pruitt Inlying Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: II (two) Product Code: MJN Dated: October 29, 2004 Received: November 3, 2004

Dear Ms. Modjarrad:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 3 re(s) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 tose stated in the encreations) is trgms )
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, an accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not require appear al controls provisions of the Act. The I ou may, mercerore, manel ate act include requirements for annual registration, listing of general controls provisions of the rece, 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 If your device is elassined (600 as 10) als. Existing major regulations affecting your device can may be subject to Subletical 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. Sara Modjarrad

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 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 Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

orna R. Willines

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): __ Ko430 2_3________________________________________________________________________________________________________________________________________

Device Name: Next Generation Pruitt-Inahara Outlying Carotid Shunt

Indications For Use:

1. The 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.
1. 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. Lechner

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number ٢٥4 ろ02 ろ

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).