The Pruitt-Inahara®, Inahara-Pruitt® and Pruitt® F3 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 proposed Pruitt® F3 Shunts are designed to serve as temporary blood conduits 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 Pruitt® F3 Shunts are tri-lumen devices 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 internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.

AI/ML Overview

The provided document is a 510(k) summary for the Pruitt® F3 Carotid Shunt, seeking substantial equivalence to a predicate device. It details the device's design, intended use, and technological characteristics. However, it does not contain acceptance criteria or a study report proving the device meets specific performance criteria in the way a clinical or AI performance study would.

Instead, this document focuses on demonstrating substantial equivalence to an already approved predicate device (Next Generation Pruitt-Inahara® Outlying Carotid Shunt, K043023) primarily through comparisons of materials, design, and bench testing.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this specific document.

The document states:
"The safety and effectiveness of the proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses."

This implies that the "study" demonstrating safety and effectiveness was a series of bench tests, not a clinical trial or an AI algorithm performance study.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and bench tests, rather than setting and reporting against specific quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for an AI device).

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

This information is not applicable/not provided as this document describes bench testing for a physical medical device, not an AI/software device that would typically have a "test set" of data.

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

This information is not applicable/not provided. Ground truth in the context of this device would relate to engineering specifications and performance during bench testing, not expert consensus on medical images or diagnoses.

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

This information is not applicable/not provided.

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:

This information is not applicable/not provided. This is a physical medical device, not an AI system assisting human readers.

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

This information is not applicable/not provided.

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

For this type of device, the "ground truth" would be established by engineering specifications, material properties, and physical performance under controlled bench testing conditions, comparing against the predicate device and established standards. The document does not explicitly state the specific ground truth types (e.g., specific tensile strength values, flow rates, balloon inflation pressures).

8. The sample size for the training set:

This information is not applicable/not provided. This is for a physical device, not an AI training set.

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

This information is not applicable/not provided.

Summary

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

MAY 2 7 2005

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:	781/221-2266
Fax:	781/221-2223
Contact Person:	Amy Watzke
Date Prepared:	04/04/05
Device Trade Names:	Pruitt® F3 Outlying Carotid Shunt(without T-Port)Pruitt® F3 Outlying Carotid Shunt (with T-Port)Pruitt® F3 Inlying Carotid Shunt (with T-Port)Pruitt® F3 Inlying Carotid Shunt(without T-Port)
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 the Pruitt® F3 Outlying Carotid Shunt without T-port, the Pruitt® F3 Outlying Carotid Frant with T-port, the Pruitt® F3 Inlying Carotid Shunt with T-port and the Pruitt® Onlying Carotid Shunt without T-port (the Pruitt® F3 Shunts) are substantially equivalent with regard to these features in the predicate device, the Next Generation Pruitt-Inahara® Outlying Carotid Shunt (K043023, December 3, 2004).

Device Description:

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

sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.

The Pruitt® F3 Shunts are tri-lumen devices 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 internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.

Intended Use:

The Pruitt® F3 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.

Technoloqical Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed devices are substantially equivalent ടterilization and pashaging of the new Pruitt® F3 Shunts compared to that of the predicate carotid shunt are:

. Physical Changes
- Removal of the T-Port (for Outlying without T-Port and Inlying without o T-Port versions)
- o Reduction in the length of the shunt body (for Inlying versions)
- o Reduction in French size from 10.5F to 10F

Performance Data:

The safety and effectiveness of the proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LeMaitre Vascular, Inc. c/o Ms. Amy Watzke International Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K051067

Pruitt® F3 Outlying and Inlying Carotid Shunts with and without T-Port Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (Two) Product Code: MJN Dated: April 4, 2005 Received: April 26, 2005

Dear Ms. Watzke:

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 11 your de ree to such additional controls. Existing major regulations affecting your device can may or bayers tode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Amy Watzke

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr a wean that your device complies with other requirements of the Act that I Dri has made a aond regulations administered by other Federal agencies. You must of any it cach statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Hot of CFR Part 801); good manufacturing practice requirements as set CI K Part 607); mooning (D. CFR Part 820); and if applicable. the electronic forul in the quant) by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 5 (0(k) 1 ms letter will and w yours of substantial equivalence of your device to a legally prematics notification: "The Britismation 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 11 you abon 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/cdrl/industry/support/index.html.

Sincerely yours,

Duma R. Lochner

Image /page/3/Picture/5 description: The image shows a signature. The signature is composed of a series of curved and angular lines. The lines are dark and appear to be written with a pen or marker. The signature is illegible and does not resemble any recognizable letters or words.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):	K051067
Device Name:	Pruitt® F3 Outlying Carotid Shunt (without T-Port)Pruitt® F3 Outlying Carotid Shunt (with T-Port)Pruitt® F3 Inlying Carotid Shunt (without T-Port)Pruitt® F3 Inlying Carotid Shunt (with T-Port)

Indications For Use:

1. The Pruitt-Inahara®, Inahara-Pruitt® and Pruitt® F3 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. Vochner

'Division Sign-Off) Ivision of Cardiovascular Devices

ت مل بال (k) Number _ F مل تاريخ ج تبارك ج م

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).