The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.

AI/ML Overview

The provided text describes a medical device, the LeMaitre 8F Occlusion Catheter, and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.

The document outlines functional and safety testing, but these tests are for the physical catheter's performance (e.g., inflation volume, burst volume) rather than for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a physical medical device clearance, not an AI/algorithm-based one:

A table of acceptance criteria and the reported device performance: The document only lists types of tests, not specific acceptance criteria (e.g., a minimum inflation pressure value) or detailed performance results that would be typically found for an AI system (e.g., sensitivity, specificity, AUC).
Sample size used for the test set and the data provenance: No test set information for an algorithm is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no algorithm test set.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document focuses on:

Device Description: Physical characteristics of the LeMaitre 8F Occlusion Catheter.
Intended Use: Temporary vessel occlusion.
Predicate Device: Fogarty Occlusion Catheter (K093911).
Substantial Equivalence: Claiming similar intended use and fundamental scientific technology as the predicate.
Functional/Safety Testing: Mentioning tests like "Volume Required to Inflate Balloon to IFU Indicated Diameter," "Inflation Pressure," "Radial Force," "Contact Area," "Inflation Time," "Deflation Time," and "Burst Volume." These are physical device performance tests.
Sterilization and Biocompatibility: Confirming compliance with relevant standards.

To summarize, the provided text does not contain the type of AI/algorithm performance study details you are asking for.

Summary

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510 (k) Summary

Submitter's information:

Name:	LeMaitre Vascular, Inc.
Address:	63 Second AvenueBurlington, MA USA 01803
Phone:	781-425-1727
Fax:	781-425-5049NOV 0 6 2013
Contact Person:	Bryan Cowell, MSc., RAC
Date of preparation:	June 24, 2013
Device Name:	LeMaitre 8F Occlusion Catheter
Trade Name.	LeMaitre 8F Occlusion Catheter
Common/ Classification Name:	Catheter, intravascular occluding, temporary
Classification Panel:	21CFR §870.4450
Class:	II (2)
Product Code:	MJN

Establishment Registration: 1220948

Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803

Owner/Operator: 1220948

Device Description:

Intended Use:

The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.

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Predicate Device:

K093911 510(k): Device Name: Fogarty Occlusion Catheter

Substantial Equivalence:

Fundamental Scientific Technological Characteristics:

The LeMaitre 8F Occlusion Catheter maintains the same intended use and fundamental scientific technology as the predicate device.

Functional/ Safety testing:

The verification activities conducted indicate that LeMuitre 8F Occlusion Catheter device meets the product performance requirements of the device specifications and does not raise any additional safety issues.

Sterilization:

The device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization".

Biocompatibility:

All blood contact portions of the device were subjected to biocompatibility testing according to ISO 10993 guidelines for an externally communicating device with limited contact duration (<24 hours), with circulating blood. The biocompatibility assessment established that 8F Occlusion Catheter is biocompatible.

Summary of Product Testing:

The following tests have been completed to evaluate the safety and performance of LeMaitre 8F occlusion catheter compared with the predicate device:

Volume Required to Inflate Balloon to IFU Indicated Diameter �
. Inflation Pressure
Radial Force .
Contact Area o
. Inflation Time
Deflation Time .
. Burst Volume

Conclusion:

LeMaitre Vascular has demonstrated that the LeMaitre 8F Occlusion Catheter is substantially equivalent to the predicate device based on its intended use and fundamental scientific technology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

November 6, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

LeMaitre Vascular, Inc. c/o Mr. Xiang (Vic) Zhang Director of Regulatory Affairs 63 Second Ave. Burlington, MA 01803

Re: K132022

Trade/Device Name: LeMaitre 8F Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: October 22, 2013 Received: October 29, 2013

Dear Mr. Zhang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Xiang (Vic) Zhang

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours. Bram D. Zuckerman -S

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)	K132022/S002
Device Name	LeMaitre 8F Occlusion Catheter.
Indications	LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801. 109)

for Use

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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).