The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.

AI/ML Overview

This medical device is a modeling catheter used in conjunction with self-expanding endoprostheses in large diameter vessels. The provided text contains information about its acceptance criteria and the studies conducted.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Radial outward force meets specification	Completed (implies meeting specifications)
Apposition Length meets specification	Completed (implies meeting specifications)
Simulated Anatomical Use successful	Completed (implies successful performance)
Biocompatibility (ISO 10993 guidelines)	All blood contact portions passed for <24 hours contact
Sterilization (ANSVAAMI/ISO 11135-1:2007)	Validated for ethylene oxide (EO) sterilization

2. Sample Size and Data Provenance for Test Set

The document does not specify sample sizes for the "Radial outward force," "Apposition Length," or "Simulated Anatomical Use" tests.
The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned. These tests appear to be laboratory-based engineering performance tests rather than clinical studies with patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and therefore not provided in the document. The device verification activities ("Radial outward force," "Apposition Length," "Simulated Anatomical Use") are technical performance evaluations, not diagnostic studies requiring expert-established ground truth.

4. Adjudication Method for Test Set

This information is not applicable and therefore not provided in the document. As mentioned above, the tests are technical performance evaluations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted. This device is a medical instrument (catheter), not a diagnostic or AI-driven imaging tool that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states, "The following tests have been completed to evaluate the performance of the catheter with shorter cage: Radial outward force, Apposition Length, Simulated Anatomical Use." These tests assess the intrinsic performance of the device without human-in-the-loop performance being a variable.

7. Type of Ground Truth Used

The ground truth used for the performance tests appears to be engineering specifications and established laboratory testing protocols. For biocompatibility, the ground truth is adherence to ISO 10993 guidelines. For sterilization, the ground truth is adherence to ANSVAAMI/ISO 11135-1:2007. These are objective, measurable standards rather than subjective expert consensus, pathology, or outcomes data typically associated with diagnostic algorithms.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This document describes a medical device, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided, as there is no "training set" for this type of medical device.

Summary

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K123531

510 (k) Summary

Submitter's information:

DEC 1 4 2012

Name:	LeMaitre Vascular, Inc.
Address:	63 Second Avenue
	Burlington, MA USA 01803
Phone:	781-425-1727
Contact	Bryan Cowell, MSc., RAC
Person:

Date of preparation:	14 Nov 2012
Device Name:	UnBalloon Non-Occlusive Modeling Catheter
Trade Name.	UnBalloon Non-Occlusive Modeling Catheter

Common/ Classification Catheter, Percutaneous / Modeling Catheter Name: Classification Panel: 21CFR §870.1250 Class: II (2)

DQY

Product Code:

Establishment Registration: 1220948

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

Owner/Operator: 1220948

Proposed Device Description:

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Proposed Intended Use:

The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.

Predicate Device:

510(k):	K121839
Device Name:	UnBalloon Non-Occlusive Modeling Catheter
SE Date:	08/08/2012
Regulation Number:	870.1250
Device Class Name:	Catheter, Percutaneous
Device Class:	2

510(k):	K110891
Device Name:	UnBalloon Non-Occlusive Modeling Catheter
SE Date:	09/13/2011
Regulation Number:	870.1250
Device Class Name:	Catheter, Percutaneous
Device Class:	2

Substantial Equivalence:

Fundamental Scientific Technological Characteristics:

The UnBalloon Non-Occlusive Modeling Catheter is a silicone surface coated percutaneous/modeling catheter designed for vascular surgeons. This submission is to include additional product sizes.

Functional/ Safety testing:

The verification activities conducted indicate that UnBalloon Non-Occlusive Modeling 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 ANSVAAMI/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), in circulating blood. There is no new material used for the additional catheter sizes as discussed in this submission.

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Summary of Product Testing:

The following tests have been completed to evaluate the performance of the catheter with shorter cage: .

ﻳ

Radial outward force Apposition Length Simulated Anatomical Use

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold, black font. The text is centered in the image. There is a logo to the left of the text.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

LeMaitre Vascular, Inc. c/o Mr. Bryan Cowell Principal Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

DEC 1 4 2012

Re: K123531

Trade/Device Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: November 15, 2012 Received: November 16, 2012

Dear Mr. Cowell:

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

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Page 2 - Mr. Bryan Cowell

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to hittp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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)	K123531
Device Name	UnBalloon Non-Occlusive Modeling Catheter
Indications for Use	The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X
	OR Over-The-Counter Use

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K123531:

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).