The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling Catheter with an expandable Nitinol mesh in a 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 Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the UnBalloon Non-Occlusion Modeling Catheter, based on the provided text:

Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical trial or AI model validation study. Therefore, many of the typical acceptance criteria and study details for AI/software-as-a-medical-device (SaMD) are not applicable or not present in this type of submission. The device described is a physical catheter, not an AI model.

Acceptance Criteria and Reported Device Performance

Given that this is a physical medical device and not an AI/software device, the "acceptance criteria" are related to its physical performance, safety, and functional equivalence to a predicate device. There are no explicit, quantifiable acceptance criteria presented in the format often seen for AI model performance (e.g., sensitivity, specificity thresholds). Instead, the document summarizes various tests performed to ensure the device meets its specifications and is substantially equivalent.

Acceptance Criteria Category	Reported Device Performance
Functional/Safety Performance	Verification activities conducted on the subject device demonstrated it "meets the product performance requirements of the device specifications and the modifications presented do not raise additional safety issues." Specific tests performed include: dimensional analysis, apposition length, radial outward force, freedom from leakage, fatigue and simulated use, force at break (bond strength), and interaction with stent graft materials.
Biocompatibility	All blood contact portions of the device passed biocompatibility testing according to ISO 10993 guidelines, establishing it as "biocompatible." No new materials were introduced, so existing biocompatibility tests remain valid.
Sterilization	Device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007. The sterilization process remains unchanged from the predicate.
Substantial Equivalence to Predicate Device	The modified UnBalloon is "substantially equivalent to the predicate UnBalloon catheter based on the same intended use and fundamental scientific technological characteristics."
Stent Graft Modeling Effectiveness (Modified)	The modification (increased outer diameter from 14 Fr to 16 Fr for thoracic models) aims "to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen)." Specific performance metrics for this improvement are not detailed beyond the aim.

Study Details (Applicable to a Physical Medical Device Submission)

Sample size used for the test set and the data provenance:
- The document mentions "Animal testing (ovine study)" as one of the completed tests. However, the specific sample size (number of animals) for this study is not provided.
- Data provenance for the animal study is "ovine" (sheep), which is a common animal model for cardiovascular devices. It would be considered prospective for the purposes of the animal study itself.
- For the other listed tests (e.g., dimensional analysis, fatigue), these are typically in-vitro (benchtop) tests, and the "sample size" would refer to the number of devices or components tested. This information is not specified in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a physical catheter, not an AI/software device that generates outputs requiring expert interpretation to establish ground truth (e.g., image classifications). The "ground truth" for a physical device is its measurable physical properties and performance in specified tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable to a physical device submission of this nature. Adjudication methods are typically used for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, neither of which is relevant here.
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 is not applicable. This device is a physical catheter, not an AI assistance tool for human readers. No MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a physical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical medical device, the "ground truth" is established by:
  - Physical measurements and engineering specifications: For tests like dimensional analysis, radial outward force, apposition length, and force at break.
  - Standardized test methods/protocols: For tests like freedom from leakage, fatigue and simulated use, interaction with stent graft materials, sterilization, and biocompatibility.
  - Physiological observation/measurement in animal models: For the ovine animal study.
The sample size for the training set:
- This is not applicable. There is no "training set" as this is a physical device, not a machine learning model.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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K 133026 DEC 3 1 2013

510 (k) Summary

Submitter's information:

Name:	LeMaitre Vascular, Inc.
Address:	63 Second AvenueBurlington, MA USA 01803
Phone:	781-425-1727
Contact Person:	Bryan Cowell, MSc., RAC
Date of preparation:	September 24, 2013
Device Name:	UnBalloon Non-Occlusion Modeling Catheter
Trade Name:	UnBalloon Non-Occlusion Modeling Catheter
Common/ Classification Name:	Catheter, Percutaneous
Classification Panel:	21CFR §870.1250
Class:	II (2)
Product Code:	DQY

Establishment Registration: 1220948

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

Owner/Operator: 1220948

Proposed Device Description:

This submission modifies the current UnBalloon Non-Occlusive Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.

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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):	K123531
Device Name:	UnBalloon Non-Occlusion Modeling Catheter
SE Date:	12/14/2012
Regulation Number:	21CFR §870.1250
Device Class Name:	Catheter, Percutaneous
Device Class:	2

510(k):	K121839
Device Name:	UnBalloon Non-Occlusive Modeling Catheter
SE Date:	08/08/2012
Regulation Number:	21CFR §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:	21CFR §870.1250
Device Class Name:	Catheter, Percutaneous
Device Class:	2

Substantial Equivalence:

The modified UnBalloon is substantially equivalent to the predicate UnBalloon catheter based on the same intended use and fundamental scientific technological characteristics.

Functional/ Safety testing:

The verification activities conducted on the subject device that the modified UnBalloon Non-Occlusion Modeling Catheter meets the product performance requirements of the device specifications and the modifications presented do not raise 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". The Sterilization process remains unchanged.

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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 UnBalloon Non-Occlusion Modeling Catheter is biocompatible.

No new materials are being introduced in the modified UnBalloon and the current biocompatibility tests remains valid.

Summary of Product Testing:

The following tests have been completed to evaluate the performance of the Subject Device the UnBalloon Non-Occlusive Modeling Catheter:

1. Dimensional analysis
1. Apposition length
1. Radial outward force
1. Freedom from leakage
1. Fatigue and simulated use
1. Force at break (i.e., bond strength)
1. Interaction with stent graft materials (light microscope and SEM study)
1. Animal testing (ovine study)

Conclusion:

LeMaitre Vascular has demonstrated that the subject device: the UnBalloon Non-Occlusion Modeling Catheter is substantially equivalent to the predicate device(s) based on its intended use and fundamental scientific technology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

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

December 31, 2013

LeMaitre Vascular, Inc. C/O Bryan Cowell, MSc., RAC Principal Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

Re: K133026

Trade/Device Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: November 25, 2013 Received: November 26, 2013

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

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Page 2 - Bryan Cowell

forth in the quality systems (OS) 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/MedicaiDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

M.A. Hillemann

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

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Indications for Use Statement

510(k)Number(if known)	K133026
Device Name	UnBalloon Non-Occlusive Modeling Catheter
Indicationsfor Use	The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in themodeling of self-expanding endoprostheses in large diameter vessels.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109)

Over-The-Counter Use_

M. A. Hillemann

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).