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.

AI/ML Overview

The provided text describes a 510(k) summary for the UnBalloon Non-Occlusive Modeling Catheter, focusing on its substantial equivalence to a predicate device and product testing. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document is a regulatory submission for premarket notification, demonstrating that the device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested information points, particularly those related to a study proving device performance against acceptance criteria, cannot be extracted from this document, as such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document mentions "product performance requirements of the device specifications" and lists various tests, but it does not explicitly define specific numerical or qualitative acceptance criteria for each test (e.g., a specific tensile strength value, or a specific duration for fatigue testing without failure). It only states that the device "meets the product performance requirements."

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable criteria in the document. The document asserts the device meets unspecified "product performance requirements."	Not explicitly stated with quantifiable results. The document generally states the device meets requirements without providing specific performance values for the following tests:
	Worst case simulated use
	Fatigue
	Hemostasis
	Bond tensile strength
	Radial outward force
	Compatibility with endoprostheses
	Lubricity testing
	Silicone curing characterization
	Silicone curing process characterization study
	Silicone shelf life validation
	Bushing & seal process qualification

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

Not provided. The document refers to "product characterization and validation" and "verification activities" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes, often in the context of AI/ML device evaluations. The reported testing is primarily in-vitro/bench testing for a physical catheter, not an AI diagnostic device.

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

Not applicable/Not provided. As noted above, this is not relevant for the type of product testing described.

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:

Not applicable. This device is a physical catheter, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical catheter.

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

The "ground truth" for the engineering performance tests (like fatigue, tensile strength, etc.) would be established by engineering specifications, industry standards, and validated testing methodologies against which the device's performance is measured. The document implies compliance with these without detailing them. For biocompatibility, it refers to "ISO 10993 guidelines."

8. The sample size for the training set:

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

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

Not applicable. See point 8.

Summary

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<|2|83°

AUG

8 2012

510 (k) Summary

Submitter's information:

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

Date of preparation:	3 June 2012
Device Name:	UnBalloon Non-Occlusive Modeling Catheter
Trade Name.	UnBalloon Non-Occlusive Modeling Catheter and UnBalloonNon-Occlusive Catheter

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

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):	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.

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 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), in circulating blood.

Summary of Product Testing:

The following has been assessed through product characterization and validation: Worst case simulated use * Fatigue Hemostasis Bond tensile strength* Radial outward force Compatibility with endoprostheses

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Lubricity testing* Silicone curing characterization* Bilicone curing churacterization
Silicone curing process characterization study* Silicone shelf life validation* Bushing & seal process qualification*

*testing specific to the silicone addition to the UnBalloon

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Public Health Service

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

8 2012 AUG

LeMaitre Vascular, Inc. c/o Mr. Andrew Hodgkinson Vice President of Regulatory, Quality & Clinical Affairs 63 Second Avenue Bedford, MA 01803

Re: K121839

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: June 20, 2012 Received: July 9, 2012

Dear Mr. Hodgkinson:

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.

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Page 2 – Mr. Andrew Hodgkinson

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 or uny 1 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 Of R Far 60 7), accember (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 rr you http://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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Allehan

, 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)	K121839
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
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CM & Weller

(Division Sign-Off)

Division of Cardiovascular Devices

Division of Cardiovass -------------------------------------------------------------------------------------------------------------------------------------------------------

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).