UNBALLOON NON-OCCLUSIVE MODELING CATHETER

K121839 · LeMaitre Vascular, Inc. · DQY · Aug 8, 2012 · Cardiovascular

Device Facts

• Record ID: K121839
• Device Name: UNBALLOON NON-OCCLUSIVE MODELING CATHETER
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 8, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The UnBalloon Non-Occlusive Modeling Catheter is a percutaneous device used by vascular surgeons to assist in the modeling of self-expanding endoprostheses. It features an expandable Nitinol mesh mounted on a catheter, housed within a 14F retractable sheath. The device is inserted over a 0.035 or 0.038 inch guidewire. The operator uses a blue handle to sheath/unsheath the mesh and a clear handle/luer to control mesh expansion. The Nitinol mesh design allows for vessel modeling without occluding blood flow. Radiopaque markers facilitate positioning under fluoroscopy. The device is silicone-coated to enhance performance. By ensuring proper apposition of endoprostheses against vessel walls, the device aids in the successful deployment of vascular implants.

Clinical Evidence

Bench testing only. Evidence includes product characterization and validation: simulated use, fatigue, hemostasis, bond tensile strength, radial outward force, compatibility with endoprostheses, lubricity, silicone curing characterization, shelf life, and bushing/seal process qualification. Biocompatibility testing performed per ISO 10993 for externally communicating devices with limited contact duration (<24 hours) in circulating blood.

Technological Characteristics

Percutaneous modeling catheter with expandable Nitinol mesh; 14F retractable sheath; medical-grade silicone surface coating. Compatible with 0.035/0.038 inch guidewires. Radiopaque markers for fluoroscopic visualization. Sterilized via ethylene oxide (EO) per ANSI/AAMI/ISO 11135-1:2007. Biocompatibility per ISO 10993.

Indications for Use

Indicated for use by vascular surgeons to assist in the modeling of self-expanding endoprostheses within large diameter vessels.

Regulatory Classification

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.

Predicate Devices

• UnBalloon Non-Occlusive Modeling Catheter (K110891)

Submission Summary (Full Text)

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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 UnBalloon<br>Non-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:

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.

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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 [phone] or [phone] 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 |
|----------------------------------------|---------------------------|
|----------------------------------------|---------------------------|

CM & Weller

(Division Sign-Off)

Division of Cardiovascular Devices

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