UNBALLOON NON-OCCLUSION MODELING CATHETER

K133026 · LeMaitre Vascular, Inc. · DQY · Dec 31, 2013 · Cardiovascular

Device Facts

• Record ID: K133026
• Device Name: UNBALLOON NON-OCCLUSION MODELING CATHETER
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 31, 2013
• Decision: SESE
• Submission Type: Traditional
• 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

UnBalloon Non-Occlusive Modeling Catheter is a percutaneous catheter featuring an expandable Nitinol mesh housed in a retractable sheath. Designed for use in large diameter vessels to assist in the modeling (apposition) of self-expanding endoprostheses. Input: manual operation via handles; the blue handle controls sheathing/unsheathing, while the clear handle/luer controls mesh expansion. The device accommodates 0.035 or 0.038 inch guidewires. Radiopaque markers and Nitinol mesh provide fluoroscopic visibility for precise positioning. The mesh design allows for radial outward force application without occluding blood flow. Used by clinicians in a clinical setting; output is the mechanical expansion of the mesh against the endoprosthesis to ensure proper vessel wall apposition. Benefits include improved stent graft modeling effectiveness.

Clinical Evidence

Bench testing included dimensional analysis, apposition length, radial outward force, leakage testing, fatigue and simulated use, force at break, and interaction with stent graft materials (light microscopy and SEM). Animal testing (ovine study) was also conducted to evaluate performance.

Technological Characteristics

Medical grade silicone surface coated catheter with expandable Nitinol mesh. Features retractable sheath, radiopaque markers, and dual-handle control system. Compatible with 0.035/0.038 inch guidewires. Sterilized via ethylene oxide (EO) per ANSI/AAMI/ISO 11135-1:2007. Biocompatibility assessed per ISO 10993 for limited contact (<24 hours) with circulating blood.

Indications for Use

Indicated for assisting in the modeling of self-expanding endoprostheses in 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-Occlusion Modeling Catheter (K123531)
• UnBalloon Non-Occlusion Modeling Catheter (K121839)
• UnBalloon Non-Occlusion Modeling Catheter (K110891)

Submission Summary (Full Text)

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K 133026 DEC 3 1 2013

## 510 (k) Summary

#### Submitter's information:

| Name: | LeMaitre Vascular, Inc. |
|------------------------------|----------------------------------------------|
| Address: | 63 Second Avenue<br>Burlington, 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:

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.

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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
- 2. Apposition length
- 3. Radial outward force
- 4. Freedom from leakage
- 5. Fatigue and simulated use
- 6. Force at break (i.e., bond strength)
- 7. Interaction with stent graft materials (light microscope and SEM study)
- 8. 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 [phone] or [phone] 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 [phone] or [phone] 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)<br>Number<br>(if known) | K133026 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | UnBalloon Non-Occlusive Modeling Catheter |
| Indications<br>for Use | The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the<br>modeling of self-expanding endoprostheses in large diameter vessels. |

### Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use_

M. A. Hillemann