THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER

K110891 · LeMaitre Vascular, Inc. · DQY · Sep 13, 2011 · Cardiovascular

Device Facts

• Record ID: K110891
• Device Name: THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 13, 2011
• 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

Percutaneous catheter designed to assist in modeling self-expanding endoprostheses; features expandable Nitinol mesh within 14F retractable sheath. Unlike traditional balloon catheters, mesh design allows expansion without occluding blood flow; minimizes pressure buildup on proximal end of endoprostheses during modeling. Device includes radiopaque markers for fluoroscopic positioning; inner lumen accommodates 0.035 or 0.038 inch guidewire. Operated by physician in clinical setting; blue handle controls sheathing/unsheathing; clear handle/luer controls mesh expansion. Used to enhance primary attachment in landing zones or treat type 1a endoleaks. Non-occlusive design allows surgeon to accurately model grafts without risks associated with flow obstruction.

Clinical Evidence

Post-market surveillance data from 13 cases (4 thoracic, 9 abdominal) in Brazil and EU. Technical success achieved in all cases with no reported adverse events or device malfunctions. Used with various stent grafts (e.g., Zenith TX2, Endurant, Excluder). Median 3 deployments per case; mean deployment time 36.6 seconds. Radiopacity rated 'good'. Radial force deemed appropriate in 62% of cases. No device failures or cage entrapment reported.

Technological Characteristics

Expandable Nitinol mesh; 14F retractable sheath; radiopaque markers; guidewire lumen (0.035/0.038 inch). Mechanical expansion mechanism via handle/luer. Biocompatibility tested per ISO 10993-1. Non-occlusive design. Sterilized device.

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

• Cook Coda Balloon Catheter (K032869)
• Medtronic Reliant Balloon Catheter (K050038)
• Gore Tri-Lobe Balloon Catheter (K033670)

Reference Devices

• LeMaitre TAArget
• Gore Excluder
• Cook Zenith TX2
• Cook Proform
• Medtronic Endurant
• Jotec E-Vita
• Gore TAG
• Gore C-TAG
• Aorfix

Submission Summary (Full Text)

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SEP 1 3 2011

## SECTION 5: 510(k) SUMMARY

| Submitter: | LeMaitre Vascular, Inc.<br>63 Second Avenue<br>Burlington, MA 01803 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Hodgkinson<br>Vice President, Clinical, Regulatory and Quality Affairs<br>Phone: [phone] x108<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | 9/13/2011 |
| Trade Name: | The UnBalloon Non-Occlusive Modeling Catheter |
| Common Name: | Modeling Catheter |
| Classification Name: | Percutaneous Catheter |
| Predicate Devices: | Cook Coda Balloon Catheter - K032869<br>Medtronic Reliant Balloon Catheter - K050038<br>Gore Tri-Lobe Balloon Catheter - K033670 |
| Device Description: | The UnBalloon Non-Occlusive Modeling Catheter consists of an<br>expandable Nitinol mesh in a 14F retractable sheath. The Nitinol<br>mesh design allows for expansion without occluding blood flow. The<br>Nitinol mesh and radiopaque markers are highly visible under<br>fluoroscopy and assist in the positioning of the device. The inner<br>lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire<br>access. Side ports and clear handle/luer allow the device and<br>guidewire lumen to be flushed. The blue handle allows the device to<br>be sheathed/unsheathed while the clear handle/luer controls the<br>expansion of the Nitinol mesh. |
| Intended Use: | The UnBalloon Non-Occlusive Modeling Catheter is intended to assist<br>in the modeling of self-expanding endoprostheses in large diameter<br>vessels. |
| Summary of | The UnBalloon is a percutaneous catheter designed to assist in |
| Technological<br>Characteristics: | modeling of self-expanding endoprostheses without obstructing blood<br>flow. This device differs from the predicate devices as it is designed<br>to eliminate the pressure that typically builds up on the proximal end<br>of those devices when inflated. By eliminating occlusion (or partial<br>occlusion), the risks associated with occlusion during ballooning of an<br>endovascular prosthesis may be minimized, potentially allowing the<br>surgeon to more accurately model grafts that have been deployed. |
| Summary of Product<br>Testing: | The following has been assessed through product characterization and<br>validation:<br>Worst case Simulated use<br>Inflation/Deflation time<br>Freedom from leakage<br>Kink resistance<br>Fatigue<br>Hemostasis<br>Bond tensile strength<br>Radial outward force<br>Compatibility with endoprostheses<br>Physiological insult – animal testing (Acute and 28-day) |
| Summary of OUS<br>Post Market<br>Surveillance | Between 14-June-2011 and 16-August-2011, LeMaitre Vascular<br>attended 13 cases in Brazil and the European Union using the<br>UnBalloon Non-Occlusive Modeling Catheter. In all cases we<br>achieved technical success with no reported adverse events or device<br>related malfunctions. The device performed successfully in 4 thoracic<br>cases and 9 abdominal cases using a variety of stent grafts. The<br>endoprostheses that were modeled included the LeMaitre TAArget<br>(n=1, 8%); Gore Excluder (n=1, 8%); Cook Zenith TX2, Proform<br>(n=2, 16%); Medtronic Endurant (n=1, 8%); Jotec E-Vita (n=2, 16%);<br>Gore TAG or C-TAG (n=1, 8%); Aorfix (n=1, 8%) and 1 (8%)<br>unknown. Devices ranged in size from 24mm to 40mm at the most<br>proximal diameter.<br>The UnBalloon was used to enhance primary attachment in the landing<br>zone (n=8; 62%) while it was used 1 time (8%) to successfully treat a<br>type 1a endoleak. Other uses included: Enhancement of Primary<br>Attachment Zone + Modeling of device overlap (n=2; 15%); Modeling<br>of Mainbody (n=1; 7.7%); Modeling of overlapping zone (n=1; 7.7%).<br>The UnBalloon was deployed a median 3 times per case with mean<br>deployment time of 36.6 sec +/- 39.2sec (Range 5 - 110sec.).<br>Blood loss through the device was minimal with only 1 recorded result<br>of 3ml that emanated through the guidewire lumen as expected.<br>Radiopacity received an overall rating of 'good' in most cases with 2<br>cases relaying some difficulty seeing the inner marker bands or sheath<br>marker.<br>The applied modeling force (radial force) was estimated as<br>"appropriate" in 8 (62%) cases while 5 (37%) rated it as<br>"unknown/cannot judge."<br>No device failures were reported in any case. The Nitinol cage was<br>resheathed in all cases without any issues and there were no reports of<br>the Nitinol cage getting hooked or caught in any Endovascular<br>devices. No other complications or adverse events were reported.<br>These initial clinical results indicate that the UnBalloon Non-<br>Occlusive Modeling Catheter performs as intended and is as safe and<br>effective as the predicate devices. |
| Summary of Pre-<br>clinical Study: | The biocompatibility of the device was tested per ISO10993-1. |
| Conclusion: | LeMaitre Vascular has demonstrated that The UnBalloon Non-<br>Occlusive Modeling catheter is substantially equivalent to the<br>predicate devices based on its indications for use and fundamental<br>scientific technology. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

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

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

1 3 2011

Re: K110891

Trade Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 30, 2011 Received: August 31, 2011

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 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 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 go to http://www.fda.gov/Aboutl7DA/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/ReportalProblem/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.

Juc

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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## SECTION 4: INDICATION FOR USE STATEMENT

510(k) Number : _ K 110891

Device Name: The 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.

Prescription Use______________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K110891