Passeo-18 Peripheral Dilation Catheter

K151744 · Biotronik, Inc. · LIT · Oct 8, 2015 · Cardiovascular

Device Facts

• Record ID: K151744
• Device Name: Passeo-18 Peripheral Dilation Catheter
• Applicant: Biotronik, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Oct 8, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Passeo-18 is a percutaneous transluminal angioplasty (PTA) catheter used by physicians in clinical settings to dilate stenotic peripheral vessels and arteriovenous dialysis fistulae. The device features a dilatation balloon that inflates to a specific diameter at a defined pressure; radiopaque markers at balloon ends facilitate fluoroscopic positioning. The catheter includes a soft tapered tip for advancement, two proximal Luer-ports (one for inflation/deflation, one for flushing), and hydrophobic coatings on the shaft and balloon. The physician advances the catheter over a guidewire to the target lesion under fluoroscopic guidance. Inflation of the balloon compresses the obstructive lesion, restoring vessel patency. The device is provided sterile and is intended for single use. It benefits patients by providing a minimally invasive method to treat peripheral arterial disease and maintain dialysis access.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing, including dimensional inspection, simulated use, mechanical testing (balloon compliance, burst strength, fatigue, tensile strength, kink resistance, torsional rigidity, rotatability), biocompatibility (cytotoxicity, GC/MS, FT-IR), and sterilization validation.

Technological Characteristics

Percutaneous transluminal angioplasty catheter; balloon dilatation principle. Features hydrophobic silicone shaft coating and hydrophobic patchwork balloon coating. Radiopaque markers for fluoroscopic visualization. Materials verified via FT-IR and GC/MS. Sterilization via Ethylene Oxide (EO) to SAL 10^-6. Compatible with standard guidewires and introducer sheaths.

Indications for Use

Indicated for patients requiring dilation of stenotic segments in femoral, popliteal, and infrapopliteal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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

• Passeo-18 (K072765)

Submission Summary (Full Text)

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

October 8, 2015

BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035

Re: K151744

Trade/Device Name: Passeo-18 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: September 4, 2015 Received: September 9, 2015

Dear Mr. Brumbaugh:

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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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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# Appendix 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K151744

Device Name

Passeo-18 peripheral dilatation catheter

Indications for Use (Describe)

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters. To the left of the word is a square symbol with the letters "BIO" inside. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

# Passeo-18 Peripheral Dilatation Catheter Special 510(k) Premarket Notification

# 510(k) Summary

| Name and Address of Sponsor: | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person and Phone Number: | Jon Brumbaugh<br>Vice President, Requlatory Affairs and Compliance<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | June 24, 2015 |
| Device Name: | |
| Proprietary Name: | Passeo-18 |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification: | Class II (21 CFR 870.1250) |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Code: | LIT |

#### Predicate Device:

| | 510(k) # | Device Name | Manufacturer | Date of Clearance |
|------------|----------|-------------|--------------|-------------------|
| Predicate: | K072765 | Passeo-18 | BIOTRONIK | 12-Dec-2007 |

# General Description:

The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion.

The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.

The dilatation catheter is compatible wire and introducer sheath sizes according to the recommendations on the label.

#### Indication for Use:

The Passeo-18 peripheral dilatation catheter is indicated to the femoral, poplited and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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Image /page/4/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle that is divided into four quadrants by a plus sign. To the right of the circle is the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

| Sizes | Balloon Length (mm) | | | 20 | | | 40 | | | 60 | | | 80 | | | 120 | | | 150 | | | 170 | | | 200 | | | 220 | | |
|------------------------|---------------------|---|--------------------|----|-----|-----|----|-----|-----|----|-----|-----|----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|
| | | | Usable Length (cm) | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 | 90 | 130 | 150 |
| Nominal Balloon Ø (mm) | 2 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 2.5 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 3 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 3.5 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 4 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 5 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 6 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |
| | 7 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | | | |

# Purpose of Submission:

BIOTRONIK submits this 510(k) for clearance of additional device size configurations for the Passeo-18 including additional balloon lengths up to 220mm, referred to collectively as Passeo-18 LE. Additionally, a minor change affecting the entire product range that includes consolidation to a single balloon catheter design. Other changes previously documented as letters to file are also reported.

# Summary of technological characteristics in comparison to Predicate Device:

Testing according to the existing design controls demonstrates that the Passeo-18 LE is comparable to the predicate device. The Passeo-18 catheters are identical to the predicate in terms of indications for use, intended use and principles of operation and fundamental technology. Modifications to technological characteristics do not raise new or different questions of safety and effectiveness.

Additional balloon lengths and balloon diameters have been added to the product line. Catheters will now be constructed using one, consolidated design instead of two separate design variants. Minor changes to the grade of materials for catheter construction and materials for packaging have been included. The substantial equivalence of these modifications are supported by producted according to the existing design controls.

#### Non-Clinical Performance Testing

| Test Name | Test Conditions / Specifications | Summary Results |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dimensional Verification | |
| Visual and<br>Dimensional<br>Inspection | The balloon catheter was visually inspected for defects,<br>printing, coating homogeneity, x-ray marker positioning<br>and adherence to dimensional specs. | Inspectional acceptance criteria<br>were met. |
| Crossing Profile<br>(system profile) | The diameter of the device is measured by passing the<br>device through a ring-hole gauge to verify French size<br>compatibility. | Acceptance criteria for crossing<br>profile were met. Crossing<br>profile is within specs of<br>predicate. |
| | Simulated Use Testing | |
| Simulated Use | Testing is conducted to demonstrate that the balloon<br>catheter can be safely and reliably prepared, delivered,<br>and retracted using the recommended techniques and<br>instructions for use, without damage to the device. | Acceptance criteria were met.<br>Test shows device performs<br>similar to predicate in a<br>simulated use environment. |
| Test Name | Test Conditions / Specifications | Summary Results |
| Trackability and<br>Pushability | Test recorded frictional force (N) when tracked over a<br>guide wire in arterial model | Acceptance criteria were met.<br>Test shows device performs<br>similar to predicate in a<br>simulated use environment. |
| Pullback and<br>reintroduction test | With the balloon in an appropriate sheath, the friction to<br>introduce and pullback the device after inflation to RBP is<br>evaluated. | Pullback and reintroduction was<br>comparable or better than<br>comparator product. Device<br>performs similar to predicate. |
| Balloon Inflation /<br>Deflation Time | Inflation and deflation time are measured with the device<br>placed in an anatomical model. Inflation and deflation<br>times were measured for characterization. | Inflation time was characterized<br>and deflation time was<br>determined to be according to<br>specifications within the<br>instructions for use. |
| Compatibility with<br>Contrast media | Devices were stored for in contrast medium (ionic and<br>non-ionic) for a specified time, dilated to RBP and then<br>visually inspected. | No visible damage or<br>deformation. Device performs<br>similar to predicate. |
| | Mechanical Testing | |
| Balloon Compliance<br>Radial | Radial compliance is calculated as the<br>between balloon diameter at NP and at RBP. | Radial compliance meets<br>acceptance criteria. Device<br>performs similar to predicate |
| Balloon Compliance<br>Axial | Axial compliance (balloon length at RBP and NP) of the<br>device is measured to verify that it meets product<br>specification. | The difference between balloon<br>length at RBP and NP is within<br>specification. |
| Balloon burst<br>strength | This test determines the balloon Rated Burst Pressure<br>(RBP). The balloon is inflated until burst and pressure at<br>burst is recorded. The burst failure mode is recorded. | Balloons met acceptance criteria<br>for lower 99.9% quantile at 95%<br>confidence interval for all sizes. |
| Balloon Fatigue | The balloons were subjected to repeat inflation/deflation<br>cycles to determine survivability of the balloon. Any loss<br>of pressure, whether due to failure of the balloon, shaft or<br>proximal or distal seals, was reported as a test failure. All<br>failure modes were recorded. | Results demonstrate that 90%<br>of the balloons will survive the<br>test with at least 95%<br>confidence. |
| Tensile Strength<br>Catheter | Following simulated use, a tensile strain is applied along<br>the relevant catheter region until the first sign of fracture.<br>The force (Fmax) at first sign of damage is recorded. | Tensile strength performance<br>(Fmax) for distal and proximal<br>balloon sections met<br>performance specifications. |
| Resistance to Kink | Test was performed to determine the minimum bending<br>radius of the catheter shaft at proximal and distal<br>locations | Measured mean catheter kink<br>radius was well within the<br>acceptance criteria. |
| Torsional rigidity | Test was performed to assess the ability to inflate and<br>deflate the balloon following application of a torsional<br>load. | Device meets acceptance<br>criteria. Device performs similar<br>to predicate. |
| Rotatability | Test was performed to evaluate torque response. The<br>proximal end of the device is rotated until the first<br>rotational movement at the distal end is observed. | Device meets acceptance<br>criteria. Device performs similar<br>to predicate. |
| Test Name | Test Conditions / Specifications | Summary Results |
| Post-Dilatation Test | In a simulated arterial model, balloon is positioned within a deployed stent and subjected to multiple inflation/deflation cycles. | All samples withstood all inflation/deflation cycles within the stent without bursting. Device performs similar to predicate. |
| | Biocompatibility | |
| Cytotoxicity | L929 cells are incubated with test article extracts and evaluated for percentage of cell growth inhibition and compared to a control sample (control: cells exposed to extraction medium). | Growth analyses of cells cultured with test article extract showed no cytotoxic effects of the test article. |
| Gas<br>Chromatography –<br>Mass Spectrometry<br>(GC/MS) | The old materials are compared to the new materials.<br>The test articles are extracted in different solvents (polar and non-polar, e.g. purified water, isopropyl alcohol and hexane) and the extracts are analyzed by GC-MS fingerprint analysis. | There are no significant differences between old and new materials |
| Fourier Transform<br>Infrared<br>Spectroscopy<br>(FT-IR) analysis | Fourier Transform Infrared Spectroscopy (FT-IR) was utilized to compare the chemical composition of the new materials and old materials The resulting FT-IR spectra were compared. | Materials had greater than 99% correlation according to FT-IR analysis. The new materials are similar to the predicate. |
| | Sterilization Validation | |
| Correction factor<br>and bioburden | Test conducted to determine typical device bioburden prior to sterilization. | Determine bioburden correction factor. Device meets specifications for CFU/device. |
| Test for inhibitors<br>and activators,<br>Pyrogen test | Test conducted to determine device endotoxin levels after manufacturing. | Bacterial endotoxin test results met acceptance criteria. |
| Validation of the<br>Sterilization<br>Success | Test was performed according to determine if sterilization parameters are sufficient for a SAL of 1x10-6. | Testing confirmed SAL of 10-6.<br>The device performs similar to predicate. |
| Residual gas<br>analysis: EO and<br>ECH | Test conducted to determine EO and ECH residuals on the device following two sterilization cycles. | Device meets acceptance criteria. The device performs similar to predicate. |

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Image /page/5/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK symbol on the left and the word "BIOTRONIK" in large, bold, dark blue letters on the right. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

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Image /page/6/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle with a cross through it, followed by the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

# Clinical Test Data

The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application.

# Labeling

The instructions for use and labeling were updated with the relevant new device size information.

#### Conclusion

Based on the non-clinical performance testing using existing design controls from the predicate, the subject Passeo-18 catheter performs as well as the predicate and is therefore substantially equivalent to the predicate Passeo-18 catheter.