Passeo-14 Peripheral Dilatation Catheter

K152240 · Biotronik, Inc. · LIT · Oct 8, 2015 · Cardiovascular

Device Facts

• Record ID: K152240
• Device Name: Passeo-14 Peripheral Dilatation Catheter
• Applicant: Biotronik, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Oct 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

Device Story

Passeo-14 is a percutaneous transluminal angioplasty (PTA) catheter used for dilating stenotic lower limb arteries. The device features a dilatation balloon designed to inflate to specific diameters at defined pressures; radiopaque markers at balloon ends facilitate fluoroscopic positioning. The catheter includes a soft tapered tip for advancement and two proximal Luer-ports: one for balloon inflation/deflation and one for flushing the guide wire lumen. The shaft utilizes a hydrophobic silicone coating proximally and a hydrophilic polymeric coating distally; the balloon features a hydrophilic patchwork coating. Used in clinical settings by physicians, the device is advanced over a guide wire to the lesion site. Inflation improves arterial perfusion by dilating the stenosis. The device is compatible with standard guide wires and introducer sheaths.

Clinical Evidence

No clinical data submitted. Substantial equivalence is based on non-clinical bench testing, including dimensional verification, simulated use, mechanical performance (burst pressure, fatigue, tensile strength, kink resistance), and biocompatibility/sterilization validation.

Technological Characteristics

Percutaneous transluminal angioplasty catheter. Materials: Hydrophobic silicone (proximal shaft), hydrophilic polymeric coating (distal shaft), hydrophilic patchwork (balloon). Radiopaque markers for fluoroscopy. Dimensions: 1.5-4.0 mm balloon diameter, 20-220 mm length. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for balloon dilatation of stenotic lower limb arteries to improve perfusion.

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-35 (K142379)

Reference Devices

• Amphirion Deep PTA (K083919)
• NanoCross 0.014 OTW PTA Dilatation Catheter (K090849)
• Bantam (K093139)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

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

October 8, 2015

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

Re: K152240

Trade/Device Name: Passeo-14 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 7, 2015 Received: August 10, 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 of medical devicerelated adverse events) (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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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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# Indications for Use

510(k) Number (if known)

K152240

#### Device Name Passeo 14 Peripheral Dilatation Catheter

Indications for Use (Describe)

The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Passeo-14 Peripheral Dilatation Catheter Traditional 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, Regulatory 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: | October 6, 2015 |
| Device Name: | |
| Proprietary Name: | Passeo-14 |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification: | Class II (21 CFR 870.1250) |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Code: | LIT |

#### Predicate and Reference Devices:

| | 510(k) # | Device Name | Manufacturer | Date of Clearance |
|-----------|----------|------------------------------------------------|--------------|-------------------|
| Predicate | K142379 | Passeo-35 | BIOTRONIK | 5-Dec-2014 |
| Reference | K083919 | Amphirion Deep PTA | Invatec | 13-Mar-2009 |
| Reference | K090849 | NanoCross 0.014 OTW PTA<br>Dilatation Catheter | Ev3 Inc. | 1-May-2009 |
| Reference | K093139 | Bantam | Clearstream | 30-Dec-2009 |

#### General Description:

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic in lower limb arteries. 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 guide wire lumen.

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The dilatation catheter has a hydrophobic silicone coating on the outer surface of the proximal shaft and a hydrophilic polymeric based coating on the outer surface of the distal shaft, coated over 150 mm length (valid for 1.5 and 2 mm balloon diameter and 20 to 100 mm balloon length) or coated over 75 mm length (valid for 2 mm balloon diameter and 140 to 220 mm balloon length, and 2.5 to 4 mm balloon diameter and 20 to 220 mm balloon lenqth). The balloon has a hydrophilic patchwork coating.

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

### Indication for Use:

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

| Sizes | | | | | | | | | | | | | | | | | | | | | | |
|------------------------|-----|-----|-----|-----|-----|-----|-----|-----|-----|----|-----|-----|----|-----|-----|----|-----|-----|----|-----|-----|---|
| Balloon Length (mm) | 20 | 40 | 70 | 100 | 140 | 180 | 220 | | | | | | | | | | | | | | | |
| Usable Length (cm) | 90 | 120 | 150 | 90 | 120 | 150 | 90 | 120 | 150 | 90 | 120 | 150 | 90 | 120 | 150 | 90 | 120 | 150 | 90 | 120 | 150 | |
| Nominal Balloon Ø (mm) | 1.5 | x | x | x | x | x | x | | | | | | | | | | | | | | | |
| | 2 | 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 |
| | 3 | 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 | | | | | | |
| | 4 | 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 the new device, Passeo-14.

#### Summary of technological characteristics in comparison to Predicate Device:

The technological differences between the Passeo-14 and the predicate (Passeo-35; K142379) can be summarized as differences in materials of construction and changes to device dimensions (Passeo-14 has smaller balloon diameters and longer balloon lengths). These differences do not affect the principles of operation or intended use. Therefore, the different technological characteristics of the devices do not raise different questions of safety and effectiveness.

The different characteristics' effects on the performance of the Passeo-14 were evaluated using established scientific methods prescribed in the following FDA guidance documents:

- . Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (#1608) – Published 8-Sep-2010.
- . Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" - Draft Guidance for Industry and Food and Drug Administration Staff (#1811) - Published 23-Apr-2013.

Non-clinical testing results demonstrate acceptable bench top performance and biological safety of the Passeo-14 in support of the substantial equivalence to the predicate.

The balloon diameter range of the Passeo-14 is similar to the "Amphirion Deep 0.014 OTW PTA Balloon Catheter" (Invatec Innovative Technologies, S.R.L; K083919) that has a balloon diameter range of 2.0-4.0 mm and a balloon length range of 20-210 mm.

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# Non-Clinical Performance Testing

| Test Name | Test Description / Purpose | 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. |
| 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 reference devices<br>(K083919; K093139; K090849)<br>in a simulated use environment. |
| Deflated Balloon<br>Profile | The test is conducted to evaluate the deflated balloon<br>profile after inflation | Acceptance criteria were met.<br>Test shows deflated profile is<br>less than 4F for all sizes. |
| 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 reference devices<br>(K083919; K093139) in a<br>simulated use environment. |
| Torqueability | This test evaluates the transfer of rotational movement<br>from the manifold to the distal tip (torque response). | Rotational movement was<br>transmitted. Test was passed. |
| 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. | Measured pullback and<br>reintroduction forces met<br>acceptance criteria. |
| Balloon Rated Burst<br>Pressure | 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>20 inflation cycles with at least<br>95% confidence. |
| Balloon Compliance<br>Radial | Radial compliance is calculated as the difference<br>between balloon diameter at NP and at RBP. | Radial compliance meets<br>acceptance criteria. Device<br>performs similar to predicate<br>(K142379) |
| 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 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. |
| Test Name | Test Description / Purpose | Summary Results |
| 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. |
| Tip pull test | The purpose of this test is to determine the bond strength<br>of the distal tip of the Passeo-14 products. | All tested samples met<br>acceptance criteria. |
| Flexibility and kink<br>test | The purpose of this test is to verify that the Passeo-14<br>products will not kink at bend radii which are appropriate<br>for the intended anatomy. | All tested samples passed the<br>test at the clinically relevant<br>radius |
| 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 bond /<br>Torque Strength | The purpose of this test is to verify whether the<br>functionality of the Passeo-14 products is still given after<br>application of a torsional load. | Acceptance criteria were met.<br>Test was passed. |
| Visibility /<br>Radiopacity | The purpose of this test is to evaluate X-ray visibility<br>(also referred to as radiopacitiy) of the Passeo-14<br>products. | Acceptance criteria were met.<br>Test was passed. |
| Coating Integrity | The purpose of this test is to evaluate the ability of the<br>coating to resist damage due to loading, tracking,<br>deployment and delivery system withdrawal. | Passeo-14 coating performs<br>comparable or better than<br>reference devices (K083919;<br>K090849) |
| Adhesive Strength<br>of Catheter Coating<br>(hydrophobic<br>coating) | This test evaluates the adhesive strength of the coating<br>after tracking, deployment and withdrawal to support<br>coating integrity testing. | All samples passed visual<br>inspection. |
| Particulate<br>Evaluation | This test determines the size and quantity of particles<br>that could potentially be introduced into the bloodstream<br>during delivery, deployment and retraction of Passeo-14<br>products. | Particle sizes ≤10, 25 and 50µm<br>were below threshold.<br>Passeo-14 particle counts were<br>less than reference devices<br>(K090849). |
| Corrosion<br>Resistance<br>(Catheter) | The radiopaque markers were assessed for corrosion<br>resistance | No signs of corrosion were<br>visible on the samples tested.<br>The test was passed. |
| 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. |
| Connector test | The purpose of this test is to ensure that the Luer lock<br>fittings of the manifolds are resistant to air leakage,<br>excessive torque and stress cracking | All samples met acceptance<br>criteria. |
| Indelibility and<br>adhesive strength of<br>printing | The purpose of this report is to verify that the printing on<br>the Passeo-14 products is indelible and readable after<br>exposure to solvents. | All samples tested showed<br>readable printing following<br>exposure to solvent. |
| Visual Inspection<br>(following exposure<br>to adverse<br>environmental<br>conditions) | The purpose of this test is to ensure that the Passeo-14<br>products maintain their integrity after exposure to<br>conditions experienced during normal transport, storage<br>and handling. | All devices passed inspection of<br>shipping container, box integrity,<br>pouch integrity, labeling<br>integrity, product fixation and<br>device integrity. |
| Test Name | Test Description / Purpose | Summary Results |
| Biocompatibility | | |
| Cytotoxicity | L929 cells are incubated with test article extracts and<br>evaluated for percentage of cell growth inhibition and<br>compared to the control (control: cells exposed to<br>extraction medium). | Growth analyses of cells<br>cultured with test article extract<br>showed no cytotoxic effects.<br>Test was passed. |
| Sensitization | Polar and non-polar test article extracts are intradermally<br>injected and topically applied to test animals. Animals are<br>observed for skin reaction after 24 and 48 hours. | Test animals showed no allergic<br>skin reaction compared to the<br>control group. Test was passed. |
| Irritation /<br>Intracutaneous<br>reactivity | The test was conducted by injecting polar and non-polar<br>test article extracts and extraction vehicle blank in<br>animals. The sites were observed for erythema and<br>edema at 24, 48 and 72 hours. | There were no signs of irritation.<br>Test was passed. |
| Acute systemic<br>toxicity | Polar and non-polar test article extracts were injected<br>into test animals. The animals were observed over a 72<br>hour period and then assessed for toxicity. | The test was passed as there<br>were no signs of acute systemic<br>toxicity. |
| Pyrogenicity | Polar extracts of the test article were injected<br>intravenously into test animals. The temperature was<br>measured prior to injection and between 1 and 3 hours. | None of the animals showed a<br>temperature increase above its<br>baseline temperature. Test was<br>passed. |
| Hemolysis | Direct and indirect test method was performed to<br>determine hemolysis index of the test article vs. control. | The test article showed no<br>hemolytic effect. The test was<br>passed. |
| In vitro<br>hemocompatibility<br>assay | The test article was exposed to human blood and the<br>following parameters were measured: complete blood<br>count, hematocrit, erythrocyte indices and platelet count. | There was no statistically<br>significant difference observed<br>between test article and control.<br>Test was passed. |
| Inactivated partial<br>thromboplastin time<br>assay. | The test article was exposed to human plasma and the<br>time required for clot formation was measured. | The test article did not have an<br>effect on the clotting time. Test<br>was passed |
| Lee and White<br>coagulation test | The test article was exposed to human blood and the<br>time for coagulation was measured. | The test was passed as the<br>average coagulation time was<br>within the accepted range. |
| Complement<br>activation assay<br>(C3a and SC5b-9) | The test article was exposed to human plasma and the<br>C3a and SC5b-9 proteins were quantified in the human<br>plasma. | The test was passed as the test<br>article did not induce<br>complement activation of C3 or<br>C5 proteins in human plasma. |
| In vivo<br>thromboresistance | Thrombus formation after exposure to the device was<br>evaluated in test animals. | The test article showed<br>equivalent performance<br>compared to the control article<br>(predicate device; K142379).<br>Test was passed. |
| Bacterial reverse<br>mutation assay<br>(AMES test) | This test evaluates the mutagenicity<br>of polar<br>and<br>non-polar extracts of the test article. | No toxic or mutagenic effects<br>were identified in tester strains.<br>Test was passed. |
| Mouse lymphoma<br>assay | L5178Y/TK+/- cells are incubated with polar and non-<br>polar test article extracts in the presence and absence of<br>metabolic activation. Cell colonies are then evaluated for<br>colony size and induced mutant frequency in comparison<br>to a global evaluation factor (GEF) | The mutant frequencies of the<br>test article extracts did not<br>exceed the GEF of their<br>concurrent negative control.<br>Test was passed. |
| Test Name | Test Description / Purpose | Summary Results |
| In Vivo Mouse<br>Micronucleus Assay | This test evaluated mutagenicity of polar and non-polar<br>test article extracts by evaluating change in percentage<br>of micronucleated polychromatic erythrocytes in test<br>animals in comparison to the control | There was no statistically<br>significant increase in the<br>percentage of micronucleated<br>polychromatic erythrocytes. The<br>test was passed. |
| Sterilization Validation | | |
| Correction factor<br>and bioburden | Test conducted to determine typical device bioburden<br>prior to sterilization. | Determine bioburden correction<br>factor. Device meets<br>specifications for CFU/device. |
| Bacterial endotoxin<br>test (Pyrogen test) | Test conducted to determine device endotoxin levels<br>after manufacturing. | Bacterial endotoxin test results<br>met acceptance criteria. |
| Validation of the<br>Sterilization<br>Success | Test was performed according to determine if sterilization<br>parameters are sufficient for a SAL of 1x10-6. | Testing confirmed SAL of 10-6.<br>The device performs similar to<br>predicate (K142379). |
| Residual gas<br>analysis: EO and<br>ECH | Test conducted to determine EO and ECH residuals on<br>the device following two sterilization cycles. | Device meets acceptance<br>criteria. The device performs<br>similar to predicate (K142379). |

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## 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.

## Conclusion

Based on the non-clinical performance testing, the subject Passeo-14 catheter is substantially equivalent to the predicate (K142379).