The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.

The balloon catheter shaft has two Luer ports at the proximal end. One port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.

AI/ML Overview

This document describes the Biotronik Passeo-35 Peripheral Dilatation Catheter (K142379) and its substantial equivalence to a predicate device (K082933). The submission primarily focuses on non-clinical performance testing for additional device size configurations and material changes.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive list of non-clinical tests performed on the Passeo-35 Peripheral Dilatation Catheter. The "Test Conditions / Specifications" column often implicitly or explicitly states the acceptance criteria, while the "Summary Results" column indicates whether these criteria were met.

Due to the length, a complete table is not feasible here. Instead, a representative sample of acceptance criteria and results is provided.

Test Name	Acceptance Criteria (or implicit in description)	Reported Device Performance
Biocompatibility Testing
Cytotoxicity	No cytotoxic effects of the test article on L929 cells.	"Growth analyses of cells cultured with test article extract showed no cytotoxic effects of the test article."
Sensitization	No reactions identified as sensitization.	"No reactions were identified as sensitization."
Irritation / Intracutaneous reactivity	No signs of irritation for polar and non-polar extracts.	"There were no signs of irritation of the polar and non-polar test article extracts injected intracutaneously into rabbits."
Acute systemic toxicity	No compound-related mortalities, no significant body weight loss, clinically normal animals, no gross pathology.	"There were no compound related mortalities, no significant body weight loss was recorded and all animals appeared clinically normal. At necropsy no evidence of gross pathology of organs was found. The test article was considered to have no acute toxic characteristics."
Pyrogenicity	No single animal showed a temperature increase higher or equal to 0.5°C above its initial temperature.	"No single animal showed a temperature increase higher or equal to 0.5°C above its initial temperature. The test article is considered to be non-pyrogenic."
Hemocompatibility	No significant changes in cell counts, TAT complex generation identical to reference, no evidence of hemolysis.	"There were no significant changes in the cell counts and the coagulation system activation value measured as TAT complex generation of the test article was identical in comparison with the reference. There was no evidence of hemolysis."
GC-MS / FT-IR	No differences in detected substances / >99% correlation to predicate materials.	"GC/MS fingerprint analysis... yielded no differences in the type of detected substances... Materials had greater than 99% correlation according to FT-IR analysis."
Non-Clinical Performance Testing
Visual and Dimensional Inspection	All inspectional acceptance criteria (e.g., no defects, correct printing, correct marker positioning, specified dimensions) met.	"Inspectional acceptance criteria were met."
Crossing Profile	Acceptance criteria for crossing profile met; within specs of predicate.	"Acceptance criteria for crossing profile were met. Crossing profile is within specs of predicate."
Simulated Use / Balloon Prep, Deployment, Retraction	Acceptance criteria met; performs similar to predicate in simulated use.	"Acceptance criteria for balloon prep, deployment and retraction were met. Test shows device performs similar to predicate in a simulated use environment."
Deflated Balloon Profile	Withdrawal force less than minimal tensile; deflated balloon diameter less than max crossing profile.	"Acceptance criteria were met: withdrawal force is less than minimal tensile and deflated balloon diameter is less than max crossing profile."
Trackability	Acceptance criteria for comparison to the predicate met.	"Acceptance criteria for comparison to the predicate were met."
Pushability	Comparable or better (greater) than the existing Passeo-35 range.	"Acceptance criteria for comparison to predicate devices were met."
Torqueability / Torque Strength	Qualitative assessment showed rotation transfers to distal tip; all balloons passed inflation test.	"Qualitative assessment showed rotation transfers to distal tip on average between 10 and 16 rotations and all balloons passed inflation test. Device meets torqueability and torque strength acceptance criteria."
Pullback and Reintroduction test	Pullback and reintroduction comparable or better than comparator product; product specifications met for 1st and 2nd pullback force; safe retrieval after burst.	"Pullback and reintroduction was comparable or better than comparator product. Product specifications were met for 1st and 2nd pullback force values. Balloon can be safely retrieved after burst."
Balloon Inflation / Deflation Time	Deflation time according to specifications within instructions for use.	"Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use."
Flexibility and kink test	No kink, function not compromised at 20mm radius, guidewire movable, successful inflation/deflation.	"No kink occurred nor was the function of the device compromised at the clinically relevant radius of 20 mm. The guide wire was movable during testing and it was possible to inflate and to deflate the balloon to and from NP."
Particulate Evaluation	Number of particulates released either the same as (p-value >0.05) or less than (p-value <0.05) comparator device.	"The number of particulates released by the Passeo-35 LE were either the same as (p-value >0.05) or were less than the comparator device (p-value <0.05)."
X-ray Visibility	Markers visible with contrast values approximately equivalent to a 10mm thick aluminum plate (based on predicate).	"The markers are unchanged from the predicate and the predicate (K082933) results show that markers are visible with contrast values approximately equivalent to a 10mm thick aluminum plate."
Corrosion Resistance	No signs of corrosion visible on tested samples.	"No signs of corrosion were visible on the samples tested."
Compatibility with Contrast media	No visible damage or deformation after 1-hour in contrast solution; balloon inflation to RBP possible.	"No visible damage or deformation after 1-hour in contrast solution. Balloon inflation to RBP was possible after contrast exposure."
Balloon Compliance Radial	All balloon diameters within tolerance and radial compliance meets acceptance criteria.	"All balloon diameters are within tolerance and radial compliance meets acceptance criteria."
Balloon Compliance Axial	Difference between balloon length at RBP and NP within specification.	"The difference between balloon length at RBP and NP is within specification."
Balloon RBP	Balloons met acceptance criteria for lower 99.9% quantile at 95% confidence interval for all sizes.	"Balloons met acceptance criteria for lower 99.9% quantile at 95% confidence interval for all sizes."
Balloon Rated Fatigue Testing	90% of balloons survive the test with at least 95% confidence.	"Results demonstrate that 90% of the balloons will survive the test with at least 95% confidence."
Tensile Strength of the Entire Catheter	Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications.	"Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications."
Tip pull test	All tested samples met acceptance criteria for mean tensile strength.	"All tested samples met acceptance criteria for mean tensile strength."
Resistance to Kink	Measured mean catheter kink radius well within acceptance criteria.	"Measured mean catheter kink radius was well within the acceptance criteria."
Adhesive Strength of Catheter hydrophobic Coating	No delamination or residual particles observed on tape or catheter; all samples passed.	"No delamination or residual particles were observed on the tape or the catheter. All samples tested passed."
Connector Test	Connector meets acceptance criteria and complies with ISO 594-2.	"Connector meets acceptance criteria and complies with ISO 594-2."
Indelibility and adhesive strength of printing	All samples showed readable printing following exposure to solvent.	"All samples tested showed readable printing following exposure to solvent."
Post-Dilatation Test	All samples withstood 10 inflation/deflation cycles within the stent without bursting.	"All samples withstood 10 inflation/deflation cycles within the stent without bursting."
Visual Inspection of packaging after exposure to adverse environmental conditions	All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity.	"All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of devices or tests) for each specific non-clinical test. It generally refers to "test article," "samples," or "all sizes." For example, for "Balloon RBP," it mentions "all sizes," implying multiple devices were tested across the range of diameters and lengths.

Test Set: No specific number for a single "test set" is provided across all tests. Each test likely utilized a relevant number of samples appropriate for the specific test's statistical requirements, though these numbers are not detailed.
Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a laboratory or simulated environment (e.g., "anatomical model," "Crossover model," "polymer tube"). There is no mention of country of origin, but given it's a submission to the FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's reasonable to infer the testing was conducted either internally by the manufacturer or by a contracted lab, adhering to international standards (e.g., ISO, ASTM, DIN EN ISO, USP). The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate the performance of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The studies are non-clinical, mechanical, and biocompatibility tests. They do not involve expert interpretation or human assessment of image data or clinical outcomes that would require a "ground truth" established by experts in the sense of a medical device intended for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no expert human reading involved in these non-clinical tests. The results are typically quantitative measurements or qualitative observations by trained technicians or automated systems according to defined protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document explicitly states: "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." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable. The device is a physical medical device (catheter), not a software algorithm or AI that would have "standalone performance."

7. Type of Ground Truth Used

The concept of "ground truth" as typically used for AI/software in medicine (e.g., pathology, clinical outcomes) is not directly applicable here. For these non-clinical tests, "ground truth" would correspond to:

Engineering specifications and standards: e.g., ISO, ASTM, DIN EN ISO, USP standards that define acceptable performance ranges and test methodologies.
Predicate device performance: The performance of the previously cleared Passeo-35 (K082933) serves as a benchmark or "ground truth" for demonstrating substantial equivalence for many parameters.
Material properties: Established properties of materials (e.g., for biocompatibility tests).
Defined physical measurements: e.g., specified balloon diameters, lengths, pressures.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device undergoing non-clinical validation studies, not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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

December 5, 2014

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

Re: K142379

Trade/Device Name: Passeo-35 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 4, 2014 Received: November 5, 2014

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

Indications for Use

K142379 510(k) Number (if known):

Device Name: Passeo-35 Peripheral Dilatation Catheter

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle on the left, 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.

Passeo-35 Peripheral Dilatation Catheter Special 510(k) Premarket Notification 510(k) Summary

Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
510(k) Contact Person and Phone Number:	Jon BrumbaughVice President, Regulatory Affairs and ComplianceBIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035Phone: (888) 345-0374Fax: (503) 635-9936jon.brumbaugh@biotronik.com
Date Prepared:	December 5, 2014
Device Name:
Proprietary Name:	Passeo-35 Peripheral Dilatation Catheter
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:	K082933	Passeo-35	BIOTRONIK	3-Nov-2008

General Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in bold, dark blue letters, with a light blue circle containing the letters "BIO" to the left. Below the name is the phrase "excellence for life" in a smaller, light blue font.

Indication for Use:

The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Purpose of Submission:

BIOTRONIK submits this 510(k) for clearance of additional device size configurations for the Passeo-35 including additional balloon lengths up to 200mm. In addition, device and packaging materials changes are documented and labeling is updated for clarity as well as to reflect the new sizes and RBPs.

Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line
Parameters	Passeo-35K082933	Passeo-35Subject Device	Rationale for SubstantialEquivalence
Proprietary name	Passeo-35 PeripheralDilatation Catheter	Passeo-35 PeripheralDilatation Catheter	Same
Common name	PTA catheter	PTA catheter	Same
Classification	Class II (21 CFR 870.1250)	Class II (21 CFR 870.1250)	Same
Classificationname	Catheter, angioplasty,peripheral, transluminal	Catheter, angioplasty,peripheral, transluminal	Same
Product code	LIT	LIT	Same
Intended use / Indications for Use
Intended use	The Passeo-35 PeripheralDilatation Catheter is intendedfor dilatation of stenoticsegments in peripheralvessels and arteriovenousdialysis fistulae.	The Passeo-35 PeripheralDilatation Catheter is intendedfor dilatation of stenoticsegments in peripheralvessels and arteriovenousdialysis fistulae.	Same
Indications forUse	The Passeo-35 PeripheralDilatation Catheter isindicated to dilate stenosis inthe renal, iliac, femoral,popliteal and infrapoplitealarteries and for the treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.	The Passeo-35 PeripheralDilatation Catheter isindicated to dilate stenosis inthe renal, iliac, femoral,popliteal and infrapoplitealarteries and for the treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.	Same
Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line
Parameters	Passeo-35K082933	Passeo-35Subject Device	Rationale for SubstantialEquivalence
Contraindications	All general contraindicationsfor percutaneous transluminalangioplasty (PTA) arecontraindications for thisdevice. Contraindications forthis device and peripheraldilatation catheters in generalare:• Lesions that cannot bereached or treated with thesystem• Large amounts of acute orsubacute thrombus at thetarget lesion• Perforated vessels• Lesion that lies within oradjacent to an aneurysm• Uncorrected bleedingdisorders• Renal insufficiency or anallergy to contrast mediaFurthermore, all procedure-related contraindications asdescribed in the national andinternational guidelines of therespective medicalassociations apply.	All general contraindicationsfor percutaneous transluminalangioplasty (PTA) arecontraindications for thisdevice. Contraindications forthis device and peripheraldilatation catheters in generalare:• Lesions that cannot bereached or treated with thesystem• Large amounts of acute orsubacute thrombus at thetarget lesion• Perforated vessels• Lesion that lies within oradjacent to an aneurysm• Uncorrected bleedingdisorders	Same
Intended user	Physicians competent in PTAprocedures	Physicians competent in PTAprocedures	Same
Method ofplacement	Standard percutaneousaccess to site over a guidewire, with fluoroscopicvisualization	Standard percutaneousaccess to site over a guidewire, with fluoroscopicvisualization	Same
Sterilization / Shelf life / Packaging
Sterilization	EO gas	EO gas	Same
SterilizationSystem	Sauter EO Sterilizer	Sauter EO SterilizerorSterichem EO Sterilizer	Does not alter intended use.Validation testing according todesign controls supportequivalence. BIOTRONIKuses either sterilizer inproduction.
SAL	10-6	10-6	Same
Shelf life	3 years	3 years	Same
Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line
Parameters	Passeo-35K082933	Passeo-35Subject Device	Rationale for SubstantialEquivalence
Protective sheath	Balloon has a protectivesheath. Spiral dispensersealed in a Tyvek® andPET/PE pouch.Product is packed in an outercardboard carton.	Balloon has a protectivesheath. Spiral dispensersealed in a Tyvek® andPET/PE pouch.Product is packaged in anouter cardboard carton.	Same
Shelf life	3 years	3 years	Same
Instructions forUse and labeling	As provided in K082933.	Minor wording & symbolchanges	Changes do not alter intendeduse, technologicalcharacteristics, or raisedifferent questions of safetyand effectiveness.
Device Design
Devicedescription	Over the wire 2-lumen ballooncatheter	Over the wire 2-lumen ballooncatheter	Same
Radiopaquemarkers	2 – one at each end of theballoonMaterial: 90% Pt / 10% IrLength: 1.5 mm	2 – one at each end of theballoonMaterial: 90% Pt / 10% IrLength: 1.5 mm	Same
Usable length[cm]	80 and 130	80, 90 and 130	Does not alter intended use.Performance testingaccording to design controlssupport equivalence.
Introducersheathcompatibility	5F (Balloon Ø: 3 – 7 mm)6F (Balloon Ø: 8 – 10 mm)	5F (Balloon Ø: 3 – 7 mm)6F (Balloon Ø: 8 – 10 mm)	Same
Crossing profile	Ø: 3-7mm: max. 0.074 inchesØ: 8-10mm: max. 0.083inches	Ø: 3-7mm: max. 0.074 inchesØ: 8-10mm: max. 0.083inches	Same
Guide wirecompatibility	0.035"	0.035"	Same
Shaft outerdiameter [F]	5	5	Same
Shaft innerdiameter [mm]	0.96	0.98	The larger inner diameter ofPasseo-35 LE does not alterthe intended use or raisedifferent safety andeffectiveness questions.Performance testing datashowed substantialequivalence to the predicate.
Balloon diameter[mm]	3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0,10.0	3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0,10.0	Same
Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line
	Passeo-35	Passeo-35	Rationale for Substantial
Parameters	K082933	Subject Device	Equivalence
Balloon length[mm]	20, 40, 60, 80, 100	20, 40, 60, 80, 100, 120,150, 170, 200( new balloon lengths forsome balloon diameter sizes,)	Same intended use and doesnot raise different safety andeffectiveness questions.Performance testing datademonstrate substantialequivalence.
Balloon wrapping	5 folds	5 folds	Same
Balloon Nominalpressure [atm]	7	7	Same
Balloon RBP[atm]	20 (Balloon Ø: 3 - 4 mm)16 (Balloon Ø: 5 - 6 mm)14 (Balloon Ø: 7 - 8 mm)12 (Balloon Ø: 9 - 10 mm)	20 (Balloon Ø: 3mm)18 (Balloon Ø: 4mm)16 (Balloon Ø: 5 - 6 mm)14 (Balloon Ø: 7 - 8 mm)12 (Balloon Ø: 9mm)11 (Balloon Ø: 10 mm)	Same intended use and doesnot raise different safety andeffectiveness questions.Performance testing datademonstrate substantialequivalence.
Materials of Construction (Direct and indirect patient contact)
Tip	Pebax 5533 SA01	Pebax 5533 SA01	Same
Balloon	Poly-Amide (PA)	Poly-Amide (PA)	Same
Catheter Shaft:Outer(2-lumen shaft) /Shaft extensiontube:	Pebax 7033 SA01	Pebax 7033 SA01	Same
Inner shaft	Pebax 7233 SA01	Pebax 7233 SA01	Same
Hydrophobiccoating (shaftand balloon)	Medical Grade Dispersionhydrophobic coating withheptane fraction	Medical Grade Dispersionhydrophobic coating withheptane fraction (new mixtureratio)	Same coating, different ratioof lubricant to heptanefraction. Biocompatibilitysupports change in coating.
Manifold (Luerhub)	Polycarbonate	Polycarbonate	Same
UV adhesive	Polyurethane OligomerMixture	Polyurethane OligomerMixture	Same
Materials of Construction (non-patient contacting)
Radiopaquemarkers	2, Pt/Ir (90/10), length 1.5mm	2, Pt/Ir (90/10), length 1.5mm	Same
Kink protector	Pebax 5533 SA01	Pebax 5533 SA01	Same
Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line
Parameters	Passeo-35K082933	Passeo-35Subject Device	Rationale for SubstantialEquivalence
Packaging Materials (non-patient contacting)
ProtectiveSheath	Outer LayerPoly-Amide (PA)Middle LayerLinear Low DensityPolyethylene, LDPEInner LayerHigh density polyethylene,HDPE	Outer LayerPoly-Amide (PA)Middle LayerMaleic anhydride ethylenecopolymerInner LayerHDPE - new supplier	Material change for packagingdoes not alter safety andeffectiveness of the device.
Dispenser (spiralring and clips)	Ring: Polyethylene;Clips: Marlex and HDPE mix	Ring: Polyethylene;Clips: HDPE & LDPE mix	Materials and supplier changefor packaging does not altersafety and effectiveness of thedevice.
Tyvek pouch	Material: PerfecFlex	Material: 20/50 OPA/PE peelfilm	Materials supplier anddimensional changes ofpackaging do not alter safetyand effectiveness.

Technological Comparison to Predicate Device:

{5}------------------------------------------------

Image /page/5/Picture/0 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. To the right of the circle is the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Biotronik. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters. Below the word is the phrase "excellence for life" in a smaller, lighter blue font. To the left of the word "BIOTRONIK" is a circular symbol with the letters "BIO" inside.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in a dark blue sans-serif font, with the word "excellence" and "for life" in a smaller, lighter blue font underneath. To the left of the name is a circular logo with the letters "BIO" inside.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in a dark blue font, with the tagline "excellence for life" in a smaller, lighter blue font underneath. To the left of the name is a circular symbol with the letters "BIO" inside.

Biocompatibility Testing

Test Name	Test Description	Results
Cytotoxicity	L929 cells are incubated with test article extracts andevaluated for percentage of cell growth inhibition andcompared to a control sample (control: cells exposedto extraction medium).	Growth analyses of cellscultured with test articleextract showed no cytotoxiceffects of the test article.
Sensitization	The test article is extracted polar/non-polar solutionaccording to ISO 10993-12 and administered topicallyto mice for 3 days. After 5 days mice are sacrificedand lymph node cells are harvested and analysed tocompute stimulation index (SI) vs. a negativesensitization control.	The stimulation index (SI),ratio of test article / negativecontrol, was calculated foreach concentration of the testarticle extract. No reactionswere identified as sensitization
Irritation / Intracutaneousreactivity	The test article is extracted with 0.9 % Sodiumchloride solution (polar) and Cottonseed Oil (non-polar) according to ISO 10993-12. Extracts areinjected into rabbits and rabbits are observed forerythema and edema immediately after injection andafter 24, 48, and 72 hours.	There were no signs ofirritation of the polar and non-polar test article extractsinjected intracutaneously intorabbits.
Test Name	Test Description	Results
Acute systemic toxicity	The test article is extracted with polar and non-polarextraction vehicles according to ISO 10993-12. Miceare injected with extracts and observed for adversereactions immediately after dosing and again at 4, 24,48, and 72 hours after injection. At termination micewere sacrificed and gross necropsy was carried out torecord gross pathological changes.	There were no compoundrelated mortalities, nosignificant body weight losswas recorded and all animalsappeared clinically normal. Atnecropsy no evidence of grosspathology of organs wasfound. The test article wasconsidered to have no acutetoxic characteristics.
Pyrogenicity	The test article is extracted with sterile, non-pyrogenicpolar solution according to ISO 10993-12. Extract isinjected into rabbits and rectal body temperatures aremeasured and recorded prior to injection and up to 3hours after injection.	No single animal showed atemperature increase higheror equal to 0.5°C above itsinitial temperature. The testarticle is considered to benon-pyrogenic.
Hemocompatibility	The test article is placed in a polymer tube filled withHeparin-anticoagulated whole human blood androtated on a modified chandler-unit. The effects of thetest article regarding TAT (thrombin-antithrombincomplex), cell count and the hemolysis are evaluatedby comparison to the predicate device.	There were no significantchanges in the cell counts andthe coagulation systemactivation value measured asTAT complex generation ofthe test article was identical incomparison with thereference. There was noevidence of hemolysis.
Gas Chromatography -Mass Spectrometry	The old materials are compared to the new materials.The test articles are extracted in different solvents(polar and non-polar, e.g. purified water, isopropylalcohol and hexane) and the extracts are analyzed byGC-MS fingerprint analysis.	GC/MS fingerprint analysis ofextractable semi-volatileorganic compounds yielded nodifferences in the type ofdetected substances in theextracts. There are nosignificant differencesbetween old and newmaterials
Fourier TransformInfrared Spectroscopy(FT-IR) analysis	Fourier Transform Infrared Spectroscopy (FT-IR) wasutilized to compare the chemical composition of thenew materials and old materials The resulting FT-IRspectra were compared.	Materials had greater than99% correlation according toFT-IR analysis. The newmaterials are similar to thepredicate.
Test Name	Test Conditions / Specifications	Summary Results
Visual and DimensionalInspection	Test was performed according to ISO 25539-2:2008,ASTM F2081-06, DIN EN ISO 10555-1:1995 +AM1:1999 + AM2:2004, ISO 10555-4:1996/2002 +Cor1:2002The balloon catheter was visually inspected asfollows:a) visual check of catheter surface for defects.b) Correct printing on the devicec) homogeneity of coating on the catheterd) Positioning of the X-ray markerse) usable length of the balloon catheterf) shaft inner diameterg) shaft outer diameter (prox/mid/dist) along differentlongitudinal paths (e.g., rotating test sample 90degrees for measurements)	Inspectional acceptancecriteria were met.
Crossing Profile (systemprofile)	This test was conducted as per ISO 25539-2:2008and ASTM F2081-6.The diameter of the device is measured by passingthe device through a ring-hole gauge. Crossing profile(proximal end of the balloon and the distal tip of thecatheter) of the catheter evaluated in terms ofsmallest French size compatibility.	Acceptance criteria forcrossing profile were met.Crossing profile is withinspecs of predicate.
	Simulated Use Testing
Simulated Use / BalloonPreparation, Deploymentand Retraction	This test addresses the requirements for qualitativeevaluation of simulated use, flex/kink, pushability,torquability and trackability of the system. The test isconducted by inserting, delivering and deploying theballoon in the model and then withdrawing the systemwhile qualitatively evaluating pushability, torquabilityand trackability.	Acceptance criteria for balloonprep, deployment andretraction were met. Testshows device performs similarto predicate in a simulated useenvironment.
Deflated Balloon Profile	The friction to introduce and pullback after inflationwas assessed. The test is conducted by measuringforce required to insert and remove a deflated balloonas the device is passed through a ring-hole gauge.	Acceptance criteria were met:withdrawal force is less thanminimal tensile and deflatedballoon diameter is less thanmax crossing profile.
Trackability	All testing performed in a Crossover model.Trackability - recorded frictional force (N) overdistance (mm) when tracked over a guide wire inarterial model and compared to predicates.	Acceptance criteria forcomparison to the predicatewere met.
Pushability	The test device is pushed through an anatomicalmodel with a proximal force while the distal reactionforce is measured. The pushing continues until aproximal force threshold is reached. The pushabilityforce must be comparable or better (greater) than theexisting Passeo-35 range.	Acceptance criteria forcomparison to predicatedevices were met.
Test Name	Test Conditions / Specifications	Summary Results
Torqueability / TorqueStrength	The catheter is preconditioned with simulated usethen the proximal end of the device is rotated counterclockwise until the first rotational movement at thedistal end is observed. In this torqued position, thedistal end of the device is clamped and the proximalend is rotated another 5 times and the device inflatedand deflated to NP to verify that it can withstand thetorsion.	Qualitative assessmentshowed rotation transfers todistal tip on average between10 and 16 rotations and allballoons passed inflation test.Device meets torqueabilityand torque strengthacceptance criteria.
Pullback andreintroduction test	The friction to introduce and pullback the device afterinflation to RBP is measured. With the balloon in anappropriate sheath, the friction to introduce andpullback the device after inflation to RBP is evaluated.Introduction and pullback are repeated three timesand on the third time, the balloon is intentionally burstbefore pullback to test if balloon can be pulled backsafely in the event of a burst.	Pullback and reintroductionwas comparable or better thancomparator product.Product specifications weremet for 1st and 2nd pullbackforce values. Balloon can besafely retrieved after burst.
Balloon Inflation /Deflation Time	Inflation and deflation times to RBP measured forcharacterization only. Inflation and deflation time aremeasured with the device placed in an anatomicalmodel and a 50:50 mixture of contrast and saline areused to inflate to RBP. The inflation time from 0.5 barto RBP is recorded. After holding the RBP for 30s, theplunger is pulled to create a vacuum while the timerequired for balloon to completely empty is recordedas deflation time.	Inflation time wascharacterized and deflationtime was determined to beaccording to specificationswithin the instructions for use.
Flexibility and kink test	The catheter is advanced over a guidewire through apredefined curve, minimum radius of 20mm (clinicallyrelevant radius) until the shaft is located in thecorresponding radius. The guide wire movability ischecked, and, subsequently, the balloon is inflated toNP and pressure is held for 30 s prior to deflation.	No kink occurred nor was thefunction of the devicecompromised at the clinicallyrelevant radius of 20 mm. Theguide wire was movableduring testing and it waspossible to inflate and todeflate the balloon to and fromNP.
Particulate Evaluation	Particles were measured using the methodsdescribed in USP <788>. The process of balloondelivery, deployment and retraction is simulated usingan in-vitro peripheral crossover model consisting of aspecially designed tortuous path to represent the iliacarteries and the crossover radius at the abdominalaortic bifurcation. The number of sub-visibleparticulates is evaluated by an optical counter forsolution samples collected after track, after retractionand cleaning. A statistical evaluation using the "t-test"analysis is conducted to compare the number ofparticulates measured of the Passeo-35 LE devices topredicate and marketed comparator devices.	The number of particulatesreleased by the Passeo-35 LEwere either the same as (p-value >0.05) or were less thanthe comparator device (p-value <0.05).

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle that is divided into quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of 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. To the left of the word "BIOTRONIK" is a circular symbol with the letters "BIO" inside.

Non-Clinical Performance Testing

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle with a plus sign in the background, followed by the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

{12}------------------------------------------------

Image /page/12/Picture/0 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.

Test Name	Test Conditions / Specifications	Summary Results
X-ray Visibility(Visibility / Radiopacity)	Radiographic images are digitized and analysedquantitatively to determine the relative contrast withrespect to reference aluminium plates with knownthicknesses.	The markers are unchangedfrom the predicate and thepredicate (K082933) resultsshow that markers are visiblewith contrast valuesapproximately equivalent to a10mm thick aluminum plate.
Corrosion Resistance	The metallic radiopaque markers) were assessed forcorrosion resistance according EN ISO 10555-1: 1995+ AM1:1999 + AM2:2004. The devices are exposed tocorrosive conditions and then checked for signs ofcorrosion.	No signs of corrosion werevisible on the samples tested.
Compatibility withContrast media	Devices were stored for 1 hour in contrast medium(ionic and non-ionic), dilated to RBP and then visuallyinspected.	No visible damage ordeformation after 1-hour incontrast solution. Ballooninflation to RBP was possibleafter contrast exposure.
Mechanical Testing
Balloon ComplianceRadial	The balloon is inflated incrementally and at eachincrement the balloon diameter is measured. Radialcompliance is calculated as the difference betweenballoon diameter at NP and at RBP.	All balloon diameters arewithin tolerance and radialcompliance meets acceptancecriteria.
Balloon ComplianceAxial	The balloon length at NP is measured with a ruler,pressure is increased up to RBP and balloon length ismeasured again and compared to the measured NPlength to determine axial compliance.	The difference betweenballoon length at RBP and NPis within specification.
Balloon RBP	The balloon is inflated incrementally until burst andpressure at burst is recorded and then the ballooncatheter is inspected for signs of damage and theburst failure mode is recorded.	Balloons met acceptancecriteria for lower 99.9%quantile at 95% confidenceinterval for all sizes.
Balloon Rated FatigueTesting	The balloons were inflated incrementally until theyreached RBP, held at RBP for 30 seconds, thendeflated. This was repeated 20 times. Any loss ofpressure, whether due to failure of the balloon, shaft,or proximal or distal seals, was reported as a testfailure. All failure modes were recorded.	Results demonstrate that 90%of the balloons will survive thetest with at least 95%confidence.
Tensile Strength of theEntire Catheter	Following simulated use, a tensile strain at a unitstrain rate of 20mm/min per mm length (as perISO-10555-1) is applied along the relevant catheterregion until the first sign of fracture. The force (Fmax)at first sign of damage is recorded.	Tensile strength performance(Fmax) for distal and proximalballoon sections metperformance specifications.
Tip pull test	Following simulated use, a tensile strain at a unitstrain rate of 20mm/min per mm length (as perISO-10555-1) is applied along the relevant catheterregion until the first sign of fracture. The force (Fmax)at first sign of damage is recorded.	All tested samples metacceptance criteria for meantensile strength.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of a circular emblem with the letters "BIO" inside, followed by the word "BIOTRONIK" in bold, dark blue letters. Below the word "BIOTRONIK" is the tagline "excellence for life" in a smaller, lighter blue font.

Test Name	Test Conditions / Specifications	Summary Results
Resistance to Kink	The test is performed by placing catheter shaft in U-shape within a vise (two fixture heads) and slowlyclosed at a constant speed. Force-displacementdiagram is measured and the kinking point isdetermined to be the first significant decrease in force.	Measured mean catheter kinkradius was well within theacceptance criteria.
Adhesive Strength ofCatheter hydrophobicCoating	After simulated use, adhesive tape segments (2-5 cmlong) are tightly affixed to the outer shaft and theballoon of the test sample. Tape is then pulled offrapidly at an angle of 80° (or 120°) and then visuallychecked with reflected light microscopy at a 20xmagnification.	No delamination or residualparticles were observed onthe tape or the catheter. Allsamples tested passed.
Connector Test	Selected tests from ISO 594-2:1998 were performedon the Luer connector / hub:a) air tightnessb) resistance to over-torqueingc) resistance to stress cracking	Connector meets acceptancecriteria and complies withISO 594-2.
Indelibility and adhesivestrength of printing	The printing on the manifold of the balloon catheterinspected after being wiped for 15 seconds with anethanol soaked fiber-free cloth.	All samples tested showedreadable printing followingexposure to solvent.
Post-Dilatation Test	In a simulated arterial model, balloon is positionedwithin a deployed stent. Balloon is inflated and held atRBP for 30s and then deflated. (Repeated 10 times.)	All samples withstood 10inflation/deflation cycles withinthe stent without bursting.
Visual Inspection ofpackaging after exposureto adverse environmentalconditions	The product shipping container was subjected toclimatic stress, dropping (2x), compression, loose loadvibration and vehicle vibration. Then the package wasinspected for integrity and the device for damage.	All devices passed inspectionof shipping container, boxintegrity, pouch integrity,labeling integrity, productfixation and device integrity.

Shelf life testing

The 3-year shelf life of Passeo-35 was validated by repeating the following non-clinical tests on aged samples:

. Functional testing including: dimensional verification, simulated use, inflation/deflation time, flex and kink, torque strength, catheter bond strength, tip pull, adhesive strength of catheter coating
Pullback and reintroduction ●
Balloon Compliance (radial & axial) .
. Balloon Burst pressure
Balloon fatigue

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 relevant new device size information.

Conclusion

Based on the non-clinical performance testing design controls from the predicate, the subject Passeo-35 catheter is substantially equivalent to the predicate Passeo-35 catheter.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).