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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Visual and Dimensional Inspection	Adherence to dimensional specs, no defects, printing and coating homogeneity, x-ray marker positioning.	Inspectional acceptance criteria were met.
Crossing Profile (system profile)	French size compatibility (measured by passing through a ring-hole gauge).	Acceptance criteria for crossing profile were met.
Simulated Use	Safe and reliable preparation, delivery, and retraction without device damage.	Acceptance criteria were met. Test shows device performs similar to reference devices (K083919; K093139; K090849) in a simulated use environment.
Deflated Balloon Profile	Deflated profile less than 4F for all sizes.	Acceptance criteria were met. Test shows deflated profile is less than 4F for all sizes.
Trackability and Pushability	Performance similar to reference devices in a simulated use environment (frictional force recorded).	Acceptance criteria were met. Test shows device performs similar to reference devices (K083919; K093139) in a simulated use environment.
Torqueability	Rotational movement transferred from manifold to distal tip.	Rotational movement was transmitted. Test was passed.
Pullback and Reintroduction test	Measured pullback and reintroduction forces within acceptance criteria.	Measured pullback and reintroduction forces met acceptance criteria.
Balloon Rated Burst Pressure	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 Fatigue	Survivability of the balloon for repeat inflation/deflation cycles (90% survival at 20 cycles).	Results demonstrate that 90% of the balloons will survive the 20 inflation cycles with at least 95% confidence.
Balloon Compliance Radial	Acceptance criteria met.	Radial compliance meets acceptance criteria. Device performs similar to predicate (K142379).
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 Inflation / Deflation Time	Deflation time according to specifications within IFU.	Inflation time was characterized and deflation time was determined to be according to specifications within the instructions for use.
Tensile Strength Catheter	Performance specifications met for distal and proximal balloon sections.	Tensile strength performance (Fmax) for distal and proximal balloon sections met performance specifications.
Tip pull test	Acceptance criteria met.	All tested samples met acceptance criteria.
Flexibility and kink test	Device will not kink at bend radii appropriate for intended anatomy.	All tested samples passed the test at the clinically relevant radius.
Resistance to Kink	Measured mean catheter kink radius well within acceptance criteria.	Measured mean catheter kink radius was well within the acceptance criteria.
Torsional bond / Torque Strength	Functionality given after application of torsional load.	Acceptance criteria were met. Test was passed.
Visibility / Radiopacity	X-ray visibility (radiopacity) acceptance criteria met.	Acceptance criteria were met. Test was passed.
Coating Integrity	Ability of coating to resist damage due to loading, tracking, deployment, and withdrawal.	Passeo-14 coating performs comparable or better than reference devices (K083919; K090849).
Adhesive Strength of Catheter Coating	Visual inspection results.	All samples passed visual inspection.
Particulate Evaluation	Particle sizes ≤10, 25, and 50µm were below threshold.	Particle sizes ≤10, 25 and 50µm were below threshold. Passeo-14 particle counts were less than reference devices (K090849).
Corrosion Resistance (Catheter)	No signs of corrosion visible on tested samples.	No signs of corrosion were visible on the samples tested. The test was passed.
Compatibility with Contrast media	No visible damage or deformation after exposure to contrast medium.	No visible damage or deformation.
Connector test	Luer lock fittings resistant to air leakage, excessive torque, and stress cracking.	All samples met acceptance criteria.
Indelibility and adhesive strength of printing	Printing indelible and readable after exposure to solvents.	All samples tested showed readable printing following exposure to solvent.
Visual Inspection (adverse environmental conditions)	Device maintains integrity after exposure to normal transport, storage, and handling conditions.	All devices passed inspection of shipping container, box integrity, pouch integrity, labeling integrity, product fixation and device integrity.
Cytotoxicity	No cytotoxic effects (evaluated by percentage of cell growth inhibition compared to control).	Growth analyses of cells cultured with test article extract showed no cytotoxic effects. Test was passed.
Sensitization	No allergic skin reaction compared to the control group.	Test animals showed no allergic skin reaction compared to the control group. Test was passed.
Irritation / Intracutaneous reactivity	No signs of irritation.	There were no signs of irritation. Test was passed.
Acute systemic toxicity	No signs of acute systemic toxicity.	The test was passed as there were no signs of acute systemic toxicity.
Pyrogenicity	No temperature increase above baseline temperature.	None of the animals showed a temperature increase above its baseline temperature. Test was passed.
Hemolysis	No hemolytic effect.	The test article showed no hemolytic effect. The test was passed.
In vitro hemocompatibility assay	No statistically significant difference between test article and control in blood parameters.	There was no statistically significant difference observed between test article and control. Test was passed.
Inactivated partial thromboplastin time assay	No effect on clotting time.	The test article did not have an effect on the clotting time. Test was passed.
Lee and White coagulation test	Average coagulation time within accepted range.	The test was passed as the average coagulation time was within the accepted range. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Complement activation assay (C3a and SC5b-9)	No induction of complement activation of C3 or C5 proteins.	The test was passed as the test article did not induce complement activation of C3 or C5 proteins in human plasma.
In vivo thromboresistance	Equivalent performance compared to the control article (predicate device).	The test article showed equivalent performance compared to the control article (predicate device; K142379). Test was passed.
Bacterial reverse mutation assay (AMES test)	No toxic or mutagenic effects identified in tester strains.	No toxic or mutagenic effects were identified in tester strains. Test was passed.
Mouse lymphoma assay	Mutant frequencies of test article extracts did not exceed GEF of concurrent negative control.	The mutant frequencies of the test article extracts did not exceed the GEF of their concurrent negative control. Test was passed.
In Vivo Mouse Micronucleus Assay	No statistically significant increase in micronucleated polychromatic erythrocytes.	There was no statistically significant increase in the percentage of micronucleated polychromatic erythrocytes. The test was passed.
Correction factor and bioburden	Device meets specifications for CFU/device.	Determine bioburden correction factor. Device meets specifications for CFU/device. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial endotoxin test (Pyrogen test)	Device endotoxin levels met acceptance criteria.	Bacterial endotoxin test results met acceptance criteria.
Validation of the Sterilization Success	SAL of 1x10^-6 achieved.	Testing confirmed SAL of 10^-6. The device performs similar to predicate (K142379).
Residual gas analysis: EO and ECH	Device meets acceptance criteria for EO and ECH residuals.	Device meets acceptance criteria. The device performs similar to predicate (K142379).

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It generally refers to "all sizes," "all tested samples," or implies replicate testing (e.g., "90% of the balloons will survive the 20 inflation cycles"). The data provenance for these non-clinical tests is internal to the manufacturer (BIOTRONIK) and is retrospective, as the tests were conducted to secure prior market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance and safety is established through engineering and biological testing against predefined specifications and regulatory standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method

Not applicable, as this is a physical medical device. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., medical imaging AI).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This is a medical device clearance for a physical non-diagnostic product, not an AI-assisted diagnostic tool. No clinical data was submitted, and the determination of substantial equivalence did not rely on clinical data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device. There is no algorithm or AI component mentioned.

7. The type of ground truth used

The "ground truth" for the non-clinical tests detailed in the document is based on pre-defined engineering specifications, international standards (ISO-10993), and FDA guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). For biocompatibility, it relies on established biological endpoints and observable reactions in in-vitro and in-vivo models.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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 (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

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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.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:	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 PTADilatation Catheter	Ev3 Inc.	1-May-2009
Reference	K093139	Bantam	Clearstream	30-Dec-2009

General Description:

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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 andDimensionalInspection	The balloon catheter was visually inspected for defects,printing, coating homogeneity, x-ray marker positioningand adherence to dimensional specs.	Inspectional acceptance criteriawere met.
Crossing Profile(system profile)	The diameter of the device is measured by passing thedevice through a ring-hole gauge to verify French sizecompatibility.	Acceptance criteria for crossingprofile were met.
Simulated Use Testing
Simulated Use	Testing is conducted to demonstrate that the ballooncatheter can be safely and reliably prepared, delivered,and retracted using the recommended techniques andinstructions for use, without damage to the device.	Acceptance criteria were met.Test shows device performssimilar to reference devices(K083919; K093139; K090849)in a simulated use environment.
Deflated BalloonProfile	The test is conducted to evaluate the deflated balloonprofile after inflation	Acceptance criteria were met.Test shows deflated profile isless than 4F for all sizes.
Trackability andPushability	Test recorded frictional force (N) when tracked over aguide wire in arterial model	Acceptance criteria were met.Test shows device performssimilar to reference devices(K083919; K093139) in asimulated use environment.
Torqueability	This test evaluates the transfer of rotational movementfrom the manifold to the distal tip (torque response).	Rotational movement wastransmitted. Test was passed.
Pullback andreintroduction test	With the balloon in an appropriate sheath, the friction tointroduce and pullback the device after inflation to RBP isevaluated.	Measured pullback andreintroduction forces metacceptance criteria.
Balloon Rated BurstPressure	This test determines the balloon Rated Burst Pressure(RBP). The balloon is inflated until burst and pressure atburst is recorded. The burst failure mode is recorded.	Balloons met acceptance criteriafor lower 99.9% quantile at 95%confidence interval for all sizes.
Balloon Fatigue	The balloons were subjected to repeat inflation/deflationcycles to determine survivability of the balloon. Any lossof pressure, whether due to failure of the balloon, shaft orproximal or distal seals, was reported as a test failure. Allfailure modes were recorded.	Results demonstrate that 90%of the balloons will survive the20 inflation cycles with at least95% confidence.
Balloon ComplianceRadial	Radial compliance is calculated as the differencebetween balloon diameter at NP and at RBP.	Radial compliance meetsacceptance criteria. Deviceperforms similar to predicate(K142379)
Balloon ComplianceAxial	Axial compliance (balloon length at RBP and NP) of thedevice is measured to verify that it meets productspecification.	The difference between balloonlength at RBP and NP is withinspecification.
Balloon Inflation /Deflation Time	Inflation and deflation time are measured with the deviceplaced in an anatomical model. Inflation and deflationtimes were measured for characterization.	Inflation time was characterizedand deflation time wasdetermined to be according tospecifications within theinstructions for use.
Test Name	Test Description / Purpose	Summary Results
Tensile StrengthCatheter	Following simulated use, a tensile strain is applied alongthe relevant catheter region 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	The purpose of this test is to determine the bond strengthof the distal tip of the Passeo-14 products.	All tested samples metacceptance criteria.
Flexibility and kinktest	The purpose of this test is to verify that the Passeo-14products will not kink at bend radii which are appropriatefor the intended anatomy.	All tested samples passed thetest at the clinically relevantradius
Resistance to Kink	Test was performed to determine the minimum bendingradius of the catheter shaft at proximal and distallocations	Measured mean catheter kinkradius was well within theacceptance criteria.
Torsional bond /Torque Strength	The purpose of this test is to verify whether thefunctionality of the Passeo-14 products is still given afterapplication of a torsional load.	Acceptance criteria were met.Test was passed.
Visibility /Radiopacity	The purpose of this test is to evaluate X-ray visibility(also referred to as radiopacitiy) of the Passeo-14products.	Acceptance criteria were met.Test was passed.
Coating Integrity	The purpose of this test is to evaluate the ability of thecoating to resist damage due to loading, tracking,deployment and delivery system withdrawal.	Passeo-14 coating performscomparable or better thanreference devices (K083919;K090849)
Adhesive Strengthof Catheter Coating(hydrophobiccoating)	This test evaluates the adhesive strength of the coatingafter tracking, deployment and withdrawal to supportcoating integrity testing.	All samples passed visualinspection.
ParticulateEvaluation	This test determines the size and quantity of particlesthat could potentially be introduced into the bloodstreamduring delivery, deployment and retraction of Passeo-14products.	Particle sizes ≤10, 25 and 50µmwere below threshold.Passeo-14 particle counts wereless than reference devices(K090849).
CorrosionResistance(Catheter)	The radiopaque markers were assessed for corrosionresistance	No signs of corrosion werevisible on the samples tested.The test was passed.
Compatibility withContrast media	Devices were stored for in contrast medium (ionic andnon-ionic) for a specified time, dilated to RBP and thenvisually inspected.	No visible damage ordeformation.
Connector test	The purpose of this test is to ensure that the Luer lockfittings of the manifolds are resistant to air leakage,excessive torque and stress cracking	All samples met acceptancecriteria.
Indelibility andadhesive strength ofprinting	The purpose of this report is to verify that the printing onthe Passeo-14 products is indelible and readable afterexposure to solvents.	All samples tested showedreadable printing followingexposure to solvent.
Visual Inspection(following exposureto adverseenvironmentalconditions)	The purpose of this test is to ensure that the Passeo-14products maintain their integrity after exposure toconditions experienced during normal transport, storageand handling.	All devices passed inspection ofshipping container, box integrity,pouch integrity, labelingintegrity, product fixation anddevice integrity.
Test Name	Test Description / Purpose	Summary Results
Biocompatibility
Cytotoxicity	L929 cells are incubated with test article extracts andevaluated for percentage of cell growth inhibition andcompared to the control (control: cells exposed toextraction medium).	Growth analyses of cellscultured with test article extractshowed no cytotoxic effects.Test was passed.
Sensitization	Polar and non-polar test article extracts are intradermallyinjected and topically applied to test animals. Animals areobserved for skin reaction after 24 and 48 hours.	Test animals showed no allergicskin reaction compared to thecontrol group. Test was passed.
Irritation /Intracutaneousreactivity	The test was conducted by injecting polar and non-polartest article extracts and extraction vehicle blank inanimals. The sites were observed for erythema andedema at 24, 48 and 72 hours.	There were no signs of irritation.Test was passed.
Acute systemictoxicity	Polar and non-polar test article extracts were injectedinto test animals. The animals were observed over a 72hour period and then assessed for toxicity.	The test was passed as therewere no signs of acute systemictoxicity.
Pyrogenicity	Polar extracts of the test article were injectedintravenously into test animals. The temperature wasmeasured prior to injection and between 1 and 3 hours.	None of the animals showed atemperature increase above itsbaseline temperature. Test waspassed.
Hemolysis	Direct and indirect test method was performed todetermine hemolysis index of the test article vs. control.	The test article showed nohemolytic effect. The test waspassed.
In vitrohemocompatibilityassay	The test article was exposed to human blood and thefollowing parameters were measured: complete bloodcount, hematocrit, erythrocyte indices and platelet count.	There was no statisticallysignificant difference observedbetween test article and control.Test was passed.
Inactivated partialthromboplastin timeassay.	The test article was exposed to human plasma and thetime required for clot formation was measured.	The test article did not have aneffect on the clotting time. Testwas passed
Lee and Whitecoagulation test	The test article was exposed to human blood and thetime for coagulation was measured.	The test was passed as theaverage coagulation time waswithin the accepted range.
Complementactivation assay(C3a and SC5b-9)	The test article was exposed to human plasma and theC3a and SC5b-9 proteins were quantified in the humanplasma.	The test was passed as the testarticle did not inducecomplement activation of C3 orC5 proteins in human plasma.
In vivothromboresistance	Thrombus formation after exposure to the device wasevaluated in test animals.	The test article showedequivalent performancecompared to the control article(predicate device; K142379).Test was passed.
Bacterial reversemutation assay(AMES test)	This test evaluates the mutagenicityof polarandnon-polar extracts of the test article.	No toxic or mutagenic effectswere identified in tester strains.Test was passed.
Mouse lymphomaassay	L5178Y/TK+/- cells are incubated with polar and non-polar test article extracts in the presence and absence ofmetabolic activation. Cell colonies are then evaluated forcolony size and induced mutant frequency in comparisonto a global evaluation factor (GEF)	The mutant frequencies of thetest article extracts did notexceed the GEF of theirconcurrent negative control.Test was passed.
Test Name	Test Description / Purpose	Summary Results
In Vivo MouseMicronucleus Assay	This test evaluated mutagenicity of polar and non-polartest article extracts by evaluating change in percentageof micronucleated polychromatic erythrocytes in testanimals in comparison to the control	There was no statisticallysignificant increase in thepercentage of micronucleatedpolychromatic erythrocytes. Thetest was passed.
Sterilization Validation
Correction factorand bioburden	Test conducted to determine typical device bioburdenprior to sterilization.	Determine bioburden correctionfactor. Device meetsspecifications for CFU/device.
Bacterial endotoxintest (Pyrogen test)	Test conducted to determine device endotoxin levelsafter manufacturing.	Bacterial endotoxin test resultsmet acceptance criteria.
Validation of theSterilizationSuccess	Test was performed according to determine if sterilizationparameters are sufficient for a SAL of 1x10-6.	Testing confirmed SAL of 10-6.The device performs similar topredicate (K142379).
Residual gasanalysis: EO andECH	Test conducted to determine EO and ECH residuals onthe device following two sterilization cycles.	Device meets acceptancecriteria. The device performssimilar 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).

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).