The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The cather is not intended for use in cither the coronary or neuro vasculature.

Device Description

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the Plato MICROCATH® 27B Microcatheter, focusing on demonstrating substantial equivalence to predicate devices, not on proving effectiveness for a new diagnostic or interventional AI device. Therefore, the traditional acceptance criteria, study design parameters, and concepts like 'human readers improve with AI' are not applicable to this submission.

Instead, the document details performance data collected from non-clinical testing to show that the new microcatheter is as safe and effective as existing, legally marketed predicate devices. The acceptance criteria essentially derive from established standards for medical devices and comparisons to the predicate devices.

Here's an adaptation of your requested table and information, tailored to the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Test (Acceptance Criteria Derived From)	Acceptance Criteria (Implicit/Explicit from standards; "Comparable to predicate" suggests meeting predicate's performance)	Reported Device Performance
Biocompatibility:
Cytotoxicity (ISO 10993-5)	Non-cytotoxic (Scores = 0)	Non-cytotoxic. Test article scores were 0 at 48 hours.
Sensitization (ISO 10993-10)	Negative for dermal sensitization (Scores = 0)	Negative for dermal sensitization. Test articles sensitization scores were all 0.
Irritation/Intracutaneous Reactivity (ISO 10993-10)	Non-irritating (No significantly greater biological reaction than control)	Non-irritating. Extracts of the test article did not show a significantly greater biological reaction than sites injected with control article.
Acute Systemic Toxicity (ISO 10993-11)	Non-toxic (No toxicity or animal weight loss)	Non-toxic. Test articles showed no toxicity or animal weight loss for both cottonseed oil and saline extracts for 72 hour test period.
Materials-Mediated Pyrogenicity (ISO 10993-11)	Non-pyrogenic (No increases in individual temperatures)	Non-pyrogenic. No increases in individual temperatures.
Hemocompatibility – Hemolysis (ASTM 758-08)	Non-hemolytic (Corrected hemolysis index below threshold)	Non-hemolytic. Corrected hemolysis index was 0.15% by direct method, 0.23% by extract.
Partial Thromboplastin Time (ASTM F2382)	Similar activation profile to predicate (Minimal activators, minimal difference in clotting times)	Both test article and predicate were minimal activators. Difference in clotting times between test article and predicate was 3 seconds.
Complement Activation (ISO 10993-4)	Less than or comparable to predicate	Complement activation by the test article was less than that of the predicate device.
Thrombogenicity in Dogs (ISO 10993-4)	Comparable to predicate (Thrombosis grade, weight changes)	Thrombosis grade comparable to predicate. Weight changes of the implants comparable between test and control articles.
Functional Testing:
Visual/Dimensional Inspection	No surface defects, visible droplets, or defects causing trauma; Meets dimensional specifications	No surface defects or visible droplets of coating on catheters. All catheters met dimensional specifications.
Air Ingress/Negative Collapse (ISO 10555)	No air ingress, no lumen collapse	Hub fittings do not allow air ingress and no evidence of lumen collapse.
Kink Resistance	Resistant to kinking around small diameter turns per specification	Device was resistant to kinking around small diameter turns per specification.
Tensile Strength/Elongation (ISO 10555-1)	Meets minimum force breakage based on tube diameters	All catheters met minimum force breakage based on tube diameters specified in ISO 10555-1.
Liquid Leakage under Pressure/Leakage at Hub (ISO 10555-1)	No leakage from hub or catheter body at specified pressures	No leakage from hub or catheter body.
Tip Stiffness (ASTM D747-10)	Comparable to predicate devices	Tip stiffness was comparable that of the predicate devices.
Pressure vs. Flow Characterization	Flow rates reported in Instructions for Use at 100 and 300 psi	Flow rates reported in Instructions for Use at 1.00 and 300 psi. (Note: "1.00" might be a typo and likely meant 100 psi as per test description.)
Static Burst Pressure (ISO 10555-1)	Maximum peak pressures exceeded 300 psi	Maximum peak pressures all exceeded 300 psi.
Dynamic Flow	No leaks, breaks or occluded lumens at 750 psi	No leaks, breaks or occluded lumens at 750 psi.
Flexibility Fatigue and Profile	No signs of cracks or breakage post worst-case simulated use	All catheters showed no signs of cracks or breakage post worst case simulated use.
Shape Retention	Maintain specified tip angle post shaping/conditioning/use; Tensile strength meets original specs after shaping	All catheters maintained specified tip angle after steam shaping, water bath conditioning and simulated use of guidewires. Tensile testing after tip shaping passed minimum tensile strength requirements.
Torque to Failure	No signs of breakage, twists or collapsed lumens after specified number of torque turns	All catheters showed no signs of breakage, twists or collapsed lumens after specified number of torque turns.
Coating Lubricity and Durability	Meets specified frictional forces	All catheters met specified frictional forces.
Coating Integrity	Acceptable coating coverage post simulated use	All samples showed acceptable coating coverage post simulated use.
Particulates	Comparable numbers of particles to predicate in each size range	The test and predicate catheters had comparable numbers of particles in each size range.
Chemical Compatibility	No signs of degradation, corrosion, or physical decomposition after exposure to agents	All catheters showed no signs of degradation, corrosion or physical decomposition.
Latex Content (ASTM D6499-07)	No detectable traces of latex found	No detectable traces of latex found.
Corrosion Resistance (ISO 10555-1)	No signs of corrosion on metallic components	No signs of corrosion on metallic components of catheters.
Radiopacity	Acceptable radiopacity (evaluated by physicians)	Both test and predicate catheters had acceptable radiopacity.
MRI Compatibility	Labeled MRI Unsafe (as applicable for conducting/magnetic materials)	Catheters are labeled MRI Unsafe on IFU.
Simulated Use	Comparable Likert scores to predicate in Guidewire tracking and guide catheter movement; Interventional devices successfully deployed	Catheters and predicate devices had comparable Likert scores in terms of Guidewire tracking and guide catheter movement. Interventional devices successfully deployed.
Cadaver Testing	Comparable performance and access time to predicate in designated target; Ability to deploy/retrieve interventional devices	Test and predicate devices both exhibited comparable performance with similar access time to the designated target.
Packaging Testing (ASTM F88-00, F2096-04)	Minimum seal strength met, no bubbles under leak test conditions	All sterile barrier pouches met minimum seal strength and showed no bubbles under leak test conditions.
Shelf Life Testing	Continued to meet specifications post accelerated aging and room temperature storage	Shelf life testing in progress. Expiration date will be advanced as aging data are available to demonstrate package and product continues to meet specifications.

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

This document primarily reports on non-clinical bench and lab testing, and some limited biological/simulated use testing. The "test set" here refers to the number of devices or samples tested for each specific non-clinical performance attribute.

Sample Sizes: Not explicitly stated for each test, but implied by the nature of bench testing where multiple samples are typically used to ensure reliability. For example, "all catheters" met specifications implies multiple catheters were tested. For animal studies (thrombogenicity) and cadaver studies, the sample size would be small (e.g., number of dogs, cadavers). For Radiopacity and Simulated Use, "physicians," plural, suggests more than one device per observer.
Data Provenance: The data is primarily from bench-top laboratory testing and in vitro studies, in accordance with ISO and ASTM standards. Some tests involve animal models (e.g., thrombogenicity in dogs) and human cadavers. The context implies these studies were conducted by the manufacturer or their contracted labs. No specific country of origin for the data is mentioned, but the submission is to the U.S. FDA, and the company is US-based. This is all prospective testing, specifically designed to demonstrate compliance for the 510(k) submission.

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

Experts: The document mentions "physicians" evaluated radiopacity and participated in cadaver testing. For simulated use, "physicians" also provided Likert scores.
Number: Not explicitly stated how many physicians were involved in these evaluations. The plural "physicians" indicates more than one.
Qualifications: Not explicitly stated in terms of years of experience or specific subspecialty (e.g., interventional radiologist), but given the context of medical device evaluation, it is implied that these are qualified medical professionals with expertise relevant to microcatheters and their use.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly detailed. For tests involving "physicians" (Radiopacity, Simulated Use, Cadaver Testing), it is stated that comparisons were made or scores obtained. The document does not specify if there was a formal adjudication process (e.g., 2+1, 3+1), rather it presents the aggregate findings or an overall determination of "comparable" or "acceptable."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (often used for diagnostic imaging AI) is not applicable to a premarket notification for a physical medical device like a microcatheter. The comparison is primarily against established performance standards and a predicate device's existing characteristics. The "simulated use" and "cadaver testing" involve human readers/users (physicians) providing feedback, but this is to assess usability and performance in a simulated environment, not an MRMC study comparing AI with and without human assistance.
Effect Size of Human readers with/without AI: Not applicable, as this is not an AI device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This submission is for a physical medical device (microcatheter), not an algorithm or AI product. The performance evaluations are intrinsic to the device itself and its interaction with biological and simulated environments.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to diagnostic or AI studies is not directly applicable here. Instead, the basis for comparison and acceptance is:

Established Industry Standards: ISO 10993 (biocompatibility), ISO 10555 (intravascular catheters), ASTM standards.
FDA Guidance: FDA guidance for Short-Term and Long-Term Intravascular Catheters, FDA Special Controls Document for PTCA Catheters.
Predicate Device Performance: Direct comparison to the ev3 Marksman™ Catheter (K111490, K091559) and the Scientia Vascular, LLC Plato MICROCATH 27 (K121734). The goal is to demonstrate that the new device is "substantially equivalent" in safety and effectiveness.
Expert Observational Consensus: For aspects like radiopacity and simulated use feedback from physicians.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set." The device design and materials are based on engineering principles and prior device knowledge.

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

Not applicable. As there is no training set for an AI model, this question does not apply. The "ground truth" for the device's design and expected performance comes from established engineering principles, regulatory standards, and the performance characteristics of predicate devices.

Summary

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

June 26, 2015

Scientia Vascular, LLC % Mr. Mark Job Third Party Reviewer Regulatory Technology Services, LLC 1394 25th St., NW Buffalo, MN 55313

Re: K143398

Trade/Device Name: Plato MICROCATH 27B Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, KRA Dated: June 5, 2015 Received: June 12, 2015

Dear Mr. Job,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143398

Device Name

Plato MICROCATH® 27B Microcatheter

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Bram D. Zuckerman -S 2015.06.26 11:47:00 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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K143398 Page 1 of 6

510(K) SUMMARY (21 CFR 807.92)

SCIENTIA VASCULAR LLC PLATO MICROCATH® 27B MICROCATHETER

510(k) Owner: Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 Tel: (775) 657-6330 Fax: (888) 503-6529

Contact Person: Sharon Rockwell Tel: (714) 695-9269 Fax: (714) 779-0406 E-mail: srockwell(@writeme.com
Date Prepared: October, 2014

Plato MICROCATH® 27B Microcatheter Trade Name:

Common Name: Microcatheter
Classification Name: Diagnostic Intravascular Catheter per 21 CFR 870.1200, DQO Continuous Flush Catheter per 21 CFR 870.1210, KRA
ev3 Marksman™ Catheter, K111490, K091559 Predicate Devices: Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter. K121734
The Plato MICROCATH® 27B Microcatheter is a single lumen Device Description: microcatheter constructed with a flexible polymer shaft of varying stiffness to aide in accessing vasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire for accessing the vasculature. The proximal end of the catheter has a diameter of 3.4F, tapering to a distal OD of 3.2F, which can be inserted into a 5F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with a straight tip configuration which can be steam-shaped to the doctor's preferred shape. A steam shaping mandrel is included in the packaging. The microcatheter has hydrophilic coating on the outer distal shaft to

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reduce friction during manipulation in vessels and has one radiopaque tip marker to facilitate fluoroscopic visualization.

Indications for Use: The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system. The catheter is not intended for use in either the coronary or neuro vasculature.

The indications for use are identical to those of the ev3 Marksman Catheter, with the exception that the Marksman Catheter is also indicated for neurovascular and coronary use. The MICROCATH 27B has not been evaluated for these indications. This difference does not affect the safety and effectiveness of the device for its intended application in the peripheral vasculature.

Technological Characteristics:

The Plato MICROCATH 27B Microcatheter is a single lumen, variable stiffness microcatheter designed to provide increased flexibility for accessing the vasculature. The proximal end of the catheter incorporates a polycarbonate Luer adapter to facilitate the attachment of accessories. The distal end has a polymeric skeletal support for improved distal navigation. The device is compatible with 5 F or larger guiding catheters and can be advanced over guidewires up to 0.025" in diameter. The distal shaft has a hydrophilic coating for lubricity and is shapeable.

The technological characteristics are comparable to the predicate device, the ev3 Marksman Catheter. The Marksman Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The distal end has a coiled support structure and the device is compatible with 4 F or larger guiding catheters and can accommodate guidewires up to 0.021" in diameter. The Marksman catheter has an embedded braid to impart strength and stiffness to the proximal end and a coiled structure in the distal end. The Plato MICROCATH 27B Microcatheter uses and embedded stainless steel braid on the proximal end and uses a polymeric skeletal support in the distal end to support the lumen and prevent collapse in tortuous vessels. The outer surface of the distal end of the catheter is coated to increase lubricity, and the catheter is shapeable. The technological differences between the Plato MICROCATH 27B Microcatheter and the ev3 Marksman Catheter do not raise new questions of safety or efficacy.

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The technological differences between the Plato MICROCATH 27B and the marketed Plato MICROCATH 27 models include 1) the rigid hypotube at the proximal end has been replace with a braided coil to increase flexibility, 2) the outer diameter has been reduced to allow the microcatheter to be advanced into small vasculature, 3) the distal end of the catheter has been modified with a replacement thermoplastic elastomer, a polymer microstructure and alternate lubricious coating to improved usability, 4) a polycarbonate hub replaces the polymethylpentene hub based on physician preferences and, 5) a platinum marker replaces the platinum marker coil. These technological differences do not raise new questions of safety or efficacy.

Non-Clinical

Performance Data: Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1:2013, the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995 and the FDA Special Controls Document for PTCA Catheters (Part VIII, section 13), dated September 8, 2010. Functional testing performed on the proposed device included:

Test	Test Method Summary	Results
Cytotoxicity	MEM elution test per ISO10993-5.	Non-cytotoxic. Test articlescores were 0 at 48 hours.
Sensitization	Kligman Maximization perISO 10993-10	Negative for dermalsensitization. Test articlessensitization scores were all 0.
Irritation/IntracutaneousReactivity	Irritatino/Intracutaneousreactivity test per ISO10993-10.	Non-irritating. Extracts of thetest article did not show asignificantly greater biologicalreaction than sites injected withcontrol article.
Acute systemic toxicity	Acute systemic injectiontest in mice per ISO-10993-11.	Non-toxic. Test articles showedno toxicity or animal weightloss for both cottonseed oil andsaline extracts for 72 hour testperiod.
Materials mediatedpyrogenicity	Rabbit pyrogen test per ISI10993-11.	Non-pyrogenic. No increases inIndividual temperatures.
Hemocompatibility –hemolysis by directcontact and extract	Direct contact method andextract method permodified ASTM 758-08.	Non-hemolytic. Correctedhemolysis index was 0.15% bydirect method, 0.23% by extract.
Test	Test Method Summary	Results
Partial ThromboplastinTime	Partial thromboplastintime per ASTM F2382.	Both test article and predicatewere minimal activators.Difference in clotting timesbetween test article andpredicate was 3 seconds.
Complement activationof C3a and SC5b-9	C3a and SC5b-9 levelstested per ISO 10993-4.	Complement activation by thetest article was less than that ofthe predicate device.
Thrombogenicity inDogs	Thrombogenicity test indogs per ISO 10993-4.	Thrombosis grade comparableto predicate. Weight changes ofthe implants comparablebetween test and controlarticles.
Visual/DimensionalInspection	Visual inspection forextraneous matter, processand surface defects ordefects that may causetrauma to vessels.Dimensional inspectionper drawings.	No surface defects or visibledroplets of coating on catheters.All catheters met dimensionalspecifications.
Air Ingress/NegativeCollapse	Tests per ISO 10555.	Hub fittings do not allow airingress and no evidence oflumen collapse.
Kink Resistance	Tests for kinks after distaltip of catheter is wrappedaround a 0.25" diameterpeg.	Device was resistant to kinkingaround small diameter turns perspecification.
TensileStrength/Elongation	Tensile testing performedper ISO 10555-1 on distal,mesial and proximalcatheter sections aftersimulated use.	All catheters met minimumforce breakage based on tubediameters specified in ISO10555-1.
Liquid Leakage underPressure/Leakage atHub	Test for leakage at 300-320 kPa per ISO 10555-1.	No leakage from hub or catheterbody.
Tip Stiffness	Test for stiffness perASTM D747-10.	Tip stiffness was comparablethat of the predicate devices.
Pressure vs. FlowCharacterization	Flow rates measured attwo typical pressures: 100and 300 psi.	Flow rates reported inInstructions for Use at 1.00 and300 psi.
Static Burst Pressure	Burst pressure tested perISO 10555-1.	Maximum peak pressures allexceeded 300 psi.
Dynamic Flow	Product used with powerinjection to 750 psi.	No leaks, breaks or occludedlumens at 750 psi.
Test	Test Method Summary	Results
Flexibility Fatigue andProfile	Worst case bend of 90°with an 8-fold safety factorfor repetitions.	All catheters showed no signs ofcracks or breakage post worstcase simulated use.
Shape Retention	Catheters must maintain aspecified % of initial angleafter water-bathconditioning and insertionsand withdrawals of aguidewire. Tensile strengthmust meet original specsafter shaping.	All catheters maintainedspecified tip angle after steamshaping, water bathconditioning and simulated useof guidewires. Tensile testingafter tip shaping passedminimum tensile strengthrequirements.
Torque to Failure	Torque turns to failure inan anatomical model toprovide a 4-fold safetyfactor.	All catheters showed no signs ofbreakage, twists or collapsedlumens after specified numberof torque turns.
Coating Lubricity andDurability	Frictional force ofuncoated and coatedcatheters determined.	All catheters met specifiedfrictional forces.
Coating Integrity	Coating uniformity andintegrity visuallyexamined on dyed samplesafter simulated use in atortuous path.	All samples showed acceptablecoating coverage post simulateduse.
Particulates	Particulates counted insizes ≥10µm, 25 µm, 50µm, 65 µm, 100 µm, 200µm and 500 µm afterinserting a guidewire andadvancing the catheterthrough a guide cathetermultiple times.	The test and predicate cathetershad comparable numbers ofparticles in each size range.
Chemical compatibility	Catheters were exposed tosaline and contrastagent/saline solutions andexamined for degradation.	All catheters showed no signs ofdegradation, corrosion orphysical decomposition.
Latex Content	Tested for trace latexproteins per ASTMD6499-07.	No detectable traces of latexfound.
Corrosion Resistance	Test for corrosionresistance per ISO 10555-1.	No signs of corrosion onmetallic components ofcatheters.
Radiopacity	Catheters and predicatesevaluated by physiciansunder simulated use inhuman cadavers.	Both test and predicate cathetershad acceptable radiopacity.
Test	Test Method Summary	Results
MRI Compatibility	Catheters containconducting and magneticmaterials and should nothave exposure to MRI.	Catheters are labeled MRIUnsafe on IFU.
Simulated Use	Anatomical modeldesigned for tortuousanatomy used forsimulated use testing.	Catheters and predicate deviceshad comparable Likert scores interms of Guidewire tracking andguide catheter movement.Interventional devicessuccessfully deployed.
Cadaver Testing	Cadaver used to evaluatecatheter and predicatedevices by physicians forperformance, access time,and ability to deploy andretrieve interventionaldevices.	Test and predicate devices bothexhibited comparableperformance with similar accesstime to the designated target.
Packaging Testing	Packaging evaluated forpouch seal strength perASTM F 88-00 and leaktests (bubble test) perASTM F 2096-04.	All sterile barrier pouches metminimum seal strength andshowed no bubbles under leaktest conditions.
Shelf Life Testing	Functions testing repeatedpost accelerated aging androom temperatureconfirmatory storage.	Shelf life testing in progress.Expiration date will beadvanced as aging data areavailable to demonstratepackage and product continuesto meet specifications.

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Conclusions: Scientia Vascular, LLC has demonstrated that the Plato MICROCATH 27B Microcatheter is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principles and the indications for use as the ev3 predicate device, and represents a modification in design and matcrials to the existing MICROCATH 27 family of products. The testing supports a determination of substantial equivalence to products previously cleared by FDA.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).