The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic agents to the peripheral and neurovascular systems. The catheter is also intended for the introduction of therapeutic agents to the peripheral system. The catheter is not intended for use in the coronary vasculature.

Device Description

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter with a flexible polymer shaft of varying stiffness to aid in navigation of the neurovasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire. The proximal end of the catheter has a diameter of 3.4F tapering to a distal OD of 3.2F. The catheter can be inserted into a 5F guide catheter. The inner diameter is constant over the entire length of the catheter shaft and accommodates guidewires up to 0.025" in diameter. The catheter is 150 cm in length with a straight tip configuration which can be shaped, using steam heat and the provided mandrels, to the users' preferred shapes. A steam shaping mandrel is included in the packaging. The microcatheter has a hydrophilic coating on the outer distal shaft to reduce friction during catheter manipulation in the vasculature and has one radiopaque tip marker at its distal tip to facilitate fluoroscopic visualization.

The subject microcatheter is identical with respect to its technological characteristics, design and materials to Scientia's currently marketed Plato MICROCATH 27B Microcatheters cleared under K143398. This 510k was prepared to expand the indications for use of the device to include its use in the neurovasculature.

AI/ML Overview

The provided document describes the acceptance criteria and a study demonstrating that the Plato MICROCATH® 27B Microcatheter meets these criteria.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Test	Test Method Summary	Acceptance Criteria (Implied from Preamendment status / Predicate) & Results
Tensile Strength	Tensile testing performed per ISO 10555-1 on distal, medial and proximal catheter sections after simulated use.	Acceptance Criteria: Meet minimum force breakage requirements specified in ISO 10555-1.Results: All catheters meet minimum force breakage requirements specified in ISO 10555-1.
Coating Lubricity and Durability	Frictional force of uncoated and coated catheters was determined.	Acceptance Criteria: Meet specified frictional force requirements.Results: All catheters met specified frictional force requirements.
Coating Integrity	Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path.	Acceptance Criteria: Acceptable coating coverage and no defects post simulated use.Results: All samples showed acceptable coating coverage and no defects were identified post simulated use.
Particulates	Particulates of various size ranges counted after inserting a guidewire and advancing the Microcatheter through a guide catheter multiple times.	Acceptance Criteria: Comparable number of particles in each size range to the predicate.Results: The test and predicate catheters had comparable numbers of particles in each size range.
Torque to Failure	Torque turns to failure in an anatomical model to provide a 4-fold safety factor.	Acceptance Criteria: No signs of breakage, twists or collapsed lumens after specified number of torque turns.Results: All catheters showed no signs of breakage, twists or collapsed lumens after specified number of torque turns.
Plato 27B Neurovascular Model Evaluation	Evaluate ability to deliver and withdraw interventional devices through catheter in a model designed to simulate the tortuous anatomy of the neurovasculature.	Acceptance Criteria: Successful delivery and withdrawal of interventional devices.Results: Interventional devices were successfully delivered into and withdrawn from the 27B Microcatheter while it was located in the model simulating the tortuous anatomy of the neurovasculature.
Liquid Leakage under Pressure/Leakage at Hub	Test for leakage at 300-320 kPa per ISO 10555-1.	Acceptance Criteria: No leakage from hub or catheter body.Results: No leakage from hub or catheter body.
Static Burst Pressure	Burst pressure tested per ISO 10555-1.	Acceptance Criteria: Maximum peak pressures all exceeded 300 psi.Results: Maximum peak pressures all exceeded 300 psi.
Air Ingress/Negative Collapse	Tests per ISO 10555.	Acceptance Criteria: Hub fittings do not allow air ingress and no evidence of lumen collapse.Results: Hub fittings do not allow air ingress and no evidence of lumen collapse.
Kink Resistance	Tests for kinks after distal tip of catheter is wrapped around cylindrical forms.	Acceptance Criteria: Device resistant to kinking around small diameter turns per specification.Results: Device was resistant to kinking around small diameter turns per specification.
Tip Stiffness	Test for stiffness per ASTM D747-10.	Acceptance Criteria: Tip stiffness comparable to predicate devices.Results: Tip stiffness was comparable that of the predicate devices.
Flexural Fatigue and Profile	Worst case bend of 90° with an 8-fold safety factor for repetitions per ASTM D747-10.	Acceptance Criteria: No signs of cracks or breakage after worst case simulated use.Results: All catheters showed no signs of cracks or breakage after worst case simulated use.
Tip Shape Retention	Catheters must retain angle shaped by steam and meet tensile strength specifications after conditioning and simulated use.	Acceptance Criteria: All tips formed by steam meet shape and tensile requirements after conditioning and simulated use.Results: All tips formed by steam met shape and tensile requirements after conditioning and simulated use.
Simulated Use	Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing.	Acceptance Criteria: Perform acceptably in evaluations of guidewire tracking and guide catheter movement, and interventional devices successfully deployed/withdrawn.Results: Catheters and predicate devices were found to perform acceptably in evaluations of guidewire tracking and guide catheter movement. Interventional devices were successfully deployed and withdrawn.
Visual/Dimensional Inspection	Visual inspection for extraneous matter, process and surface defects or defects that may cause trauma to vessels. Dimensional inspection per drawings.	Acceptance Criteria: No surface defects or visible droplets of coating; meet dimensional specifications; no clinically significant hydration.Results: No surface defects or visible droplets of coating on catheters. All catheters met dimensional specifications. Plato MICROCATH 27B Microcatheters do not exhibit clinically significant hydration as defined in ISO 10555-1:2013.
Pressure vs. Flow Characterization	Flow rates measured at two typical injection pressures per ISO 10555-1.	Acceptance Criteria: Flow rates reported in Instructions for Use at 100 and 300 psi.Results: Flow rates reported in Instructions for Use at 100 and 300 psi.
Dynamic Flow	Product used with power injector at pressure-limited setting to 700 psi.	Acceptance Criteria: No leaks, breaks or occluded lumens at 700 psi.Results: No leaks, breaks or occluded lumens at 700 psi.
Packaging Testing	Pouch evaluated for seal strength per ASTM F 88-00 and leak tests (bubble test) per ASTM F 2096-04.	Acceptance Criteria: Meet minimum seal strength and release no bubbles under leak test conditions.Results: All sterile barrier pouches met minimum seal strength and released no bubbles under leak test conditions.
Cadaver Testing	Human cadaver used to evaluate catheter and predicate devices by physicians for performance, access time, and ability to deploy and retrieve.	Acceptance Criteria: Comparable performance with similar access time to the designated target compared to predicate.Results: Test and predicate devices both exhibited comparable performance with similar access time to the designated target.
Radiopacity	Catheters and predicate devices evaluated by physicians in human cadaver model.	Acceptance Criteria: Acceptable radiopacity.Results: Both test and predicate catheters exhibited acceptable radiopacity.
MRI Compatibility	Catheters contain metallic materials and should not be exposed to MRI procedures.	Acceptance Criteria: Labeled MRI Unsafe in IFU.Results: Catheters are labeled MRI Unsafe in IFU.
Chemical compatibility	Catheters were exposed to saline and contrast agent/saline solutions and examined for degradation.	Acceptance Criteria: No signs of degradation, corrosion or physical decomposition.Results: All catheters showed no signs of degradation, corrosion or physical decomposition.
Latex Content	Tested for trace latex proteins per ASTM D6499-07.	Acceptance Criteria: No detectable traces of latex.Results: No detectable traces of latex were found.
Corrosion Resistance	Test for corrosion resistance per ISO 10555-1.	Acceptance Criteria: No signs of corrosion on metallic components.Results: No signs of corrosion on metallic components of catheters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each test in a numerical format (e.g., "n=X catheters"). Instead, it generally refers to "all catheters," "all samples," or "test and predicate catheters." The provenance of the data is primarily non-clinical, involving in-vitro testing and simulated use in anatomical models and human cadavers.

Data Provenance: Predominantly non-clinical laboratory testing (in-vitro) and human cadaver studies.
Country of Origin: Not specified, but generally assumed to be carried out by the manufacturer (Scientia Vascular LLC) or their contracted labs.
Retrospective or Prospective: All tests described are prospective, conducted specifically to demonstrate substantial equivalence for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the human cadaver testing and radiopacity evaluation, "physicians" were used to evaluate the devices. No specific number or qualifications (e.g., years of experience, specialization) of these physicians are provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method (like 2+1 or 3+1) for establishing ground truth or evaluating performance, beyond "physicians" performing evaluations in the cadaver study. The non-clinical tests rely on meeting specified standards (e.g., ISO, ASTM, internal specifications).

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

There is no MRMC comparative effectiveness study and no AI component mentioned in this document. This is a traditional medical device (microcatheter) and the testing is purely for physical and functional performance, not diagnostic accuracy with AI.

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

There is no standalone algorithm performance study as this device does not involve any algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For most functional and biocompatibility tests, the ground truth is defined by established industry standards (ISO, ASTM), FDA guidance documents, and internal engineering specifications which are based on acceptable performance limits for medical devices. For the cadaver studies, the "ground truth" for performance was based on physician evaluation and comparison to a predicate device's performance in a similar setting. There is no pathology or patient outcomes data as it's a pre-market submission for a physical device.

8. The sample size for the training set

There is no training set as this device does not incorporate machine learning or AI.

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

Not applicable, as there is no training set for this device.

Summary

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Public Health Service

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

April 18, 2017

Scientia Vascular LLC % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street. NW Buffalo, Minnesota 55313

Re: K170406

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, DQY Dated: April 13, 2017 Received: April 14, 2017

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.

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 device

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related 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 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,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170406

Device Name Plato MICROCATH® 27B Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the logo for Scientia. The logo features a stylized, blue, overlapping "S" shape, resembling a chain link. Below the symbol, the word "SCIENTIA" is written in a modern, sans-serif font, with the letters appearing in a light gray color.

510(K) SUMMARY (Per 21 CFR 807.92)

SCIENTIA VASCULAR LLC PLATO MICROCATH® 27B MICROCATHETER

510(k) Sponsor:	Scientia Vascular LLC3487 West 2100 South Suite 100West Valley City, UT 84119Tel: (775) 657-6330Fax: (888) 503-6529
Contact Person:	David Sabodski, Director of Quality AssuranceTel: 801.573.5897Fax: 888.503.6529E-mail: dsabodski@scientiavascular.com
Date Prepared:	April 10, 2017
Prepared by:	Phil Triolo PhD, RACPresident, Phil Triolo and Associates LCTel: 801.699.9846Fax: 801.328.2399E-mail: philt@philt.com
Trade Name:	Plato MICROCATH® 27B Microcatheter
Common Name:	Microcatheter for neurovascular use
Classification Nameand Product Code:	Diagnostic Intravascular Catheter per 21 CFR 870.1200, DQOContinuous Flush Catheter per 21 CFR 870.1210, KRAPercutaneous Catheter per 21 CFR 870.1250, DQY
Predicate Device:	ev3 Marksman™ Catheter (K111490, K091559)
Reference Device:	Scientia Vascular, LLC Plato MICROCATH 27 Microcatheter(K143398)

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Device Description:

Indications for Use:

NOTE: The indications for use are the same as those of the predicate ev3 Marksman Catheter, with the exception that the Marksman Catheter is also indicated for coronary use. The identical reference MICROCATH 27B is currently cleared for the intended use of the introduction of interventional devices and infusion of diagnostic or therapeutic agents to the peripheral system; not the neurovascular system.

Technological Characteristics:

The Plato MICROCATH 27B Microcatheter is a single lumen, variable stiffness microcatheter designed to provide increased flexibility for navigating the peripheral and neurovasculature. The proximal end of the catheter incorporates a polycarbonate female Luer adapter to facilitate the attachment of accessories and devices terminating in a male Luer. 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 steam-shapeable distal shaft has a hydrophilic coating applied to impart lubricity.

The technological characteristics of the new microcatheter are comparable to those of the predicate device, the ev3 Marksman Catheter. Both the Marksman Catheter and the Plato 27B have a single PTFE lumen within a polymeric laminate. Both catheters have variable stiffness along the length designed for a flexible distal end and a stable proximal end enabling the catheter to be introduced over a steerable guidewire into the peripheral

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Scientia Vascular LLC Traditional 510(k) Plato MICROCATH® 27B Microcatheter

and neurovasculature systems. The proximal end of both catheters incorporates a standard female luer adapter to facilitate the attachment of devices and accessories that terminate in male luer adapters. The proximal ends of both catheters also have a reinforcing braid embedded in the polymeric coatings to impart strength and stiffness. Both catheters are compatible with 5F or larger guiding catheters and can accommodate guidewires up to 0.021" in diameter. The distal ends of both catheters have a steam shapeable tip. Further, the outer surface of the distal ends of both catheters has a hydrophilic coating to aid catheter movement in the vasculature.

The Plato MICROCATH 27B differs from the predicate Marksman Catheter in that the predicate has a coiled support structure embedded in the polymeric laminate at its distal end while the Plato 27B has a polymeric skeletal support embedded in the polymeric laminate at its distal end. Both designs provide mechanical support and minimize the potential for catheter collapse in tortuous vessels. Additionally, the predicate and MICROCATH 27B differ in material composition.

Results of tests performed on the new Plato MICROCATH 27B Microcatheter demonstrate that the new catheters perform as well as the predicate devices and/or meet requirements of relevant standards. Further, the differences in technological characteristics, including differences in materials used in the manufacture of the predicate and new catheters, do not raise different questions of safety and effectiveness.

Non-Clinical Performance Data:

Biocompatibility

The materials used in the manufacture of the subject Microcatheters are identical to those used in the manufacture of Plato MICROCATHETER 27B Microcatheters also manufactured by Scientia Vascular LLC, cleared 26 June, 2015 after review of K143398; in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).

There are no additional biologic interactions that need to be considered in order to use the cleared Microcatheters in the neurovasculature. Consequently, no additional evaluations are needed to determine that the subject Microcatheters present a low and acceptable biological and toxicological risk when used in accordance with their intended and indicated uses, and no additional biological safety information is provided in this 510(k).

Functional Testing

The results of functional testing completed to comply with ISO 10555-1:2013 requirements, the relevant portions of the FDA document, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (Part VIII. section 13), issued September 8, 2010, and the relevant portions of the FDA document, Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, issued March 16, 1995 are reported herein. The following tables summarize the functional tests performed and test results obtained to demonstrate substantial equivalence.

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Test	Test Method Summary	Results
Tensile Strength	Tensile testing performed perISO 10555-1 on distal,medial and proximal cathetersections after simulated use	All catheters meet minimum forcebreakage requirements specifiedin ISO 10555-1.
Coating Lubricity andDurability	Frictional force of uncoatedand coated catheters wasdetermined	All catheters met specifiedfrictional force requirements.
Coating Integrity	Coating uniformity andintegrity visually examinedon dyed samples aftersimulated use in a tortuouspath	All samples showed acceptablecoating coverage and no defectswere identified post simulated use.
Particulates	Particulates of various sizeranges counted after insertinga guidewire and advancingthe Microcatheter through aguide catheter multiple times.	The test and predicate cathetershad comparable numbers ofparticles in each size range.
Torque to Failure	Torque turns to failure in ananatomical model to providea 4 fold safety factor	All catheters showed no signs ofbreakage, twists or collapsedlumens after specified number oftorque turns.
Plato 27B NeurovascularModel Evaluation	Evaluate ability to deliverand withdraw interventionaldevices through catheter in amodel designed to simulatethe tortuous anatomy of theneurovasculature.	Interventional devices weresuccessfully delivered into andwithdrawn from the 27BMicrocatheter while it was locatecin the model simulating thetortuous anatomy of theneurovasculature.
Table 2. Summaries of Tests that were Repeated to Evaluate the Performance of13-month Real Time or Accelerated Aged Microcatheters to Establish aShelf Life ClaimNOTE: Summaries of tests conducted on unaged catheters werepreviously reported in K143398.
Test	Test Method Summary	Results
Liquid Leakage underPressure/Leakage at Hub	Test for leakage at 300- 320kPa per ISO 10555-1	No leakage from hub or catheterbody
Static Burst Pressure	Burst pressure tested per ISO10555-1	Maximum peak pressures allexceeded 300 psi.
Air Ingress/NegativeCollapse	Tests per ISO 10555	Hub fittings do not allow airingress and no evidence of lumencollapse
Kink Resistance	Tests for kinks after distal tipof catheter is wrapped aroundcylindrical forms	Device was resistant to kinkingaround small diameter turns perspecification
Tip Stiffness	Test for stiffness per ASTMD747-10	Tip stiffness was comparable thatof the predicate devices.
Flexural Fatigue andProfile	Worst case bend of 90° withan 8-fold safety factor forrepetitions per ASTM D747-10	All catheters showed no signs ofcracks or breakage after worstcase simulated use.
Tip Shape Retention	Catheters must retain angleshaped by steam and meettensile strength specificationsafter conditioning andsimulated use.	All tips formed by steam metshape and tensile requirementsafter conditioning and simulateduse.
Simulated Use	Anatomical model designedto simulate the tortuousanatomy of theneurovasculature used forsimulated use testing.	Catheters and predicate deviceswere found to perform acceptablyin evaluations of guidewiretracking and guide cathetermovement. Interventional deviceswere successfully deployed andwithdrawn.
Table 2. Summaries of Tests that were Repeated to Evaluate the Performance of13-month Real Time or Accelerated Aged Microcatheters to Establish aShelf Life ClaimNOTE: Summaries of tests conducted on unaged catheters werepreviously reported in K143398.
Test	Test Method Summary	Results
Visual/DimensionalInspection	Tests per ISO 10555-1Visual inspection for extraneous matter, process and surface defects or defects that may cause trauma to vessels.Dimensional inspection per drawings	No surface defects or visible droplets of coating on catheters.All catheters met dimensional specifications. Plato MICROCATH 27B Microcatheters do not exhibit clinically significant hydration as defined in ISO 10555-1:2013.
Pressure vs. FlowCharacterization	Flow rates measured at two typical injection pressures per ISO 10555-1	Flow rates reported in Instructions for Use at 100 and 300 psi
Dynamic Flow	Product used with power injector at pressure-limited setting to 700 psi	No leaks, breaks or occluded lumens at 700 psi
Packaging Testing	Pouch evaluated for seal strength per ASTM F 88-00 and leak tests (bubble test) per ASTM F 2096-04	All sterile barrier pouches met minimum seal strength and released no bubbles under leak test conditions.

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Test	Test Method Summary	Results
Cadaver Testing	Human Cadaver used toevaluate catheter andpredicate devices byphysicians for performance,access time, and ability todeploy and retrieve	Test and predicate devices bothexhibited comparable performancewith similar access time to thedesignated target.
Radiopacity	Catheters and predicatedevices evaluated byphysicians in human cadavermodel	Both test and predicate cathetersexhibited acceptable radiopacity.
MRI Compatibility	Catheters contain metallicmaterials and should not beexposed to MRI procedures.	Catheters are labeled MRI Unsafein IFU.
Chemical compatibility	Catheters were exposed tosaline and contrastagent/saline solutions andexamined for degradation.	All catheters showed no signs ofdegradation, corrosion or physicaldecomposition.
Latex Content	Tested for trace latex proteinsper ASTM D6499-07	No detectable traces of latex werefound.
Corrosion Resistance	Test for corrosion resistanceper ISO 10555-1	No signs of corrosion on metalliccomponents of catheters

Table 3. Summaries of Tests Whose Results Were Already Reported in K143398 nd are Being Leveraged for this Premarket Notifi

Conclusion:

Scientia Vascular, LLC has presented information in this premarket notification supporting its contention that the Plato MICROCATH 27B Microcatheter is substantially equivalent with respect to technological characteristics and indications for use to the ev3 predicate device.

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).