The Plato MICROCATH® 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

Device Description

The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F 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 two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.

AI/ML Overview

The provided text describes the "SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER". It does not describe a study involving acceptance criteria related to an AI/ML device, but rather the non-clinical performance data for a microcatheter device. Therefore, I will extract information relevant to the device's performance against non-clinical acceptance criteria.

Here's the breakdown of the information as per the request, adapted for a non-AI/ML medical device:

1. A table of acceptance criteria and the reported device performance

The document lists "Non-Clinical Performance Data" which served as the basis for demonstrating substantial equivalence. These can be considered the acceptance criteria for functional and safety aspects of the device.

Acceptance Criteria (Test Performed)	Reported Device Performance
Visual/Dimensional Inspection	Concluded to function as intended (implied pass)
Air Ingress/Negative Collapse	Concluded to function as intended (implied pass)
Kink Resistance	Concluded to function as intended (implied pass)
Tensile Strength/Elongation	Concluded to function as intended (implied pass)
Liquid Leakage under Pressure/Leakage at Hub	Concluded to function as intended (implied pass)
Tip Stiffness	Concluded to function as intended (implied pass)
Pressure vs. Flow Characterization	Concluded to function as intended (implied pass)
Static and Dynamic Burst Pressure	Concluded to function as intended (implied pass)
Flex Fatigue	Concluded to function as intended (implied pass)
Shape Retention	Concluded to function as intended (implied pass)
Coating Lubricity and Durability	Concluded to function as intended (implied pass)
Coating Integrity	Concluded to function as intended (implied pass)
Particulates	Concluded to function as intended (implied pass)
Chemical compatibility	Concluded to function as intended (implied pass)
Latex	Concluded to function as intended (implied pass)
Corrosion Resistance	Concluded to function as intended (implied pass)
Biocompatibility (ISO 10993)	Testing performed and results supported substantial equivalence
Functional Testing (ISO 10555-1)	Met the requirements of ISO 10555-1
Simulated Use (Anatomical Model)	Navigated successfully, guidewire tracking and movement tested (implied pass)
Human Cadaver Model Performance	Comparable to the predicate for advancement to the intended vascular site

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

Sample Size:
- For the non-clinical bench testing, specific sample sizes are not provided in the document. The tests likely involved multiple units of the Plato MICROCATH 27 Microcatheter.
- For the simulated use testing, an "anatomical model" was used. The number of models or tests conducted is not specified.
- For the human cadaver model, the term "a human cadaver model" is used, implying at least one but the exact number of cadavers or trials is not specified.
Data Provenance: The tests are explicitly described as "Non-Clinical Performance Data" and include "bench testing," "simulated-use testing," and testing in a "human cadaver model." This indicates the data is from controlled laboratory and simulated environments. The country of origin of the testing is not specified, but the submission is to the FDA (United States). This testing would be considered prospective, as it was conducted specifically to evaluate the device.

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)

This section is not applicable as the document describes non-clinical and simulated-use testing of a physical medical device, not an AI/ML system requiring expert ground truth for interpretation. The evaluation was based on engineering specifications, standardized test methods (ISO 10993, ISO 10555-1), and performance in physical models.

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

This is not applicable. The device's performance was evaluated against physical and functional criteria, not expert interpretations requiring adjudication.

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

This is not applicable. The document describes a physical medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system that would involve human readers.

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

This is not applicable. This document is about a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance was established through:

Compliance with international standards (ISO 10993, ISO 10555-1).
Demonstration of expected functional performance in various bench tests (e.g., kink resistance, tensile strength, burst pressure, coating lubricity).
Comparative performance to a predicate device in simulated anatomical and human cadaver models for key operational aspects like maneuverability and advancement.

8. The sample size for the training set

This is not applicable. This document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable. This document describes a physical medical device, not an AI/ML system.

Summary

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

K|21734

Image /page/0/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized letter 'S' above the word 'SCIENTIA' in a futuristic-looking font. The 'S' is made up of thick, rounded lines, giving it a bold and modern appearance.

JUL 30 2012

510(K) SUMMARY (21 CFR 807.92)

SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER

510(k) Owner:

Scientia Vascular LLC 2700 South 900 West Suite D Salt Lake 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

May, 2012 Date Prepared:

Plato MICROCATH® 27 Microcatheter Trade Name:

Common Name: Microcatheter

Classification Name: Percutaneous catheter per 21 CFR 870.1200, DOO

Predicate Device: ev3 Rebar-027, K993672

The Plato MICROCATH® 27 Microcatheters are single lumen Device Description: catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F 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 two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.

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

Indications for Use: LLC Plato MICROCATH The Scientia Vascular 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

The indications are substantively identical to those of the ev3 Rebar-027 microcatheter.

Technological Characteristics:

The Plato MICROCATH 27 Microcatheter is designed with a low profile distal shaft with enhanced skeletal support, and a proximal hypotube to increase the ability to advance the catheter in peripheral and neuro vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The device is compatible with 6 Fr or larger guiding catheters and can be advanced over guidewires up to 0.025". The distal shaft has a hydrophilic coating for lubricity.

The technological characteristics are comparable to the predicate device, the ev3 Rebar-027 Microcatheter. The Rebar-027 is a single lumen 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 catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft. The outer surface of the catheter is coated to increase lubricity.

The technological differences between the Plato MICROCATH 27 Microcatheter and the predicate device reside in the design of the The predicate catheter has embedded catheter reinforcement. wires which are shaped to impart additional strength and stiffness. to the proximal and distal ends. The Plato MICROCATH 27 Microcatheter uses a proximal stainless steel hypotube to improve the control the physician has over the distal end and then uses a polymeric skeletal support in the distal end to support the lumen and prevent collapse in tortuous vessels. The 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 with Amendments 1 and 2, and in the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995. Testing performed on the proposed device included:

Visual/Dimensional Inspection .

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

Air Ingress/Negative Collapse
Kink Resistance �
Tensile Strength/Elongation .
Liquid Leakage under Pressure/Leakage at Hub .
. Tip Stiffness
Pressure vs. Flow Characterization .
Static and Dynamic Burst Pressure .
Flex Fatigue .
. Shape Retention
. Coating Lubricity and Durability
Coating Integrity .
Particulates .
Chemical compatibility �
. Latex
Corrosion Resistance .

Additionally, simulated use testing included navigating the device through an anatomical model to test the guidewire tracking and movement within the catheter. In a human cadaver model, the device was comparable to the predicate for advancement to the intended vascular site.

Conclusions:

The non-clinical bench testing, simulated-use testing and human cadaver test results demonstrate that the Plato MICROCATH 27 Microcatheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate devices in small tortuous vessels. The testing supports a determination of substantial equivalence to products previously cleared by FDA.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

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

JUL 30 2012

Scientia Vascular LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K121734

Trade/Device Name: Plato MICROCATH 27 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: June 12, 2012 Received: June 13, 2012

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.

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

Page 2 - Mr. Mark Job

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 device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.S. Hillel

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 121734

Device Name: Plato MICROCATH® 27 Microcatheter

Indications for Use: The Plato MICROCATH® 27 Microcatheter is intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.A. Hilleben

(Division Sign-Off) Division of Cardiovascular Devices

¥121734 510(k) Number

Page 1 of 1 _

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).