The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

Device Description

The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a study involving diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, the typical elements requested about acceptance criteria, study design for diagnostic performance, sample sizes, expert ground truth adjudication, MRMC studies, and training set details are not applicable to this type of regulatory submission.

The "studies" mentioned in the document are engineering performance tests and biocompatibility tests, not clinical studies assessing diagnostic accuracy or human reader performance.

Here's a breakdown based on the provided document and why most of your questions cannot be answered:

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

The document lists types of tests performed, but it does not provide a table with specific quantitative acceptance criteria or the numerical results from these tests. It simply states that:

"The device performance was verified through the following tests: Deliverability, Hydrophilic Coating Evaluation, Structural Integrity, ISO 10555-1 Verification, ISO 594 Hub Verification."
"Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity."
"The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device."

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

Sample sizes: Not specified. The tests mentioned are likely bench tests using a certain number of device samples, not patient data.
Data provenance: Not applicable, as this is related to bench and biocompatibility testing of the device itself, not patient data from a clinical setting.

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)

Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant here. The "ground truth" for these engineering tests is adherence to established engineering standards (e.g., ISO) and predetermined acceptance limits for physical properties.

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

Not applicable. This concept pertains to adjudicating disagreements among human readers or experts for diagnostic ground truth, which is not part of this 510(k) submission for a microcatheter.

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

Not applicable. This is not an AI-enabled diagnostic device. It's a medical instrument used for accessing vasculature and delivering agents.

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

Not applicable. This is not an algorithm.

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

The "ground truth" equivalent for these tests are the pre-defined engineering specifications and ISO standards that the device must meet to demonstrate safe and effective performance for its intended use. For biocompatibility, the ground truth is the absence of adverse biological reactions as per ISO 10993-1.

8. The sample size for the training set

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

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

Not applicable.

In summary: The provided document is a 510(k) summary for a Class II medical device (microcatheter) that demonstrates substantial equivalence primarily through bench testing and biocompatibility testing, not clinical performance studies involving diagnostic accuracy or human interpretation. The questions posed are highly relevant to AI/ML diagnostic device submissions but do not apply to this specific regulatory filing.

Summary

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April 30. 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Vascular Solutions LLC Steph Pahl Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K210647

Trade/Device Name: SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: March 1, 2021 Received: March 3, 2021

Dear Steph Pahl:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@)tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows the name "Lydia S. Glaw -S" in a large, bold font. The text is arranged in two lines, with "Lydia S." on the first line and "Glaw -S" on the second line. The background is a light blue color with a faint, geometric pattern.

Digitally signed by Lydia S. Glaw -S Date: 2021.04.30 12:22:30 -04'00'

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210647

Device Name

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT 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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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: March 1, 2021

Submitter's Name / Contact Person

Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person

Steph Pahl Regulatory Product Specialist Tel: 763-762-2641 Fax: 763-251-0363

General Information

Trade Name	SuperCross microcatheterSuperCross FT microcatheterSuperCross AT microcatheter
Common / Usual Name	Catheter
Classification Name	21 CFR 870.1250, DQY, Percutaneous catheter, Class II
Predicate Device	K101659, SuperCross microcatheter (Vascular Solutions, Inc.)

Device Description

Intended Use

Technological Characteristics Comparison

The key technological differences between the SuperCross microcatheters and the predicate device are the addition of flexible and angled tip versions and a change to the hub and markerbals.

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Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the Supercross microcatheters.

The device performance was verified through the following tests:

. Deliverability
Hydrophilic Coating Evaluation
Structural Integrity
. ISO 10555-1 Verification
. ISO 594 Hub Verification

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

. Cytotoxicity
. Sensitization
Irritation
. Systemic Toxicity
. Material Mediated Pyrogenicity
Hemolysis
Complement Activation ●
. Thrombogenicity

The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device.

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).