Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.

Device Description

The M2 Navigation catheter and GuideLiner Navigation catheter (Navigation catheters) are rapidexchange catheters with a working length of 163 cm. The device is available in eight sizes and is compatible with GuideLiner catheters (GuideLiner Navigation catheter models) and 6F, 7F, and 8F guide catheters (M2 Navigation catheter models).

The distal portion of the device is a 25 cm single-lumen catheter that serves as the guidewire lumen. Portions of the outer diameter (OD) of the lumen are cross shaped to allow blood to flow around the catheter while staying centered within a guide catheter or GuideLiner catheter. The device is compatible with 0.014 inch exchange length or 180 cm guidewires. The catheter lumen is constructed with two durometers of Pebax (polyether block amide) resin over a polyimide-PTFE composite liner. The device has one radiopaque marker band located 2 mm from the distal tip. The OD of the lumen has a silicone wipe to enhance deliverability to the target vasculature. The proximal end of the lumen transitions to a 304V stainless steel pushwire that has non-radiopaque positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip. A short Pebax hub/sleeve covers the proximal end of the pushwire.

AI/ML Overview

The provided text describes a medical device, the M2 Navigation Catheter and GuideLiner Navigation Catheter, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, it does not involve a study of clinical effectiveness with acceptance criteria for device performance as would be seen for AI/ML devices or novel therapies.

Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, MRMC study details, standalone performance, training set details) because the provided text is for a traditional medical device (catheter) cleared via the 510(k) process, which relies on demonstrating similarity to an already legally marketed device, not on complex performance metrics established through clinical trials or studies like those for AI/ML or drug devices.

The "studies" mentioned in the document are verification tests comparing the new device to its predicate, focusing on physical and material characteristics, rather than clinical performance or diagnostic accuracy.

Here's what can be extracted from the provided text regarding the "study" that proves the device meets "acceptance criteria," interpreted within the context of a 510(k) submission for a catheter:

Acceptance Criteria and Device Performance (for a physical catheter device via 510(k) pathway)

Acceptance Criteria Category (Verification Test)	Reported Device Performance (Outcome)
Visual Inspections	Met acceptance criteria (no label legibility issues, sharp edges, irregularities, lubricious wipe issues)
Dimensional Verifications	Met acceptance criteria
Positioning Mark Tape Test	Met acceptance criteria
Simulated Anatomy/Concomitant Device Use	Met acceptance criteria
Kink Test	Met acceptance criteria
Bond Tensile Test	Met acceptance criteria
Torque Test	Met acceptance criteria
Biocompatibility Assessment	Not required due to similarity of materials and manufacturing processes with predicate and other VSI devices

Study Details:

The "study" in this context refers to a series of verification tests performed by the manufacturer, Vascular Solutions, Inc., to demonstrate that the new Navigation Catheters are substantially equivalent to the predicate GuideLiner Catheter (K091750).

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. These would typically be engineering test samples, not human subjects.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by the manufacturer (Vascular Solutions, Inc.) in the USA. These are engineering studies, not clinical data sets from patients.
- Retrospective or Prospective: These are prospective engineering tests performed on manufactured devices.
2. 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. For these types of physical/mechanical verification tests, "ground truth" is established by engineering specifications and standards, not by clinical expert consensus. The "experts" would be engineers and quality control personnel performing the tests according to established protocols.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical interpretations (e.g., image reading) where disagreement among experts might occur. This is not relevant for physical device testing.
4. 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 device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function or the validation described.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical catheter, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering specifications and standards. For example, "dimensional verifications" would use established engineering tolerances as their ground truth. "Kink" would have a defined level of acceptable deflection or resistance to kinking.
7. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
8. How the ground truth for the training set was established:
- Not applicable. No training set exists.

Summary: The provided document describes the clearance of a medical catheter through the 510(k) pathway. The "studies" and "acceptance criteria" discussed are engineering verification tests designed to demonstrate that the new device is functionally equivalent and as safe as its predicate. This is entirely different from the types of studies and criteria used for AI/ML devices or therapies where clinical performance metrics (like sensitivity, specificity, clinical outcomes, or reader improvement) are the focus.

Summary

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0.1383

MAR 2 0 2012

2 510(k) Summarv

[As required by 21 CFR 807.92]

510(k) Number: KII2000

Date Prepared: July 19, 2011

Submitter's Information / Contact Person

Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person

Matt Nienstedt Regulatory Product Specialist Tel: 763.656.4317 (direct) Fax: 763.656.4253 Email: mnienstedt@vasc.com

Alternate Contact Person Stacy Quellette Senior Regulatory Operations Associate Tel: 763.656.4217 (direct) . Fax: 763.656.4253 Email: souellette@vasc.com

General Information

Trade Name	M2 Navigation Catheter and GuideLiner Navigation Catheter
Common / Usual Name	Percutaneous catheter
Classification Name	21 CFR 870.1250, Percutaneous Catheter
Predicate Device	GuideLiner Catheter (K091750 - Vascular Solutions, Inc.)

Device Description

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composite liner. The device has one radiopaque marker band located 2 mm from the distal tip. The OD of the lumen has a silicone wipe to enhance deliverability to the target vasculature. The proximal end of the lumen transitions to a 304V stainless steel pushwire that has non-radiopaque positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip. A short Pebax hub/sleeve covers the proximal end of the pushwire.

Intended Use / Indications

Technological Characteristics

Navigation catheters and predicate GuideLiner devices have the same design components consisting of a proximal hub, push wire, and distal lumen. Minor dimensional differences reflect the additional sizes for compatibility of the Navigation catheters with various guide catheters and GuideLiner catheters. Minor material changes were also implemented to increase the lumen flexibility, provide a longer, distal tip that tapers, and simplify device manufacturing.

Inner diameters (ID) of Navigation catheters differ from the predicate GuideLiner catheter. The smaller IDs of Navigation catheters allow for a tapered tip design. The OD of Navigation catheters are cross shaped while the OD of GuideLiner catheters are round.

Substantial Equivalence and Summarv of Studies

Navigation catheters are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design was qualified through the following tests:

. Visual inspections for:
- o label legibility, wear, or smudging
- sharp edges, points, irregularities o
- lubricious wipe o
Dimensional verifications .
. Positioning mark tape test
. Simulated anatomy/concomitant device use
. Kink
. Bond tensile
. Torque

A biomaterial assessment concluded that biocompatibility testing was not required based on the similarity of materials and manufacturing processes utilized in the predicate device and other devices manufactured by Vascular Solutions, Inc. Results of the verification testing met the specified acceptance criteria and did not raise new safety or performance questions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, framing the eagle symbol.

Public Health Service

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

MAR 2 0 2012

Vascular Solutions, Inc. c/o Mr. Matt Nienstedt Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369

Re: K112100

Trade/Device Name: M2 Navigation Catheter and GuideLiner Navigation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 1, 2012 Received: February 2, 2012

Dear Mr. Nienstedt:

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.

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

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Page 2 - Mr. Matt Nienstedt

(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/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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Hillebert

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

K112100 510(k) Number (if known):

Device Name: M2 Navigation Catheter and GuideLiner Navigation Catheter

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cm. A. Hillebem

(Division Sian-Off) Division of Cardiovascular Devices

1112100 510(k) Number

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).