The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic agents.

Device Description

The Twin-Pass Torque is a dual lumen catheter consisting of an over-the-wire (OTW) lumen that runs the full length of the catheter, exiting just proximal to the distal tip, and a rapid exchange (RX) delivery lumen on the distal segment. The two exit ports are each marked by a radiopaque platinum-iridium marker band and the device shaft has two positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, which are not visible under fluoroscopy.

AI/ML Overview

This document is a 510(k) premarket notification for the "Twin-Pass Torque" catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for device performance based on patient outcomes or diagnostic accuracy. Therefore, information regarding reader studies, ground truth establishment, or multi-reader multi-case analyses is not applicable.

Here's an breakdown of the available information:

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

The document lists performance tests conducted to establish substantial equivalence. For each test, the document states that "The results of the verification tests met the specified acceptance criteria." However, the specific numerical acceptance criteria or detailed numerical performance results are not provided in this summary.

Acceptance Criteria (General)	Reported Device Performance (General)
Met specified acceptance criteria	Passed Kink resistance
Met specified acceptance criteria	Passed Guidewire insertion
Met specified acceptance criteria	Passed Tip flexibility
Met specified acceptance criteria	Passed Distal shaft flexibility
Met specified acceptance criteria	Passed Proximal shaft support
Met specified acceptance criteria	Passed Coating lubricity/Durability
Met specified acceptance criteria	Passed Radiopacity
Met specified acceptance criteria	Passed Guidewire deflection
Met specified acceptance criteria	Passed Distal tip length
Met specified acceptance criteria	Passed Torque control
Met specified acceptance criteria	Passed Torque transmission
Met specified acceptance criteria	Passed Tensile strength
Met specified acceptance criteria	Passed Torque strength
Met specified acceptance criteria	Passed Torque robustness
Met specified acceptance criteria	Passed Hub luer tests (air leak, burst, compatibility)
Met specified acceptance criteria	Passed Hydrophilic coating particulate
Met specified acceptance criteria	Passed Package integrity
Met specified acceptance criteria (ISO 10993-1)	Passed Cytotoxicity
Met specified acceptance criteria (ISO 10993-1)	Passed Sensitization
Met specified acceptance criteria (ISO 10993-1)	Passed Irritation
Met specified acceptance criteria (ISO 10993-1)	Passed Systemic toxicity
Met specified acceptance criteria (ISO 10993-1)	Passed Pyrogenicity
Met specified acceptance criteria (ISO 10993-1)	Passed Hemocompatibility

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 describes performance tests (bench testing), not a clinical trial with a "test set" in the context of patient data. The sample sizes for these engineering and biocompatibility tests are not specified in this summary. The data provenance is also not specified, but given it's bench testing, it would originate from the manufacturer's testing facility.

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. This is not a study assessing diagnostic accuracy or human interpretation. It's about mechanical and biological performance of a medical device.

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

Not applicable.

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 document does not describe a MRMC study or an AI-powered device.

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

Not applicable. This document is for a physical medical device (catheter), not an algorithm or AI.

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

For the performance tests, the "ground truth" would be the engineering and physical standards and specifications established for the device's functional characteristics (e.g., kink resistance, tensile strength) and the biological response standards for biocompatibility (e.g., ISO 10993-1).

8. The sample size for the training set

Not applicable. There is no software or algorithm involved that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

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

February 1, 2017

Vascular Solutions, Inc. Ms. Lisa Gallatin Director of Regulatory 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K162467

Trade/Device Name: Twin-Pass Torque Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 27, 2016 Received: December 28, 2016

Dear Ms. Gallatin:

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 (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.

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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,

Fernando
Aguel-S

for 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

510(k) Number (if known) K162467

Device Name Twin-Pass Torque

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: December 21, 2016

510(k) Number: __K162467

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Lisa Gallatin, RAC Director of Regulatory Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Twin-Pass Torque
Common / Usual Name	Dual access catheter
Classification Name	Catheter, percutaneous
Predicate Device	K083784, Twin-Pass dual access catheter, Vascular Solutions, Inc.
Reference Device	K142065 and K151981, Turnpike catheter

Device Description

Intended Use

The Twin-Pass Torque catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Technological Characteristics Comparison

Twin-Pass Torque is similar in design to the predicate device and both are dual lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature, facilitate placement and exchange of guidewires and subselectively infuse agents. With the exception of dimensional, material and package configuration differences, the Twin-Pass Torque is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests.

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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 and results did not raise new questions of safety or effectiveness. The Twin-Pass dual access catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

. Kink resistance
. Guidewire insertion
. Tip flexibility
. Distal shaft flexibility
Proximal shaft support ●
Coating lubricity/Durability ●
Radiopacity
Guidewire deflection ●
Distal tip length ●
. Torque control
Torque transmission ●
Tensile strength .
. Torque strength
Torque robustness
Hub luer tests (air leak, burst, compatibility)
Hydrophilic coating particulate
. Package integrity

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

. Cytotoxicity
Sensitization
. Irritation
Systemic toxicity ●
. Pyrogenicity
. Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Twin-Pass Torque dual access catheter is 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).