The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

Device Description

The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.

AI/ML Overview

The provided document is a 510(k) summary for the Venture 038 catheter, a medical device. It does not describe an AI/ML powered device or a study involving human readers or AI assistance. Therefore, many of the requested fields are not applicable.

1. Table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	Not specified (implied to meet functional requirements)	Passed
Kink Radius	Not specified (implied to meet functional requirements)	Passed
Visual Inspection	Not specified (implied to meet functional requirements)	Passed
Tip Deflection	Not specified (implied to meet functional requirements)	Passed
Tip Rotation	Not specified (implied to meet functional requirements)	Passed
Tensile Strength	Not specified (implied to meet functional requirements)	Passed
Liquid Leak	Not specified (implied to meet functional requirements)	Passed
Liquid Leak Under Pressure	Not specified (implied to meet functional requirements)	Passed
Injection Pressure	Not specified (implied to meet functional requirements)	Passed
Aspiration	Not specified (implied to meet functional requirements)	Passed
Corrosion	Not specified (implied to meet functional requirements)	Passed
Particulate Count	Not specified (implied to meet functional requirements)	Passed
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement Activation, In Vitro Hemocompatibility, Coagulation, Thrombogenicity)	Per ISO 10993-1	Passed

Note: The document states "The results of the verification tests met the specified acceptance criteria," but it does not explicitly list the specific quantitative or qualitative acceptance criteria for each test. Instead, it generally indicates that the device passed these tests.

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

This information is not provided in the document. The document describes bench tests and biocompatibility tests, not studies with test sets in the context of AI/ML or clinical data.

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 information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring expert ground truth for a test set.

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

This information is not applicable as the document does not describe a study involving adjudication of a test set by human experts.

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 information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML powered device or a MRMC study.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a ground truth in that context. The "ground truth" for the device's performance would be the physical properties and functional results observed during the bench tests, compared against design specifications and relevant standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a training set.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.

Summary

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Public Health Service

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June 7, 2017

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

Vascular Solutions, Inc. Ms. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369

Re: K171335

Trade/Device Name: Venture 038 catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 5, 2017 Received: May 8, 2017

Dear Ms. Vite:

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,

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)

K171335

Device Name Venture 038 catheter

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: May 5, 2017

510(k) Number: K171335

Submitter's Name / Contact Person

Manufacturer	Contact Person
Vascular Solutions, Inc.	Beka Vite
6464 Sycamore Court North	Sr. Regulatory Product Specialist
Minneapolis, MN55369 USA	Tel: 763-656-4300
Establishment Registration # 2134812	Fax: 763-656-4253

General Information

Trade Name	Venture 038 catheter
Common / Usual Name	Catheter, Percutaneous
Classification Name	Class II
Predicate Device	K040922 and K042910 - 0.014" Venture Wire Control Catheter, Velocimed Inc.
Reference Device	K142065 - Turnpike Catheter, Vascular Solutions, Inc.

Device Description

Indications for Use

Technological Characteristics Comparison

A comparison of technological differences between the subject and predicate device is provided below.

Characteristic	Subject Device	Predicate Device
Intended Use	Directing, steering, controlling, and supporting a guidewire to access discrete regions of the vasculature	Directing, steering, controlling, and supporting a guidewire to access discrete regions of the vasculature
Anatomical Location	Peripheral vasculature	Coronary and peripheral vasculature
	Venture 038 Catheter	Venture Wire Control Catheter

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Characteristic	Subject Device	Predicate Device
	Venture 038 Catheter	Venture Wire Control Catheter
Working Length	120 cm and 70 cm	140 cm and 70 cm
GuidewireCompatibility	0.035" or 0.038"	0.014"
Lubricous Coating	Hydrophilic coating
Sterility	Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence that the Venture 038 catheter is substantially equivalent to the predicate device. The Venture 038 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:

Simulated Use
Kink Radius
Visual Inspection ●
. Tip Deflection
Tip Rotation
Tensile Strength ●
. Liquid Leak
Liquid Leak Under Pressure
Injection Pressure
Aspiration
Corrosion
Particulate Count ●

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

. Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Pyrogenicity ●
Hemolysis
Complement Activation
In Vitro Hemocompatibility
Coagulation ●
Thrombogenicty

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Venture 038 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).