The V•Stick™ Vascular Access Set assists in gaining vascular access for the placement of 0.035" and 0.038" guidewires into the vascular system using small needle access. It is composed of a 21ga puncture needle with and without silicone coating, and available with or without an echogenic tip. A coaxial introducer set with a 4F or 5F sheath and a standard or stiff 3F dilator is included. Finally a 0.018" stainless steel or Nitinol guidewire with a platinum or palladium alloy coil tip.

AI/ML Overview

The provided document K130730 describes the V•Stick™ Vascular Access Set, which is a medical device for gaining vascular access. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria in the traditional sense of a diagnostic or AI device. Therefore, the device description and the study relate to non-clinical performance tests.

Here's a breakdown of the acceptance criteria and supporting information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance / Outcome
Functional/Mechanical	Dimensional Verification	Not explicitly detailed, but implied to be compliant with design specifications.
	Visual Inspection	Not explicitly detailed, but implied to be compliant with design specifications.
	Weld Strength	Not explicitly detailed, but implied to be compliant with design specifications.
	Radiopacity	Guidewire spring tip is made of radiopaque material (similar to predicate).
	Ultrasound Visibility	Distal tip of 21ga puncture needle may or may not have echogenic properties (similar to predicate).
	Sharpness	Not explicitly detailed, but implied to be compliant with design specifications.
	Stiffness Comparison	Not explicitly detailed, but implied to be compliant with design specifications.
	Tensile Strength	Not explicitly detailed, but implied to be compliant with design specifications.
Biocompatibility	Cytotoxicity	Results demonstrate substantial equivalence; no new safety questions.
	Sensitization	Results demonstrate substantial equivalence; no new safety questions.
	Acute systemic toxicity	Results demonstrate substantial equivalence; no new safety questions.
	Hemocompatibility	Results demonstrate substantial equivalence; no new safety questions.
	Irritation/intracutaneous reactivity	Results demonstrate substantial equivalence; no new safety questions.

Note: The document emphasizes substantial equivalence rather than explicit quantitative acceptance criteria for each test. The performance is reported as meeting the requirements for demonstrating substantial equivalence to predicate devices.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: The document does not specify exact sample sizes for each non-clinical performance test. It broadly states that "Performance tests (Non-Clinical)" were conducted.
Data Provenance: The tests are non-clinical, meaning they were likely conducted in a laboratory setting. No information about country of origin of data or retrospective/prospective nature is applicable as these are not human subject studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this submission. The device is a vascular access set, and the studies performed are non-clinical (mechanical, material, biocompatibility). There is no "ground truth" in the context of expert interpretation for diagnostic performance.

4. Adjudication Method for the Test Set:

This information is not applicable to this submission as it pertains to non-clinical performance tests, not studies requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The V•Stick™ Vascular Access Set does not involve human interpretation in its function.

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

No, this is not applicable. The V•Stick™ Vascular Access Set is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering standards, material specifications, and biocompatibility guidelines (e.g., ISO 10993-1). The device's performance was compared against these established benchmarks, and its characteristics were compared against those of the predicate devices.

8. The Sample Size for the Training Set:

This submission describes a medical device, not an AI or machine learning product. Therefore, there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for this type of device, this question is not applicable.

Summary

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NOV 2 2 2013

K130730

pg 1/3

510(k) Summary

Date Prepared:	March 27, 2013
Company:	Argon Medical3600 SW 47th Ave.Gainesville, FL 32608
	Facility Registration number: 1037610
Contact:	Jennifer BonacciRegulatory Affairs ManagerPhone: 352-519-5029Fax: 352-338-0662Email: jennifer.bonacci@argonmedical.com
Sterilization Site	STERIS Isomedix Services, Inc.2072 Southport RoadSpartanburg, SC 29306-6299, USAFacility Registration number: 1047843
Device trade name:	V•Stick™ Vascular Access Set
Device CommonName:	Vascular access set
Device classification:	Introducer, catheterProduct code, DYB21 CFR 870.1340Class II
Legally marketeddevice to which thedevice is substantiallyequivalent:	K011790 MicroCruiser® Plus Introducer SetK091584 Merit MAK (Mini Access Kit)K851834 Manan GWI Guidewire Introducer
Description of thedevice:	The V•Stick™ Vascular Access Set assists in gaining vascularaccess for the placement of 0.035" and 0.038" guidewires into thevascular system using small needle access. It is composed of a21ga puncture needle with and without silicone coating, andavailable with or without an echogenic tip. A coaxial introducerset with a 4F or 5F sheath and a standard or stiff 3F dilator isincluded. Finally a 0.018" stainless steel or Nitinol guidewirewith a platinum or palladium alloy coil tip.
Indications for Use:	The V•Stick™ Vascular Access Sets intended for use in theintroduction and placement of guidewires and/or catheters

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Technological The subject of this 510(k) is to provide an additional offering for Characteristics: the current V.Stick Vascular Access Set to include a 0.018" guidewire with a palladium/rhenium coil tip and a silicone coated . 21 ga puncture needle in addition to the existing co-axial introducer set.

The V.Stick Vascular Access Set is similar in design components. dimensions, and materials to the predicate devices. The MicroCruiser® [K011790], Merit MAK [K091584], and V.Stick are all available in the same French and 0.018" guidewire sizes. The lengths of the co-axial introducer, guidewire and puncture needle are identical. The materials found in all three sets are similar. The spring tip of the 0.018" guidewire is made of radiopaque material as is the guidewire tip in the predicate set.

The distal tip of the 21ga puncture needle may or may not have echogenic properties which are also true in the predicate sets. This needle is also provided with a silicone coating just as the predicate Manan Guidewire Introducer Needle [K851834].

The V.Stick Vascular Access Set, like the predicate devices, is compatible with guidewires with a maximum outer diameter of 0.038". All three access sets are sterilized in an ethylene oxide process and have similar sterile barrier packaging materials.

The V.Stick Vascular Access Set has the same indications for use, technical characteristics, and materials as the MicroCruiser® Plus Introducer. The V.Stick Vascular Access Set has the same introducer needle with silicone coating as the Manan GWI Guide Wire Introducer and the same intended use. The V.StickTM Vascular Access Set has the same 0.018" guidewire with palladium alloy coil tip as the Merit MAK® Mini Access Kit and the same intended use.

Substantial Equivalence:

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Performance tests (Non-Clinical):

The V.Stick Vascular Access Set is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:

o Dimensional Verification . Visual Inspection
- . Weld Strength
Radiopacity .

Sensitization

Ultrasound Visibility .
Sharpness

Stiffness Comparison

Tensile Strength .
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
. Cytotoxicity .
- Acute systemic toxicity Hemocompatibility .
Irritation/intracutaneous reactivity .

The results of this testing demonstrates that the V.StickTM Vascular Access Set, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 22, 2013

Argon Medical C/O Jennifer Bonacci Regulatory Affairs Manager 3600 Southwest 47th Avenue Gainesville, FL 32608 US

Re: K130730

Trade/Device Name: V-Stick™ Vascular Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 17, 2013 Received: October 23, 2013

Dear Ms. Bonacci:

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 murketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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 mislcading.

If your device is classified (sec above) into cither 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.

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Page 2 - Ms. Jennifer Bonacci

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Hillerman

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130730

Device Name V.Stick™ Vascular Access Set

Indications for Use (Describe)

V.Stick™ Vascular Access Sets intended for use in the introduction and placement of guidewires and/or catheters

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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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

M. L. Hillemann

FORM FDA 3881 (9/13)

PSC Publishim Services (301) 443-474) EP

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).