The Benelli Access Device is a 4 F intravascular over-the-needle catheter consisting of a 6.9 cm high-density polyethylene shaft and a polypropylene hub. The distal end of the shaft terminates in a tapered tip for smooth entry into the vasculature. A polypropylene rotating suture wing is provided on the distal end of the hub and is used to secure the catheter to the patient and prevent dislodgement. The catheter hub has a sidearm that attaches to extension tubing. A three-way stopcock is attached to the distal end of the extension tubing to provide multiple access points to the catheter lumen, allowing for easier flushing, fluid delivery, and blood sampling.

The Benelli Access Device is sold as part of an intravascular catheterization kit. This kit includes the following components:

. Benelli Access Device (4 F x 6.9 cm catheter with sidearm tubing and 3-way stopcock)
Intraluminal protection system (needleless access port)
21 G x 9 cm echogenic needle .
. 0.018" x 40 cm guidewire.

AI/ML Overview

The provided 510(k) summary for the Benelli Access Device describes a medical device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML study design are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies that prove it meets those criteria, as detailed in an FDA submission for a traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Technological Characteristics (Bench Testing)
Insertion force	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Radiopacity	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Liquid leak	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Aspiration	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Tensile	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Corrosion	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Kink	Qualified (Results were satisfactory, demonstrating substantial equivalence to predicate devices and fitness for intended use).
Biocompatibility Testing (per ISO 10993-1)
Cytotoxicity	Passed (Results indicated no new safety or performance questions).
Acute systemic toxicity	Passed (Results indicated no new safety or performance questions).
Sensitization	Passed (Results indicated no new safety or performance questions).
Hemocompatibility	Passed (Results indicated no new safety or performance questions).
Irritation/intracutaneous reactivity	Passed (Results indicated no new safety or performance questions).
Material Suitability	Evaluated through bench testing and biomaterial assessments. The materials are commonly used in vascular access devices, and the evaluation found no new safety or performance concerns.

Study Proving Device Meets Acceptance Criteria:

The Benelli Access Device demonstrates substantial equivalence to predicate devices (K021120 Arrow Arterial Catheterization Device and K032843 Nexiva Closed IV Catheter System) based on comparisons of functionality, technological characteristics, and Indications for Use. The device design was qualified through a series of design verification tests and biocompatibility assessments.

Details on the Study:

The document describes the following types of studies:

Design Verification Testing (Bench Testing): This involved a series of tests to ensure the device's physical and mechanical properties met the pre-defined specifications. These tests included insertion force, radiopacity, liquid leak, aspiration, tensile strength, corrosion resistance, and kink resistance. The report states that the "Results of the design verification testing ... did not raise new safety or performance questions." This implies the device met its pre-established performance criteria for these parameters.
Biocompatibility Testing: Conducted per ISO 10993-1, this testing evaluated the biological response to the device materials. Specific tests included cytotoxicity, acute systemic toxicity, sensitization, hemocompatibility, and irritation/intracutaneous reactivity. Similar to design verification, the report indicates that "biomaterial assessments did not raise new safety or performance questions," meaning the device materials were found to be safe for their intended biological contact.
Material Suitability Evaluation: While not a "study" in the traditional sense, the document mentions an evaluation of material suitability for clinical use. This involved reviewing the common use of the selected materials in vascular access devices and confirming their appropriateness through bench testing and biomaterial assessments.

Not Applicable (N/A) Categories for this Device (as it is not an AI/ML system):

The following points are not applicable as this document describes a traditional medical catheter and not a diagnostic AI/ML algorithm.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No patient data or "test set" in the context of an AI/ML algorithm was used).
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): N/A (Ground truth from experts is not applicable to a physical device's performance testing).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device is the pre-defined engineering specifications and ISO standards for device performance and biocompatibility.
The sample size for the training set: N/A (No training set for an AI/ML algorithm).
How the ground truth for the training set was established: N/A.

Summary

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510(k) Summary 2

Date Prepared: May 11, 2011

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763-656-4300; Fax: 763-656-4250 Establishment Registration # 2134812

Contact Person Jennifer Ruether Sr. Regulatory Product Specialist

General Information

Trade Name	Benelli Access Device
Common / Usual Name	Catheter, percutaneous
Classification Name	870.1250; DQY; Percutaneous catheter; Class II
Predicate Devices	K021120 Arrow Arterial Catheterization Device (ArrowInternational, Inc.
Predicate Devices	K032843 Nexiva Closed IV Catheter System (BectonDickinson Infusion Therapy Systems, Inc.)

Device Description

The Benelli Access Device is sold as part of an intravascular catheterization kit. This kit includes the following components:

. Benelli Access Device (4 F x 6.9 cm catheter with sidearm tubing and 3-way stopcock)
Intraluminal protection system (needleless access port)
21 G x 9 cm echogenic needle .
. 0.018" x 40 cm guidewire.

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Intended Use / Indications

The Benelli is intended for use in accessing the peripheral vasculature.

Technological Characteristics

The Benelli Access Device is similar to the predicate devices in design and performance. The three devices consist of the over-the-needle catheter design and are available in similar dimensions. The Benelli Access Device and the Nexiva Closed IV Catheter System both have additional access points to allow for device flushing and fluid delivery. The Benelli Access Device utilizes different materials of construction from the predicate devices; however, these materials are commonly used in vascular access devices. Material suitability for the intended clinical use was evaluated through bench testing and biomaterial assessments.

Substantial Equivalence and Summary of Studies

The Benelli Access Device 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:

. Insertion force
Radiopacity .
. Liquid leak
Aspiration .
Tensile
Corrosion
Kink

Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:

. Cytotoxicity
Acute systemic toxicity .
Sensitization .
Hemocompatibility ●
Irritation/intracutaneous . reactivity
Results of the design verification testing and biomaterial assessments did not raise new safety or performance questions.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MI) 20993-0002

Vascular Solutions, Inc. c/o Ms. Jennifer Ruether Sr. Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369

AUG - 1 2011

Re: K111334

Trade/Device Name: Benelli Access Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 11, 2011 Received: May 12, 2011

Dear Ms. Ruether:

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.

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Page 2 - Ms. Jennifer Ruether

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

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): K111334

Device Name: Benelli Access Device Kit

Indications for Use:

The Benelli is intended for use in accessing the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K111334

Page 1 of 1 (Posted November 13, 2003)

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).