(81 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functionality of a catheter and kit, with no mention of AI or ML.
No
The device is described as an "Access Device" intended for "accessing the peripheral vasculature." Its components and function (catheter, guidewire, needle) are for gaining entry and delivering fluids or sampling blood, not for treating a disease or condition.
No
The device is described as an "Access Device" used for accessing the peripheral vasculature for fluid delivery and blood sampling. There is no mention of it being used to diagnose conditions or processes.
No
The device description clearly outlines physical hardware components including a catheter, hub, suture wing, extension tubing, stopcock, needle, and guidewire. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "accessing the peripheral vasculature." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter and related components used for accessing blood vessels, delivering fluids, and potentially drawing blood from the patient. It does not describe a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens.
The device is clearly intended for direct clinical intervention and access to the patient's circulatory system, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Benelli is intended for use in accessing the peripheral vasculature.
Product codes
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 (Arrow |
| International, Inc. | |
| Predicate Devices | K032843 Nexiva Closed IV Catheter System (Becton |
| Dickinson Infusion Therapy Systems, Inc.) |
Device Description
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.
1
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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.
2
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.
3
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
4
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)