The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (< 30 days) to sample blood, monitor blood pressure, and administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath® Midline is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 7mL/second.

Device Description

The AccuCath® Midline Catheter System has a usable length catheter of 3.1 inches in multiple Gauge sizes. The device(s) are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath® Midline is substantially equivalent functional characteristics and design to the predicates [Bard Access PowerGlide™ Device (K121073) and AccuCath® BC (K140504)]. The AccuCath® Midline catheter hub is identical in design to that of the AccuCath® BC's catheter's hub. including the built-in blood control septum. Additionally, the AccuCath® Midline, like the AccuCath® BC (K140504) predicate, consists of a radiopaque catheter with a blood control valve mechanism that is delivered over a guidewire with atraumatic coiled tip design; a notched needle to enhance flashback visualization, and a body / handle that serves as an integrated safety container to mitigate the risk of sharps injuries. The AccuCath® Midline is identical to the AccuCath BC® in that it features a septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure male luer connection is made. The flow path will remain opened once a secure male luer connection has been made.

AI/ML Overview

This document is a 510(k) summary for the AccuCath® Midline Catheter System, seeking substantial equivalence to existing predicate devices. It focuses on the device's design, intended use, and bench testing to demonstrate its safety and effectiveness.

Based on the provided text, there is NO study described that assesses the device's clinical performance in terms of acceptance criteria, such as accuracy, sensitivity, or specificity, which would be typical for an AI/algorithm-driven device. The document primarily discusses the device's physical and functional characteristics and bench testing against established standards for medical devices.

Therefore, I cannot provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics for an AI device.

However, I can provide information based on the "Performance Data" section of the document, which focuses on bench testing and adherence to standards for medical devices.

Here's an analysis based on the provided document, focusing on the absence of information relevant to AI-driven device performance and the presence of information related to traditional medical device testing:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI study (e.g., sensitivity, specificity, accuracy). Instead, it lists standards against which the device was tested. The "performance" mentioned refers to the device successfully meeting the requirements of these standards.

Acceptance Criteria (from standards)	Reported Device Performance
Biocompatibility:
ISO 10993-1:2009 (Biological Evaluation)	Demonstrated substantial equivalence to predicates in terms of safety and effectiveness. (Implies meeting biocompatibility requirements)
Packaging & Sterilization:
ASTM D4169-09 (Performance Testing of Shipping Containers)	Met (Implied by "demonstrates substantial equivalence" and listing the standard)
ASTM F88/F88M-09 (Seal Strength)	Met (Implied)
ASTM F1929 (Detecting Seal Leaks)	Met (Implied)
ASTM F1980-07 (2011) (Accelerated Aging)	Met (Implied)
ISO 11607-1:2009 (Packaging for Terminally Sterilized Medical Devices)	Met (Implied)
Functional/Physical Characteristics:
ISO 594-1:1986 (Conical Fittings, Luer)	Met (Implied)
ISO 594-2:1998 (Conical Fittings, Lock)	Met (Implied)
ISO 7864:1993 (Sterile Hypodermic Needles)	Met (Implied)
ISO 9626:1991 (Stainless Steel Needle Tubing)	Met (Implied)
ISO 10555-1:2013 (Intravascular Catheters - General)	Met (Implied)
ISO 10555-5:2013 (Intravascular Catheters - Over-Needle Peripheral)	Met (Implied)
Guidance Document No. 934 (Sharps Injury Prevention)	Met (Implied by device description of integrated safety container)

Note: The document states "Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrates the AccuCath® Midline Cather is substantial equivalence, in terms of the safety and effectiveness, to the referenced predicate devices." This implies that the device met the requirements of the listed standards, but specific numerical results are not provided.

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 applicable/not provided as the "performance data" refers to bench testing against engineering and material standards, not a clinical study on a patient test set for an AI/algorithm.

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/not provided. Ground truth in the context of expert review for diagnostic/AI performance is not relevant to the bench testing described.

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

This information is not applicable/not provided. Adjudication methods are used for resolving disagreements in expert ground truth, which is not relevant to the bench testing described.

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/not provided. No MRMC study or study involving human readers with or without AI assistance is mentioned.

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

This information is not applicable/not provided. This device is a physical medical catheter, not an algorithm, so a standalone algorithm performance study is not relevant.

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

This information is not applicable/not provided for the type of "performance data" presented. The "ground truth" for the bench testing would be the specifications and requirements defined by the referenced ASTM and ISO standards.

8. The sample size for the training set

This information is not applicable/not provided. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided. Not an AI/ML algorithm.

In summary: The provided document is a 510(k) summary for a physical medical device, the AccuCath® Midline Catheter System. The "performance data" described pertains to standard bench testing and compliance with material, manufacturing, and design standards, not to the performance of an AI/algorithm-driven device or clinical outcomes. Therefore, most of the requested points, which are highly specific to AI/ML device evaluation, are not applicable to this document.

Summary

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

January 8,2015

Vascular Pathways, Inc. Mr. Scott Pease Vice President Regulatory Affairs and Quality Assurance 1847 Trade Center Way Naples, Florida 34109

Re: K142136

Trade/Device Name: AccuCath® Midline Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 20, 2014 Received: November 24, 2014

Dear Mr. Pease:

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 - Mr. Pease

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/Resourcesfor You/Industry/default.htm. 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,

Susan Runno, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K142136

Device Name

AccuCath® Midline Catheter System

Indications for Use (Describe)

The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (< 30 days) to sample blood pressure, and administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath® Midline is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 7mL/second.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) SUMMARY

AccuCath® Midline Catheter System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Vascular Pathways, Inc. 1847 Trade Center Way Naples, FL 34109

Cell: 678-689-8010 Office: 239-254-0391 Fax: 239-513-1533

Contact Person: Scott Pease, VP of Regulatory Affairs and Quality Assurance (spease@vascularpathways.com)

Date Prepared: July 31, 2014

Name of Device	AccuCath® Midline Catheter System
----------------	-----------------------------------

Classification Name Intravascular Catheter

Product Code / Regulation FOZ / 21 CFR § 880.5200

Classification Class 2

Predicate Devices

Bard Access PowerGlide™ Device (K121073) Vascular Pathways, Inc., AccuCath® BC Intravascular Catheter System (K140504)

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Indications for Use

Device Description / Technological Characteristics

Performance Data

Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrates the AccuCath® Midline Cather is substantial equivalence, in terms of the safety and effectiveness, to the referenced predicate devices. In vitro bench testing included an assessment of all design input requirements and confirmation that the output of the design process met all design input requirements was completed, including those relating to appropriate standards, as follows:

ASTM D4169-09 - Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F88/F88M-09 - Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1929 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-07 (2011) - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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. Guidance Document No. 934 - Medical Devices with sharps injury prevention features (August 9, 2005)
ISO 594-1:1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and ● Certain Other Equipment - Part 1: General Requirements
o ISO 594-2:1998 – Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
ISO 7864:1993 - Sterile Hypodermic Needles for Single Use
. ISO 9626:1991 – Stainless Steel Needle Tubing for Manufacture of Medical Devices
o ISO 10555-1:2013 – Sterile, Single Use Intravascular Catheters - Part 1: General Requirements
o ISO 10555-5:2013 - Sterile, Single Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters
ISO 10993-1:2009 – Biological Evaluation of Medical Devices- Part I: Evaluation and Testing
o ISO 11607-1:2009 – Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems, and packaging systems

Summary of Substantial Equivalence

Based upon the device description, technical characteristics and test data provided within this submission, the AccuCath® Midline Catheter System is substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).