The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products.

Rated for maximum power injection flow rate of 6ml/s.

Device Description

The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.

AI/ML Overview

The provided text describes a 510(k) summary for the HydroMID 5F Dual Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device through bench testing. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader study or clinical performance with ground truth established by experts/pathology/outcomes data.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and performance bench testing of a physical medical device (a catheter), not a medical device software or AI algorithm. Therefore, many of the requested categories in the prompt (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device submission.

However, I can extract the information relevant to the device's performance and the "acceptance criteria" as described in the 510(k) summary for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

The document states: "All tests passed the acceptance criteria specified for both the subject and predicate devices." It does not provide specific numerical acceptance criteria or numerical reported performance values for each test. Instead, it lists the types of tests conducted.

Test Type	Acceptance Criteria (General Statement)	Reported Device Performance (General Statement)
Power injection flow rate	Not explicitly detailed, but implied to meet an acceptable standard.	Passed; supports a 6ml/s rating (higher than predicate's 3.5ml/s).
Static burst strength	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Catheter length	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Dimensional verification	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Catheter kink/resistance	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Tensile (tubing and joint)	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Particulate	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Packaging distribution	Not explicitly detailed, but implied to meet an acceptable standard.	Passed.
Sterility	Not explicitly detailed, but implied to meet an acceptable standard.	Passed. (Sterilized by ethylene oxide, as stated in Device Description)
MR compatibility	Not explicitly detailed, but implied to meet an acceptable standard (MRI Conditional).	Passed. (MRI Conditional)
Shelf-life	Not explicitly detailed, but implied to meet an acceptable standard.	Passed. (Performance demonstrated at T=0 and over shelf life).

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

Sample Size: The document states: "Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria." However, the specific numerical sample size for each test is not provided.
Data Provenance: The tests are described as "Bench Data" conducted internally by the manufacturer, Access Vascular Inc. The country of origin for the data is not explicitly stated, but the company address is Billerica, MA, which implies the testing was conducted in the United States. The data is prospective in the sense that it was generated for this 510(k) submission to demonstrate the performance of the new device design.

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

Not Applicable. This is a physical medical device. Ground truth for its performance is established by engineering and material science testing against predefined specifications, not by human expert review of images or clinical outcomes in the typical sense of AI/image analysis.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3. Testing results are objective measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

Not Applicable. This is a physical medical device (catheter), not a software or AI device intended to assist human readers.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance revolves around its physical and functional properties meeting predetermined engineering specifications and validated test methods (e.g., pressure resistance, flow rates, dimensional accuracy, material properties like tensile strength and kink resistance, sterility, and MRI compatibility). These are objective criteria, not based on expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and materials are based on established engineering principles and prior device iterations.

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

Not Applicable. See point 8.

Summary

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March 27, 2025

Access Vascular, Inc. Scott Blood Vice President, Ouality & Regulatory 749 Middlesex Turnpike Billerica, Maryland 01821

Re: K244059

Trade/Device Name: HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 27, 2025 Received: February 27, 2025

Dear Scott Blood:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K244059

Device Name

Indications for Use (Describe)

Rated for maximum power injection flow rate of 6ml/s.

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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K244059 510(k) Summary

This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.

Submitter Information

510(k) Sponsor	Access Vascular Inc.
Address	749 Middlesex Turnpike Billerica MA 01821
Contact Person(s)	Mr. Scott Blood; Vice President, Quality & Regulatory
Phone:	978.729.5978
Email:	sblood@accessvascularinc.com
Date Prepared:	February 28, 2025

Proposed Device(s)

Common/Usual Name:	Intravascular Catheter
Trade/Proprietary Name:	HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102);HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104);HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
Classification Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Classification:	880.5200
Product Code:	FOZ
Class:	II
Device Panel:	General Hospital

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Predicate Device(s)

The predicate device is the HydroMID Product Family of Midline Catheters, which was previously cleared under premarket application K220772.

Reference Device(s)

The reference device is the HydroPICC-251 5F Dual Lumen, which was previously cleared under premarket application K213550.

Device Description

Indications for Use

Rated for maximum power injection flow rate of 6ml/s.

Substantial Equivalence Discussion

The following table is a matrix of the intended use and technological characteristics between the subject device and the predicate device. The table also discusses why these differences do not introduce new or different questions of safety and effectiveness.

Specification	HydroMID 5F Dual LumenMidline CatheterProposed Device (K244059)	HydroMID 4FSingle LumenMedline Catheter(K220772)Predicate Device	Same / Differentbetween Proposedand Predicate?
Intended Use	Intended for short- or long-term peripheral access to thecentral venous system forintravenous therapy	Same	Same
Indications for Use	The HydroMID 5F Dual LumenMidline Catheter is indicated	Same	Same
Specification	HydroMID 5F Dual LumenMidline CatheterProposed Device (K244059)	HydroMID ProductFamily of MidlineCatheters (K220772)Primary Predicate Device	Same / Differentbetween Proposedand Predicate?
	for short term access (< 30days) to the peripheral venousaccess system for intravenoustherapy, including but notlimited to, the administrationof fluids, medications, and thesampling of blood and bloodproducts.Rated for maximum powerinjection flow rate of 6ml/s.
Device Classification	II	Same	Same
Product Code	FOZ	Same	Same
Regulation	21 CFR 880.5200	Same	Same
Prescription Device	Yes	Same	Same
Intended population	Adult and pediatric	Same	Same
Catheter Type	Midline Catheter (MID)	Same	Same
Catheter Outer DiameterFrench Size	5 French (1.67mm PostHydrated)	4 French (1.40mm PostHydrated)	Different
Catheter Outer Diameter assupplied	5 French (1.60mm SuppliedDry)	4 French (1.30 mm SuppliedDry)	Different
Catheter Inner Diameter	D-shaped lumens each greaterthan or equal to 0.48mm2	1mm	Different
Useable Length	20cm	Same	Same
Priming Volume	< 1.0mL	Same	Same
Guidewire Compatibility	$\text{\O}.018"$	Same	Same
Catheter Shaft Design	Taper	Same	Same
Number of Lumens	2	1	Different
Clamp ID Tag	2	1	Different
Key Device Components	Catheter shaft, suture wing,extension tube, Luer hub	Same	Same
Access	Short Term	Same	Same
Use with Power Injection andSpecified Flow Rate	Yes6ml/s	Same	Same
Specification	HydroMID 5F Dual LumenMidline CatheterProposed Device (K244059)	HydroMID ProductFamily of MidlineCatheters (K220772)Primary Predicate Device	Same / Differentbetween Proposedand Predicate?
Catheter Materials	Radiopaque hydrophilic polyolcatheter with Luer lock hub,polyurethane extensiontubing, and suture wing.	Same	Same
X-Ray Confirmation Required	Yes	Same	Same
Sterilization Method	Ethylene Oxide	Same	Same
Single Use	Yes	Same	Same
MRI Safety	MRI Conditional	Same	Same
How Supplied	Convenience Kit:Basic IR KitFull Nursing KitMaximal Barrier Kit	Same	Same
Catheter Markings	Markings (every cm)	Same	Same

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Discussion of Similarities and Differences

Similarities

Intended Use – There is no change to the intended use of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The intended use remains identical to the previously cleared predicate device.

Indications for Use - There is no change to the Indications for Use of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The Indications for Use remains identical to the previously cleared predicate device.

Classification - There is no change to the classification of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The classification remains identical to the previously cleared predicate device.

Accessories - There is no change to the accessories provided with the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The accessories remain identical to the previously cleared predicate device.

Design - While most of the design features of the predicate device are the same with the proposed devices, there are minor changes to the design of the proposed device with respect to the previouslycleared HydroMID Product Family of Midline Catheters (K220772). Any design differences are explained below.

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Materials – There is no change to the materials of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The materials remain identical to the previously cleared predicate device.

Sterility - There is no change to the sterilization or sterility of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The sterilization and sterility remain identical to the previously cleared predicate device.

Principles of Operation –There is no change to the principles of the proposed and predicate HydroMID Product Family of Midline Catheters (K220772) devices. The principles of operation remain identical to the previously cleared predicate device.

Differences

Power Injection Rating - The reference device indicates a power injection rating of 3.5 mL/s, while the subject device specifies 6.0 mL/s. Performance testing at T=0 and over the shelf life demonstrates the difference does not raise new or different questions of safety or effectiveness by this modification.

Design - There are changes to the design of the proposed device with respect to the predicate HydroMID Product Family of Midline Catheters (K220772) devices. Those changes are:

Change from 4 French outside diameter to 5 French outside diameter
Add second lumen, requiring a second Clamp ID Tag and luer fitting.
. Change lumen cross-section from circular 1mm diameter to "D"-shaped of similar cross-sectional area

The design changes from a 4Fr to a 5Fr catheter OD, an additional lumen and a different cross-sectional shape from circular to "D" shape do not raise new questions of safety and effectiveness. The power injection rating, which was tested as part of the verification of the product design. The French size is equivalent to the reference device. The addition of a second lumen is identical to that of the reference device. The need for a second Clamp ID Tag and luer fitting is identical to the reference device, which also includes a second lumen. No luer connection testing was required with the addition of this second luer fitting, as the second luer fitting is identical to the one used on the reference device, which was cleared per K213550. Both luminal area values are close in dimension and are therefore substantially equivalent. The lumen cross-section is identical to that on the reference device.

The reference device was used to leverage the specification and methods to demonstrate the differences in technological characteristics between the subject and predicate devices do not raise new or different questions of safety and effectiveness..

Bench Data

The following tests were conducted to show substantial equivalence to the predicate device:

. Power injection flow rate
. Static burst strength
Catheter length
Dimensional verification
Catheter kink/ resistance ●

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Tensile (tubing and joint) ●
Particulate
Packaging distribution
. Sterility
MR compatibility .
Shelf-life

Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria.

All testing was completed with final, finished devices that represent commercial product. All tests passed the acceptance criteria specified for both the subject and predicate devices. The results of the testing show that the subject device is substantially equivalent to the predicate device.

Conclusion

The differences in technological characteristics do not raise new or different questions of safety and effectiveness. There is no change to the intended use of the subject device compared to the predicate device. This 510(k) proposes a modification to the power injection rating specification similar to that of the reference device (HydroPICC- 251 5Fr Dual Lumen K213550). Performance data provided in this submission demonstrates that the modification of the power injection rating is supported, and the subject and predicate devices can be considered substantially equivalent.

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).