(86 days)
No
The summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The testing focuses on physical properties and equivalence to a predicate device.
No
Explanation: The device is a midline catheter used for intravenous therapy, fluid administration, medication administration, and blood sampling. While it facilitates medical treatment, it does not itself provide a therapeutic effect or treat a disease. Its function is to provide access for other therapeutic interventions.
No
The device is a midline catheter used for intravenous therapy, fluid and medication administration, and blood sampling. Its intended use is for therapeutic and access purposes, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter and associated hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "short term access (
N/A
Intended Use / Indications for Use
The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (
§ 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).
0
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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
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)
Indications for Use (Describe)
The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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
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.
Indications for Use
The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (