HydroPICC 5F Dual Lumen Catheter
Device Facts
| Record ID | K213550 |
|---|---|
| Device Name | HydroPICC 5F Dual Lumen Catheter |
| Applicant | Access Vascular, Inc. |
| Product Code | LJS · General Hospital |
| Decision Date | May 4, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
Device Story
HydroPICC 5F Dual Lumen Catheter is a peripherally inserted central catheter (PICC) used for central venous access. Device consists of radiopaque hydrophilic polyol catheter shaft, suture wing, Luer lock hubs, and polyurethane extension tubes. Used in clinical environments by healthcare professionals for fluid/medication administration, blood sampling, pressure monitoring, and power injection of contrast media. Device provides two D-shaped lumens to facilitate dual-channel access. Effectiveness in reducing thrombus accumulation is noted via in vivo models. Clinicians insert the catheter peripherally to reach the central venous system; output is the delivery or sampling of fluids/medications. Benefits include reliable venous access and reduced thrombus formation compared to standard catheters.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including compliance with EN ISO 10555-1/3, EN ISO 13868, and MRI safety standards (ASTM F2052, F2182, F2213, F2119). Biocompatibility evaluated per ISO 10993-1. Sterility validated via Ethylene Oxide (ISO 11135-1). Shelf-life validated via accelerated aging (ASTM F1980-16).
Technological Characteristics
5F dual-lumen PICC; radiopaque hydrophilic polyol catheter shaft; polyurethane extension tubing; Luer lock hub; suture wing. Sterilized via Ethylene Oxide (SAL 10^-6). MRI conditional. Power injection rated to 3.5 ml/s. Complies with EN ISO 10555-1/3, EN ISO 13868, ASTM F2052, F2182, F2213, F2119, F88/F88-15, F2096, and F1980-16.
Indications for Use
Indicated for adult patients requiring short- or long-term peripheral access to the central venous system for intravenous therapy, including fluid/medication/nutrient administration, blood sampling, central venous pressure monitoring, and power injection of contrast media at a maximum flow rate of 3.5ml/s.
Regulatory Classification
Identification
A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Predicate Devices
- HydroPICC-142 Catheter (K193015)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2022
Access Vascular Inc Brian Hanley VP, R&D and Operation 749 Middlesex Turnpike Billerica, Massachusetts 01820
## Re: K213550
Trade/Device Name: HydroPICC 5F Dual Lumen Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: April 29, 2022 Received: May 2, 2022
# Dear Brian Hanley:
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. 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 located 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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,
Payal Patel 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
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K213550
Device Name HydroPICC 5F Dual Lumen Catheter
Indications for Use (Describe)
Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
Rated for maximum power injection flow rate of 3.5ml/s
Type of Use (Select one or both, as applicable)
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> 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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the words "ACCESS VASCULAR" stacked on top of each other. The "A" in "ACCESS" is stylized with a line extending down and to the left, creating a visual element that resembles a vascular pathway. The word "ACCESS" is in a darker shade of blue than the word "VASCULAR."
## K213550 510(k) Summary
#### Preparation Date: May 5, 2022
#### Submitter:
Access Vascular Inc. 749 Middlesex Turnpike Billerica, MA 01820
#### Contact:
Brian M. Hanley VP, R&D and Operations Tel: 781.538.6594 x101
#### Subject Device
| Trade Name: | HydroPICC 5F Dual Lumen Catheter |
|-----------------------|-----------------------------------------------------------|
| Manufacturer: | Access Vascular Inc. |
| Common Name: | Intravascular Catheter |
| Regulation: | 21 CFR 880.5970 |
| Regulation Name: | Percutaneous, Implanted, Long Term Intravascular Catheter |
| Regulatory Class: | II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |
#### Predicate Device:
| 510(k) Reference: | K193015 |
|-------------------|------------------------|
| Trade Name: | HydroPICC-142 Catheter |
#### Device Description
The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.
HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
#### Indication for Use
| Characteristics | Predicate Device<br>HydroPICC-142 | Subject Device<br>HydroPICC-251 |
|---------------------|---------------------------------------------------------------------------------------------|---------------------------------|
| | K193015 | K213550 |
| Indications for Use | Indicated for short- or long-<br>term peripheral access to the<br>central venous system for | Same |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the word "ACCESS" in a bold, sans-serif font. Below "ACCESS" is the word "VASCULAR" in a similar font, but in a lighter shade of blue. The "A" in "ACCESS" has a line extending from the left side of the "A" to the top of the "V" in "VASCULAR".
| | intravenous therapy, including<br>but not limited to the<br>administration of fluids,<br>medications, and nutrients; the<br>sampling of blood; central<br>venous pressure monitoring;<br>and power injection of contrast<br>media.<br><br>Rated for a maximum power<br>injection flow rate of 3.5ml/s | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Prescription Only or<br>Over the counter | Prescription Only | Same |
## Discussions of differences in Indications for Use statement:
The indications for use statement for the subject device is identical to the predicate device. The HydroPICC 5F Dual Lumen Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the HydroPICC 5F Dual Lumen Catheter can be considered substantially equivalent to the predicate device.
## Technological Characteristics
The following table shows a comparison of the technological characteristics between the HydroPICC 5F Dual Lumen Catheter and the cited predicate is sufficient detail to provide an understanding of the basis for determining substantial equivalence.
| Technological Characteristics | Predicate Device | Subject Device | Comment |
|----------------------------------------|--------------------------------------------------|-------------------------------------------------------------|---------------------------------|
| | HydroPICC-142 4F<br>K193015 | HydroPICC-251 5F DL<br>Catheter K213550 | |
| Device Classification | II | II | Same |
| Product Code | LJS | LJS | Same |
| Regulation | 21 CFR 880.5970 | 21 CFR 880.5970 | Same |
| Prescription Device | Yes | Yes | Same |
| Intended population | Adult | Adult | Same |
| Catheter Type | Peripherally Inserted<br>Central Catheter (PICC) | Peripherally Inserted<br>Central Catheter (PICC) | Same |
| Catheter Outer Diameter<br>French Size | 4 French (1.40mm)<br>(Post Hydrated) | 5 French (1.67 mm)<br>(Post Hydrated) | Difference: see<br>comment # 1 |
| Catheter Outer Diameter as<br>supplied | 1.30 mm<br>(Supplied dehydrated) | 1.60 mm<br>(Supplied dehydrated) | Difference - see<br>comment # 1 |
| Catheter Inner Diameter | 1mm | D-shaped lumens each<br>greater than or equal to<br>0.48mm² | Difference - see<br>comment # 2 |
| Useable Length | 55cm | Same | Same |
| Priming Volume | < 1.0mL | Same | Same |
| Guidewire Compatibility | ∅.018" | ∅.018" | Same |
| Catheter Shaft Design | Taper | Taper | Same |
| Number of Lumens | 1 | 2 | Difference - see<br>comment # 2 |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Access Vascular. The word "ACCESS" is in a dark blue, sans-serif font. Below it, "VASCULAR" is in a lighter blue, also in a sans-serif font. The "V" in "VASCULAR" is stylized to look like a medical device, possibly a catheter or a similar vascular access tool.
| Key Device Components | Catheter shaft, suture<br>wing, extension tube,<br>Luer hub | Catheter shaft, suture<br>wing, extension tube,<br>Luer hub | Same |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------|
| Short- or Long-Term Access | Yes | Yes | Same |
| Use with Power Injection and<br>Specified Flow Rate | Yes | Yes | Same |
| | 3.5 ml/s | 3.5 ml/s | Same |
| Static Burst Pressure | Average max pressure<br>exceeds power<br>injection pressure | Average max pressure<br>exceeds power<br>injection pressure | Same |
| Catheter Materials | Radiopaque hydrophilic<br>polyol catheter with<br>Luer lock hub,<br>polyurethane extension<br>tubing, and suture wing | Radiopaque hydrophilic<br>polyol catheter with<br>Luer lock hub,<br>polyurethane extension<br>tubing, and suture wing | Same |
| X-Ray Confirmation Required | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use | Yes | Yes | Same |
| MRI Safety | MRI Conditional | MRI Conditional | Same |
| How Supplied | Convenience Kit:<br>Basic IR Kit<br>Full Nursing Kit<br>Maximal Barrier Kit | Convenience Kit:<br>Basic IR Kit<br>Full Nursing Kit<br>Maximal Barrier Kit | Same |
Discussions of differences in technological characteristics:
## Comment #1 - French Size:
The subject device is 1 French size larger in diameter than the single lumen predicate device because a larger diameter was needed to accommodate the introduction of a second lumen. The subject device provides clinicians with the option of a second lumen for the same intended use as predicate device. The difference in French size between the subject device and predicate device are minor and do not raise any different questions of safety and effectiveness as determined through performance testing.
## Comment #2 - Lumen Configuration:
The subject device is provided with two d-shaped lumens as compared to the single, round lumen of the predicate device because the subject device is a dual lumen catheter which requires a different lumen configuration and inner diameter to accommodate the second lumen. The difference in lumen configuration between the subject device and predicate device are minor and do not raise any different questions of safety and effectiveness as determined through performance testing.
#### Performance Testing
The sterile single lumen HydroPICC 5 F Dual lumen Catheter (PICC 251) described in this summary was tested and demonstrated to be in conformance with the following FDA recognized standards.
- . EN ISO 10555-1:2013 – Intravascular Catheters – Sterile and Single Use Catheters Part 1: General Requirements
- . EN ISO 10555-3:2013 – Intravascular Catheters – Sterile and Single Use Catheters Part 3: Central Venous Catheters
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the word "ACCESS" in a bold, sans-serif font. Below the word "ACCESS" is a stylized image of a blood vessel, with the word "VASCULAR" written in a similar font to "ACCESS". The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
- . EN ISO 13868:2014 Catheters – Test Method for Kinking of Single Lumen Catheters and Medical Tubing
- . ASTM F2052:2015 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- . ASTM F2182: 2011 "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213: 2017 "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
- ASTM F2119: 2013 "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"
## Biocompatibility
The biocompatibility of the HydroPICC is both direct blood path. The catheter body (radiopaque hydrophilic polyol) is direct body contact for greater than 30days and Luer lock hub, polyurethane extension tubing, and suture wing are external body contacting for greater than 30 days. evaluation of the HydroPICC in accordance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process."
## Sterility, Shipping, and Shelf-life
- The HydroPICC Catheter is sterility Assurance Level (SAL) of 10-6 via a validated overkill Ethylene Oxide (EO) method. This validated cycle meets the requirements of ISO 11135-1 as determined through AAMI TIR28:2016 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization
- . Package integrity testing, after environmental conditioning and simulated transportation complies to ISTA 3A:2016 (Packaged Products for Parcel Delivery System Shipment 70kg (150 Ib.) or Less) and ASTM D4169 to demonstrate protection of product and sterility maintenance.
- . All labeling was evaluated according to ISO 15223-1:2016 (Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General Requirements) and the subject device was determined to have the appropriate labeling.
- . Sterile Barrier Packaging Testing complies to Seal strength ASTM F88/F88-15 and Detecting Gross Leaks ASTM F20965
- . Shelf life 13 months is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
## Conclusion:
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the HydroPICC 5F Dual Lumen Catheter is substantially equivalent to the predicate device, the HydroPICC-142 4F Catheter cleared by K193015.
