HydroPICC

K172885 · Access Vascular, Inc. · LJS · Feb 20, 2018 · General Hospital

Device Facts

• Record ID: K172885
• Device Name: HydroPICC
• Applicant: Access Vascular, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Feb 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous 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. HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec.

Device Story

HydroPICC is a 4Fr, 55cm peripherally inserted central catheter (PICC) designed for short- or long-term access to the superior vena cava. The device is supplied in a kit containing insertion and maintenance accessories, including a tear-away introducer, guidewire, and adhesive fixation device. It is operated by healthcare professionals in clinical settings. The catheter body is composed of a hydrophilic polyol material, which is designed to reduce thrombosis accumulation. The device supports power injection of contrast media at flow rates up to 3.5 mL/sec. Healthcare providers use the catheter for intravenous therapy, blood sampling, and pressure monitoring. By reducing thrombus formation, the device aims to improve catheter performance and patient outcomes during venous access.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility testing (ISO 10993-1) and extensive mechanical testing (power injection flow, burst strength, kink/flex resistance, tensile strength, and catheter compatibility). Thrombus accumulation was evaluated using in vitro blood loop and in vivo models.

Technological Characteristics

4Fr, 55cm PICC; hydrophilic polyol catheter body; radiopaque; single lumen. Sterilized via Ethylene Oxide (ISO 11135-1). Accessories include tear-away introducer, guidewire, and adhesive fixation device. Rated for power injection up to 3.5 mL/sec.

Indications for Use

Indicated for 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.

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

• NMI PICC III, currently marketed as the BioFlo PICC (K121089)
• Spectrum Silicone Peripherally Inserted Central Venous Catheter (PICC) (K021557)

Reference Devices

• Bard StatLock (K943147)

Submission Summary (Full Text)

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February 20, 2018

Access Vascular, Inc Elizabeth Kinnal Senior Regulatory Affairs Specialist and Quality Engineer 175 Middlesex Turnpike Bedford, Massachusetts 01730

Re: K172885

Trade/Device Name: HydroPICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: January 10, 2018 Received: January 11, 2018

Dear Elizabeth Kinnal:

We have reviewed vour 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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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 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172885

Device Name HydroPICC

Indications for Use (Describe)

HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intrapy, 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.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the word "ACCESS" in a darker shade of blue on top of the word "VASCULAR" in a lighter shade of blue. The "A" in "ACCESS" is stylized with a line extending down and to the left, connecting to the "V" in "VASCULAR".

# 510(k) Summary for the HydroPICC PICC

Date prepared: 16 February, 2018

# Submitter:

Access Vascular, Inc. 175 Middlesex Turnpike Bedford, MA 01730 Tel. [phone]

### Contact:

Elizabeth Kinnal Access Vascular, Inc. Tel. [phone]

## Subject Device

| Trade Name: | HydroPICC |
|-----------------------|------------------------|
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5970 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |

#### Predicate Devices

| Trade Name: | NMI PICC III, currently marketed as the BioFlo PICC |
|-----------------------|-----------------------------------------------------|
| Manufacturer: | Navilyst Medical, Inc. |
| 510(k) Reference: | K121089 |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5970 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |

The predicate has not been subject to a design-related recall.

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| Trade Name: | Spectrum Silicone Peripherally Inserted Central Venous Catheter (PICC) |
|-----------------------|------------------------------------------------------------------------|
| Manufacturer: | Cook Medical |
| 510(k) Reference: | K021557 |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5200 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |

The predicate has not been subject to a design-related recall.

# Device Description

The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC). HydroPICC has been shown to be effective in reducing thrombosis accumulation. Reduction of thrombosis accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombosis formation.. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter. The following accessories are provided with the HydroPICC:

- Tear-away Introducer ●
- Introducer needle .
- Guidewire ●
- Male Cap Plug .
- 60cm. Paper Tape Measure ●
- Needle-Free Valve ●
- Luer Lock Syringe ●
- Adhesive Fixation Device Bard StatLock (Venetec, K943147) ●
- Scalpel ●
- Transparent Film Dressing ●

# Indications for Use

HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous 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.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec.

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The Indications for Use statement for the HydroPICC is identical to the predicate device (K121089).

## Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of the HydroPICC are substantially equivalent to the predicate, the Navilyst BioFlo (K121089) in terms of intended use, application, user population, basic design, performance, and labeling.

Briefly, both the subject and predicate device are,

- . intended for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.
- available in 4 French size
- . rated for maximum power injection flow rate up to 3.5ml
- . available kitted with a range of procedural accessories for user convenient; and
- . demonstrates reduction of thrombosis accumulation using in vitro and in vivo models.

The only difference between the subject device and the K121089 predicate is the composition of the catheter body, however the results of biocompatibility and mechanical testing and evaluation of compatibility with sterilization, demonstrate the subject device raises no additional questions related to safety or effectiveness. In addition, the subject device and predicate device were tested concurrently in the Catheter Thrombus Accumulation Using in vitro Blood Loop and Catheter Compatibility with Medications testing, and the results demonstrate that the proposed device is substantially equivalent to the predicate device with regard to catheter body performance.

| Specification | BioFlo PICC<br>with ENDEXO<br>Technology<br>Angiodynamics<br>K121089 | Spectrum Silicone<br>Catheter<br>COOK<br>K021557 | HydroPICC<br>Access Vascular<br>PICC-141 | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for<br>short- or long-<br>term peripheral<br>access to the<br>central venous<br>system for<br>intravenous<br>therapy. | The COOK<br>Spectrum@<br>Silicone Catheter is<br>used for the<br>intravenous<br>administration of<br>nutrient fluids,<br>chemotherapeutic<br>agents and other<br>drugs for therapy,<br>blood sampling, | Same as<br>K121089,<br>Substantially<br>equivalent to<br>K01557.<br>Difference does<br>not raise<br>additional safety<br>or effectiveness<br>questions. Intended for short-<br>or long-term<br>peripheral access<br>to the central<br>venous system for<br>intravenous<br>therapy. | |
| Specification | BioFlo PICC<br>with ENDEXO<br>Technology<br>Angiodynamics<br>K121089 | Spectrum Silicone<br>Catheter<br>COOK<br>K021557 | HydroPICC<br>Access Vascular<br>PICC-141 | |
| | | blood delivery, and<br>venous pressure<br>monitoring. The<br>catheter is<br>impregnated with<br>the<br>antimicrobials<br>minocycline and<br>rifampin to help<br>provide protection<br>against catheter<br>related<br>bloodstream<br>infections (CRBSI).<br>It is not intended to<br>be used as a<br>treatment for<br>existing infections.<br>Catheters are<br>available in single<br>and double lumen<br>PICC; and<br>single, double and<br>triple lumen CVC.<br>The device is<br>supplied sterile and<br>intended for one-<br>time use. | | |
| Indication for<br>Use | BioFlo is<br>indicated for<br>short- or long-<br>term peripheral<br>access to the<br>central venous<br>system for<br>intravenous<br>therapy, including<br>but not limited to;<br>the administration<br>of fluids,<br>medications, and<br>nutrients; the<br>sampling of blood; | The COOK<br>Spectrum@ Silicone<br>Catheter is used for<br>the intravenous<br>administration of<br>nutrient fluids,<br>chemotherapeutic<br>agents and other<br>drugs for therapy,<br>blood sampling,<br>blood delivery, and<br>venous pressure<br>monitoring. The<br>catheter is | HydroPICC is<br>indicated for short-<br>or long-term<br>peripheral access to<br>the central venous<br>system for<br>intravenous therapy,<br>including but not<br>limited to; the<br>administration of<br>fluids, medications,<br>and nutrients; the<br>sampling of blood;<br>central venous<br>pressure<br><br>Same as<br>K121089,<br>Substantially<br>equivalent to<br>K01557.<br>Difference does<br>not raise<br>additional safety<br>or effectiveness<br>questions. | |
| Specification | BioFlo PICC<br>with ENDEXO<br>Technology<br>Angiodynamics<br>K121089 | Spectrum Silicone<br>Catheter<br>COOK<br>K021557 | HydroPICC<br>Access Vascular<br>PICC-141 | |
| | central venous<br>pressure<br>monitoring; and<br>power injection of<br>contrast media. | antimicrobials<br>minocycline and<br>rifampin to help<br>provide protection<br>against catheter-<br>related<br>bloodstream<br>infections (CRBSI). It<br>is not intended to be<br>used as a treatment<br>for existing<br>infections. Catheters<br>are available in single<br>and double lumen<br>PICC; and single,<br>double and triple<br>lumen CVC. | monitoring; and<br>power injection of<br>contrast media. | |
| Device Class | Class II | Class II | Class II | |
| Product Code | LJS | LJS | LJS | |
| Regulation<br>Number | 880.5970 | 880.5970 | 880.5970 | |
| Prescription<br>Device | Yes | Yes | Yes | |
| Catheter<br>Type | Peripherally<br>Inserted Central<br>Catheter (PICC) | Peripherally Inserted<br>Central Catheter<br>(PICC) | Peripherally<br>Inserted Central<br>Catheter (PICC) | |
| Catheter<br>Outer<br>Diameter | 4 French | 4 French | 4 French | |
| Catheter<br>Inner<br>Diameter | 0.90mm | 0.66mm | 0.90mm | |
| Usable<br>Catheter<br>Length | 55cm | 60cm | 55cm | |
| Specification | BioFlo PICC<br>with ENDEXO<br>Technology<br>Angiodynamics<br>K121089 | Spectrum Silicone<br>Catheter<br>COOK<br>K021557 | HydroPICC<br>Access Vascular<br>PICC-141 | |
| | | | | not raise<br>additional safety<br>or effectiveness<br>questions. |
| Guidewire<br>compatibility | 0.018" | 0.018" | 0.018" | Same |
| Catheter<br>Shaft Design | With taper | No taper | No taper | Same as<br>K021557,<br>Substantially<br>equivalent to<br>K121089. Blood<br>loop testing with<br>K121089<br>demonstrated no<br>impact on safety<br>or effectiveness. |
| Number of<br>Catheter<br>Lumens | Single | Single | Single | Same |
| Key Device<br>Components | Catheter Shaft,<br>Suture Wing,<br>Extension Tube,<br>Luer Hub | Catheter Shaft, Suture<br>Wing, Extension<br>Tube, Luer Hub | Catheter Shaft,<br>Suture Wing,<br>Extension Tube,<br>Luer Hub | Same |
| Short or<br>Long Term<br>Access | Yes | Yes | Yes | Same |
| Use with<br>Power<br>Injection<br>Power<br>Settings Flow<br>Rate | Yes<br>Flow rate:<br>3.5mL/sec | No | Yes<br>Flow rate:<br>3.5mL/sec | Same as<br>K121089. |
| X-Ray<br>Confirmation<br>Required | Yes | Yes | Yes | Same |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use | Yes | Yes | Yes | Same |
| Length<br>Marking | Yes | No | No | Same as<br>K021557,<br>Substantially<br>equivalent to<br>K121089.<br>Labeling for<br>HydroPICC |
| Specification | BioFlo PICC<br>with ENDEXO<br>Technology<br>Angiodynamics<br>K121089 | Spectrum Silicone<br>Catheter<br>COOK<br>K021557 | HydroPICC<br>Access Vascular<br>PICC-141 | |
| Catheter<br>Materials | Radiopaque,<br>polyurethane<br>catheter with luer<br>lock hub,<br>polyurethane<br>extension tube,<br>and suture wing | Radiopaque silicone<br>catheter with luer<br>lock hub, with<br>extension tube and<br>suture wing | Radiopaque,<br>hydrophilic polyol<br>catheter with luer<br>lock hub,<br>polyurethane<br>extension tube, and<br>suture wing | includes sizing<br>information<br>similar to<br>K021557.<br>Therefore, no<br>impact on safety<br>or effectiveness.<br>Substantially<br>equivalent.<br>Testing<br>described above<br>demonstrated no<br>impact on safety<br>or effectiveness. |
| Ink | MD-1001 No-Tox<br>Medical Device<br>Ink, NT 16 Black<br>w/ MD01210<br>Reducer | Not present | Not present | Same as<br>K021557.<br>Biocompatibility<br>testing of the<br>proposed device<br>demonstrated no<br>impact on safety<br>or effectiveness. |
| How supplied | Convenience kit | Convenience kit | Convenience kit | Same |

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# Performance Data

The following performance data were provided in support of the substantial equivalence determination:

#### Biocompatibility Testing

The biocompatibility evaluation of the HydroPICC was conducted 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." The battery of testing included the following tests:

- Cytotoxicity ●
- Intracutaneous reactivity ●
- Sensitization ●
- Intramuscular Implant
- Pyrogenicity ●
- Chemical Extractables ●
- In vivo thrombogenicity ●

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#### Mechanical Testing

- Power Injection Flow Rate .
- Static Burst Strength ●
- Lifecycle Power Injections ●
- Gravity Flow Rate ●
- Catheter Length ●
- Priming Volume ●
- Dimensional Verification (including ID, OD, Length) ●
- Catheter Kink/Flex Resistance (including Elongation, Stiffness, Flex Life Strength) ●
- Alcohol Compatibility
- Catheter Marking & Identification/Radio Detectability Testing ●
- Tensile Testing (of Catheter and Assembly)
- Catheter Compatibility with Medications
- Catheter Thrombus Accumulation Evaluation Using in Vitro Blood Loop ●
- Catheter Collapse Resistance ●
- Central Venous Pressure Monitoring ●
- Pyrogens testing (Limulus Amoebocyte Lysate and Material Mediated) ●

## Sterilization

The HydroPICC Catheter is sterility Assurance Level (SAL) of 10 via a validated overkill Ethylene Oxide (EO) method. This validated cycle meets the requirements of ISO 11135-1.

# Conclusion

Based on the intended use, technological characteristics, and performance testing, the HydroPICC device meets the requirements that are considered sufficient for its intended use as compared to the predicate devices cited. Therefore, the subject device is substantially equivalent to the predicates.