Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (PICC catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes.
The device is a peripherally inserted central catheter (PICC) used for administering fluids, medications, and nutrients, as well as for blood sampling and central venous pressure monitoring, which are all therapeutic interventions.

Diagnostic

No
Explanation: The device, HydroPICC, is a catheter used for administering fluids, medications, nutrients, sampling blood, and monitoring central venous pressure. It is a therapeutic and access device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a peripherally inserted central catheter (PICC), which is a physical medical device, not software. The performance studies also focus on physical and mechanical properties of the catheter.

IVD (In Vitro Diagnostic)

Based on the provided information, the HydroPICC is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly describes a device for direct patient access to the central venous system for administering substances, sampling blood from the patient, and monitoring pressure within the patient. This is an in-vivo application.
Device Description: The description details a catheter inserted into the body.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body to provide information about a physiological state, health, or disease. While it mentions "in vitro and in vivo models" for evaluating thrombosis accumulation, this refers to testing the device's properties, not its intended use as a diagnostic tool for patient samples.

IVD devices are specifically designed to be used on specimens (like blood, urine, tissue) taken from the human body to provide diagnostic information. The HydroPICC's function is to provide access to the body for various medical procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LJS

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

central venous system, superior vena cava (SVC)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121089, K021557

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	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. 781-538-6594

Contact:

Elizabeth Kinnal Access Vascular, Inc. Tel. 978-618-7945

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
with ENDEXO
Technology
Angiodynamics
K121089 | Spectrum Silicone
Catheter
COOK
K021557 | HydroPICC
Access Vascular
PICC-141 | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for
short- or long-
term peripheral
access to the
central venous
system for
intravenous
therapy. | The COOK
Spectrum@
Silicone Catheter is
used for the
intravenous
administration of
nutrient fluids,
chemotherapeutic
agents and other
drugs for therapy,
blood sampling, | Same as
K121089,
Substantially
equivalent to
K01557.
Difference does
not raise
additional safety
or effectiveness
questions. Intended for short-
or long-term
peripheral access
to the central
venous system for
intravenous
therapy. | |
| Specification | BioFlo PICC
with ENDEXO
Technology
Angiodynamics
K121089 | Spectrum Silicone
Catheter
COOK
K021557 | HydroPICC
Access Vascular
PICC-141 | |
| | | blood delivery, and
venous pressure
monitoring. The
catheter is
impregnated with
the
antimicrobials
minocycline and
rifampin to help
provide protection
against catheter
related
bloodstream
infections (CRBSI).
It is not intended to
be used as a
treatment for
existing infections.
Catheters are
available in single
and double lumen
PICC; and
single, double and
triple lumen CVC.
The device is
supplied sterile and
intended for one-
time use. | | |
| Indication for
Use | BioFlo 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; | The COOK
Spectrum@ Silicone
Catheter is used for
the intravenous
administration of
nutrient fluids,
chemotherapeutic
agents and other
drugs for therapy,
blood sampling,
blood delivery, and
venous pressure
monitoring. The
catheter is | 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

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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 ●

10

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.