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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the HydroPICC device, focusing on its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for an AI/algorithm-based device.

The HydroPICC is a medical device (a peripherally inserted central catheter), and the performance data presented relates to its physical and biological properties. This document does not describe an AI or algorithm-driven device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies for an AI/algorithm.

Specifically, the document focuses on:

Biocompatibility Testing: 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, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radio Detectability Testing, Tensile Testing, Catheter Compatibility with Medications, Catheter Thrombus Accumulation Evaluation Using in Vitro Blood Loop, Catheter Collapse Resistance, Central Venous Pressure Monitoring, Pyrogens testing.
Sterilization: Validated overkill Ethylene Oxide (EO) method.

These are standard tests for a physical medical device and do not involve AI/algorithm performance metrics such as sensitivity, specificity, AUC, or the involvement of expert readers for ground truth establishment.

Therefore, I cannot fulfill the request as the provided text does not contain information about an AI/algorithm-driven device or its associated acceptance criteria and study proving its performance.

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.

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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 (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 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

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 PICCwith ENDEXOTechnologyAngiodynamicsK121089	Spectrum SiliconeCatheterCOOKK021557	HydroPICCAccess VascularPICC-141
Intended Use	Intended forshort- or long-term peripheralaccess to thecentral venoussystem forintravenoustherapy.	The COOKSpectrum@Silicone Catheter isused for theintravenousadministration ofnutrient fluids,chemotherapeuticagents and otherdrugs for therapy,blood sampling,	Same asK121089,Substantiallyequivalent toK01557.Difference doesnot raiseadditional safetyor effectivenessquestions. Intended for short-or long-termperipheral accessto the centralvenous system forintravenoustherapy.
Specification	BioFlo PICCwith ENDEXOTechnologyAngiodynamicsK121089	Spectrum SiliconeCatheterCOOKK021557	HydroPICCAccess VascularPICC-141
		blood delivery, andvenous pressuremonitoring. Thecatheter isimpregnated withtheantimicrobialsminocycline andrifampin to helpprovide protectionagainst catheterrelatedbloodstreaminfections (CRBSI).It is not intended tobe used as atreatment forexisting infections.Catheters areavailable in singleand double lumenPICC; andsingle, double andtriple lumen CVC.The device issupplied sterile andintended for one-time use.
Indication forUse	BioFlo isindicated forshort- or long-term peripheralaccess to thecentral venoussystem forintravenoustherapy, includingbut not limited to;the administrationof fluids,medications, andnutrients; thesampling of blood;	The COOKSpectrum@ SiliconeCatheter is used forthe intravenousadministration ofnutrient fluids,chemotherapeuticagents and otherdrugs for therapy,blood sampling,blood delivery, andvenous pressuremonitoring. Thecatheter is	HydroPICC isindicated for short-or long-termperipheral access tothe central venoussystem forintravenous therapy,including but notlimited to; theadministration offluids, medications,and nutrients; thesampling of blood;central venouspressureSame asK121089,Substantiallyequivalent toK01557.Difference doesnot raiseadditional safetyor effectivenessquestions.
Specification	BioFlo PICCwith ENDEXOTechnologyAngiodynamicsK121089	Spectrum SiliconeCatheterCOOKK021557	HydroPICCAccess VascularPICC-141
	central venouspressuremonitoring; andpower injection ofcontrast media.	antimicrobialsminocycline andrifampin to helpprovide protectionagainst catheter-relatedbloodstreaminfections (CRBSI). Itis not intended to beused as a treatmentfor existinginfections. Cathetersare available in singleand double lumenPICC; and single,double and triplelumen CVC.	monitoring; andpower injection ofcontrast media.
Device Class	Class II	Class II	Class II
Product Code	LJS	LJS	LJS
RegulationNumber	880.5970	880.5970	880.5970
PrescriptionDevice	Yes	Yes	Yes
CatheterType	PeripherallyInserted CentralCatheter (PICC)	Peripherally InsertedCentral Catheter(PICC)	PeripherallyInserted CentralCatheter (PICC)
CatheterOuterDiameter	4 French	4 French	4 French
CatheterInnerDiameter	0.90mm	0.66mm	0.90mm
UsableCatheterLength	55cm	60cm	55cm
Specification	BioFlo PICCwith ENDEXOTechnologyAngiodynamicsK121089	Spectrum SiliconeCatheterCOOKK021557	HydroPICCAccess VascularPICC-141
				not raiseadditional safetyor effectivenessquestions.
Guidewirecompatibility	0.018"	0.018"	0.018"	Same
CatheterShaft Design	With taper	No taper	No taper	Same asK021557,Substantiallyequivalent toK121089. Bloodloop testing withK121089demonstrated noimpact on safetyor effectiveness.
Number ofCatheterLumens	Single	Single	Single	Same
Key DeviceComponents	Catheter Shaft,Suture Wing,Extension Tube,Luer Hub	Catheter Shaft, SutureWing, ExtensionTube, Luer Hub	Catheter Shaft,Suture Wing,Extension Tube,Luer Hub	Same
Short orLong TermAccess	Yes	Yes	Yes	Same
Use withPowerInjectionPowerSettings FlowRate	YesFlow rate:3.5mL/sec	No	YesFlow rate:3.5mL/sec	Same asK121089.
X-RayConfirmationRequired	Yes	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Same
Single Use	Yes	Yes	Yes	Same
LengthMarking	Yes	No	No	Same asK021557,Substantiallyequivalent toK121089.Labeling forHydroPICC
Specification	BioFlo PICCwith ENDEXOTechnologyAngiodynamicsK121089	Spectrum SiliconeCatheterCOOKK021557	HydroPICCAccess VascularPICC-141
CatheterMaterials	Radiopaque,polyurethanecatheter with luerlock hub,polyurethaneextension tube,and suture wing	Radiopaque siliconecatheter with luerlock hub, withextension tube andsuture wing	Radiopaque,hydrophilic polyolcatheter with luerlock hub,polyurethaneextension tube, andsuture wing	includes sizinginformationsimilar toK021557.Therefore, noimpact on safetyor effectiveness.Substantiallyequivalent.Testingdescribed abovedemonstrated noimpact on safetyor effectiveness.
Ink	MD-1001 No-ToxMedical DeviceInk, NT 16 Blackw/ MD01210Reducer	Not present	Not present	Same asK021557.Biocompatibilitytesting of theproposed devicedemonstrated noimpact on safetyor 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.

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.”