The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.

Device Description

The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study:

Important Note: The provided document is a 510(k) summary for a medical device (SOFIA PLUS/Distal Access Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish novel performance criteria. Therefore, the "acceptance criteria" discussed are largely based on meeting the performance of the predicate and generally recognized good manufacturing practices and testing standards for similar devices. There isn't a "device performance" in the sense of accuracy/sensitivity/specificity for a diagnostic AI, but rather functional performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size for each bench test. Instead, it refers to "test articles" being evaluated. For the thrombogenicity study, it mentions "two out of two test sites and two out of two control sites" which implies a very small sample size for that specific animal study.
Data Provenance: The studies are retrospective in the sense that they are laboratory bench tests and some animal biocompatibility tests for a new device intended to demonstrate equivalence to an already marketed device. The location of the testing is not explicitly stated, but MicroVention, Inc. is a U.S. company (Tustin, California), suggesting a U.S. origin for the tests. Some data (e.g., Radio Detectability, ISO 594-2 tests, Biocompatibility) are explicitly noted as "Prior test data from predicate device," meaning they were established from the previously approved SOFIA Distal Access Catheter (K142014/K131482).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This document describes technical device performance testing, not diagnostic or clinical performance requiring expert ground truth in the traditional sense of medical image interpretation (e.g., radiologists). The "ground truth" for these tests is defined by established engineering specifications, medical device standards (e.g., ISO 594-2, ISO 10555-1, ISO 10993 series), and comparisons to predicate and competitive devices. The evaluations (e.g., rating of ease of assembly, observation of kinks) would have been performed by qualified laboratory personnel following test protocols, but specific "experts" or their qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements or performance evaluations against defined criteria, not observations requiring adjudication by multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the physical and biological performance of an intravascular catheter, not on the interpretation of medical images or an AI's diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are all "standalone" in the sense that they evaluate the device's physical and biocompatible properties directly against predetermined criteria, without human interaction as part of a diagnostic or interpretive loop. The "standalone" here means device-only testing, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests includes:

Engineering Specifications: Defined dimensional requirements, force thresholds, flow rates, etc.
International Standards: Compliance with ISO standards (e.g., ISO 594-2 for luer connectors, ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
Predicate Device Performance: Comparison to the performance of the legally marketed predicate device (SOFIA Distal Access Catheter).
Competitive Device Performance: Comparison to the performance of other devices in the market.
Visual/Qualitative Assessment: Graded ratings (e.g., for simulated use, coating durability), and observations for the presence/absence of kinks, cracks, leakage, etc., performed by trained technicians according to protocols.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter), not an AI/ML algorithm. Therefore, there is no "training set." The materials and design are "trained" through iterative engineering and manufacturing processes, but not in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as outlined in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2015

Microvention, Inc. Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Ave Tustin, California 92780

Re: K150366

Trade/Device Name: Sofia 6F PLUS/Distal Access Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DQO Dated: February 11, 2015 Received: February 12, 2015

Dear Ms. Gong:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150366

Device Name SOFIA PLUS/Distal Access Catheter

Indications for Use (Describe)

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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510(k) Summary
Trade Name:	SOFIA™ PLUS CatheterSOFIA™ Distal Access Catheter
Generic Name:	Percutaneous Catheter
Classification:	Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO)
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.
Contact:	Naomi Gong
Date:	2015 February 11
Predicate Device:	SOFIA Distal Access Catheter (K142014/K131482)

Device Description:

Indications For Use:

	SOFIA Distal Access Catheter(predicate)	SOFIA PLUS/Distal AccessCatheter
Intended Use	Intended for general intravascular use, including the neuro and peripheral vasculature.It can be used to facilitate the introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.	Same
MaterialCatheter Body	Outer layer of polyurethane elastomer (Polyblend and Pellethane), polyether block amide (Pebax) and polyamide (Grilamid); inner layer of stainless steel braid/coil, PTFE and polyolefin elastomer	Same
Marker	Platinum/Iridium
Hub	Nylon
Strain Relief	Polyurethane
Introducer	Pebax
Shaping Mandrel	Stainless steel
Catheter size	5 F	6F
ID	0.055 inch (1.4 mm)	0.070 inch (1.78 mm)
OD	0.068 inch (1.7 mm)	0.0825 inch (2.1 mm)
Effective Length	115-125 cm	115-135 cm

Technological Comparison:

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	SOFIA Distal Access Catheter(predicate)	SOFIA PLUS/Distal AccessCatheter
Coating	Hydrophilic coating(Hydak® - same)	Same
Tip Configuration	Steam shapeable by user	Same
Guidewire Compatibility	0.035 inch	Same
Accessories	Introducer sheath and shaping mandrel	Same
Method of Supply	Sterile and single use	Same
Sterilization Method	Ethylene Oxide	Same
Packaging Configuration	Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer and shaping mandrelplaced on a polyethylene packaging card that isinserted into a Tyvek® pouch. Pouch and IFUplaced in bleached sulfate carton box.	Same

Verification and Test Summary:

Bench Testing
Test	Results	Conclusions
Simulated Use	Test articles achieved a rating ≥ 3 forpreparation/ease of assembly, introducersheath interaction, introducer peel away,tracking with guidewire/microcatheter,microcatheter/guidewire lockup, lubricityand durability of hydrophilic coating,microcatheter/ guidewire removal,removal/ aspiration of clot, mechanicalclot retriever and stent delivery with noparticles	Device performs as intendedunder simulated useconditions
Equipment Interface	Test articles compatible with 0.035-inchguidewire, 7F or larger guidecatheter/guiding sheath, common RHVsusing insertion tool, stopcocks and ≤0.027-inch microcatheters	Device compatible withrecommended accessoriescommonly used inintravascular procedures
Dimensional and Physical Attributes	Test articles met the specified dimensionalrequirements for catheter OD, catheter ID,overall working length, length of distalsection, length of distal tip to marker bandand total length of hub/strain relief	Device met establisheddimensional and physicalspecifications
Kink Resistance	No kinks at 1 cm, 4 cm, 12 cm and 25 cmfrom distal tip when wrapped around0.025, 0.030, 0.040-inch pin gaugesNo kinks noted during simulated usetesting	Device resistant to kinkingaround small radii turns
Tip Shapeability	Tip angle of test article equivalent tocompetitive devices after steam shapingusing mandrel with an angle ofapproximately 90°	Shapeability of distal tip aftersteam shaping – for reference
Radio Detectability	Distal marker band visible underfluoroscopy(Prior test data from predicate device)	Device radiopacity equivalentto or better than predicate andcompetitive devices
Gauging (ISO 594-2)	Gauging pin and hub align in limit planes(Prior test data from predicate device)	Device hub meets therequirements of ISO 594-2
Bench Testing
Test	Results	Conclusions
Separation Force (ISO 594-2)	Mating parts separation force greater than 25 N (Prior test data from predicate device)	Device hub meets the requirements of ISO 594-2
Unscrewing Torque (ISO 594-2)	Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds (Prior test data from predicate device)	Device hub meets the requirements of ISO 594-2
Stress Cracking (ISO 594-2)	No stress cracks on test article hub (Prior test data from predicate device)	Device hub meets the requirements of ISO 594-2
Ease of Assembly (ISO 594-2)	Components fit together securely with no resistance observed between test article luer and reference fitting (Prior test data from predicate device)	Device hub meets the requirements of ISO 594-2
Resistance to Overriding (ISO 594-2)	Test article luer does not override reference fitting threads (Prior test data from predicate device)	Device hub meets the requirements of ISO 594-2
Durability/Lubricity of Hydrophilic Coating	Test article achieved a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity.	Device tracks easily with no coating cracking or separation
Catheter Stiffness	Device stiffness equivalent to predicate and competitive devices	Device tracks in tortuous anatomy while advancing to target site
Torque Strength	No catheter breakage after 50 rotations	Device torque strength same as predicate device
Catheter Flexural Fatigue	No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing	Device integrity suitable for intended clinical use
Surface Contamination	Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm2, embedded particulatesDistal tip smooth and tapered	Device integrity suitable for intended clinical use
Force at Break (Distal and Hub)	PTFE inner layer not delaminatedCatheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction	Tensile strength test results equivalent to predicate and competitive devices
Flow Rate	Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices	Device meets specified requirements for delivery of diagnostic agents
Static Burst Pressure	No damage of pressurized catheter at 46 psi	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1
Fluid Leakage at > 46 psi	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1
Air Leakage	No air leakage at hub into syringe for 15 seconds	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1
Dynamic Burst	Test articles did not burst at or below 300 psi	Device met labeled maximum infusion pressure of 300 psi
Particulate Test	Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume	Device met specifications for maximum allowable particles

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				Note: Biocompatibility was prior test data from predicate device.

Biocompatibility	Result	Conclusions
Cytotoxicity (ISO 10993-5)- MEM elution assay	Cell culture treated with test articleexhibited slight reactivity (Grade 1)	Non-cytotoxic
Sensitization/Irritation (ISO 10993-10)- Guinea pig maximization sensitization	Extracts of the test article elicited noreaction at the challenge (0%sensitization) following the inductionphase (Grade 1).	Weak allergic potentialor sensitizing capacity
Sensitization/Irritation (ISO 10993-10)- Intracutaneous reactivity	Extracts of the test article did notshow a significantly greaterbiological reaction than the sitesinjected with the control article	Non-irritant
Hemocompatibility – Rabbit Blood Direct andIndirect Contact (ISO 10993-4)	The hemolysis index was 0.13%(direct contact) and 0.0% (indirectcontact)	Non-hemolytic
Hemocompatibility – Unactivated PartialThromboplastin Time Assay Direct Contact (ISO10993-4)	No statistically significant differencefound between the UnactivatedPartial Thromboplastin Time (UPTT)of the plasma exposed to the testarticle and that of the plasma exposedto either the negative control or theuntreated control	No effect oncoagulation
Hemocompatibility - Complement ActivationAssay (ISO 10993-4)	C3a and SC5b-9 levels ≤ negativeand untreated controls	No effect oncomplement activation
Hemocompatibility - Thrombogenicity Study inDogs (ISO 10993-4)	Minimal thrombosis observed with aGrade 0 in two out of two test sitesand two out of two control sites	No significantthrombosis
Systemic Toxicity - Systemic Injection Test(ISO 10993-11)	Extracts of test article did not inducea significantly greater biologicalreaction than the control extractswhen injected in Swiss Albino mice	No toxic effects
Systemic Toxicity - Rabbit Pyrogen Test (ISO10993-11)	The temperature increases(maximum) was 0.03°C frombaseline	Non-pyrogenic

Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA PLUS/Distal Access Catheter when compared with the predicate device, SOFIA Distal Access Catheter (K142014/K131482).

The devices,

" Have the same intended use,
Use the same operating principle, ■
Incorporate the same basic design,
. Are packaged and sterilized using same methods.

In summary, the SOFIA PLUS/Distal Access Catheter described in this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Test	Acceptance Criteria (Implied / Stated)	Reported Device Performance and Conclusions
Bench Testing
Simulated Use	Device performs as intended under simulated use conditions. (Implied: Achieves rating $\geq$ 3 in preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/ guidewire removal, removal/ aspiration of clot, mechanical clot retriever, and stent delivery with no particles.)	Test articles achieved a rating $\geq$ 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/ guidewire removal, removal/ aspiration of clot, mechanical clot retriever and stent delivery with no particles. Conclusion: Device performs as intended under simulated use conditions.
Equipment Interface	Device compatible with recommended accessories commonly used in intravascular procedures. (Implied: Compatible with 0.035-inch guidewire, 7F or larger guide catheter/guiding sheath, common RHVs, stopcocks, and $\leq$ 0.027-inch microcatheters.)	Test articles compatible with 0.035-inch guidewire, 7F or larger guide catheter/guiding sheath, common RHVs using insertion tool, stopcocks and $\leq$ 0.027-inch microcatheters. Conclusion: Device compatible with recommended accessories commonly used in intravascular procedures.
Dimensional and Physical Attributes	Device meets established dimensional and physical specifications. (Implied: Meets specified requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band, and total length of hub/strain relief.)	Test articles met the specified dimensional requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band and total length of hub/strain relief. Conclusion: Device met established dimensional and physical specifications.
Kink Resistance	Device resistant to kinking around small radii turns. (Implied: No kinks at 1 cm, 4 cm, 12 cm, and 25 cm from distal tip when wrapped around 0.025, 0.030, 0.040-inch pin gauges; no kinks noted during simulated use testing.)	No kinks at 1 cm, 4 cm, 12 cm and 25 cm from distal tip when wrapped around 0.025, 0.030, 0.040-inch pin gauges. No kinks noted during simulated use testing. Conclusion: Device resistant to kinking around small radii turns.
Tip Shapeability	Shapeability of distal tip after steam shaping – for reference. (Implied: Equivalent to competitive devices when shaped to approximately 90°.)	Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°. Conclusion: Shapeability of distal tip after steam shaping – for reference.
Radio Detectability	Device radiopacity equivalent to or better than predicate and competitive devices. (Implied: Distal marker band visible under fluoroscopy.)	Distal marker band visible under fluoroscopy. (Prior test data from predicate device). Conclusion: Device radiopacity equivalent to or better than predicate and competitive devices.
Gauging (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: Gauging pin and hub align in limit planes.)	Gauging pin and hub align in limit planes. (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Separation Force (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: Mating parts separation force greater than 25 N.)	Mating parts separation force greater than 25 N (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Unscrewing Torque (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: Luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds.)	Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Stress Cracking (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: No stress cracks on test article hub.)	No stress cracks on test article hub (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Ease of Assembly (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: Components fit together securely with no resistance observed between test article luer and reference fitting.)	Components fit together securely with no resistance observed between test article luer and reference fitting (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Resistance to Overriding (ISO 594-2)	Device hub meets the requirements of ISO 594-2. (Implied: Test article luer does not override reference fitting threads.)	Test article luer does not override reference fitting threads (Prior test data from predicate device). Conclusion: Device hub meets the requirements of ISO 594-2.
Durability/Lubricity of Hydrophilic Coating	Device tracks easily with no coating cracking or separation. (Implied: Achieves a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity.)	Test article achieved a rating of $\geq$ 3 during simulated use testing for coating durability and lubricity. Conclusion: Device tracks easily with no coating cracking or separation.
Catheter Stiffness	Device tracks in tortuous anatomy while advancing to target site. (Implied: Stiffness equivalent to predicate and competitive devices.)	Device stiffness equivalent to predicate and competitive devices. Conclusion: Device tracks in tortuous anatomy while advancing to target site.
Torque Strength	Device torque strength same as predicate device. (Implied: No catheter breakage after 50 rotations.)	No catheter breakage after 50 rotations. Conclusion: Device torque strength same as predicate device.
Catheter Flexural Fatigue	Device integrity suitable for intended clinical use. (Implied: No flexural fatigue after repeated bending and hoop stress during testing.)	No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing. Conclusion: Device integrity suitable for intended clinical use.
Surface Contamination	Device integrity suitable for intended clinical use. (Implied: Free from surface contaminants, particulates > 0.02 mm², embedded particulates, and has a smooth tapered distal tip.)	Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. Conclusion: Device integrity suitable for intended clinical use.
Force at Break (Distal and Hub)	Tensile strength test results equivalent to predicate and competitive devices. (Implied: PTFE inner layer not delaminated, catheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction.)	PTFE inner layer not delaminated. Catheter force at break $\geq$ 3.37 lbf for distal section and hub/catheter junction. Conclusion: Tensile strength test results equivalent to predicate and competitive devices.
Flow Rate	Device meets specified requirements for delivery of diagnostic agents. (Implied: Flow rate at 100 psi and 300 psi with diagnostic agents equivalent to or better than competitive devices.)	Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices. Conclusion: Device meets specified requirements for delivery of diagnostic agents.
Static Burst Pressure	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No damage of pressurized catheter at 46 psi.)	No damage of pressurized catheter at 46 psi. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
Fluid Leakage at > 46 psi	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds.)	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
Air Leakage	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1. (Implied: No air leakage at hub into syringe for 15 seconds.)	No air leakage at hub into syringe for 15 seconds. Conclusion: Device integrity suitable for intended clinical use and met requirements of ISO 10555-1.
Dynamic Burst	Device met labeled maximum infusion pressure of 300 psi. (Implied: Test articles did not burst at or below 300 psi.)	Test articles did not burst at or below 300 psi. Conclusion: Device met labeled maximum infusion pressure of 300 psi.
Particulate Test	Device met specifications for maximum allowable particles. (Implied: Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume.)	Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume. Conclusion: Device met specifications for maximum allowable particles.
Biocompatibility		(Note: Biocompatibility was prior test data from predicate device.)
Cytotoxicity (ISO 10993-5)	Non-cytotoxic. (Implied: Cell culture treated with test article exhibits slight reactivity (Grade 1).)	Cell culture treated with test article exhibited slight reactivity (Grade 1). Conclusion: Non-cytotoxic.
Sensitization/Irritation (ISO 10993-10)	Weak allergic potential or sensitizing capacity. (Implied: Extracts elicit no reaction (0% sensitization) following induction phase (Grade 1).)	Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1). Conclusion: Weak allergic potential or sensitizing capacity.
Sensitization/Irritation (Intracutaneous)	Non-irritant. (Implied: Extracts do not show significantly greater biological reaction than control sites.)	Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article. Conclusion: Non-irritant.
Hemocompatibility (Rabbit Blood)	Non-hemolytic. (Implied: Hemolysis index $\leq$ acceptable limits, e.g., 5% based on ISO standards; reported values are 0.13% direct, 0.0% indirect.)	The hemolysis index was 0.13% (direct contact) and 0.0% (indirect contact). Conclusion: Non-hemolytic.
Hemocompatibility (UPTT)	No effect on coagulation. (Implied: No statistically significant difference in UPTT compared to controls.)	No statistically significant difference found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to either the negative control or the untreated control. Conclusion: No effect on coagulation.
Hemocompatibility (Complement Activation)	No effect on complement activation. (Implied: C3a and SC5b-9 levels $\leq$ negative and untreated controls.)	C3a and SC5b-9 levels $\leq$ negative and untreated controls. Conclusion: No effect on complement activation.
Hemocompatibility (Thrombogenicity Study)	No significant thrombosis. (Implied: Minimal thrombosis observed.)	Minimal thrombosis observed with a Grade 0 in two out of two test sites and two out of two control sites. Conclusion: No significant thrombosis.
Systemic Toxicity (Systemic Injection)	No toxic effects. (Implied: Extracts do not induce significantly greater biological reaction than control extracts.)	Extracts of test article did not induce a significantly greater biological reaction than the control extracts when injected in Swiss Albino mice. Conclusion: No toxic effects.
Systemic Toxicity (Rabbit Pyrogen Test)	Non-pyrogenic. (Implied: Temperature increases (maximum) $\leq$ acceptable limits, e.g., 0.5°C; reported value 0.03°C.)	The temperature increases (maximum) was 0.03°C from baseline. Conclusion: Non-pyrogenic.