Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Device Description

The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

AI/ML Overview

This document describes the pre-clinical bench testing conducted for the Phenom® 27 Catheter, a medical device. The purpose of the study was to demonstrate that a modified version of the catheter (with an increased effective length) is substantially equivalent to the previously cleared predicate device.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each test. Instead, it describes each test, its purpose, and concludes with a qualitative "Results" section, often stating that the results are "within the expected range" or "equivalent" to the predicate device, or that all samples "passed."

Here's an adapted table based on the provided information, interpreting the "Test Method Summary" as implicitly defining the acceptance criteria (i.e., meeting the standard, providing a reference, or demonstrating functional equivalence) and "Results" as the device's performance against these criteria.

Test Description	Implicit Acceptance Criterion (based on Test Method Summary)	Reported Device Performance
Catheter Flow Rate	Provide user with flow rate reference using various contrast media and pressure conditions.	Flow rate data collected, new geometry resulted in slightly lower flow rates, but within expected range and equivalent to predicate.
Flow rate for each lumen, according to ISO 10555-1	Compliance to catheter standard BS EN ISO 10555-1: 2013.	Flow rate data collected, new geometry resulted in slightly lower flow rates, but within expected range and equivalent to predicate. All passing results.
Dead Space Volume	Provide user with dead space volume (fill volume) of the catheters.	New geometry resulted in slightly larger dead space volume, but passing results within expected range and equivalent to predicate.
Accessibility/ Tractability Test	Modified Catheter can reach M1 region of tortuous neurovascular model when tested at body temperature with appropriate accessories and flushing conditions.	All tested articles (modified and predicate) were able to reach M1 region. All samples passed, confirming functional equivalence.
Dimensional Verification	All dimensional requirements meet specified attributes; visual and dimensional inspection on pre- and post-sterile.	Test samples inspected, passed specified attributes. All test articles met visual and dimensional specifications pre- and post-sterilization. Modified and predicate meet same equivalent requirements.
Material verification	All materials are as specified in raw material, final assembly, subassembly specifications and vendor certifications.	Results verified all materials are as specified and identical to predicate, therefore equivalent.
Catheter/ Guide Catheter Compatibility	Catheter can track through a guiding catheter with an I.D. ≥ 0.0445".	Added length to proximal shaft does not affect working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test.
Catheter/Guide Wire Compatibility	Catheter is able to track over a guide wire ≤ 0.025" in diameter.	Added length to proximal shaft does not affect working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test.
Catheter/ RHV Compatibility and Leakage Verification	Catheter is compatible with rotating hemostasis value (RHV) in dimension and RHV will not leak during use.	Added length does not affect RHV connection (identical RHV); passing test results of predicate apply and are equivalent.
Shaft Stiffness	Catheter shaft to meet specification on stiffness.	Added length to proximal shaft does not affect stiffness of working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test.
Chemical Compatibility	Catheter should show no damage when exposed to saline and contrast medium.	Materials are all identical; passing test results of predicate apply and are equivalent.
Shaping Mandrel compatibility & shapeability	Steam shaping mandrel fits distal lumen; tip meets retention specification and dimensional shrinkage OD and ID requirements.	Added length to proximal shaft does not affect working (distal) shaft subjected to tip shaping; passing test results of predicate apply and are equivalent.
Kink Resistance	Catheter distal shaft will not kink when tested per BS EN 13868:2002 Annex A; and lumen integrity when catheter is looped to predetermined diameter.	Added length to proximal shaft does not affect working (distal) shaft subjected to kinking; passing test results of predicate apply and are equivalent.
Conical Fitting for Hub	Catheter hub will meet testing requirements as specified in BS EN 1707:1997.	Added length does not affect hub connection (identical hub); passing test results of predicate apply and are equivalent.
Corrosion Resistance	Catheter shall show no sign of corrosion per ISO10555-1:2013 Annex A.	Materials are all identical; passing test results of predicate apply and are equivalent.
Tensile Strength of catheter body, hub attachment, distal attachment	Tip, distal, mid, proximal and hub junctions meet tensile strength requirement per EN ISO-10555-1: Annex B.	Added length does not affect various catheter segments, hub or distal attachments; passing test results of predicate apply and are equivalent.
Liquid Leakage at Hub	No liquid leakage detected per BS EN ISO 10555-1:2013 Annex C.	Added length modification does not affect hub attachments; passing test results of predicate apply and are equivalent.
Air Leakage During Aspiration	No leak detected when tested BS EN ISO 10555-1:2013 Annex D.	Added length does not affect various catheter segments and joints; passing test results of predicate apply and are equivalent.
Rupture Pressure	Catheter can withstand predetermined static and dynamic rupture pressure testing.	Added length does not affect various catheter segments, joints or methods of fabrication; passing test results of predicate apply and are equivalent.
Particulate	Verify particulate levels catheter.	Added length does not affect material, method and environment of fabrication affecting particulates; passing test results of predicate apply and are equivalent.
Outer Surface Coating Lubricity and Durability	Predetermined friction force of the coating.	Added length to proximal shaft does not affect working (distal) shaft which is coated; passing test results of predicate apply and are equivalent.
Flexural Fatigue	Catheter structure remains intact after predetermined number of cycles when used to access in a simulated torturous path model.	Added length does not affect design of shaft segments or joints affecting flexural fatigue; passing test results of predicate apply and are equivalent.

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

Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X catheters were tested"). It uses phrases like "All test samples," "All samples," or implies multiple units were tested (e.g., "Flow rate data was collected for the modified (160cm) device and the predicate device (150cm)").
Data Provenance: The study described is a pre-clinical bench testing study. This means the data was generated in a laboratory setting, not from human or animal subjects. The provenance is internal Cathera, Inc. testing, not from any specific country of origin in terms of patient data. It is prospective in the sense that the testing was conducted on the modified device to demonstrate its performance.

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

This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires human adjudication. The "results" are objective measurements or observations against predefined standards or comparison with a predicate device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not the subject of this document.

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

No, a standalone algorithm performance study was not done. This document describes the bench testing of a physical medical device (catheter), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this pre-clinical bench testing is based on engineering specifications, international and national standards (e.g., ISO 10555-1, BS EN 13868:2002, BS EN 1707:1997), and comparison to the established performance of the legally marketed predicate device. For example, for flow rate, the "expected range" and "equivalence" to the predicate served as the reference. For dimensional verification, the "specified attributes" were the ground truth. For accessibility/tractability, reaching the M1 region of the neurovascular model was the ground truth for success.

8. The Sample Size for the Training Set

This information is not applicable as this document describes the testing of a physical medical device, not an AI system that requires a "training set."

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

This information is not applicable for the same reason as point 8.

Summary

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June 11, 2018

Cathera, Inc. Victor Ham Chief Regulatory & Quality Officer 627 National Avenue Mountain View, California 94043

Re: K180959

Trade/Device Name: Phenom 27 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: May 30, 2018 Received: May 31, 2018

Dear Victor Ham:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 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,

Xiaolin Zheng -S

for 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) K180959

Device Name Phenom 27 Catheter

Indications for Use (Describe)

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

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 - K180959

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitted by:

Cathera, Inc. 627 National Ave. Mountain View, CA 94043 Tel.: (650) 388-5088 Fax: (650) 390-0107

Contact Person: Victor Ham

Date summary prepared: April 22, 2018

Trade Name: Phenom® 27 Catheter

Common Name: Catheter

Classification Name & Product Codes:

Percutaneous Catheter (21 CFR 870.1250, Product Code DOY) Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA)

Predicate Devices: Phenom® 27 Catheter (510K # K151638)

Device Description:

Indications for Use:

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

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Device Comparison of Technological Characteristics

Table A provides a comparison of the technological characteristics of the Phenom® 27 Catheter and the modified Phenom® 27 Catheter with additional effective length.

TechnologicalCharacteristic	Phenom® 27, predicate(510k # K151638)	Phenom® 27, modified(510k # K180959)	Rationale forDifference (if present)
Indication for Use	Phenom® Catheters are intendedfor the introduction ofinterventional devices and infusionof diagnostic or therapeutic agentsinto the neuro, peripheral, andcoronary vasculatures.	Identical	N/A-No difference
Composite Shaft	PTFE composite polymericcatheter	Identical	N/A-No difference
Composite Shaftsupport	Stainless Steel Reinforcement	Identical	N/A-No difference
Hub	Polyamide	Identical	N/A-No difference
Stain Relief	Thermoplastic elastomer	Identical	N/A-No difference
Marker(s)	Platinum/Iridium Alloy	Identical	N/A-No difference
Coating	Polymeric hydrophilic coating	Identical	N/A-No difference
Proximal OD	3.1F (1.02mm)	Identical	N/A-No difference
Distal OD	2.8F (0.91mm)	Identical	N/A-No difference
Proximal ID	0.027 inches (0.69 mm)	Identical	N/A-No difference
Distal ID	0.027 inches (0.69 mm)	Identical	N/A-No difference
Effective Length Range(cm)	75 to 150	75 to 160	Increasing the length of theproximal shaft provide thephysicians extra length for set-up. Working (distal) shaft ofcatheter is the same thereforeequivalent.
Tip Configurations	Steam shapeable straight tip	Identical	N/A-No difference
Accessories
Steam shaping mandrel	Stainless Steel	Identical	N/A-No difference
Packaging & Sterilization
Packaging materialsand configuration	Catheter package insidedispensing coil; inside Tyvek®pouch; inside cardboard box	Identical	N/A-No difference
Sterilization	Ethylene Oxide	Identical	N/A-No difference

Table A-Summary of Technological Characteristics, Components and Materials

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Conclusion- Based on the comparison shown in Table A (above), the technological characteristic of the modified Phenom® 27 and the predicate Phenom® 27 are equivalent. The only design modification was to increase the effective length from 150 cm to 160 cm. This provides the user with additional length during the set-up procedure which does not alter the intended use or the fundamental scientific technology of the device as originally cleared for the predicate device and therefore substantially equivalent.

Performance Testing - Bench

As identified in the risk analysis, the increased length would require testing of the flow rate and dead space volume. Testing was conducted according to the same method used for the original predicate device. Accessibility and tractability testing was performed to verify that modified catheter can reach M1 region of tortuous neurovascular model. The modification to add extra length to the catheter did not affect the design or function of the distal shaft of the catheter that enters the body. All other tests performed on the predicate device apply to the modified version. A summary of the pre-clinical bench testing performed for the Phenom® 27 Catheter and the modified Phenom® 27 Catheter is presented in the Table B below:

Test Description	Test Method Summary	Results
Catheter Flow Rate	The purpose of the testing is toprovide the user with a flow ratereference when using variouscontrast media and pressureconditions. Similar to thepredicate device, 2 pressureconditions and 3 commonlyused contrast media are used forthe testing. High pressure vesseland tank, timer and scale areused to determine flow rate.	Flow rate data was collected for themodified (160cm) device and thepredicate device (150cm). As expected,the new geometry result in slightlydifferent fluid dynamics (i.e., lower flowrates). The results are within the expectedrange and therefore are equivalent.
Flow rate for eachlumen, according toISO 10555-1	Test method is to verifycompliance to catheter standardBS EN ISO 10555-1: 2013.Conditions, method andequipment as prescribed in thestandard.	Flow rate data was collected for themodified (160 cm) device and thepredicate device (150 cm). As expected,the new geometry result in slightlydifferent fluid dynamics (i.e., lower flowrates). The passing results are within theexpected range and therefore areequivalent.
Dead Space Volume	The purpose of the testing is toprovide the user with the deadspace volume (fill volume) ofthe catheters.	Data was collected for the modified (160cm) device and the predicate device (150cm). As expected, the new geometryresult in slightly larger dead spacevolume. The passing results within theexpected range and therefore areequivalent.
Test Description	Test Method Summary	Results
Accessibility/Tractability Test	The purpose is to verify that themodified Catheter can reach M1region of tortuous neurovascularmodel. Test were conducted atbody temperature, using theappropriate guidewires, guidecatheters, RHV and continuousflushing conditions to mimicactual use.	Data was collected for the modified (160cm) device and the predicate device (150cm). Similar to the predicate device, alltested articles were able to reach M1region of model neurovasculature. Allsamples passed. This confirms functionalequivalence between the predicate and themodified device. The added length to theproximal shaft does not affect the working(distal) shaft of the catheter.
DimensionalVerification	Purpose is to verify that alldimensional requirements willmeet the specified attributes.Performed visual anddimensional inspection on pre-and post-sterile.	Test samples were inspected and passedthe specified attributes as specified. Alltest articles met the visual anddimensional specifications pre-sterilization and post-sterilization.Modified and predicate device meet thesame equivalent requirements.
Material verification	The purpose is to verify that allmaterials are as specified in rawmaterial, final assembly,subassembly specifications andvendor certifications.	The results verified that all materials areas specified and confirms that all materialof the modified device and the predicateare identical therefore equivalent.
Catheter/ GuideCatheterCompatibility	The purpose is to verify that thecatheter can track through aguiding catheter with an I.D.≥ 0.0445".	The added length to the proximal shaftdoes not affect the working (distal) shaftof the catheter that goes through theguide catheter. The passing test results ofthe predicate device apply to themodified device and therefore equivalent.Results are also confirmed withAccessibility/Tractability Test (above).
Catheter/Guide WireCompatibility	Catheter is able to track over theguide wire that is ≤ 0.025" indiameter.	The added length to the proximal shaftdoes not affect the working (distal) shaftof the catheter that goes through theguide catheter. The passing test results ofthe predicate device apply to themodified device and therefore equivalent.Results are also confirmed withAccessibility/Tractability Test (above).
Catheter/ RHVCompatibility andLeakageVerification	Catheter is compatible withrotating hemostasis value (RHV)in dimension and RHV will notleak during use.	The added length to the catheter shaftdoes not affect the RHV connection. It isthe identical RHV. The passing testresults of the predicate device apply tothe modified device and thereforeequivalent.
Test Description	Test Method Summary	Results
Shaft Stiffness	Catheter shaft to meetspecification on stiffness.	The added length to the proximal shaftdoes not affect the shaft stiffness of theworking (distal) shaft of the catheter thatgoes into the body. The passing testresults of the predicate device apply to themodified device and therefore equivalent.Results are also confirmed withAccessibility/ Tractability Test (above).
ChemicalCompatibility	Catheter should show no damagewhen exposed to saline andcontrast medium.	Materials are all identical. The passingtest results of the predicate device applyto the modified device and thereforeequivalent.
Shaping Mandrelcompatibility &shapeability	The purpose is to verify that thesteam shaping mandrel fits thedistal lumen of the catheter; thetip meets retention specificationand dimensional shrinkage ODand ID requirements.	The added length to the proximal shaftdoes not affect the working (distal) shaftof the catheter is subjected to tip shaping.The passing test results of the predicatedevice apply to the modified device andtherefore equivalent.
Kink Resistance	The purpose of the test is toverify that the catheter distalshaft will not kink when testedin accordance with BS EN13868:2002 Annex A; andlumen integrity when catheter islooped to predetermine diameter.Method, equipment andconditions as prescribed instandard.	The added length to the proximal shaftdoes not affect the working (distal) shaftof the catheter is subjected to kinking.The passing test results of the predicatedevice apply to the modified device andtherefore equivalent.
Conical Fitting forHub	The purpose of the test is toverify that the catheter hub willmeet the testing requirements asspecified in BS EN 1707:1997.Method, equipment andconditions as prescribed instandard.	The added length to the catheter proximalshaft does not affect the hub connection.It is the identical hub. The passing testresults of the predicate device apply tothe modified device and thereforeequivalent.
CorrosionResistance	Catheter shall show no sign ofcorrosion per ISO10555-1:2013Annex A.(material characterization only)	Materials are all identical. The passingtest results of the predicate device applyto the modified device and thereforeequivalent.
Test Description	Test Method Summary	Results
Tensile Strength ofcatheter body, hubattachment, distalattachment	The tip, distal, mid, proximal andhub junctions should meet thetensile strength requirement perEN ISO-10555-1: Annex B.Method, equipment andconditions as prescribed instandard.	The added length to the proximal shaftdoes not affect the various cathetersegments, hub or distal attachments of thecatheter. The passing test results of thepredicate device apply to the modifieddevice and therefore equivalent.
Liquid Leakage atHub	No liquid leakage detected perBS EN ISO 10555-1:2013Annex C. Method, equipmentand conditions as prescribedin standard.	The added length modification does notaffect the hub attachments to the catheter.The passing test results of the predicatedevice apply to the modified device andtherefore equivalent.
Air Leakage DuringAspiration	No leak detected when tested BSEN ISO 10555-1:2013 Annex D.Method, equipment andconditions as prescribed instandard.	The added length does not affect thevarious catheter segments and joints ofthe catheter. The passing test results ofthe predicate device apply to themodified device and therefore equivalent.
Rupture Pressure	Verify that the catheter canwithstand predetermined staticand dynamic rupture pressuretesting.	The added length does not affect thevarious catheter segments, joints ormethods of fabrication of the catheter.The passing test results of the predicatedevice apply to the modified device andtherefore equivalent.
Particulate	Verify particulate levelscatheter.	The added length does not affect thematerial, method and environment offabrication of the catheter that affectsparticulates. The passing test results ofthe predicate device apply to themodified device and therefore equivalent.
Outer SurfaceCoating Lubricityand Durability	Test is to verify predeterminefriction force of the coating.	The added length to the proximal shaftdoes not affect the working (distal) shaftof the catheter which is coated. Thepassing test results of the predicatedevice apply to the modified device andtherefore equivalent.
Flexural Fatigue	The test method is to verify thatthe catheter structure will remainintact after predeterminednumber of cycles when used toaccessing in a simulatedtorturous path model.	The added length does not affect thedesign of the shaft segments or joints ofthe catheter which affect flexural fatigue.The passing test results of the predicatedevice apply to the modified device andtherefore equivalent.

Table B- Summary of Pre-Clinical Bench Testing

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Conclusion of the Pre-Clinical Bench Testing

Based on the non-clinical testing provided above in Table B, the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed device. The additional length will assist the user in the set-up procedures without affecting the performance or safety of the device. The accessibility, trackability, high pressure flow rate testing show that the modified device is substantially equivalent to the predicate device.

Substantial Equivalence Determination

The information presented in the 510k shows that the modified Phenom® 27 Catheters are substantially equivalent to predicate Phenom® 27 catheters regarding the following aspects:

Design:	The subject and predicate devices are substantially equivalent with respect to design characteristics. The modified devices provide the user with additional effective length on the proximal shaft of the catheter which remain outside the patient. The working (distal) shaft of the catheter that enters the body is identical.
Function:	The subject and predicate devices are substantially equivalent with respect to functional characteristics. The modified devices provide the user with additional length on the proximal shaft of the catheter to assist in the procedural set-up. The working (distal) portion of the catheter that enters the body is identical. Trackability and accessibility testing was performed to verify that the modified catheter can reach the MI region of the neurovascular model.
Manufacturing:	The subject and predicate devices are the same with respect to technological manufacturing processes.
Materials:	The subject and predicate devices are composed of identical materials, all of which have an extensive clinical history of safe use in medical devices.
Indications:	The subject and predicate devices have identical indications.
Packaging:	The subject and predicate devices utilize same packaging configurations.
Sterilization:	The subject and predicate devices are both sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
Labeling:	Both the subject and predicate devices have similar labeling.

Conclusion for Substantial Equivalence Determination

Based on the comparison of the technological characteristics and the non-clinical testing provided in Table A & Table B (respectively, above), the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed Phenom ® 27. The additional length of the proximal shaft will assist the user in the set-up procedures without affecting the safety performance of the device.

Testing was conducted to show that no new risks were identified, and that the performance and risk profile is the same as the predicate devices cleared for the market. Additional testing as identified in the risk analysis was performed to show that the modified Phenom® 27device is substantially equivalent to the predicate Phenom® 27 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).