The Alivio Ventricular Catheter and Flusher System) is for use in the treatment of patients with hydrocephalus, as components of a shunt system when draining of cerebrospinal fluid (CSF) is indicated. The Alivio Flusher may be used by a qualified clinician as a tool to facilitate a non-invasive retrograde fluid flush of the Alivio Ventricular Catheter to unblock inlet holes or open its relief membrane to restore or increase CSF flow in a non-flowing shunt. The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions.

Device Description

The Alivio System, consisting of the Alivio Flusher and Alivio Ventricular Catheter, is an implantable component of a CSF Shunt System used in the treatment of patients with Hydrocephalus. The Ventricular Catheter is implanted in the ventricle and connected distally to the Flusher, which is in turn connected to a commercially available flow regulating valve (not provided as part of the Alivio System).

Similar to manual pumping of a flow requlating valve or performing an invasive shunt tap via the flow regulating valve; the Alivio Flusher, a fluid reservoir, may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush to the Alivio Ventricular Catheter to unblock occluded, proximal inlet holes. If the inlet holes are not able to be unblocked, the retrograde fluid flush will open the relief membrane of the Alivio Ventricular Catheter, creating a new fluid pathway to restore or increase CSF flow in a non-flowing shunt with occluded inlet holes. Once the relief membrane has been used to restore flow in a non-flowing shunt, subsequent retrograde fluid flushing of the Alivio Ventricular Catheter with the Alivio Flusher may not be sufficient to reopen the relief membrane, which may become occluded similar to proximal catheter inlet holes.

After flushing the device, standard methods of care should be used to determine that the reservoir is refilled prior to flushing a second time. Similar to commercially available reservoirs used in shunt systems, refilling of the Flusher reservoir can be confirmed by palpation of the dome. Repeated flushing of the device with an empty reservoir may not be effective. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the Alivio System.

The Alivio Flusher does not requlate flow of the shunt system. A flow requlating shunt valve is not provided with the Alivio System. During passive fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. The Alivio System is compatible and has been tested with the Integra Contour-Flex™ Valve. The Alivio System is designed to be compatible with all commercially available flow requlating valves with standard inlet connectors, similar to the integra "Contour-Flex"" Valve.

AI/ML Overview

The Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device for treating hydrocephalus. The FDA document K172006 provides information on the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with recognized standards and successful completion of various tests, with results deemed suitable for the intended use and substantially equivalent to predicate devices. Specific quantitative acceptance criteria are not explicitly detailed for all tests in the provided text, but the reported performance consistently states that the criteria were met.

Test Category	Acceptance Criteria (Implicit from "Test Method Summary")	Reported Device Performance and Conclusions
Biocompatibility	Non-cytotoxic (ISO 10993-5)	Results support that the Alivio System is non-cytotoxic.
	Non-sensitizer (ISO 10993-10)	Results support that the Alivio System is a non-sensitizer.
	Non-irritant (ISO 10993-10)	Results support that the Alivio System is a non-irritant.
	Non-toxic (systemic) (ISO 10993-11)	Results support that the Alivio System is non-toxic.
	Non-pyrogenic (material-mediated) (ISO 10993-11)	Results support that the Alivio System is non-pyrogenic.
	Non-mutagenic (Ames Mutagenicity, ISO 10993-3)	Results support that the Alivio System is non-mutagenic.
	Non-hemolytic (ISO 10993-4)	Results support that the Alivio System is non-hemolytic.
	Non-carcinogenic, non-mutagenic, non-toxic (Exhaustive Chemical Characterization, ISO 10993-18, ISO 10993-17)	Results support that Alivio System is non-carcinogenic, non-mutagenic, and non-toxic.
	Compliance with allowable extract levels (Metals Analysis, ASTM F647)	Results support that the Alivio System is in compliance with the allowable extract levels outlined in Section 5.2 and Appendix X2.5 of ASTM F647.
Packaging	Meets performance for partial simulation (ISTA-2A), detecting gross leaks (ASTM F2096-11), and seal strength (ASTM F88-09).	All testing passed.
Sterilization	Achieves a 10-6 sterility assurance level (SAL) (ANSI/AAMI/ISO 11137-1, -2, -3).	Terminal sterilization validation testing supports a 10-6 SAL.
Pyrogenicity	Endotoxin levels less than 2.15 EU/device (0.06 EU/mL) (ANSI/AAMI ST72:2011).	All units tested met the criteria of less than 2.15 EU/device (0.06 EU/mL).
Shelf Life	Maintains visual/dimensional, surface, particulate, strength, reliability, and system performance at intended shelf life (Accelerated and Real-time Aging).	Results support expiration dating on the labeling, successfully comparing devices at time 0 and the intended shelf life.
Pressure Leak Tests & Pressure Flow Characteristics	Passes pressure leak test; appropriate pressure-flow characteristics as per ASTM F 647-94(2014) Sections A 2.8.1.1 and A2.8.1.2 and ISO 7197:2006 (E) Sections 4.4 and 4.6.	All devices passed the pressure leak test and the appropriate pressure flow characteristic graph is provided in the device labeling.
Durability and System Level Functional Test	Meets acceptance criteria (ASTM F 647-94(2014)).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Flusher and Catheter Dynamic Break Strength Test	Meets acceptance criteria (ISO 7197:2006 (E) Section 4.9). No component rupture or breakage.	All results met acceptance criteria per protocol and applicable standards. During this test, no component ruptured or broke.
Flusher and Catheter Tensile Strength Test	Meets acceptance criteria (ASTM F 647-94(2014)).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Flusher Pressure Handling Test	Meets acceptance criteria (ISO 7197:2006 (E) Section 4.11).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Alivio Cartridge Performance Test	Demonstrates compliance with requirements for cartridge performance (flush pressure).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Catheter Bond Pressure Test	Withstands pressure testing at a minimum of twice the maximum relief membrane opening pressure specification.	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use.
Alivio Flusher Reliability Test	Demonstrates reliable flushing during expected useful life, with no mechanical damage and acceptable pressure/volume output.	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
MR Safety	Complies with FDA guidance to label "MR Safe" in all MR environments (ASTM F647-94(2014), Section 6.1.3).	All implanted Alivio System materials/components comply with the FDA guidance to label "MR Safe" in all MR environments.
Alivio System Imaging	Demonstrates compliance with imaging requirements (ASTM F 647-94(2014) and ISO 7197:2006).	All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device.
Occlusion Flushing Performance	Ability of retrograde flush to unblock inlet holes in simulated occlusions.	Comparative testing demonstrated that the Alivio System performance is suitable for its intended use and is substantially equivalent to the predicate device. Flushing of the Alivio System was able to restore flow in the ventricular catheter with simulated blocked inlet holes.
Comparative Performance Testing in Animals (Several studies)	Meets functional requirements; no new questions of safety and efficacy; substantially equivalent to predicate (various acute and subacute timepoints, histological analysis).	All results met acceptance criteria and demonstrated that the Alivio System meets its performance criteria. No significant difference of histological analysis of tissue between Alivio System and predicate was found. Testing demonstrated that the Alivio System does not raise any new questions of safety and efficacy and is substantially equivalent to the predicate. (One small animal model was not suitable for comparative testing, but found no histological difference).
Usability and Human Factors Testing	Ease of preparation, implantation, and use for intended use per labeling, in accordance with ANSI/AAMI HE 75, IEC 62366:2007, and FDA Human Factors Draft Guidance.	All acceptance criteria were met and the device performed as expected according to its specifications and in compliance with applicable recognized standards. Minor technological differences do not raise new types of safety and efficacy concerns, evaluated by 24 neurosurgeons.
Alivio Flusher Clinical Study	Functional safety in patients undergoing shunt revision surgery; users able to perform primary steps; no safety issues; increase or restore flow in occluded/sluggish catheters (NCT02651337).	The outcomes on 4 patients treated at the time of submission met the criteria for success outlined in the protocol. All users were able to perform the primary steps needed to use the Alivio Flusher for its intended use and use environment. No safety issues associated with the device were observed. These results demonstrate that the Alivio Flusher could increase or restore flow in occluded or sluggish flowing catheters.

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

Biocompatibility, Packaging, Sterilization, Pyrogenicity, Shelf Life, Pressure Leak/Flow, Durability, Break Strength, Tensile Strength, Pressure Handling, Cartridge Performance, Catheter Bond Pressure, Flusher Reliability, MR Safety, System Imaging, Occlusion Flushing Performance: These were bench and laboratory studies. Specific sample sizes for each bench test are not provided, but generally, these involve sufficient samples to establish statistical validity for the test method. The data provenance is from preclinical (laboratory/bench) testing.
Comparative Performance Testing in Animals:
- Pilot animal study 1: N=1 (evaluated at acute timepoint). Provenance: Preclinical animal study.
- Pilot animal study 2: N=2 (evaluated at subacute and acute timepoints). Provenance: Preclinical animal study.
- Pilot animal study 3: N=2 (evaluated at acute timepoints). Provenance: Preclinical animal study.
- Animal study 4: N=11 (evaluated at subacute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
- Animal study 5: N=6 (evaluated at acute timepoints). Provenance: Preclinical animal study, conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
Usability and Human Factors Testing: The number of users (experts) involved was 24 neurosurgeons. Provenance: Simulated clinical use model, which is a form of preclinical testing.
Alivio Flusher Clinical Study: N=4 patients. Provenance: Clinical study (registered as NCT02651337).

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

Usability and Human Factors Testing: 24 neurosurgeons (intended users) of varying experience. Their specific years of experience are not mentioned, but their role as "neurosurgeons" implies significant medical expertise relevant to the device's application.
Alivio Flusher Clinical Study: The "users" in the clinical study performed the primary steps and their ability to do so was assessed. While not explicitly stated as "ground truth establishment," their successful use contributed to the device's functional safety assessment and efficacy. The study involved clinicians, overseen by a physician for patient care.

4. Adjudication Method for the Test Set

This document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple experts. For the usability study, it indicates that the "24 neurosurgeons (intended users) of varying experience" evaluated the device, implying a consensus or aggregated assessment rather than a specific adjudication protocol. For the clinical study, the outcome was based on the "criteria for success outlined in the protocol."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any AI component mentioned in the context of human reader improvement. The device (Alivio System) is a physical medical device (catheter and flusher system), not an AI-based diagnostic or assistive software.

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

This question is not applicable as the Alivio System is a physical medical device, not an algorithm or AI solution. The performance tests evaluate the device's physical and functional characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable in the same way to this physical medical device. Instead, the studies rely on:

Compliance with recognized standards: For most preclinical tests (e.g., ISO, ASTM), the "ground truth" is adherence to established engineering and material performance specifications.
Histopathology analysis: In animal studies, histological analysis of tissue provided objective data for safety comparisons.
Comparative performance data: Comparison against predicate devices' known performance characteristics.
Clinical outcomes data: For the small clinical study, the "criteria for success outlined in the protocol" served as the evaluation metric for the device's functional safety and ability to restore/increase CSF flow.
User feedback/observational data: From the usability study involving neurosurgeons.

8. The sample size for the training set

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as the Alivio System is a physical medical device, not a software algorithm that requires a training set or its associated ground truth establishment.

Summary

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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 23, 2018

Alcyone Lifesciences, Inc. % Elsa Chi Abruzzo, RAC, FRAPS President & CEO Cygnus Regulatory 3753 Vineyard Place Cincinnati, Ohio 45226

Re: K172006

Trade/Device Name: Alivio Ventricular Catheter and Flusher System (Alivio System) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: October 9, 2017 Received: October 10, 2017

Dear Elsa Chi Abruzzo:

This letter corrects our substantially equivalent letter of November 9, 2017.

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 of medical device-related adverse events) (21 CFR 803); good

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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,

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) K172006

Device Name

Alivio Ventricular Catheter and Flusher System (Alivio System)

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 - K172006

Alivio Ventricular Catheter and Flusher System (Alivio System)

Company Name:	Alcyone Lifesciences, Inc.
Company Address:	250 Jackson StreetMill No. 5, Unit 494Lowell, Massachusetts 01852, USA
Phone:	978-709-1946
Facsimile:	978-451-7646
Contact Person:	Elsa Chi Abruzzo, RAC, FRAPS
Date Prepared:	June 30, 2017
Trade Name:	Alivio Ventricular Catheter and Flusher System (Alivio System)
Common or Usual Name:	CSF Shunt System
Classification Name:	Shunt, Central Nervous System and Components
Classification:	Class II
Product Code andRegulation:	JXG, 21CFR 882.5550
Classification Panel:	Neurology
Predicate Device:	Primary PredicateIntegraTM Contour-FlexTM Valve and Shunt System (K033698)Reference PredicatesNeuroDX Development ShuntCheck © III (K123554)Codman® Medos® Ventricular Catheter (K944222)

Intended Use / Indications for Use

Description of Device

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Ventricular Catheter Description

The Alivio Ventricular Catheter is made from silicone elastomer and barium sulfate, with an inner diameter of 1.27 mm and outer diameter of 2.54 mm. The Ventricular Catheter is 150 mm in length and is supplied with 20 inlet holes at the proximal end. There is a silicone relief membrane at the proximal end of the catheter distal to the inlet holes. The relief membrane is designed to open via a manual depression of the Flusher dome to provide the neurosurgeon with a non-invasive and consistent method to restore flow in a suspected non-flowing shunt system. The relief membrane has only been tested as a one-time use feature. This Ventricular Catheter is MR safe and is not made with natural rubber latex.

A stainless-steel stylet is provided with the Alivio Ventricular Catheter for insertion of the catheter into the ventricle.

Flusher Description

The Alivio Flusher is a reservoir system encased in a flexible silcone housing. The device consists of a common barbed connector that allows direct connection to the ventricular catheter. The device has a flush dome (reservoir) that feeds into a rigid encased flush valve opens at a predetermined pressure and sends a controlled retrograde pulse of fluid towards the ventricular cather open the blocked inlet holes or open the relief membrane.

The Alivio Flusher does not regulate flow of the shunt system or the flow regulating valve. A flow regulating shunt valve is not provided with the Alivio Flusher is compatible with all shunt valves with standard barbed connections. During passive flow, fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher.

The Alivio Flusher offers the clinician a non-invasive means to flush the ventricular catheter in the case of obstructed flow through the ventricular catheter. At the clinician's discretion, retrograde flushing of the ventricular catheter can be performed by depression of the flush dome, which sends a controlled and limited pulse of fluid (CSF, or sterile saline introduced from the priming procedure before implant) into the ventricular

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catheter to resume flow by opening suspected blocked inlet holes or opening the relief membrane of the Alivio Ventricular Catheter to restore antegrade flow in the shunt system.

During flushing, the passive channel is manually occluded to create temporary one-way flow into the ventricular catheter. After the controlled and limited pulse of fluid is sent from the dome is released, the flush dome refills with CSF from the ventricular catheter and resumes free flowing fluid through the passive flow channel.

Once the relief membrane has been used to restore flow in a non-flowing shunt system, subsequent retrograde fluid flushing of the Alivio Ventricular Catheter with the Alivio Flusher may not be sufficient to reopen the relief membrane, which may become occluded similar to proximal catheter inlet holes. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the Alivio System.

The Alivio System does not provide a mechanism for detecting obstruction or restricted flow.

The Flusher is MR safe and is not made with natural rubber latex.

Technological Characteristics

	SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
Regulation	21CFR882.5550	21CFR882.5550	21CFR882.5550	21CFR882.5550	Equivalent
Class	Class II	Class II	Class II	Class II	Equivalent
Product Code	JXG	JXG	JXG	JXG	Equivalent
Trade Name	Shunt, CentralNervous System andComponents	Shunt, CentralNervous System andComponents	Shunt, CentralNervous System andComponents	Shunt, CentralNervous System andComponents	Equivalent
Intended Use	The Alivio VentricularCatheter and FlusherSystem (Alivio System)is for use in thetreatment of patientswith hydrocephalus, ascomponents of a shuntsystem when drainingor shunting ofcerebrospinal fluid(CSF) is indicated.The Alivio Flusher maybe used by a qualifiedclinician as a tool tofacilitate a non-invasive retrogradefluid flush of the AlivioVentricular Catheter tounblock inlet holes oropen its reliefmembrane to restoreor increase CSF flowin a non-flowing shunt.The Alivio Flusher isnot intended to changestandard carepractices for diagnosis,treatment, or follow-upof patients withproximal catheter	For Use in thetreatment of patientswith hydrocephalus.The valve is acomponent of asystem designed toshunt cerebrospinalfluid from theventricles of the brainto an appropriatedrainage site, suchas the atrium of theheart or peritonealcavity.	Aids in the detectionof flow in implantedCSF shunts.ShuntCheck includesMicro-Pumper, acomponent which maybe used to temporarilyincrease CSF flow insuspected non-flowing, patent shuntsduring theShuntCheck test.ShuntCheck cannotalone diagnose CSFshunt function ormalfunction. Theclinical diagnosis ofCSF shunt function ormalfunction,incorporating the flowinformation fromShuntCheck, shouldbe made only by aqualifiedneurosurgeon.	For use in thetreatment ofhydrocephalus as acomponent of shuntsystem when drainingor shunting of CSF isindicated.	Equivalent
	SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
	occlusions.
Indications forUse	Treatment ofhydrocephalus	Treatment ofhydrocephalus	Treatment ofhydrocephalus	Treatment ofhydrocephalus	Equivalent
	Drains CSF to reduceintracranial pressureand CSF volume andincreases flow in asuspected non-flowingshunt	Drains CSF toreduce intracranialpressure and CSFvolume	Temporarily increasesflow in a suspectednon-flowing, patentshunt	Drains CSF to reduceintracranial pressureand CSF volume	Equivalent
	Proximal pumping ofthe reservoir toincrease CSF flow insuspected non-flowingshunts.	Proximal and distalpumping andinjection of thereservoir to regulateflow	Vibrational pumping ofthe reservoir totemporarily increaseCSF flow in suspectednon-flowing, patentshunts.	N/A	Equivalent
	Implantable	Implantable	Not Implantable	Implantable	Equivalent
	Single use	Single use	Single use	Single use	Equivalent
TargetPopulation	Patients withhydrocephalus	Patients withhydrocephalus	Patients withhydrocephalus	Patients withhydrocephalus	Equivalent
Anatomical Sites	Brain ventricle andHead	Head	Head	Brain Ventricle	Equivalent
Where Used	Operating Room	Operating room	Operating room	Operating room	Equivalent
Energy Used	None	None	None	None	Equivalent
	Labeling indicates sizeand length	Labeling indicatessize and length	Labeling indicates sizeand length	Labeling indicatessize and length	Equivalent
Human Factors	Labeling indicates flowvs. pressure labels	Labeling indicatesflow vs. pressurelabels	Labeling indicates flowvs. pressure labels	N/A	Equivalent
	Can be manipulatedwith gloved hand	Can be manipulatedwith gloved hand	Can be manipulatedwith gloved hand	N/A	Equivalent
Design	Designed to be placedin the ventricle of thebrain and under thescalp	Designed to beplaced under thescalp (valvecomponent only)	Designed to be placedtemporarily on thescalp and on theclavicle	Designed to beplaced in the ventricleof the brain(ventricular catheteronly)	Equivalent
	flexible catheter toremain implanted inthe brain	N/A	N/A	flexible catheter toremain implanted inthe brain	Equivalent
	Series of holes atproximal end of thecatheter for fluidmovement	N/A	N/A	Series of holes atproximal end of thecatheter for fluidmovement	Equivalent
	20 flow holes	N/A	N/A	24 flow holes	Equivalent
	4 lines of 5 holes	N/A	N/A	3 lines of 8 holes	Equivalent
	bullet shaped tip	N/A	N/A	bullet shaped tip	Equivalent
	A single reliefmembrane distal to theproximal inlet holes ofthe catheter to open ata threshold pressurefor restoration of fluid	N/A	N/A	N/A	EquivalentThe reliefmembrane isequivalent to inletholes since itprovides fluid entry
SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
movement				into catheter whenopened. The reliefmembrane canonly be opened ifthe inlet holes areblocked.
Length from proximaltip to the most distalholes and reliefmembrane is 0.720"	N/A	N/A	Length from proximaltip to the most distalholes is 0.720"	Equivalent
Catheter is notimpregnated withantimicrobial agents.	N/A	N/A	Catheter is notimpregnated withantimicrobial agents.	Equivalent
Barium sulfate-filledcatheter	N/A	N/A	Barium sulfate-filledcatheter	Equivalent
Inner diameter ofcatheter: 0.050"	N/A	N/A	Inner diameter ofcatheter: 0.055" or0.050"	Equivalent
Outer diameter ofcatheter: 0.100"	N/A	N/A	Outer diameter ofcatheter: 0.106" or0.100"	Equivalent
Catheter length: 15cminitially (other commonlengths may beoffered)	N/A	N/A	Catheter length: 14,15, 23 cm	Equivalent
Length markings: 1 dotat 10cm and 2 dots at15cm	N/A	N/A	1 dot at 10cm and 2dots at 15cm	Equivalent
Stylet for catheterinsertion	N/A	N/A	Stylet for catheterinsertion	Equivalent
Reservoir (Rickham orcomparable). Nottested or made as aclaim.	Reservoir (Rickhamor comparable). Nottested or made as aclaim.	N/A	Can be used inconjunction with aRickham or otherreservoirs	Equivalent
Right angle clipcompatible(not provided)	N/A	N/A	Right angle clip	Equivalent
Flushing -unidirectional controlby occluders	Flushing -bidirectional controldone by occluders	Vibrational pressure,direction unknown	N/A	Equivalent
Flush direction onlytowards ventricle(proximal)	Flushing directionstoward ventricle(proximal) ordrainage (distal)	Unknown	N/A	Equivalent
Increases flow througha non-flowing catheter	Use of retrogradeflush or shunt tap toincrease flowpossible, but not aclaim	Increases flow througha non-flowing catheter	N/A	Equivalent
Flow regulation (allowspassive flow for use in-line with a one-waycheck valve to regulateflow in system)	One way check valveto regulate flow insystem	Does not affect flowregulation	N/A	Equivalent
Fluid filled reservoir	0.25 mL fluid filled	N/A	N/A	Equivalent
	SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
	less than 0.5 mL	reservoir
	Barb fittings forconnection toventricular catheterand shunt valve	Barb fittings forconnection toventricular catheter	N/A	N/A	Equivalent
	Series of channels toallow fluid movementfrom dome intoventricular catheterand fluid from theventricular catheter todome and rest of shuntsystem	Series of channels toallow fluid movementfrom dome intoventricular catheterand fluid from theventricular catheterto dome and rest ofshunt system	N/A	N/A	Equivalent
	Inner channeldiameter: greater than1mm	Inner channeldiameter unknown	N/A	N/A	EquivalentPassive flowchannel diametermeets ISO7197:2006
	40mm in length17mm in width10mm height	32mm in length16mm in width8mm in height	N/A	N/A	Equivalent topredicate andsize/dimensionacceptable to userper human factorsstudies conducted
	Reservoir and shuntaccessories withstanduse forces	Reservoir withstandsflushing and shunttaps.	Reservoir and shuntaccessories withstandvibrations	N/A	Equivalent
	Can be used withdimensionallycompatible shuntsystem components	Can be used withdimensionallycompatible shuntsystem components	Can be used withdimensionallycompatible shuntsystem components	Can be used withdimensionallycompatible shuntsystem components	Equivalent
	Low profile forimplantation under thescalp	Low profile forimplantation underthe scalp	N/A	N/A	Equivalent
	Soft and flexible outerhousing	Soft and flexibleouter housing	N/A	N/A	Equivalent
	Rigid sections in thehousing to seat valves	Rigid sections in thehousing	N/A	N/A	Equivalent
	Occluders (distaldrainage channel isoccluded during flush)	Distal and proximaloccluders	Unknown (likely N/A)	N/A	Equivalent
	Printing to indicatedirection of flow andposition	Printing to indicatedirection of flow andposition	N/A	N/A	Equivalent
Performance	Retrograde pulse intothe ventricular catheter(created by manualpumping - depressingdome/flusher with afixed reservoir volume)	Retrograde pulseinto the ventricularcatheter whenproximal occluder isactivated - forcewithin system andlimited by fixedreservoir volume.	Retrograde vibrationsinto ventricularcatheter - force insystem and to patientunknown	N/A	Equivalent
	One way flow betweenthe reservoir andventricular catheterwhen device is	One way flowbetween reservoirand catheters whenoccluder is pressed	N/A	N/A	Equivalent
	SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
	pumped	and reservoir ispumped
	Reservoir refills afterpumping	Reservoir refills afterpumping	Reservoir refills aftervibrations	N/A	Equivalent
	Normal shunt functionresumes after pumping	Normal shuntfunction resumesafter pumping	Normal shunt functionresumes aftervibrations	N/A	Equivalent
	Catheter diverts fluidfrom ventricle	Catheter diverts fluidfrom ventricle(through checkvalve)	N/A	Catheter diverts fluidfrom ventricle	Equivalent
	Relief membraneremains open afteractivating	Inlet holes areintended to remainpatent to providefluid path.	N/A	Inlet holes areintended to remainpatent to provide fluidpath.	EquivalentProvides samefluid path intocatheter as openinlet holes
	Ventricular Catheter:silicone with BaSO4filler, relief membranesilicone	N/A	N/A	Ventricular Catheter:BaSO4 filled siliconeelastomer	Equivalent
	Valves: silicone	Valves: silicone	N/A	N/A	Equivalent
Materials	Dome/outer housing:silicone	Outer housing:silicone	N/A	N/A	Equivalent
	N/A	Needle guard:polypropylene	N/A	N/A	N/A
	N/A	N/A	Micro-pumper:Polyurethane plastic	N/A	N/A
Biocompatibility	Tissue contact testedper ISO 10993:Biological Evaluationof Medical Devices	Tissue contact testedper ISO 10993:Biological Evaluationof Medical Devices	Tissue contact testedper ISO 10993:Biological Evaluationof Medical Devices	Tissue contact testedper ISO 10993:Biological Evaluationof Medical Devices	Equivalent
	Non-pyrogenic	Non-pyrogenic	N/A	Non-pyrogenic	Equivalent
	Safe in 1.5T MRIenvironment	Safe in 1.5T MRIenvironment	N/A	Safe in 1.5T MRIenvironment	Equivalent
Compatibilitywith environmentand otherdevices	Safe in an x-rayenvironment	Safe in an x-rayenvironment	No radiation	Safe in an x-rayenvironment	Equivalent
	Compatible withcurrent shunt systemsand accessories	Compatible withcurrent shuntsystems andaccessories	N/A	Compatible withcurrent shuntsystems andaccessories	Equivalent
	Compatible with longterm CSF contact andsaline	Compatible with longterm CSF contactand saline	N/A	Compatible with longterm CSF contactand saline	Equivalent
Radiopacity	BaSO4 filled siliconeelastomer	BaSO4 filled siliconeelastomer	N/A	BaSO4 filled siliconeelastomer	N/A
Sterility	Terminally sterilized for10-6 SAL with nodamage to systemcomponents.Validated perANSI/AAMI/ISO11137-2; Sterilization	Terminally sterilizedfor 10-6 SAL with nodamage to systemcomponents.Validated perrecognized	None	Terminally sterilizedfor 10-6 SAL with nodamage to systemcomponents.Validated perrecognized	Equivalent
	SUBJECT DEVICEAlcyoneAlivio System(K172006)	PRIMARYPREDICATEIntegraNeurosciencesContour-Flex Valveand Shunt System(K033698)	REFERENCEPREDICATENeuroDxDevelopment, LLCShuntCheck III(K123554)	REFERENCEPREDICATECodman MedosVentricular Catheter(K944222)	EquivalenceComparison
	of health care products- Radiation	sterilization standard.		sterilization standard.
Electrical Safety	N/A	N/A	IEC 60601 Tested	N/A	N/A
MechanicalSafety	Manual flushing(pumping) generatesequivalent ventricularsuction/flushing withno valve damage oralteration	Manual flushing(pumping) generatesequivalent ventricularsuction/flushing withno valve damage oralteration	Micro-Pumpergenerates lessventricular suctionthan manual shuntpumping, no valvedamage or alteration	N/A	Equivalent
Chemical Safety	Saline, CSF	Saline, CSF	Saline, CSF	Saline, CSF	Equivalent
MRICompatibility	MR Safe	MR Safe	Not MR Safe	MR Safe	Equivalent
Radiation Safety	X-ray Safe	X-ray Safe	No Radiation	X-ray Safe	Equivalent
Packaging	Packaging maintainssterility and protectsdevice. Tray, pouch,box. Catheter andflusher packagedtogether.	Packaging maintainssterility and protectsdevice. Tray, pouch,box. Multiplecomponents can bepackaged together.	Unknown	Packaging maintainssterility and protectsdevice. Tray, pouch,box. Multiplecomponents can bepackaged together.	Equivalent
Shelf Life	Labeled shelf life(expiation) will bebased on real time andaccelerated aging shelflife studies 1-3 years.	Labeled shelf life 1-3years.	Unknown	Labeled shelf life 1-3years.	Equivalent

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Rx or OTC

The Alivio System is an Rx prescription device per 21 CFR Part 801, Subpart D.

Performance Data

Preclinical and clinical tests were conducted on the Alivio System to demonstrate that it meets defined design requirements and can perform in a manner equivalent to devices currently on the market used for its intended use. Testing included verification and validation bench testing, comparative usability testing in animals, human factors evaluations in a simulated clinical use model per the available guidance, and clinical testing. The design, testing, and technical information provided for the Alivio System also comply with the applicable sections of ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] and ASTM F647: 94 (2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. The table below summarizes the performance testing conducted.

Test	Test Method Summary	Results and Conclusions
Biocompatibility	Cytotoxicity (MEM and NRU): Conducted Testingfor CSF contacting permanent implant device inaccordance with ISO 10993-1 BiologicalEvaluation of Medical Devices and FDA Guidance,Use of International Standard ISO 10993-5,"Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity"	Results support that the Alivio System isnon-cytotoxic.

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Test	Test Method Summary	Results and Conclusions
	Sensitization (Kligman): Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-10, "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"	Results support that the Alivio System is a non-sensitizer.
	Intracutaneous Reactivity: Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-10, "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"	Results support that the Alivio System is a non-irritant.
	Systemic Toxicity: Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-11, "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity"	Results support that the Alivio System is non-toxic.
	Pyrogenicity (Material Mediated): Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-11, "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity"	Results support that the Alivio System is non-pyrogenic.
	Genotoxicity (Ames Mutagenicity): Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-3, "Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity"	Results support that the Alivio System is non-mutagenic.
	Hemocompatibility (Direct and Indirect): Conducted Testing for CSF contacting permanent implant device in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-4, "Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood"	Results support that the Alivio System is non-hemolytic.
	Exhaustive Chemical Characterization: Conducted Testing in accordance with ISO 10993-1 Biological Evaluation of Medical Devices and FDA Guidance, Use of International Standard ISO 10993-18, "Biological evaluation of medical devices - Part 18: Chemical characterization of materials" and International Standard ISO 10993-17, "Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances"	Results support that Alivio System is non-carcinogenic, non-mutagenic, and non-toxic.
	Metals Analysis: Conducted Testing in accordance with ASTM F647 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application.	Results support that the Alivio System is in compliance with the allowable extract levels outlined in Section 5.2 and Appendix X2.5 of ASTM F647.
Packaging		Conducted Testing in accordance with ISTA-2A Partial Simulation Performance Tests, ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) and ASTM F88-09	Standard Test Method for Seal Strength of	All testing passed.
Test	Test Method Summary	Results and Conclusions
Sterilization	Flexible Barrier MaterialsConducted Testing in accordance withANSI/AAMI/ISO 11137-1:2006 Sterilization ofhealth care products-Microbiologicalmethods-Part 1: Determination of the populationof microorganisms on product, ANSI/AAMI/ISO11137-2:2013 Sterilization of health care products— Radiation — Part 2: Establishing the sterilizationdose, and ANSI/AAMI/ISO 11137-3:2006Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects	Terminal sterilization validation testingsupports a 10-6 SAL.
Pyrogenicity	LAL testing was validated in accordance with theapplicable FDA's Guidelines (Guideline onValidation of the Limulus Amebocyte Lysate TestAs An End-Product Endotoxin Test for Human AndAnimal Parenteral Drugs, Biological Products, andMedical Devices - 1997) and recognized standards(USP Endotoxin Reference Standard) for BacterialEndotoxin (LAL) Validation using the Kinetic-QLCTest Method.	This test validates the method formeasuring the endotoxin levels of hefinished device per ANSI/AAMIST72:2011 Bacterial endotoxins - testmethodologies, routine monitoring, andalternatives to batch testing. All unitstested met the criteria of less than 2.15EU/device (0.06 EU/mL).
Shelf Life	Accelerated and Real-time Aging was conductedon the device and packaging. Testing comparingdevices and packaging at time 0 and the intendedshelf life was conducted in accordance withapplicable standards and the productspecifications. Tests include visual/dimensionalinspections, surface inspection, particulate testing,strength and reliability testing, and systemperformance testing.	Testing, including visual/dimensionalinspections, particulate testing, surfaceinspection, mechanical and systemperformance testing comparing devices attime 0 and the intended shelf life. Resultssupports expiration dating on the labeling.
Pressure LeakTests andPressure FlowCharacteristicsTest	Conducted Testing in accordance to Sections 4.4and 4.6 of ISO 7197:2006 (E), NeurosurgicalImplants - Sterile, single-use hydrocephalus shuntsand components [Including: TechnicalCorrigendum 1 (2007)] and ASTM F647: 94(2014), Standard Practice for Evaluating andSpecifying Implantable Shunt Assemblies forNeurosurgical Application. The correspondingpressure profiles were recorded and plotted asgraphs as per ASTM F 647-94(2014), StandardPractice for Evaluating and Specifying ImplantableShunt Assemblies for Neurosurgical Application,Sections A 2.8.1.1 and A2.8.1.2 to evaluate andcompare the pressure-flow characteristics of theAlivio Catheter to Predicate Catheter.	All devices passed the pressure leak testand the appropriate pressure flowcharacteristic graph is provided in thedevice labeling.
Durability andSystem LevelFunctional Test	Conducted Testing in accordance to ASTM F 647-94(2014), Standard Practice for Evaluating andSpecifying Implantable Shunt Assemblies forNeurosurgical Application.	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse and is substantially equivalent to thepredicate device.
Flusher andCatheterDynamic BreakStrength Test	Conducted Testing for the ventricular catheter andflusher components in accordance to Section 4.9of ISO 7197:2006 (E), Neurosurgical Implants -Sterile, single-use hydrocephalus shunts to assessdynamic breaking strength.	All results met acceptance criteria perprotocol and applicable standards. Duringthis test, no component ruptured or broke.
Flusher andCatheterTensileStrength Test	Conducted Testing for the ventricular catheter andflusher to evaluate the bond/tensile strength ofthese components in accordance with ASTM F647-94(2014) "Standard Practice for Evaluatingand Specifying Implantable Shunt Assemblies forNeurosurgical Application.	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse and is substantially equivalent to thepredicate device.
Flusher	PressureHandling Test	Conducted Testing for flusher in accordance to	Section 4.11 of ISO 7197:2006 (E), NeurosurgicalImplants - Sterile, single-use hydrocephalus shunts	All results met acceptance criteria and	demonstrate that the Alivio Systemperformance is suitable for its intended

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Test	Test Method Summary	Results and Conclusions
	to assess dynamic breaking strength.	use and is substantially equivalent to thepredicate device.
Alivio CartridgePerformanceTest	This test measures the AF cartridge crackingpressure to demonstrate compliance of AFCartridge with requirements for cartridgeperformance (flush pressure).	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse and is substantially equivalent to thepredicate device.
Catheter BondPressure Test	Catheters were subjected to pressure testing at aminimum of twice the maximum relief membraneopening pressure specification.	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse.
Alivio FlusherReliability Test	Testing was conducted to verify the reliability of theAlivio Flusher to be able to flush during itsexpected useful life. Testing included anassessment of any mechanical damage and theability to flush with acceptable pressure andvolume output.	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse and is substantially equivalent to thepredicate device.
MR Safety	Conducted Assessment in accordance ASTMF647-94(2014), "Standard Practice for Evaluatingand Specifying Implantable Shunt Assemblies forNeurosurqical Application", Section 6.1.3"Magnetic Resonance Imaging (MRI)Compatibility"	All implanted Alivio Systemmaterials/components comply with theFDA guidance to label "MR Safe" in allMR environments.
Alivio SystemImaging	The devices were imaged using X-ray todemonstrate compliance with requirements forimaging per ASTM F 647-94(2014) and ISO7197:2006.	All results met acceptance criteria anddemonstrate that the Alivio Systemperformance is suitable for its intendeduse and is substantially equivalent to thepredicate device.
OcclusionFlushingPerformance	Devices were occluded with blood and othersubstances to clinically simulate proximal catheterocclusions (blocked proximal catheter inlet holes)in the Alivio System and predicate device. Thesedevices were then tested to evaluate ability of thedevice's retrograde flush to unblock inlet holes.	Comparative testing demonstrated thatthe Alivio System performance is suitablefor its intended use and is substantiallyequivalent to the predicate device.Flushing of the Alivio System was able torestore flow in the ventricular catheter withsimulated blocked inlet holes.
ComparativePerformanceTesting inAnimals	Pilot animal study (N=1 evaluated at an acutetimepoint) was conducted in two parts todemonstrate that the Alivio System meets itsfunctional requirements and was tested incomparison to the predicate to demonstrate thatthe Alivio System does not raise new questions ofsafety and efficacy and is substantially equivalentto the predicate.	All results met the acceptance criteria anddemonstrated that the Alivio Systemmeets its performance criteria. Nosignificant difference of histologicalanalysis of tissue between Alivio Systemand predicate was found. Testingdemonstrated that the Alivio System doesnot raise any new questions of safety andefficacy and is substantially equivalent tothe predicate.
ComparativePerformanceTesting inAnimals	Pilot animal study (N=2 evaluated at subacute andacute timepoints) was conducted to demonstratethat the Alivio System meets its functionalrequirements and was tested in comparison to thepredicate to demonstrate that the Alivio Systemdoes not raise new questions of safety and efficacyand is substantially equivalent to the predicate.	All results met the acceptance criteria anddemonstrated that the Alivio Systemmeets its performance criteria. Nosignificant difference of histologicalanalysis of tissue between Alivio Systemand predicate was found. Testingdemonstrated that the Alivio System doesnot raise any new questions of safety andefficacy and is substantially equivalent tothe predicate.
ComparativePerformanceTesting inAnimals	Pilot animal study (N=2 evaluated at acutetimepoints) comparing the Alivio System with thepredicate was conducted to demonstrate that thedifferences in technology do not raise newquestions of safety and is substantially equivalentto the predicates.	Results demonstrated that a small animalmodel was not suitable for comparativetesting of the Alivio System and thepredicate. However, there was nosignificant difference of histologicalanalysis of tissue between Alivio Systemand predicates.
	Animal study (N=11 evaluated at subacute	All results, including performance as well
Test	Test Method Summary	Results and Conclusions
	timepoints) comparing the Alivio System with thepredicate was conducted to demonstrate that theAlivio System meets its functional requirements,the differences in technology do not raise newquestions of safety, and is substantially equivalentto the predicates. Testing was conducted inconformance to FDA 21 CFR, Part 58-GoodLaboratory Practice for Nonclinical Studies.	as comparative CSF and histopathologyanalysis, met acceptance criteria. Testingdemonstrated that the Alivio System doesnot raise any new questions of safety andefficacy and is substantially equivalent tothe predicate.
	Animal study (N=6 evaluated at acute timepoints) comparing the Alivio System with the predicatewas conducted to demonstrate that the differencesin technology do not raise new questions of safetyand is substantially equivalent to the predicates.Testing was conducted in conformance to FDA 21CFR, Part 58-Good Laboratory Practice forNonclinical Studies.	No significant difference of histologicalanalysis of tissue between AlivioSystem and predicate was found. Testingdemonstrated that the Alivio System doesnot raise any new questions of safety andefficacy and is substantially equivalent tothe predicate.
Usability andhuman factorstesting	Testing of the Alivio System in animal and clinicalsimulation bench models was conducted toevaluate ease of preparation, implantation, anduse for its intended use according to its labelingwas conducted in accordance with ANSI/AAMI HE75, Human Factors Engineering Design of MedicalDevices, IEC 62366:2007, Medical Devices -Application of Usability Engineering to MedicalDevices, and FDA Guidance (Jun 22, 2011)Human Factors Draft Guidance.	Alivio System is deemed to meet itsspecifications for its intended use and issubstantially equivalent to the predicatedevices. In all cases the acceptancecriteria were met and the deviceperformed as expected according to itsspecifications and in compliance withapplicable recognized standards. Thesedata demonstrate that the minortechnological differences do not raise newtypes of safety and efficacy concerns asevaluated by 24 neurosurgeons (intendedusers) of varying experience in numeroussimulated clinical uses of the AlivioSystem. The Alivio System functions ascomponents of a CSF Shunt System andis substantially equivalent to its predicatedevices.
Alivio FlusherClinical Study	The Alivio Flusher was evaluated in a clinicalsetting to demonstrating functional safety of theAlivio flusher in patients undergoing shunt revisionsurgery. (NCT02651337)	The outcomes on 4 patients treated at thetime of submission met the criteria forsuccess outlined in the protocol. All userswere able to perform the primary stepsneeded to use the Alivio Flusher for itsintended use and use environment. Nosafety issues associated with the devicewere observed. These resultsdemonstrate that the Alivio Flusher couldincrease or restore flow in occluded orsluggish flowing catheters.

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Manufacturing and traceability of devices tested were conducted in accordance with 21 CFR Part 820 Good Manufacturing Practices and BS EN ISO 13485:2003 Medical Devices - Quality Management Systems. In all instances, the Alivio System functioned as intended and results observed were as expected. These test results confirm that Alivio System complies with the recognized standards, meets the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate.

Substantial Equivalence

The Alivio System is substantially equivalent to the primary predicate the Integra Contour-Flex™ Valve and Shunt System (K033698), and reference predicates the NeuroDX Development ShuntCheck III (K123554), and the Codman Medos Ventricular Catheter (K944222). The Alivio System and its predicate devices share the same Product Code and classification as components of a CSF Shunt System. The Alivio System has the same intended use as the primary predicate device and equivalent indications for use. The Alivio System also has a

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very similar design and technological characteristics to the predicate devices. Minor differences in technological characteristics do not raise new questions of safety and efficacy when all listed warnings and cautions are followed.

The key technological difference is that the Alivio Ventricular Catheter has an added relief (slit) membrane that may be opened by the flusher component to restore CSF flow in a suspected non-flowing shunt. Similar to the predicate Integra Contour-Flex Valve that can produce a retrograde flush to unblock suspected blocked inlet holes in a ventricular catheter; when manually activated by the neurosurgeon, the flusher component can noninvasively produce a retrograde flush to either unblock suspected blocked inlet holes or open the relief membrane in the Alivio Ventricular Catheter.

Similar to the ShuntCheck reference predicate, the Alivio System has features designed to restore flow in a suspected non-flowing shunt. They differ slightly in technological characteristics in that the ShuntCheck predicate uses a micropumper to create vibrational pumping of the reservoir, while the Alivio System employs manual proximal pumping of the reservoir by the neurosurgeon, similar to the primary predicate Integra Contour-Flex Valve predicate.

The Flusher does not regulate flow in the shunt system. Rather it allows for passive flow of fluid from the Alivio Ventricular Catheter to a flow regulating valve (connected distally in line with the flusher) when not manually activated by the neurosurgeon to produce a retrograde flush. The Alivio Flusher is compatible with all shunt valves with standard barbed connections, but has only been tested with the Integra Contour-Flex Valve predicate device. During passive flow, fluid from the ventricular catheter flows freely, without restriction through the passive flow channel of the Flusher. Use of the Alivio Flusher does not inhibit the function of the flow requlating valve.

The results from preclinical and clinical evaluations demonstrate that the technological and performance characteristics of the Alivio System meet defined design requirements and can perform in a manner equivalent to devices currently on the market used for its intended/indicated use. Performance data demonstrate that the Alivio System performs as intended and is substantially equivalent to its predicate(s).

Conclusions

The data and information presented within this submission of substantial equivalence to the predicate(s) listed above, and therefore market clearance of the System for its intended use. This conclusion is based upon the device equivalence in design, materials technological characteristics, principles of operation, and indications for use.

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).