Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, fluid dynamics, and biological compatibility. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

The device aids in the treatment of hydrocephalus by managing cerebrospinal fluid and restoring flow in shunts, which directly addresses a medical condition.

Diagnostic

No
The Alivio Ventricular Catheter and Flusher System is described as a treatment device for hydrocephalus that helps restore CSF flow. The text explicitly states, "The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions." This clearly indicates it does not serve a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states that the Alivio System consists of the Alivio Flusher and Alivio Ventricular Catheter, which are described as implantable components of a CSF Shunt System. The performance studies also detail extensive testing of physical components and materials, including biocompatibility, packaging, sterilization, pressure handling, durability, and tensile strength. This indicates the device is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the treatment of hydrocephalus by draining cerebrospinal fluid (CSF) as part of a shunt system. It also describes a method for flushing the catheter to restore CSF flow. This is a therapeutic and mechanical function, not a diagnostic one.
Device Description: The description details the components of the shunt system (catheter and flusher) and how they function to manage CSF flow. It explicitly states the flusher is a "tool to facilitate a non-invasive retrograde fluid flush" and is "not intended to change standard care practices for diagnosis, treatment, or follow-up."
Lack of Diagnostic Function: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on bodily samples. Its function is entirely related to the physical management of CSF flow within the body.
Performance Studies: The performance studies focus on the mechanical and biological compatibility of the device (durability, strength, biocompatibility, flushing performance, etc.) and its clinical effectiveness in restoring CSF flow. They do not involve evaluating the device's ability to diagnose a condition or measure a biological marker.

The device is an implantable medical device used for the treatment of a medical condition (hydrocephalus) by managing fluid flow within the body. This falls under the category of therapeutic devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

JXG

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 regulating 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 non-invasive 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 regulate flow of the shunt system. A flow regulating 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 regulating valves with standard inlet connectors, similar to the integra "Contour-Flex"" Valve.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain ventricle and Head

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified clinician; Operating Room

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

Not Found

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

Occlusion Flushing Performance: Devices were occluded with blood and other substances to clinically simulate proximal catheter occlusions (blocked proximal catheter inlet holes) in the Alivio System and predicate device. These devices were then tested to evaluate ability of the device's retrograde flush to unblock inlet holes.

Comparative Performance Testing in Animals:
Pilot animal study (N=1 evaluated at an acute timepoint) was conducted in two parts to demonstrate that the Alivio System meets its functional requirements and was tested in comparison to the predicate to demonstrate that the Alivio System does not raise new questions of safety and efficacy and is substantially equivalent to the predicate.
Pilot animal study (N=2 evaluated at subacute and acute timepoints) was conducted to demonstrate that the Alivio System meets its functional requirements and was tested in comparison to the predicate to demonstrate that the Alivio System does not raise new questions of safety and efficacy and is substantially equivalent to the predicate.
Pilot animal study (N=2 evaluated at acute timepoints) comparing the Alivio System with the predicate was conducted to demonstrate that the differences in technology do not raise new questions of safety and is substantially equivalent to the predicates.
Animal study (N=11 evaluated at subacute timepoints) comparing the Alivio System with the predicate was conducted to demonstrate that the Alivio System meets its functional requirements, the differences in technology do not raise new questions of safety, and is substantially equivalent to the predicates. Testing was conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
Animal study (N=6 evaluated at acute timepoints) comparing the Alivio System with the predicate was conducted to demonstrate that the differences in technology do not raise new questions of safety and is substantially equivalent to the predicates. Testing was conducted in conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.

Usability and human factors testing: Testing of the Alivio System in animal and clinical simulation bench models was conducted to evaluate ease of preparation, implantation, and use for its intended use according to its labeling was conducted in accordance with ANSI/AAMI HE 75, Human Factors Engineering Design of Medical Devices, IEC 62366:2007, Medical Devices - Application of Usability Engineering to Medical Devices, and FDA Guidance (Jun 22, 2011) Human Factors Draft Guidance. Evaluated by 24 neurosurgeons of varying experience.

Alivio Flusher Clinical Study: The Alivio Flusher was evaluated in a clinical setting to demonstrating functional safety of the Alivio flusher in patients undergoing shunt revision surgery. (NCT02651337), N=4 patients treated at the time of submission.

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

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.

Study Type: Biocompatibility
Test Method Summary: Cytotoxicity (MEM and NRU) in accordance with ISO 10993-1 and ISO 10993-5. Sensitization (Kligman) in accordance with ISO 10993-1 and ISO 10993-10. Intracutaneous Reactivity in accordance with ISO 10993-1 and ISO 10993-10. Systemic Toxicity in accordance with ISO 10993-1 and ISO 10993-11. Pyrogenicity (Material Mediated) in accordance with ISO 10993-1 and ISO 10993-11. Genotoxicity (Ames Mutagenicity) in accordance with ISO 10993-1 and ISO 10993-3. Hemocompatibility (Direct and Indirect) in accordance with ISO 10993-1 and ISO 10993-4. Exhaustive Chemical Characterization in accordance with ISO 10993-1, ISO 10993-18, and ISO 10993-17. Metals Analysis in accordance with ASTM F647.
Key Results: Results support that the Alivio System is non-cytotoxic, non-sensitizer, non-irritant, non-toxic, non-pyrogenic, non-mutagenic, non-hemolytic, non-carcinogenic, and in compliance with the allowable extract levels of ASTM F647.

Study Type: Packaging
Test Method Summary: ISTA-2A, ASTM F2096-11, ASTM F88-09.
Key Results: All testing passed.

Study Type: Sterilization
Test Method Summary: ANSI/AAMI/ISO 11137-1:2006, ANSI/AAMI/ISO 11137-2:2013, and ANSI/AAMI/ISO 11137-3:2006.
Key Results: Terminal sterilization validation testing supports a 10-6 SAL.

Study Type: Pyrogenicity
Test Method Summary: LAL testing in accordance with FDA's Guidelines and USP Endotoxin Reference Standard.
Key Results: This test validates the method for measuring the endotoxin levels of the finished device per ANSI/AAMI ST72:2011. All units tested met the criteria of less than 2.15 EU/device (0.06 EU/mL).

Study Type: Shelf Life
Test Method Summary: Accelerated and Real-time Aging. Tests include visual/dimensional inspections, surface inspection, particulate testing, strength and reliability testing, and system performance testing.
Key Results: Results support expiration dating on the labeling.

Study Type: Pressure Leak Tests and Pressure Flow Characteristics Test
Test Method Summary: ISO 7197:2006 (E) Sections 4.4 and 4.6, and ASTM F647:94 (2014). Pressure profiles recorded as per ASTM F 647-94(2014) Sections A 2.8.1.1 and A2.8.1.2.
Key Results: All devices passed the pressure leak test and the appropriate pressure flow characteristic graph is provided in the device labeling.

Study Type: Durability and System Level Functional Test
Test Method Summary: ASTM F 647-94(2014).
Key Results: 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.

Study Type: Flusher and Catheter Dynamic Break Strength Test
Test Method Summary: ISO 7197:2006 (E) Section 4.9.
Key Results: All results met acceptance criteria per protocol and applicable standards. During this test, no component ruptured or broke.

Study Type: Flusher and Catheter Tensile Strength Test
Test Method Summary: ASTM F 647-94(2014).
Key Results: 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.

Study Type: Flusher Pressure Handling Test
Test Method Summary: ISO 7197:2006 (E) Section 4.11.
Key Results: 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.

Study Type: Alivio Cartridge Performance Test
Test Method Summary: Measures the AF cartridge cracking pressure.
Key Results: 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.

Study Type: Catheter Bond Pressure Test
Test Method Summary: Catheters subjected to pressure testing at a minimum of twice the maximum relief membrane opening pressure specification.
Key Results: All results met acceptance criteria and demonstrate that the Alivio System performance is suitable for its intended use.

Study Type: Alivio Flusher Reliability Test
Test Method Summary: Assessment of mechanical damage and ability to flush with acceptable pressure and volume output during its expected useful life.
Key Results: 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.

Study Type: MR Safety
Test Method Summary: ASTM F647-94(2014) Section 6.1.3.
Key Results: All implanted Alivio System materials/components comply with the FDA guidance to label "MR Safe" in all MR environments.

Study Type: Alivio System Imaging
Test Method Summary: X-ray imaging per ASTM F 647-94(2014) and ISO 7197:2006.
Key Results: 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.

Study Type: Occlusion Flushing Performance
Test Method Summary: Devices occluded with blood and other substances to clinically simulate proximal catheter occlusions in the Alivio System and predicate device, then tested to evaluate ability of device's retrograde flush to unblock inlet holes.
Key Results: 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.

Study Type: Comparative Performance Testing in Animals
Sample Size: N=1 (acute timepoint), N=2 (subacute and acute timepoints), N=2 (acute timepoints), N=11 (subacute timepoints), N=6 (acute timepoints).
Test Method Summary: Animal studies comparing Alivio System with predicate devices to demonstrate functional requirements, safety, efficacy, and substantial equivalence. Conformance to FDA 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Studies.
Key Results: All results met acceptance 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. For one small animal model (N=2 acute timepoints), it was determined not suitable for comparative testing, but no significant histological difference was found.

Study Type: Usability and human factors testing
Test Method Summary: Testing in animal and clinical simulation bench models to evaluate ease of preparation, implantation, and use according to labeling. In accordance with ANSI/AAMI HE 75, IEC 62366:2007, and FDA Guidance (Jun 22, 2011).
Key Results: Alivio System meets specifications for intended use and is substantially equivalent to predicate devices. Acceptance criteria were met and device performed as expected. Data demonstrate that minor technological differences do not raise new types of safety and efficacy concerns as evaluated by 24 neurosurgeons. The Alivio System functions as components of a CSF Shunt System and is substantially equivalent to its predicate devices.

Study Type: Alivio Flusher Clinical Study
Sample Size: N=4 patients
Test Method Summary: Evaluation in a clinical setting to demonstrate functional safety in patients undergoing shunt revision surgery. (NCT02651337)
Key Results: Outcomes met criteria for success. All users able to perform primary steps. No safety issues observed. Results demonstrate the Alivio Flusher could increase or restore flow in occluded or sluggish flowing catheters.

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

Not Found

Predicate Device(s)

K033698

Reference Device(s)

K123554, K944222

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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)

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.

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 Street
Mill No. 5, Unit 494
Lowell, 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 and
Regulation:	JXG, 21CFR 882.5550
Classification Panel:	Neurology
Predicate Device:	Primary Predicate
IntegraTM Contour-FlexTM Valve and Shunt System (K033698)

Reference Predicates
NeuroDX Development ShuntCheck © III (K123554)
Codman® Medos® Ventricular Catheter (K944222) |

Intended Use / Indications for Use

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.

Description of Device

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).

4

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.

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

5

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 DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison |
|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 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, Central
Nervous System and
Components | Shunt, Central
Nervous System and
Components | Shunt, Central
Nervous System and
Components | Shunt, Central
Nervous System and
Components | Equivalent |
| Intended Use | The Alivio Ventricular
Catheter and Flusher
System (Alivio System)
is for use in the
treatment of patients
with hydrocephalus, as
components of a shunt
system when draining
or shunting 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 | For Use in the
treatment of patients
with hydrocephalus.
The valve is a
component of a
system designed to
shunt cerebrospinal
fluid from the
ventricles of the brain
to an appropriate
drainage site, such
as the atrium of the
heart or peritoneal
cavity. | Aids in the detection
of flow in implanted
CSF shunts.
ShuntCheck includes
Micro-Pumper, a
component which may
be used to temporarily
increase CSF flow in
suspected non-
flowing, patent shunts
during the
ShuntCheck test.
ShuntCheck cannot
alone diagnose CSF
shunt function or
malfunction. The
clinical diagnosis of
CSF shunt function or
malfunction,
incorporating the flow
information from
ShuntCheck, should
be made only by a
qualified
neurosurgeon. | For use in the
treatment of
hydrocephalus as a
component of shunt
system when draining
or shunting of CSF is
indicated. | Equivalent |
| | SUBJECT DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison |
| | occlusions. | | | | |
| Indications for
Use | Treatment of
hydrocephalus | Treatment of
hydrocephalus | Treatment of
hydrocephalus | Treatment of
hydrocephalus | Equivalent |
| | Drains CSF to reduce
intracranial pressure
and CSF volume and
increases flow in a
suspected non-flowing
shunt | Drains CSF to
reduce intracranial
pressure and CSF
volume | Temporarily increases
flow in a suspected
non-flowing, patent
shunt | Drains CSF to reduce
intracranial pressure
and CSF volume | Equivalent |
| | Proximal pumping of
the reservoir to
increase CSF flow in
suspected non-flowing
shunts. | Proximal and distal
pumping and
injection of the
reservoir to regulate
flow | Vibrational pumping of
the reservoir to
temporarily increase
CSF flow in suspected
non-flowing, patent
shunts. | N/A | Equivalent |
| | Implantable | Implantable | Not Implantable | Implantable | Equivalent |
| | Single use | Single use | Single use | Single use | Equivalent |
| Target
Population | Patients with
hydrocephalus | Patients with
hydrocephalus | Patients with
hydrocephalus | Patients with
hydrocephalus | Equivalent |
| Anatomical Sites | Brain ventricle and
Head | 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 size
and length | Labeling indicates
size and length | Labeling indicates size
and length | Labeling indicates
size and length | Equivalent |
| Human Factors | Labeling indicates flow
vs. pressure labels | Labeling indicates
flow vs. pressure
labels | Labeling indicates flow
vs. pressure labels | N/A | Equivalent |
| | Can be manipulated
with gloved hand | Can be manipulated
with gloved hand | Can be manipulated
with gloved hand | N/A | Equivalent |
| Design | Designed to be placed
in the ventricle of the
brain and under the
scalp | Designed to be
placed under the
scalp (valve
component only) | Designed to be placed
temporarily on the
scalp and on the
clavicle | Designed to be
placed in the ventricle
of the brain
(ventricular catheter
only) | Equivalent |
| | flexible catheter to
remain implanted in
the brain | N/A | N/A | flexible catheter to
remain implanted in
the brain | Equivalent |
| | Series of holes at
proximal end of the
catheter for fluid
movement | N/A | N/A | Series of holes at
proximal end of the
catheter for fluid
movement | 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 relief
membrane distal to the
proximal inlet holes of
the catheter to open at
a threshold pressure
for restoration of fluid | N/A | N/A | N/A | Equivalent
The relief
membrane is
equivalent to inlet
holes since it
provides fluid entry |
| SUBJECT DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison | |
| movement | | | | into catheter when
opened. The relief
membrane can
only be opened if
the inlet holes are
blocked. | |
| Length from proximal
tip to the most distal
holes and relief
membrane is 0.720" | N/A | N/A | Length from proximal
tip to the most distal
holes is 0.720" | Equivalent | |
| Catheter is not
impregnated with
antimicrobial agents. | N/A | N/A | Catheter is not
impregnated with
antimicrobial agents. | Equivalent | |
| Barium sulfate-filled
catheter | N/A | N/A | Barium sulfate-filled
catheter | Equivalent | |
| Inner diameter of
catheter: 0.050" | N/A | N/A | Inner diameter of
catheter: 0.055" or
0.050" | Equivalent | |
| Outer diameter of
catheter: 0.100" | N/A | N/A | Outer diameter of
catheter: 0.106" or
0.100" | Equivalent | |
| Catheter length: 15cm
initially (other common
lengths may be
offered) | N/A | N/A | Catheter length: 14,
15, 23 cm | Equivalent | |
| Length markings: 1 dot
at 10cm and 2 dots at
15cm | N/A | N/A | 1 dot at 10cm and 2
dots at 15cm | Equivalent | |
| Stylet for catheter
insertion | N/A | N/A | Stylet for catheter
insertion | Equivalent | |
| Reservoir (Rickham or
comparable). Not
tested or made as a
claim. | Reservoir (Rickham
or comparable). Not
tested or made as a
claim. | N/A | Can be used in
conjunction with a
Rickham or other
reservoirs | Equivalent | |
| Right angle clip
compatible
(not provided) | N/A | N/A | Right angle clip | Equivalent | |
| Flushing -
unidirectional control
by occluders | Flushing -
bidirectional control
done by occluders | Vibrational pressure,
direction unknown | N/A | Equivalent | |
| Flush direction only
towards ventricle
(proximal) | Flushing directions
toward ventricle
(proximal) or
drainage (distal) | Unknown | N/A | Equivalent | |
| Increases flow through
a non-flowing catheter | Use of retrograde
flush or shunt tap to
increase flow
possible, but not a
claim | Increases flow through
a non-flowing catheter | N/A | Equivalent | |
| Flow regulation (allows
passive flow for use in-
line with a one-way
check valve to regulate
flow in system) | One way check valve
to regulate flow in
system | Does not affect flow
regulation | N/A | Equivalent | |
| Fluid filled reservoir | 0.25 mL fluid filled | N/A | N/A | Equivalent | |
| | SUBJECT DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison |
| | less than 0.5 mL | reservoir | | | |
| | Barb fittings for
connection to
ventricular catheter
and shunt valve | Barb fittings for
connection to
ventricular catheter | N/A | N/A | Equivalent |
| | Series of channels to
allow fluid movement
from dome into
ventricular catheter
and fluid from the
ventricular catheter to
dome and rest of shunt
system | Series of channels to
allow fluid movement
from dome into
ventricular catheter
and fluid from the
ventricular catheter
to dome and rest of
shunt system | N/A | N/A | Equivalent |
| | Inner channel
diameter: greater than
1mm | Inner channel
diameter unknown | N/A | N/A | Equivalent
Passive flow
channel diameter
meets ISO
7197:2006 |
| | 40mm in length
17mm in width
10mm height | 32mm in length
16mm in width
8mm in height | N/A | N/A | Equivalent to
predicate and
size/dimension
acceptable to user
per human factors
studies conducted |
| | Reservoir and shunt
accessories withstand
use forces | Reservoir withstands
flushing and shunt
taps. | Reservoir and shunt
accessories withstand
vibrations | N/A | Equivalent |
| | Can be used with
dimensionally
compatible shunt
system components | Can be used with
dimensionally
compatible shunt
system components | Can be used with
dimensionally
compatible shunt
system components | Can be used with
dimensionally
compatible shunt
system components | Equivalent |
| | Low profile for
implantation under the
scalp | Low profile for
implantation under
the scalp | N/A | N/A | Equivalent |
| | Soft and flexible outer
housing | Soft and flexible
outer housing | N/A | N/A | Equivalent |
| | Rigid sections in the
housing to seat valves | Rigid sections in the
housing | N/A | N/A | Equivalent |
| | Occluders (distal
drainage channel is
occluded during flush) | Distal and proximal
occluders | Unknown (likely N/A) | N/A | Equivalent |
| | Printing to indicate
direction of flow and
position | Printing to indicate
direction of flow and
position | N/A | N/A | Equivalent |
| Performance | Retrograde pulse into
the ventricular catheter
(created by manual
pumping - depressing
dome/flusher with a
fixed reservoir volume) | Retrograde pulse
into the ventricular
catheter when
proximal occluder is
activated - force
within system and
limited by fixed
reservoir volume. | Retrograde vibrations
into ventricular
catheter - force in
system and to patient
unknown | N/A | Equivalent |
| | One way flow between
the reservoir and
ventricular catheter
when device is | One way flow
between reservoir
and catheters when
occluder is pressed | N/A | N/A | Equivalent |
| | SUBJECT DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison |
| | pumped | and reservoir is
pumped | | | |
| | Reservoir refills after
pumping | Reservoir refills after
pumping | Reservoir refills after
vibrations | N/A | Equivalent |
| | Normal shunt function
resumes after pumping | Normal shunt
function resumes
after pumping | Normal shunt function
resumes after
vibrations | N/A | Equivalent |
| | Catheter diverts fluid
from ventricle | Catheter diverts fluid
from ventricle
(through check
valve) | N/A | Catheter diverts fluid
from ventricle | Equivalent |
| | Relief membrane
remains open after
activating | Inlet holes are
intended to remain
patent to provide
fluid path. | N/A | Inlet holes are
intended to remain
patent to provide fluid
path. | Equivalent
Provides same
fluid path into
catheter as open
inlet holes |
| | Ventricular Catheter:
silicone with BaSO4
filler, relief membrane
silicone | N/A | N/A | Ventricular Catheter:
BaSO4 filled silicone
elastomer | 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 tested
per ISO 10993:
Biological Evaluation
of Medical Devices | Tissue contact tested
per ISO 10993:
Biological Evaluation
of Medical Devices | Tissue contact tested
per ISO 10993:
Biological Evaluation
of Medical Devices | Tissue contact tested
per ISO 10993:
Biological Evaluation
of Medical Devices | Equivalent |
| | Non-pyrogenic | Non-pyrogenic | N/A | Non-pyrogenic | Equivalent |
| | Safe in 1.5T MRI
environment | Safe in 1.5T MRI
environment | N/A | Safe in 1.5T MRI
environment | Equivalent |
| Compatibility
with environment
and other
devices | Safe in an x-ray
environment | Safe in an x-ray
environment | No radiation | Safe in an x-ray
environment | Equivalent |
| | Compatible with
current shunt systems
and accessories | Compatible with
current shunt
systems and
accessories | N/A | Compatible with
current shunt
systems and
accessories | Equivalent |
| | Compatible with long
term CSF contact and
saline | Compatible with long
term CSF contact
and saline | N/A | Compatible with long
term CSF contact
and saline | Equivalent |
| Radiopacity | BaSO4 filled silicone
elastomer | BaSO4 filled silicone
elastomer | N/A | BaSO4 filled silicone
elastomer | N/A |
| Sterility | Terminally sterilized for
10-6 SAL with no
damage to system
components.
Validated per
ANSI/AAMI/ISO
11137-2; Sterilization | Terminally sterilized
for 10-6 SAL with no
damage to system
components.
Validated per
recognized | None | Terminally sterilized
for 10-6 SAL with no
damage to system
components.
Validated per
recognized | Equivalent |
| | SUBJECT DEVICE
Alcyone
Alivio System
(K172006) | PRIMARY
PREDICATE
Integra
Neurosciences
Contour-Flex Valve
and Shunt System
(K033698) | REFERENCE
PREDICATE
NeuroDx
Development, LLC
ShuntCheck III
(K123554) | REFERENCE
PREDICATE
Codman Medos
Ventricular Catheter
(K944222) | Equivalence
Comparison |
| | of health care products

Radiation | sterilization standard. | | sterilization standard. | |
| Electrical Safety | N/A | N/A | IEC 60601 Tested | N/A | N/A |
| Mechanical
Safety | Manual flushing
(pumping) generates
equivalent ventricular
suction/flushing with
no valve damage or
alteration | Manual flushing
(pumping) generates
equivalent ventricular
suction/flushing with
no valve damage or
alteration | Micro-Pumper
generates less
ventricular suction
than manual shunt
pumping, no valve
damage or alteration | N/A | Equivalent |
| Chemical Safety | Saline, CSF | Saline, CSF | Saline, CSF | Saline, CSF | Equivalent |
| MRI
Compatibility | 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 maintains
sterility and protects
device. Tray, pouch,
box. Catheter and
flusher packaged
together. | Packaging maintains
sterility and protects
device. Tray, pouch,
box. Multiple
components can be
packaged together. | Unknown | Packaging maintains
sterility and protects
device. Tray, pouch,
box. Multiple
components can be
packaged together. | Equivalent |
| Shelf Life | Labeled shelf life
(expiation) will be
based on real time and
accelerated aging shelf
life studies 1-3 years. | Labeled shelf life 1-3
years. | Unknown | Labeled shelf life 1-3
years. | Equivalent |

6

7

8

9

10

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 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 10993-5,
"Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity"	Results support that the Alivio System is
non-cytotoxic.

11

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 Materials
Conducted Testing in accordance with
ANSI/AAMI/ISO 11137-1:2006 Sterilization of
health care products-Microbiological
methods-Part 1: Determination of the population
of microorganisms on product, ANSI/AAMI/ISO
11137-2:2013 Sterilization of health care products
— Radiation — Part 2: Establishing the sterilization
dose, and ANSI/AAMI/ISO 11137-3:2006
Sterilization of health care products-Radiation-
Part 3: Guidance on dosimetric aspects	Terminal sterilization validation testing
supports a 10-6 SAL.
Pyrogenicity	LAL testing was validated in accordance with the
applicable FDA's Guidelines (Guideline on
Validation of the Limulus Amebocyte Lysate Test
As An End-Product Endotoxin Test for Human And
Animal Parenteral Drugs, Biological Products, and
Medical Devices - 1997) and recognized standards
(USP Endotoxin Reference Standard) for Bacterial
Endotoxin (LAL) Validation using the Kinetic-QLC
Test Method.	This test validates the method for
measuring the endotoxin levels of he
finished device per ANSI/AAMI
ST72:2011 Bacterial endotoxins - test
methodologies, routine monitoring, and
alternatives to batch testing. All units
tested met the criteria of less than 2.15
EU/device (0.06 EU/mL).
Shelf Life	Accelerated and Real-time Aging was conducted
on the device and packaging. Testing comparing
devices and packaging at time 0 and the intended
shelf life was conducted in accordance with
applicable standards and the product
specifications. Tests include visual/dimensional
inspections, surface inspection, particulate testing,
strength and reliability testing, and system
performance testing.	Testing, including visual/dimensional
inspections, particulate testing, surface
inspection, mechanical and system
performance testing comparing devices at
time 0 and the intended shelf life. Results
supports expiration dating on the labeling.
Pressure Leak
Tests and
Pressure Flow
Characteristics
Test	Conducted Testing in accordance to Sections 4.4
and 4.6 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 corresponding
pressure profiles were recorded and plotted as
graphs as per ASTM F 647-94(2014), Standard
Practice for Evaluating and Specifying Implantable
Shunt Assemblies for Neurosurgical Application,
Sections A 2.8.1.1 and A2.8.1.2 to evaluate and
compare the pressure-flow characteristics of the
Alivio Catheter to Predicate Catheter.	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	Conducted Testing in accordance to ASTM F 647-
94(2014), Standard Practice for Evaluating and
Specifying Implantable Shunt Assemblies for
Neurosurgical Application.	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	Conducted Testing for the ventricular catheter and
flusher components in accordance to Section 4.9
of ISO 7197:2006 (E), Neurosurgical Implants -
Sterile, single-use hydrocephalus shunts to assess
dynamic breaking strength.	All results met acceptance criteria per
protocol and applicable standards. During
this test, no component ruptured or broke.
Flusher and
Catheter
Tensile
Strength Test	Conducted Testing for the ventricular catheter and
flusher to evaluate the bond/tensile strength of
these components in accordance with ASTM F
647-94(2014) "Standard Practice for Evaluating
and Specifying Implantable Shunt Assemblies for
Neurosurgical Application.	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	Conducted Testing for flusher in accordance to	Section 4.11 of ISO 7197:2006 (E), Neurosurgical
Implants - Sterile, single-use hydrocephalus shunts	All results met acceptance criteria and	demonstrate that the Alivio System
performance is suitable for its intended

12

13

Test	Test Method Summary	Results and Conclusions
	to assess dynamic breaking strength.	use and is substantially equivalent to the
predicate device.
Alivio Cartridge
Performance
Test	This test measures the AF cartridge cracking
pressure to demonstrate compliance of AF
Cartridge 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	Catheters were subjected to 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	Testing was conducted to verify the reliability of the
Alivio Flusher to be able to flush during its
expected useful life. Testing included an
assessment of any mechanical damage and the
ability to flush with acceptable pressure and
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	Conducted Assessment in accordance ASTM
F647-94(2014), "Standard Practice for Evaluating
and Specifying Implantable Shunt Assemblies for
Neurosurqical Application", Section 6.1.3
"Magnetic Resonance Imaging (MRI)
Compatibility"	All implanted Alivio System
materials/components comply with the
FDA guidance to label "MR Safe" in all
MR environments.
Alivio System
Imaging	The devices were imaged using X-ray to
demonstrate compliance with requirements for
imaging per 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	Devices were occluded with blood and other
substances to clinically simulate proximal catheter
occlusions (blocked proximal catheter inlet holes)
in the Alivio System and predicate device. These
devices were then tested to evaluate ability of the
device's retrograde flush to unblock inlet holes.	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	Pilot animal study (N=1 evaluated at an acute
timepoint) was conducted in two parts to
demonstrate that the Alivio System meets its
functional requirements and was tested in
comparison to the predicate to demonstrate that
the Alivio System does not raise new questions of
safety and efficacy and is substantially equivalent
to the predicate.	All results met the 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.
Comparative
Performance
Testing in
Animals	Pilot animal study (N=2 evaluated at subacute and
acute timepoints) was conducted to demonstrate
that the Alivio System meets its functional
requirements and was tested in comparison to the
predicate to demonstrate that the Alivio System
does not raise new questions of safety and efficacy
and is substantially equivalent to the predicate.	All results met the 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.
Comparative
Performance
Testing in
Animals	Pilot animal study (N=2 evaluated at acute
timepoints) comparing the Alivio System with the
predicate was conducted to demonstrate that the
differences in technology do not raise new
questions of safety and is substantially equivalent
to the predicates.	Results demonstrated that a small animal
model was not suitable for comparative
testing of the Alivio System and the
predicate. However, there was no
significant difference of histological
analysis of tissue between Alivio System
and 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 the
predicate was conducted to demonstrate that the
Alivio System meets its functional requirements,
the differences in technology do not raise new
questions of safety, and is substantially equivalent
to the predicates. Testing was conducted in
conformance to FDA 21 CFR, Part 58-Good
Laboratory Practice for Nonclinical Studies.	as comparative CSF and histopathology
analysis, met acceptance criteria. Testing
demonstrated that the Alivio System does
not raise any new questions of safety and
efficacy and is substantially equivalent to
the predicate.
	Animal study (N=6 evaluated at acute timepoints) comparing the Alivio System with the predicate
was conducted to demonstrate that the differences
in technology do not raise new questions of safety
and is substantially equivalent to the predicates.
Testing was conducted in conformance to FDA 21
CFR, Part 58-Good Laboratory Practice for
Nonclinical Studies.	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.
Usability and
human factors
testing	Testing of the Alivio System in animal and clinical
simulation bench models was conducted to
evaluate ease of preparation, implantation, and
use for its intended use according to its labeling
was conducted in accordance with ANSI/AAMI HE
75, Human Factors Engineering Design of Medical
Devices, IEC 62366:2007, Medical Devices -
Application of Usability Engineering to Medical
Devices, and FDA Guidance (Jun 22, 2011)
Human Factors Draft Guidance.	Alivio System is deemed to meet its
specifications for its intended use and is
substantially equivalent to the predicate
devices. In all cases the acceptance
criteria were met and the device
performed as expected according to its
specifications and in compliance with
applicable recognized standards. These
data demonstrate that the minor
technological differences do not raise new
types of safety and efficacy concerns as
evaluated by 24 neurosurgeons (intended
users) of varying experience in numerous
simulated clinical uses of the Alivio
System. The Alivio System functions as
components of a CSF Shunt System and
is substantially equivalent to its predicate
devices.
Alivio Flusher
Clinical Study	The Alivio Flusher was evaluated in a clinical
setting to demonstrating functional safety of the
Alivio flusher in patients undergoing shunt revision
surgery. (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.

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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.