Who is the manufacturer of Alivio Ventricular Catheter and Flusher System (Alivio System)?

Alcyone Lifesciences, Inc. filed the 510(k) submission for Alivio Ventricular Catheter and Flusher System (Alivio System) (K172006).

What is the FDA product code for Alivio Ventricular Catheter and Flusher System (Alivio System)?

JXG. It is classified under 21 CFR 882.5550 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Alivio Ventricular Catheter and Flusher System (Alivio System)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Alivio Ventricular Catheter and Flusher System (Alivio System)?

Integra Contour-Flex Valve and Shunt System (K033698).

Who can help prepare an FDA 510(k) submission like Alivio Ventricular Catheter and Flusher System (Alivio System)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Alivio Ventricular Catheter and Flusher System (Alivio System)

K172006 · Alcyone Lifesciences, Inc. · JXG · Nov 9, 2017 · Neurology

Device Facts

Record ID	K172006
Device Name	Alivio Ventricular Catheter and Flusher System (Alivio System)
Applicant	Alcyone Lifesciences, Inc.
Product Code	JXG · Neurology
Decision Date	Nov 9, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5550
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Alivio System consists of an implantable ventricular catheter and a flusher reservoir; used in hydrocephalus treatment. Catheter implanted in brain ventricle; connected distally to flusher and a standard flow-regulating valve. Flusher allows passive CSF flow during normal operation. When shunt flow is obstructed, clinician manually depresses flusher dome; this creates a controlled retrograde fluid pulse toward the catheter. Pulse aims to unblock proximal inlet holes or open a relief membrane to restore antegrade flow. Used in operating room by neurosurgeons. Output is restored CSF drainage. Benefits include non-invasive method to address proximal catheter occlusions without immediate surgical revision. System does not regulate flow or detect obstructions.

Clinical Evidence

Clinical evidence includes a pilot study (NCT02651337) on 4 patients undergoing shunt revision surgery, demonstrating functional safety and ability to restore flow. Preclinical evidence includes extensive bench testing (biocompatibility per ISO 10993, pressure/flow characteristics per ISO 7197/ASTM F647, durability, sterility, shelf-life) and multiple animal studies (N=1, N=2, N=11, N=6) comparing performance and histology to predicates. Human factors testing involved 24 neurosurgeons in simulated clinical models.

Technological Characteristics

Materials: Silicone elastomer and barium sulfate (catheter), silicone (flusher housing). Dimensions: Catheter 150mm length, 1.27mm ID, 2.54mm OD. Sensing/Actuation: Manual hydraulic retrograde pulse. Energy: None (manual). Connectivity: None. Sterilization: Radiation (10-6 SAL). Software: None. Standards: ISO 7197:2006, ASTM F647:94 (2014).

Indications for Use

Indicated for patients with hydrocephalus requiring CSF drainage via a shunt system. Used by clinicians to restore or increase CSF flow in non-flowing shunts by unblocking catheter inlet holes or opening a relief membrane.

Regulatory Classification

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.

Predicate Devices

Integra Contour-Flex Valve and Shunt System (K033698)

Reference Devices

NeuroDX Development ShuntCheck III (K123554)
Codman Medos Ventricular Catheter (K944222)

Related Devices

K221918 — ReFlow System Mini · Anuncia Medical, Inc. · Sep 29, 2022
K223603 — Reflow System Mini and ReFlow Mini Flusher · Anuncia Medical, Inc. · Dec 29, 2022
K140722 — INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS · Integra LifeSciences Corporation · Jan 6, 2015
K024101 — PHOENIX UNIVERSAL SHUNT SYSTEM · Phoenix Biomedical Corp. · Jan 27, 2003
K122118 — HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM · Codman & Shurtleff, Inc. · Aug 3, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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…

Alivio Ventricular Catheter and Flusher System (Alivio System)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

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Alivio Ventricular Catheter and Flusher System (Alivio System)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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