Alcyone MEMS Cannula (AMC) System

K150660 · Alcyone Lifesciences, Inc. · HCD · Apr 16, 2015 · Neurology

Device Facts

• Record ID: K150660
• Device Name: Alcyone MEMS Cannula (AMC) System
• Applicant: Alcyone Lifesciences, Inc.
• Product Code: HCD · Neurology
• Decision Date: Apr 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4060
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set, is intended for injection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."

Device Story

The Alcyone MEMS Cannula (AMC) System is a rigid, non-implantable ventricular cannula used in operating rooms or MR suites by physicians. It consists of a 25cm ceramic cannula with two independent fluid channels, transitioning to a micro-tip with side-facing outlets to prevent tissue blockage. The device connects to external infusion pumps via extension line sets. During intracranial procedures, the cannula is inserted into the brain ventricle using a stereotactic guide; the dual-channel design allows for simultaneous or independent injection of Cytarabine and aspiration of CSF. The device features a depth-stop and safety-sheath for user control. By providing a stable, MRI-compatible pathway for fluid delivery and removal, the device facilitates targeted therapeutic administration and pressure management, potentially improving clinical outcomes for patients requiring ventricular access.

Clinical Evidence

No human clinical trials were conducted. Evidence includes extensive bench testing (leak pressure, flow rates, luer pull-off, transit testing, accelerated aging, biocompatibility per ISO 10993, and sterilization validation) and animal studies (N=11 juvenile Yorkshire pigs) assessing insertion, removal, lateral shift, and comparative performance against the predicate using Gadolinium tracers. Human factors and usability testing (N=16 users, 28 uses) confirmed safe operation in simulated clinical models.

Technological Characteristics

Rigid ceramic cannula with silicon tip; two independent fluid lumens (polymer-covered silica). Dimensions: 25cm length, 1.6mm OD. MRI compatible (1.5T and 3T). Sterilization: Radiation (25 kGy, SAL 10^-6). Connectivity: Standard luer connectors for infusion pump integration. No electrical or active components.

Indications for Use

Indicated for patients requiring injection of Cytarabine into brain ventricles or aspiration of CSF from brain ventricles during intracranial procedures. Not for implant. Single patient use only.

Regulatory Classification

Identification

A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

Predicate Devices

• SurgiVision, Inc. MR Compatible Ventricular Cannula (K102101)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

April 16, 2015

Alcyone Lifesciences, Inc. % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K150660

> Trade/Device Name: Alcyone MEMS Cannula (AMC) System Regulation Number: 21 CFR 882.4060 Regulation Name: Ventricular Cannula Regulatory Class: Class I Product Code: HCD Dated: March 4, 2015 Received: March 13, 2015

Dear Mr. Job:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good 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.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carlos L. Pena -S/^

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

Enclosure

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# Indications for Use

510(k) Number (if known) K150660

Device Name Alcyone MEMS Cannula (AMC) System

Indications for Use (Describe)

The Alcyone MEMS Cannula (AMC) System consisting of the AMC Extension Line Set, is intended for injection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) SUMMARY Alcyone Lifesciences, Inc.'s MEMS Cannula (AMC)

#### Alcyone Lifesciences, Inc.

130 John Street, Boot Canal Mill Building, C-2 Lowell, Massachusetts 01852, USA Phone: [phone] Facsimile: 513-898-2106

Contact Person: Elsa Chi Abruzzo, RAC, FRAPS Date Prepared: April 10, 2015

Alcyone Lifesciences, Inc.

| Trade Name:<br>Common or Usual Name<br>Classification Name | Alcyone MEMS Cannula (AMC) System<br>Ventricular Cannula<br>Ventricular Cannula |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class I |
| Product Code and<br>Requlation: | HCD, 21 CFR 882.4060 |
| Classification Panel: | Neurology |
| Predicate Device: | K102101 SurgiVision, Inc. MR Compatible Ventricular Cannula<br>(a.k.a., MRI Interventions Inc., SmartFlow Ventricular Cannula) |

## Intended Use / Indications for Use

The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set. is intended for iniection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."

## Description of Device

The AMC System is comprised of the AMC and its Extension Line sets. The AMC is a rigid cannula comprised of two independent channels. The fluid lumens are protected inside a 25cm rigid ceramic cannula. which transitions (steps-down) to a micro-tip. The micro-tip has two independent outlets at the tip that face sideways, designed to prevent plugging during insertion into the brain. The proximal end of the rigid cannula consists of a Y-connector with standard female luers that allow connection to each independent channel. AMC Extension Line Sets with standard male/female luers must be used with the AMC to connect the AMC to an infusion pump. The AMC must be used with a support structure (e.g. a stereotactic quide) to provide support and control during insertion. A safety-sheath, as with the predicate, and depth-stop, for user convenience, are provided on the AMC for this purpose.

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Technological Characteristics
The AMC is equivalent in technological characteristics to its predicate device.

| | AMC System<br>Subject 510 (k) | SurgiVision Ventricular<br>Cannula (VC)<br>K102101 | Discussion |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Classification | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent to Predicate |
| Product Code | HCD | HCD | Equivalent to Predicate |
| Indications for Use/<br>Intended Use | The Alcyone MEMS Cannula<br>(AMC) System consisting of the<br>AMC and the AMC Extension<br>Line Set, is intended for injection<br>of Cytarabine (cytosine<br>arabinoside) or removal of<br>cerebrospinal fluid (CSF) from<br>the ventricles of the brain during<br>intracranial procedures. The<br>AMC System is not intended for<br>implant. The device is intended<br>for "single patient use only." | The MR Compatible<br>Ventricular Cannula is<br>intended for injection of<br>Cytarabine or removal of<br>CSF from the ventricles<br>during intracranial<br>procedures. The device is<br>not intended for implant.<br>This device is intended for<br>"single patient use only." | Equivalent to Predicate. |
| How Used | Gains access to brain ventricles | Gains access to brain<br>ventricles | Equivalent to Predicate |
| | Allows injection of Cytarabine<br>into the ventricles | Allows injection of<br>Cytarabine into the<br>ventricles | Equivalent to Predicate |
| | Allows aspiration of CSF from<br>the ventricles | Allows aspiration of CSF<br>from the ventricles | Equivalent to Predicate. |
| | Not implantable | Not implantable | Equivalent to Predicate |
| | Single use | Single use | Equivalent to Predicate |
| Target Population | Pt. s needing injection of<br>Cytarabine to the brain ventricles<br>or aspiration of CSF from the<br>ventricles | Pt. s needing injection of<br>Cytarabine to the brain<br>ventricles or aspiration of<br>CSF from the ventricles | Equivalent to Predicate |
| Anatomical Sites | Brain ventricle | Brain ventricle | Equivalent to Predicate |
| Where Used | Operating Room or MR Suite | Operating Room or MR<br>Suite | Equivalent to Predicate |
| | MRI/Diagnostic / Surgical Room | MRI/Diagnostic / Surgical<br>Room | Equivalent to Predicate |
| Energy Used | N/A | N/A | Equivalent to Predicate |
| Human Factors | Labeling indicates size and<br>length | Labeling indicates size and<br>length | Equivalent to Predicate. |
| | Labeling indicates flowrates | Labeling indicates<br>flowrates | Equivalent to Predicate. |
| | Can be manipulated with gloved<br>hand | Can be manipulated with<br>gloved hand | Equivalent to Predicate |

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| | AMC System<br>Subject 510 (k) | SurgiVision Ventricular<br>Cannula (VC)<br>K102101 | Discussion |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Designed to be placed through a<br>prepared opening through the<br>skull and the Dura into the brain<br>ventricle | Designed to be placed<br>through a prepared<br>opening through the skull<br>and the Dura into the brain<br>ventricle | Equivalent to Predicate |
| | Compatible with stereotactic<br>guidance systems equipped with<br>adapters possessing a 2.6mm<br>inner diameter. | Compatible with MRI<br>Interventions Stereotactic<br>Frame | Equivalent to Predicate |
| | Rigid section to enter the brain | Rigid section to enter the<br>brain | Equivalent to Predicate |
| | Straight section to enter the brain | Straight section to enter<br>the brain | Equivalent to Predicate |
| | Two holes at distal end for fluid<br>movement | Hole at distal end for fluid<br>movement | Equivalent to Predicate. One<br>hole per fluid channel. |
| Design | Distal holes | Distal holes | Equivalent to Predicate.<br>Distal holes openings are<br>towards the side designed to<br>prevent tissue blockage<br>during insertion. |
| | Body markings designed to<br>facilitate determination of<br>insertion depth | No marking on body of<br>device | Equivalent to Predicate.<br>Length marking on body to<br>help user determine depth of<br>insertion. Length markings<br>are common in these<br>devices to aid the user in<br>positioning. |
| | Length of rigid section 9" | Length of rigid section<br>10.5" (30cm) | Equivalent to Predicate.<br>Does not change user<br>interface or utility. This is<br>within the range of cleared<br>ventricular cannulas. |
| | Two lumens. Inside diameter of<br>each lumen in body: 0.010"<br>(.25mm).<br>Inside cross-section of each<br>lumen in tip: 0.002"x0.001" (.052<br>x.03mm) | One Lumen: Inside<br>diameter:<br>0.008" (0.2mm) to 0.021"<br>(0.53mm) | Equivalent to Predicate.<br>Both devices are moving<br>fluids and their different<br>inside/outside diameters<br>result in different flow rates.<br>This is within the range of<br>cleared ventricular cannulas. |
| | Outside diameter:<br>0.65" (1.6mm) | Outside diameter:<br>0.65" (1.6mm) and 0.80"<br>(2.0mm) | Equivalent to Predicate |
| | No stylet | No stylet | Equivalent to Predicate |
| | Lumen extension (10 foot) allows<br>remote (end of scanner bore)<br>injection/aspiration | Lumen extension (3 foot)<br>allows remote (end of<br>scanner bore)<br>injection/aspiration | Equivalent to Predicate.<br>Extensions allow for MR<br>compatibility. |

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| | AMC System<br>Subject 510 (k) | SurgiVision Ventricular<br>Cannula (VC)<br>K102101 | Discussion |
|-------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Lumen extension (25 foot) allows<br>remote (outside of scanner 5<br>gauss) injection/aspiration using<br>a non-MRI safe pump | Lumen extension (9 foot)<br>allows remote (outside of<br>scanner 5 gauss)<br>injection/aspiration using a<br>non-MRI safe pump | Equivalent to Predicate.<br>Extensions allow for MR<br>compatibility. |
| | Tip Sheath | Tip Sheath | Equivalent to Predicate |
| | Depth-stop bushing to facilitated<br>setting of insertion depth | No depth stop | Equivalent to Predicate.<br>With the predicate device<br>the user uses generic stops<br>when using Predicate with<br>various frames. AMC<br>provides a stop for user<br>convenience. |
| | Standard luer | Standard luer | Equivalent to Predicate. |
| | Compatible with standard syringe<br>pumps for infusion. | Compatible with syringe<br>pumps for infusion. | Equivalent to Predicate |
| | Translucent luers | Translucent luers | Equivalent to Predicate. |
| Performance | Sufficiently rigid to pass through<br>brain tissue without additional<br>support. | Sufficiently rigid to pass<br>through brain tissue<br>without additional support. | Equivalent to Predicate |
| | Flow rate of:<br>3.0mL/hr. (1.5mL/hr. per<br>channel) at <25psi internal<br>pressure per channel | Flow rate of:<br>0.3ml/hr. (0.008" ID) to<br>25ml/hr. (0.021" ID) at<br>0.7psi | Equivalent to Predicate.<br>Both devices are moving<br>fluids, and the different flow<br>rates results only from their<br>different diameters.<br>Pressures listed are internal<br>to the system. |
| | Aspiration rate of:<br>2.4mL/hr. (1.2mL/hr. per<br>channel) using an air vacuum of<br>10mL from a syringe. | Aspiration rate of:<br>0.1ml/hr. (0.008" ID) to<br>8.7ml/hr. (0.021" ID) | Equivalent to Predicate.<br>Both devices are moving<br>fluids, and the different flow<br>rates results only from their<br>different diameters. |
| Materials | Rigid body:<br>Ceramic body<br>Silicon tip | Rigid body:<br>Ceramic<br>Polymer Tip | Equivalent to Predicate.<br>Both devices provide a rigid<br>MRI compatible material for<br>the body. Both devices have<br>a step down design to a<br>smaller tip. |
| Materials | Through lumen:<br>Polymer covered silica<br>Silicon | Through lumen:<br>Polymer covered silica | Equivalent to Predicate.<br>Both devices have a<br>continuous fluid pathway<br>and are MRI compatible and<br>biocompatible. |
| | Detachable lumen extensions:<br>Polymer | Non-detachable lumen<br>extensions:<br>Polymer covered silica | Equivalent to Predicate.<br>Both devices have a<br>continuous fluid pathway |

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| | AMC System<br>Subject 510 (k) | SurgiVision Ventricular<br>Cannula (VC)<br>K102101 | Discussion |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | | | and are MRI compatible and<br>biocompatible. |
| | Proximal connector:<br>Female luer connection | Proximal connector:<br>Female luer connection | Equivalent to Predicate. |
| Biocompatibility | Limited exposure device, < 24<br>hours (Not implantable). | Limited exposure device, < 24 hours (Not implantable). | Equivalent to Predicate per<br>ISO 10993: Biological<br>Evaluation of Medical<br>Devices. |
| | Non-pyrogenic | Non-pyrogenic | Equivalent to Predicate.<br>Meets USP criteria for type<br>of contact. |
| Compatibility with<br>environment and<br>other devices | Safe in 1.5T and 3T MRI<br>environment | Safe in 1.5T MRI<br>environment | Equivalent to Predicate |
| | Female luer connector on<br>proximal end fits all male luer<br>connections (e.g. Syringe tips) | Female luer connector on<br>proximal end fits all male<br>luer connections (e.g.<br>Syringe tips) | Equivalent to Predicate |
| | Compatible with Stereotactic<br>Frames with 2.6mm adapter | Compatible with MRI<br>Interventions Stereotactic<br>Frame | Equivalent to Predicate. |
| Sterility | 10-6 SAL | 10-6 SAL | Equivalent to Predicate per<br>ANSI/AAMI/ISO 11137-2;<br>Sterilization of health care<br>products - Radiation. |
| Electrical Safety | N/A | N/A | N/A |
| Mechanical Safety | N/A | N/A | N/A |
| Chemical Safety | Lumen materials non-reactive to<br>Cytarabine, Saline, CSF | Lumen materials non-<br>reactive to Cytarabine,<br>Saline, CSF | Equivalent to Predicate |
| | Silica lumen non-reactive | Silica lumen non-reactive | Equivalent to Predicate |
| Thermal Safety | MRI Safe. All brain contacting<br>components tested in a 3.0T<br>environment | MRI Safe. All brain<br>contacting components<br>tested in a 1.5T<br>environment | Equivalent to Predicate |
| Radiation Safety | N/A | N/A | Equivalent to Predicate |
| Packaging | AMC - Tray, pouch, SBS box.<br>Extension Lines - Pouch, Pouch,<br>SBS box | Tray, pouch, box. Catheter<br>with extension lines in<br>same box. | Equivalent to Predicate |
| Shelf Life | 1 year | Unknown. Assumed to be<br>>1 year | Equivalent to Predicate |

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#### Rx or OTC

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

#### Performance Data

Bench and animal tests were conducted on the AMC 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 per the applicable standards and guidances included verification and validation testing, comparative usability testing in animals, and human factors evaluations in a simulated clinical use model. This is described in the summary tables below.

| Test | Test Method Summary | Results |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AMC System | AMC and Extension Line<br>Set (as a System) Line<br>were tested for leak<br>pressure and Infusion/<br>Aspiration flow. | Testing passed and results demonstrate the AMC<br>System is safe for its intended use and substantially<br>equivalent to the predicate device. |
| Leak Pressure<br>Testing | As applicable testing was<br>done with room<br>temperature water, body<br>temperature Cytarabine<br>(for infusion), and body<br>temperature CSF (for<br>aspiration). | Leak Pressure<br>AMC and Extension line systems withstood pressure<br>spikes with no leaks. |
| Infusion Flow<br>Testing | | Infuse Flow Rate and Pressure<br>AMC System reached specified flow rate within the<br>specified time and was capable of injecting fluid at it<br>maximum flow rate. |
| Aspiration Testing | | Aspiration Rate<br>The AMC was capable of aspirating at its maximum<br>aspiration rate. |
| Extension Line Set<br>patency Testing<br>Luer pull-off<br>testing | Extension Line Sets were<br>tested for line patency<br>during bend and luer pull. | Testing passed and results demonstrate the Extension<br>Line sets are safe for their intended use and<br>substantially equivalent to the predicate device. |
| | | Extension Line Patency<br>Extension lines remained patent with a worst case<br>expected bend radius<br><br>Luer Pull-off<br>All units were above the maximum luer pull force<br>specification (worst case for clinical use plus safety<br>factor) |

## Summary of AMC System Performance Testing

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| Test | Test Method Summary | Results |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AMC Brain<br>insertion, removal,<br>and lateral shift<br>testing | Testing was conducted to<br>test compliance of AMC<br>with specified requirements<br>for brain insertion, removal,<br>and lateral shift strengths. | Testing passed and results demonstrate the AMC<br>System is safe for its intended use and met its<br>specifications.<br>Brain Insertion and Removal<br>AMC withstood insertion and removal into a bovine<br>brain without breaking and detaching.<br>Brain Lateral Shift<br>AMC or AMC tip did not break or detach when laterally<br>shifted in bovine brain tissue in any direction from the<br>insertion location. |
| AMC tip-<br>compression,<br>bullet-nose pull-<br>out, and y-<br>connector pull-out<br>testing | Testing was conducted to<br>demonstrate compliance of<br>AMC with requirements for<br>tip compression strength,<br>and pullout strengths of the<br>bullet-nose and y-<br>connector bond strengths. | Testing passed and results demonstrate the AMC<br>System is safe for its intended use and met its<br>specifications.<br>Axial Tip Compression Force<br>The AMC or AMC micro-tip withstood the acceptance<br>criteria for axial compressive force based on clinically<br>relevant forces with safety factor.<br>Pull-out strengths of bonds<br>The AMC withstood the acceptance criteria for<br>minimum pull-out force based on clinically relevant<br>forces with safety factor. |
| Magnetic<br>Resonance (MR)<br>Safe Testing | Testing was conducted to<br>demonstrate MR Safety of<br>the AMC and Extension<br>Line Sets per the FDA<br>guidance for MR Safety<br>and Compatibility. | The AMC System is MR Safe for its intended use and<br>substantially equivalent to the predicate device.<br>MR Compatibility<br>The AMC is MR Safe in 1.5 Tesla and 3Tesla magnets. |
| Test | Test Method Summary | Results |
| Cytarabine<br>Infusion<br>Compatibility | Testing was conducted to<br>demonstrate compliance of<br>AMC and Extension Lines<br>with it specified<br>requirements for<br>Cytarabine concentration<br>infusion (clinically relevant<br>concentration).<br>Testing evaluated effect of<br>infusion of Cytarabine<br>through the AMC System<br>with respect to Cytarabine<br>concentration post infusion<br>and on device integrity<br>after prolonged exposure to<br>Cytarabine and acute<br>infusion. | Testing passed and results demonstrate the AMC<br>System is safe for its intended use and substantially<br>equivalent to the predicate device.<br>Cytarabine Compatibility<br>The materials of the fluid path of the AMC are<br>compatible with Cytarabine infusion of a specified<br>clinically relevant concentration. There was no visible<br>degradation or reduction in strength below<br>specifications of the AMC and Extension lines after<br>prolonged exposure or acute infusion of Cytarabine at<br>its maximum permitted clinical concentration and<br>durations. There was no change in Cytarabine<br>concentration post infusion. |
| Transit Testing<br>(Packaging<br>Qualification) | Testing was conducted to<br>demonstrate compliance of<br>the AMC and Extension<br>Lines with transit testing<br>requirements per ISTA-2A. | Testing passed and results demonstrate that the AMC<br>System packaging meets its functionality requirements<br>and the integrity of the package as a sterile barrier was<br>maintained after conducting actual or simulated<br>Transportation Testing Conditions. |
| Accelerated Aging | Protocol defines the<br>methods and materials to<br>conduct accelerated aging<br>of AMC and Extension<br>Lines and packaging<br>materials | Testing demonstrates that the AMC System is safe for<br>its labeled expiration dating and substantially equivalent<br>to the predicate device. |
| Biocompatibility | Testing was conducted to<br>demonstrate compliance of<br>the AMC and Extension<br>Lines with ISO 10993<br>biocompatibility<br>requirements. | All tissue contacting materials used in the AMC System<br>are biocompatible per ISO 10993 –Biological evaluation<br>of Medical Devices, Externally Communicating Device -<br>Tissue contact, limited duration A < 24 hours.<br>The following tests were done:<br>Cytotoxicity (MEM and NRU Elution)<br>●<br>Systemic Toxicity<br>●<br>Intracutaneous Reactivity<br>●<br>Sensitization (Klingman Maximization)<br>●<br>Hemocompatibility (Indirect)<br>●<br>Material Mediated Pyrogen<br>● |
| Test | Test Method Summary | Results |
| Sterilization<br>Validation | Testing was conducted to<br>demonstrate compliance of<br>the AMC and Extension<br>Lines with Sterilization<br>Validation Standards to<br>achieve a desired SAL. | Testing substantiates the use of 25 kGy as the<br>minimum sterilization dose to achieve a sterility<br>assurance level, SAL, of $10^{-6}$ , which is required for its<br>intended use and is equivalent to the predicate device. |
| LAL Validation | Testing was conducted to<br>demonstrate compliance of<br>the AMC and Extension<br>Lines with LAL<br>requirements per the USP<br>guidance for CNS<br>contacting devices. | Testing demonstrated that all devices met an Endotoxin<br>levels of <2.15 EU/device required for its intended use<br>Per FDA Guidance Guideline on Validation of the<br>Limulus Amebocyte Lysate Test As An End-Product<br>Endotoxin Test for Human And Animal Parenteral<br>Drugs, Biological Products, and Medical Devices –<br>1997- and equivalent to the predicate device. |

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# AMC System Animal Testing

| Test | Test Method Summary | Results |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | All results met acceptance criteria per<br>protocol and applicable standards and<br>indicate the AMC Systems is safe for its<br>intended use and equivalent to the<br>predicate device. |
| AMC and<br>Extension Line<br>design validation<br>and performance<br>evaluation | Protocol defines the methods and<br>materials to assess the conceptual<br>design of the AMC and Extension<br>Lines during the concept-<br>development phase to meet its<br>specifications per its intended use.<br>N=7 Juvenile Yorkshire Pigs<br>(Acute Study) | This animal study demonstrated that the<br>AMC System met its specifications as<br>follows:<br>● Insertion depth to target anatomies<br>● Ease of use<br>● Two independent channels function to<br>their specifications for infusion and<br>aspiration<br>● Minimal/none occlusions during<br>insertion<br>● Compatible with stereotactic<br>procedures<br>● Minimal to no backflow and acceptable<br>distribution of infusate |

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| Test | Test Method Summary | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AMC and<br>Extension Line<br>design validation<br>and performance<br>evaluation | Protocol defines the methods and<br>materials to assess the final design<br>of the AMC and Extension Lines<br>during the design development and<br>design-freeze phase to meet its<br>specifications per its intended use. | All results met acceptance criteria per<br>protocol and applicable standards and<br>indicate the AMC Systems is safe for its<br>intended use and equivalent to the<br>predicate device. (same as above) |
| | N=4 Juvenile Yorkshire Pigs<br>(Acute Study) | |
| AMC and<br>Extension Line<br>comparison with<br>SurgiVision MR<br>Compatible<br>Ventricular<br>Cannula K102101<br>(a.k.a. MRII<br>SmartFlow<br>Cannula) | Comparison of the AMC and<br>Extension Lines with the SmartFlow<br>(SF) cannula. Studies were done<br>using Gadolinium (MR traces)<br>infusions.<br>Model - Juvenile Yorkshire Pig<br>Test samples – AMC vs SF with<br>Gadolinium (MR tracer).<br>N=4 acute animals<br>N=6 survival animals (survival for 4-<br>weeks post infusion) | All results met acceptance criteria per<br>protocol and applicable standards. The<br>AMC performed substantially equivalent to<br>the SF predicate device and according to<br>its specifications. |

## AMC System Human Factors and Usability Testing Summary

| Test | Test Method Summary | Results |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| AMC and Extension<br>Lines User Validation<br>testing and Human<br>Factors Testing | Testing was conducted per the applicable<br>standards and guidances and obtained user<br>feedback in a simulated clinical use evaluation<br>of the AMC and Extension Lines. | All results met acceptance<br>criteria per protocol and<br>applicable standards. The<br>AMC performed safely for its<br>intended use and as |
| | N= 16 Users with repeat uses totaling 28 uses. | expected by the users per<br>the AMC System instructions<br>for use. |

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 –

{13}------------------------------------------------

Quality Management Systems - Requirements for Regulatory Purposes. In all instances, the AMC functioned as intended and results observed were as expected. These test results confirm that AMC is safe, meets the design inputs, and raises no new safety or efficacy concerns. A summary of the AMC's design control activities with regards to risk analysis and verification and validation activities is provided in this 510 (k) submission.

#### Substantial Equivalence

The AMC has the same intended use/indications for use along with similar design, materials of construction, and similar technological characteristics as its predicate device. While there are technological differences between the AMC and the predicate, the SurgiVision MR Compatible Ventricular Cannula (such as two fluid channels in the AMC versus one in the predicate, different exit hole configuration, and dimensional differences); these differences do not raise new types of safety and effectiveness questions when all listed warnings and cautions are followed.

The results from preclinical evaluations, including comparative animal testing, human factors and usability studies in a simulated clinical use model; demonstrate that the technological and performance characteristics of the AMC 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 AMC performs as intended and is substantially equivalent to its predicate the SurgiVision MR Compatible Ventricular Cannula.

## Conclusions

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