(34 days)
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."
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.
This document is a 510(k) premarket notification for the Alcyone MEMS Cannula (AMC) System, aiming to demonstrate its substantial equivalence to a predicate device. It is a regulatory submission, not a study report per se, and as such, it focuses on demonstrating equivalence rather than establishing novel acceptance criteria or conducting a traditional clinical study with defined endpoints for performance metrics like sensitivity/specificity.
Therefore, many of the requested categories (acceptance criteria performance, sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not directly applicable or explicitly stated in the context of an AI/ML-driven device evaluation. This document is for a medical device (cannula) and its evaluation is based on engineering and preclinical testing.
However, I can extract information related to the device's characteristics and the tests performed to demonstrate its safety and performance equivalence to a predicate device. I will adapt the requested table and sections to best fit the available information.
1. Table of Acceptance Criteria (as implied by equivalence to predicate) and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., specific clinical performance thresholds like sensitivity/specificity for a diagnostic AI). Instead, it demonstrates that the AMC System's performance characteristics are equivalent to or meet the requirements for its intended use, similar to the predicate device. The "acceptance criteria" are implied by successful completion of various engineering, biocompatibility, and functional tests, and by demonstrating substantial equivalence to the predicate.
| Characteristic / Test | Implied Acceptance Criteria (Equivalence/Performance Requirement) | Reported Device Performance and Discussion |
|---|---|---|
| Indications for Use / Intended Use | Equivalent to predicate device. Intended for injection of Cytarabine or removal of CSF from ventricles, not for implant, single patient use. | Equivalent to Predicate. The AMC System has the same intended use. |
| Classification & Product Code | Equivalent to predicate device (Class I, HCD, 21 CFR 882.4060). | Equivalent to Predicate. |
| Leak Pressure Testing | Withstand pressure spikes with no leaks. | Passed. AMC and Extension line systems withstood pressure spikes with no leaks. |
| Infusion Flow Testing | Reach specified flow rate within specified time, capable of injecting fluid at maximum flow rate. (Target: 3.0mL/hr. (1.5mL/hr. per channel) at <25psi internal pressure). | Passed. AMC System reached specified flow rate within the specified time and was capable of injecting fluid at its maximum flow rate. (This is different from the predicate's stated range of 0.3ml/hr to 25ml/hr, but the discussion notes this results from different diameters and is within the range of cleared ventricular cannulas, thus considered equivalent in function). |
| Aspiration Rate Testing | Capable of aspirating at maximum aspiration rate. (Target: 2.4mL/hr. (1.2mL/hr. per channel) using an air vacuum of 10mL from a syringe). | Passed. The AMC was capable of aspirating at its maximum aspiration rate. (This is different from the predicate's stated range of 0.1ml/hr to 8.7ml/hr, but similar to infusion, discussion notes this results from different diameters and is considered equivalent). |
| Extension Line Patency Testing | Extension lines remain patent with worst-case expected bend radius. | Passed. Extension lines remained patent with a worst case expected bend radius. |
| Luer Pull-off Testing | All units above maximum luer pull force specification (worst case for clinical use plus safety factor). | Passed. All units were above the maximum luer pull force specification. |
| AMC Brain Insertion & Removal | Withstand insertion and removal into brain tissue without breaking and detaching. | Passed. AMC withstood insertion and removal into a bovine brain without breaking and detaching. |
| AMC Brain Lateral Shift | AMC or AMC tip not break or detach when laterally shifted in brain tissue in any direction from insertion location. | Passed. AMC or AMC tip did not break or detach when laterally shifted in bovine brain tissue in any direction from the insertion location. |
| Axial Tip Compression Force | Withstand acceptance criteria for axial compressive force based on clinically relevant forces with safety factor. | Passed. The AMC or AMC micro-tip withstood the acceptance criteria for axial compressive force based on clinically relevant forces with safety factor. |
| Pull-out strengths of bonds (bullet-nose, y-connector) | Withstand acceptance criteria for minimum pull-out force based on clinically relevant forces with safety factor. | Passed. The AMC withstood the acceptance criteria for minimum pull-out force based on clinically relevant forces with safety factor. |
| Magnetic Resonance (MR) Safety | MR Safe in 1.5T and 3T MRI environment (predicate 1.5T). | MR Safe. The AMC is MR Safe in 1.5 Tesla and 3Tesla magnets. Equivalent to Predicate. |
| Cytarabine Compatibility | Materials compatible with Cytarabine infusion (clinically relevant concentration); no visible degradation or strength reduction; no change in Cytarabine concentration post infusion. | Passed. The materials of the fluid path of the AMC are compatible with Cytarabine infusion of a specified clinically relevant concentration. No visible degradation or reduction in strength below specifications. No change in Cytarabine concentration post infusion. |
| Transit Testing (Packaging Qualification) | Packaging meets functionality requirements; integrity of package as sterile barrier maintained after transportation testing. | Passed. The AMC System packaging meets its functionality requirements and the integrity of the package as a sterile barrier was maintained after conducting actual or simulated Transportation Testing Conditions. |
| Accelerated Aging | Safe for its labeled expiration dating. | Passed. Demonstrates that the AMC System is safe for its labeled expiration dating. |
| Biocompatibility | All tissue-contacting materials biocompatible per ISO 10993 (limited duration, < 24 hours). Tests: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Hemocompatibility, Material Mediated Pyrogen. | Passed. All tissue contacting materials used are biocompatible per ISO 10993. The specified tests were conducted. |
| Sterilization Validation | Achieve a sterility assurance level (SAL) of 10^-6 with 25 kGy dose. | Passed. Testing substantiates the use of 25 kGy as the minimum sterilization dose to achieve a sterility assurance level, SAL, of 10^-6. |
| LAL Validation (Endotoxin) | Endotoxin levels < 2.15 EU/device. | Passed. All devices met an Endotoxin level of <2.15 EU/device. |
| Animal Testing (Pre-clinical) | Meet specifications for insertion depth, ease of use, independent channel function (infusion/aspiration), minimal/none occlusions, compatible with stereotactic procedures, minimal to no backflow, acceptable infusate distribution. Substantially equivalent to predicate. | Passed. In original concept-development and final design validation animal studies, all results met acceptance criteria per protocol and applicable standards, indicating the AMC System is safe for its intended use and equivalent to the predicate device. In the comparative study, the AMC performed substantially equivalent to the predicate device (SmartFlow). |
| Human Factors and Usability Testing | Safe for intended use and performed as expected by users per instructions for use. | Passed. All results met acceptance criteria per protocol and applicable standards. The AMC performed safely for its intended use and as expected by the users per the AMC System instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several test sets for different types of evaluations, which are primarily engineering and preclinical tests, not clinical performance studies for an AI/ML device.
- AMC System Performance (Leak, Infusion, Aspiration, Patency, Pull-off): Sample sizes are not explicitly stated for individual bench tests but are typically based on engineering validation standards.
- AMC Brain Insertion, Removal, Lateral Shift Testing: Sample sizes for this mechanical testing are not explicitly stated.
- AMC Tip Compression, Pull-out Testing: Sample sizes are not explicitly stated.
- Magnetic Resonance (MR) Safe Testing: Sample sizes for this are not explicitly stated but generally involve testing representative samples.
- Cytarabine Infusion Compatibility: Sample sizes are not explicitly stated.
- Transit Testing (Packaging): Sample sizes are not explicitly stated but would be based on ISTA-2A standards.
- Accelerated Aging: Protocol defines methods and materials; sample size not explicitly stated.
- Biocompatibility: Sample sizes for in vitro and in vivo biocompatibility tests are not explicitly stated but are conducted according to ISO 10993 standards.
- Sterilization Validation: Sample sizes for radiation sterilization validation are not explicitly stated but are determined by ANSI/AAMI/ISO 11137-2.
- LAL Validation: Sample sizes are not explicitly stated but are determined by USP guidance.
- Animal Testing (Design Validation and Performance Evaluation):
- Concept-development phase: N=7 Juvenile Yorkshire Pigs (Acute Study).
- Design-freeze phase: N=4 Juvenile Yorkshire Pigs (Acute Study).
- Comparative study vs. Predicate: N=4 acute animals, N=6 survival animals (survival for 4-weeks post infusion).
- Human Factors and Usability Testing: N=16 Users with repeat uses totaling 28 uses.
Data Provenance: The document does not specify the country of origin for the data for most tests, but they are generally performed in a laboratory setting or by contract research organizations (CROs) adhering to international standards (e.g., ISO, USP, FDA guidance). The animal studies used "Juvenile Yorkshire Pigs." All non-human testing is retrospective from the perspective of the 510(k) submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is largely irrelevant for a device like a ventricular cannula, where "ground truth" is typically established by engineering specifications, physical measurements, and biological responses rather than expert consensus on interpretive data (which is common for AI/ML diagnostic tools).
- Bench and Animal Tests: The "ground truth" or performance standards are established by predefined design requirements, applicable international and national standards (e.g., ISO, USP, FDA guidance), and the performance characteristics of the legally marketed predicate device. This involves engineering and scientific experts, but not in the qualitative assessment sense of a radiologist for image interpretation.
- Human Factors and Usability Testing: Involved N=16 "Users," who would be qualified to interact with the device in a simulated clinical setting. Their feedback on ease of use and adherence to instructions serves as "ground truth" for usability. Specific qualifications (e.g., years of experience as a neurosurgeon or nurse) are not detailed but are implied to be relevant clinical users.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used when subjective expert interpretation is involved in establishing ground truth, such as in reading medical images. This process is not applicable to the engineering, biocompatibility, and functional testing described for the Alcyone MEMS Cannula (AMC) System. The "ground truth" (or compliance) is determined by objective measurements against predefined specifications and regulatory standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device (cannula), not an AI-driven software or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device. It does not have an algorithm that performs standalone. Its function is to be used by a human healthcare professional for injecting or removing fluids.
7. The Type of Ground Truth Used
For the Alcyone MEMS Cannula (AMC) System, the "ground truth" varies by the type of test:
- Technical/Engineering Tests (Leak, Flow, Mechanical Safety): Ground truth is based on established engineering specifications, physical measurements, performance data from the predicate device, and compliance with relevant industry standards (e.g., pressure ratings, flow rates, material stresses).
- Biocompatibility: Ground truth is based on compliance with ISO 10993 standards and the biological response of materials. This involves specific test methods (e.g., cytotoxicity assays, animal toxicity studies) with predefined acceptance criteria for biological safety.
- Sterility and Endotoxin: Ground truth for sterility is a Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11137-2. Ground truth for endotoxin is an endotoxin level < 2.15 EU/device per USP guidance.
- MR Safety: Ground truth is defined by the device being "MR Safe" according to FDA guidance, demonstrated by specific magnetic field interaction tests.
- Animal Testing: Ground truth is derived from the device meeting predefined functional specifications, observed performance in a biological system (e.g., insertion depth, channel function, occlusion, backflow), and qualitative/quantitative comparison to the predicate device in the animal model.
- Human Factors/Usability: Ground truth is based on user feedback and observations of ease of use, adherence to instructions, and overall safety during simulated use by relevant clinical personnel.
8. The Sample Size for the Training Set
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device; it does not involve machine learning or an "algorithm" with a "training set." Its design and performance are based on engineering principles, material science, and preclinical testing, not on data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this physical medical device.
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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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 513-236-0857 Facsimile: 513-898-2106
Contact Person: Elsa Chi Abruzzo, RAC, FRAPS Date Prepared: April 10, 2015
Alcyone Lifesciences, Inc.
| Trade Name:Common or Usual NameClassification Name | Alcyone MEMS Cannula (AMC) SystemVentricular CannulaVentricular Cannula |
|---|---|
| Classification: | Class I |
| Product Code andRequlation: | HCD, 21 CFR 882.4060 |
| Classification Panel: | Neurology |
| Predicate Device: | K102101 SurgiVision, Inc. MR Compatible Ventricular Cannula(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 SystemSubject 510 (k) | SurgiVision VentricularCannula (VC)K102101 | Discussion | |
|---|---|---|---|
| Classification | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent to Predicate |
| Product Code | HCD | HCD | Equivalent to Predicate |
| Indications for Use/Intended Use | The Alcyone MEMS Cannula(AMC) System consisting of theAMC and the AMC ExtensionLine Set, is intended for injectionof Cytarabine (cytosinearabinoside) or removal ofcerebrospinal fluid (CSF) fromthe ventricles of the brain duringintracranial procedures. TheAMC System is not intended forimplant. The device is intendedfor "single patient use only." | The MR CompatibleVentricular Cannula isintended for injection ofCytarabine or removal ofCSF from the ventriclesduring intracranialprocedures. The device isnot intended for implant.This device is intended for"single patient use only." | Equivalent to Predicate. |
| How Used | Gains access to brain ventricles | Gains access to brainventricles | Equivalent to Predicate |
| Allows injection of Cytarabineinto the ventricles | Allows injection ofCytarabine into theventricles | Equivalent to Predicate | |
| Allows aspiration of CSF fromthe ventricles | Allows aspiration of CSFfrom 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 ofCytarabine to the brain ventriclesor aspiration of CSF from theventricles | Pt. s needing injection ofCytarabine to the brainventricles or aspiration ofCSF 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 MRSuite | Equivalent to Predicate |
| MRI/Diagnostic / Surgical Room | MRI/Diagnostic / SurgicalRoom | Equivalent to Predicate | |
| Energy Used | N/A | N/A | Equivalent to Predicate |
| Human Factors | Labeling indicates size andlength | Labeling indicates size andlength | Equivalent to Predicate. |
| Labeling indicates flowrates | Labeling indicatesflowrates | Equivalent to Predicate. | |
| Can be manipulated with glovedhand | Can be manipulated withgloved hand | Equivalent to Predicate |
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| AMC SystemSubject 510 (k) | SurgiVision VentricularCannula (VC)K102101 | Discussion | |
|---|---|---|---|
| Design | Designed to be placed through aprepared opening through theskull and the Dura into the brainventricle | Designed to be placedthrough a preparedopening through the skulland the Dura into the brainventricle | Equivalent to Predicate |
| Compatible with stereotacticguidance systems equipped withadapters possessing a 2.6mminner diameter. | Compatible with MRIInterventions StereotacticFrame | Equivalent to Predicate | |
| Rigid section to enter the brain | Rigid section to enter thebrain | Equivalent to Predicate | |
| Straight section to enter the brain | Straight section to enterthe brain | Equivalent to Predicate | |
| Two holes at distal end for fluidmovement | Hole at distal end for fluidmovement | Equivalent to Predicate. Onehole per fluid channel. | |
| Design | Distal holes | Distal holes | Equivalent to Predicate.Distal holes openings aretowards the side designed toprevent tissue blockageduring insertion. |
| Body markings designed tofacilitate determination ofinsertion depth | No marking on body ofdevice | Equivalent to Predicate.Length marking on body tohelp user determine depth ofinsertion. Length markingsare common in thesedevices to aid the user inpositioning. | |
| Length of rigid section 9" | Length of rigid section10.5" (30cm) | Equivalent to Predicate.Does not change userinterface or utility. This iswithin the range of clearedventricular cannulas. | |
| Two lumens. Inside diameter ofeach lumen in body: 0.010"(.25mm).Inside cross-section of eachlumen in tip: 0.002"x0.001" (.052x.03mm) | One Lumen: Insidediameter:0.008" (0.2mm) to 0.021"(0.53mm) | Equivalent to Predicate.Both devices are movingfluids and their differentinside/outside diametersresult in different flow rates.This is within the range ofcleared ventricular cannulas. | |
| Outside diameter:0.65" (1.6mm) | Outside diameter:0.65" (1.6mm) and 0.80"(2.0mm) | Equivalent to Predicate | |
| No stylet | No stylet | Equivalent to Predicate | |
| Lumen extension (10 foot) allowsremote (end of scanner bore)injection/aspiration | Lumen extension (3 foot)allows remote (end ofscanner bore)injection/aspiration | Equivalent to Predicate.Extensions allow for MRcompatibility. |
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| AMC SystemSubject 510 (k) | SurgiVision VentricularCannula (VC)K102101 | Discussion | |
|---|---|---|---|
| Design | Lumen extension (25 foot) allowsremote (outside of scanner 5gauss) injection/aspiration usinga non-MRI safe pump | Lumen extension (9 foot)allows remote (outside ofscanner 5 gauss)injection/aspiration using anon-MRI safe pump | Equivalent to Predicate.Extensions allow for MRcompatibility. |
| Tip Sheath | Tip Sheath | Equivalent to Predicate | |
| Depth-stop bushing to facilitatedsetting of insertion depth | No depth stop | Equivalent to Predicate.With the predicate devicethe user uses generic stopswhen using Predicate withvarious frames. AMCprovides a stop for userconvenience. | |
| Standard luer | Standard luer | Equivalent to Predicate. | |
| Compatible with standard syringepumps for infusion. | Compatible with syringepumps for infusion. | Equivalent to Predicate | |
| Translucent luers | Translucent luers | Equivalent to Predicate. | |
| Performance | Sufficiently rigid to pass throughbrain tissue without additionalsupport. | Sufficiently rigid to passthrough brain tissuewithout additional support. | Equivalent to Predicate |
| Flow rate of:3.0mL/hr. (1.5mL/hr. perchannel) at <25psi internalpressure per channel | Flow rate of:0.3ml/hr. (0.008" ID) to25ml/hr. (0.021" ID) at0.7psi | Equivalent to Predicate.Both devices are movingfluids, and the different flowrates results only from theirdifferent diameters.Pressures listed are internalto the system. | |
| Aspiration rate of:2.4mL/hr. (1.2mL/hr. perchannel) using an air vacuum of10mL from a syringe. | Aspiration rate of:0.1ml/hr. (0.008" ID) to8.7ml/hr. (0.021" ID) | Equivalent to Predicate.Both devices are movingfluids, and the different flowrates results only from theirdifferent diameters. | |
| Materials | Rigid body:Ceramic bodySilicon tip | Rigid body:CeramicPolymer Tip | Equivalent to Predicate.Both devices provide a rigidMRI compatible material forthe body. Both devices havea step down design to asmaller tip. |
| Materials | Through lumen:Polymer covered silicaSilicon | Through lumen:Polymer covered silica | Equivalent to Predicate.Both devices have acontinuous fluid pathwayand are MRI compatible andbiocompatible. |
| Detachable lumen extensions:Polymer | Non-detachable lumenextensions:Polymer covered silica | Equivalent to Predicate.Both devices have acontinuous fluid pathway |
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| AMC SystemSubject 510 (k) | SurgiVision VentricularCannula (VC)K102101 | Discussion | |
|---|---|---|---|
| and are MRI compatible andbiocompatible. | |||
| Proximal connector:Female luer connection | Proximal connector:Female luer connection | Equivalent to Predicate. | |
| Biocompatibility | Limited exposure device, < 24hours (Not implantable). | Limited exposure device, < 24 hours (Not implantable). | Equivalent to Predicate perISO 10993: BiologicalEvaluation of MedicalDevices. |
| Non-pyrogenic | Non-pyrogenic | Equivalent to Predicate.Meets USP criteria for typeof contact. | |
| Compatibility withenvironment andother devices | Safe in 1.5T and 3T MRIenvironment | Safe in 1.5T MRIenvironment | Equivalent to Predicate |
| Female luer connector onproximal end fits all male luerconnections (e.g. Syringe tips) | Female luer connector onproximal end fits all maleluer connections (e.g.Syringe tips) | Equivalent to Predicate | |
| Compatible with StereotacticFrames with 2.6mm adapter | Compatible with MRIInterventions StereotacticFrame | Equivalent to Predicate. | |
| Sterility | 10-6 SAL | 10-6 SAL | Equivalent to Predicate perANSI/AAMI/ISO 11137-2;Sterilization of health careproducts - Radiation. |
| Electrical Safety | N/A | N/A | N/A |
| Mechanical Safety | N/A | N/A | N/A |
| Chemical Safety | Lumen materials non-reactive toCytarabine, Saline, CSF | Lumen materials non-reactive to Cytarabine,Saline, CSF | Equivalent to Predicate |
| Silica lumen non-reactive | Silica lumen non-reactive | Equivalent to Predicate | |
| Thermal Safety | MRI Safe. All brain contactingcomponents tested in a 3.0Tenvironment | MRI Safe. All braincontacting componentstested in a 1.5Tenvironment | Equivalent to Predicate |
| Radiation Safety | N/A | N/A | Equivalent to Predicate |
| Packaging | AMC - Tray, pouch, SBS box.Extension Lines - Pouch, Pouch,SBS box | Tray, pouch, box. Catheterwith extension lines insame box. | Equivalent to Predicate |
| Shelf Life | 1 year | Unknown. Assumed to be>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 LineSet (as a System) Linewere tested for leakpressure and Infusion/Aspiration flow. | Testing passed and results demonstrate the AMCSystem is safe for its intended use and substantiallyequivalent to the predicate device. |
| Leak PressureTesting | As applicable testing wasdone with roomtemperature water, bodytemperature Cytarabine(for infusion), and bodytemperature CSF (foraspiration). | Leak PressureAMC and Extension line systems withstood pressurespikes with no leaks. |
| Infusion FlowTesting | Infuse Flow Rate and PressureAMC System reached specified flow rate within thespecified time and was capable of injecting fluid at itmaximum flow rate. | |
| Aspiration Testing | Aspiration RateThe AMC was capable of aspirating at its maximumaspiration rate. | |
| Extension Line Setpatency TestingLuer pull-offtesting | Extension Line Sets weretested for line patencyduring bend and luer pull. | Testing passed and results demonstrate the ExtensionLine sets are safe for their intended use andsubstantially equivalent to the predicate device. |
| Extension Line PatencyExtension lines remained patent with a worst caseexpected bend radiusLuer Pull-offAll units were above the maximum luer pull forcespecification (worst case for clinical use plus safetyfactor) |
Summary of AMC System Performance Testing
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| Test | Test Method Summary | Results |
|---|---|---|
| AMC Braininsertion, removal,and lateral shifttesting | Testing was conducted totest compliance of AMCwith specified requirementsfor brain insertion, removal,and lateral shift strengths. | Testing passed and results demonstrate the AMCSystem is safe for its intended use and met itsspecifications.Brain Insertion and RemovalAMC withstood insertion and removal into a bovinebrain without breaking and detaching.Brain Lateral ShiftAMC or AMC tip did not break or detach when laterallyshifted in bovine brain tissue in any direction from theinsertion location. |
| AMC tip-compression,bullet-nose pull-out, and y-connector pull-outtesting | Testing was conducted todemonstrate compliance ofAMC with requirements fortip compression strength,and pullout strengths of thebullet-nose and y-connector bond strengths. | Testing passed and results demonstrate the AMCSystem is safe for its intended use and met itsspecifications.Axial Tip Compression ForceThe AMC or AMC micro-tip withstood the acceptancecriteria for axial compressive force based on clinicallyrelevant forces with safety factor.Pull-out strengths of bondsThe AMC withstood the acceptance criteria forminimum pull-out force based on clinically relevantforces with safety factor. |
| MagneticResonance (MR)Safe Testing | Testing was conducted todemonstrate MR Safety ofthe AMC and ExtensionLine Sets per the FDAguidance for MR Safetyand Compatibility. | The AMC System is MR Safe for its intended use andsubstantially equivalent to the predicate device.MR CompatibilityThe AMC is MR Safe in 1.5 Tesla and 3Tesla magnets. |
| Test | Test Method Summary | Results |
| CytarabineInfusionCompatibility | Testing was conducted todemonstrate compliance ofAMC and Extension Lineswith it specifiedrequirements forCytarabine concentrationinfusion (clinically relevantconcentration).Testing evaluated effect ofinfusion of Cytarabinethrough the AMC Systemwith respect to Cytarabineconcentration post infusionand on device integrityafter prolonged exposure toCytarabine and acuteinfusion. | Testing passed and results demonstrate the AMCSystem is safe for its intended use and substantiallyequivalent to the predicate device.Cytarabine CompatibilityThe materials of the fluid path of the AMC arecompatible with Cytarabine infusion of a specifiedclinically relevant concentration. There was no visibledegradation or reduction in strength belowspecifications of the AMC and Extension lines afterprolonged exposure or acute infusion of Cytarabine atits maximum permitted clinical concentration anddurations. There was no change in Cytarabineconcentration post infusion. |
| Transit Testing(PackagingQualification) | Testing was conducted todemonstrate compliance ofthe AMC and ExtensionLines with transit testingrequirements per ISTA-2A. | Testing passed and results demonstrate that the AMCSystem packaging meets its functionality requirementsand the integrity of the package as a sterile barrier wasmaintained after conducting actual or simulatedTransportation Testing Conditions. |
| Accelerated Aging | Protocol defines themethods and materials toconduct accelerated agingof AMC and ExtensionLines and packagingmaterials | Testing demonstrates that the AMC System is safe forits labeled expiration dating and substantially equivalentto the predicate device. |
| Biocompatibility | Testing was conducted todemonstrate compliance ofthe AMC and ExtensionLines with ISO 10993biocompatibilityrequirements. | All tissue contacting materials used in the AMC Systemare biocompatible per ISO 10993 –Biological evaluationof Medical Devices, Externally Communicating Device -Tissue contact, limited duration A < 24 hours.The following tests were done:Cytotoxicity (MEM and NRU Elution)●Systemic Toxicity●Intracutaneous Reactivity●Sensitization (Klingman Maximization)●Hemocompatibility (Indirect)●Material Mediated Pyrogen● |
| Test | Test Method Summary | Results |
| SterilizationValidation | Testing was conducted todemonstrate compliance ofthe AMC and ExtensionLines with SterilizationValidation Standards toachieve a desired SAL. | Testing substantiates the use of 25 kGy as theminimum sterilization dose to achieve a sterilityassurance level, SAL, of $10^{-6}$ , which is required for itsintended use and is equivalent to the predicate device. |
| LAL Validation | Testing was conducted todemonstrate compliance ofthe AMC and ExtensionLines with LALrequirements per the USPguidance for CNScontacting devices. | Testing demonstrated that all devices met an Endotoxinlevels of <2.15 EU/device required for its intended usePer FDA Guidance Guideline on Validation of theLimulus Amebocyte Lysate Test As An End-ProductEndotoxin Test for Human And Animal ParenteralDrugs, Biological Products, and Medical Devices –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 perprotocol and applicable standards andindicate the AMC Systems is safe for itsintended use and equivalent to thepredicate device. | ||
| AMC andExtension Linedesign validationand performanceevaluation | Protocol defines the methods andmaterials to assess the conceptualdesign of the AMC and ExtensionLines during the concept-development phase to meet itsspecifications per its intended use.N=7 Juvenile Yorkshire Pigs(Acute Study) | This animal study demonstrated that theAMC System met its specifications asfollows:● Insertion depth to target anatomies● Ease of use● Two independent channels function totheir specifications for infusion andaspiration● Minimal/none occlusions duringinsertion● Compatible with stereotacticprocedures● Minimal to no backflow and acceptabledistribution of infusate |
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| Test | Test Method Summary | Results |
|---|---|---|
| AMC andExtension Linedesign validationand performanceevaluation | Protocol defines the methods andmaterials to assess the final designof the AMC and Extension Linesduring the design development anddesign-freeze phase to meet itsspecifications per its intended use. | All results met acceptance criteria perprotocol and applicable standards andindicate the AMC Systems is safe for itsintended use and equivalent to thepredicate device. (same as above) |
| N=4 Juvenile Yorkshire Pigs(Acute Study) | ||
| AMC andExtension Linecomparison withSurgiVision MRCompatibleVentricularCannula K102101(a.k.a. MRIISmartFlowCannula) | Comparison of the AMC andExtension Lines with the SmartFlow(SF) cannula. Studies were doneusing Gadolinium (MR traces)infusions.Model - Juvenile Yorkshire PigTest samples – AMC vs SF withGadolinium (MR tracer).N=4 acute animalsN=6 survival animals (survival for 4-weeks post infusion) | All results met acceptance criteria perprotocol and applicable standards. TheAMC performed substantially equivalent tothe SF predicate device and according toits specifications. |
AMC System Human Factors and Usability Testing Summary
| Test | Test Method Summary | Results |
|---|---|---|
| AMC and ExtensionLines User Validationtesting and HumanFactors Testing | Testing was conducted per the applicablestandards and guidances and obtained userfeedback in a simulated clinical use evaluationof the AMC and Extension Lines. | All results met acceptancecriteria per protocol andapplicable standards. TheAMC performed safely for itsintended use and as |
| N= 16 Users with repeat uses totaling 28 uses. | expected by the users perthe AMC System instructionsfor 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 –
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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.
§ 882.4060 Ventricular cannula.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.