(34 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of a cannula system, with no mention of AI or ML capabilities.
Yes
This device is intended for the injection of cytarabine or removal of cerebrospinal fluid from the brain ventricles, which are therapeutic actions.
No
The device is described as being for "injection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain." This indicates a therapeutic or procedural purpose (delivery of medication, removal of fluid), not a diagnostic one.
No
The device description clearly outlines physical components like a rigid ceramic cannula, micro-tip, Y-connector, extension line sets, safety-sheath, and depth-stop. The performance studies also detail bench and animal testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of a drug (Cytarabine) or the removal of cerebrospinal fluid (CSF) from the brain ventricles. This is a direct intervention on the patient's body for therapeutic or diagnostic purposes (removing CSF for analysis, though the device itself isn't performing the analysis).
- Device Description: The device is a cannula and extension line system designed for physically delivering or removing fluids from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis of the removed CSF or the injected drug in vitro. It is a tool for accessing and manipulating fluids within the body.
The device is a surgical/interventional tool, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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."
Product codes
HCD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room or MR Suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of AMC System Performance Testing:
- Test: AMC System (as a System) Line tested for leak pressure and Infusion/Aspiration flow.
- Test Method Summary: As applicable testing was done with room temperature water, body temperature Cytarabine (for infusion), and body temperature CSF (for aspiration).
- Results: Testing passed and results demonstrate the AMC System is safe for its intended use and substantially equivalent to the predicate device.
- Test: Leak Pressure Testing
- Results: AMC and Extension line systems withstood pressure spikes with no leaks.
- Test: Infusion Flow Testing
- Results: Infuse Flow Rate and Pressure AMC System reached specified flow rate within the specified time and was capable of injecting fluid at it maximum flow rate.
- Test: Aspiration Testing
- Results: Aspiration Rate The AMC was capable of aspirating at its maximum aspiration rate.
- Test: Extension Line Set patency Testing Luer pull-off testing
- Test Method Summary: Extension Line Sets were tested for line patency during bend and luer pull.
- Results: Testing passed and results demonstrate the Extension Line sets are safe for their intended use and substantially equivalent to the predicate device. Extension Line Patency: Extension lines remained patent with a worst case expected bend radius. Luer Pull-off: All units were above the maximum luer pull force specification (worst case for clinical use plus safety factor).
- Test: AMC Brain insertion, removal, and lateral shift testing
- Test Method Summary: Testing was conducted to test compliance of AMC with specified requirements for brain insertion, removal, and lateral shift strengths.
- Results: Testing passed and results demonstrate the AMC System is safe for its intended use and met its specifications. Brain Insertion and Removal: AMC withstood insertion and removal into a bovine brain without breaking and detaching. Brain Lateral Shift: AMC or AMC tip did not break or detach when laterally shifted in bovine brain tissue in any direction from the insertion location.
- Test: AMC tip-compression, bullet-nose pull-out, and y-connector pull-out testing
- Test Method Summary: Testing was conducted to demonstrate compliance of AMC with requirements for tip compression strength, and pullout strengths of the bullet-nose and y- connector bond strengths.
- Results: Testing passed and results demonstrate the AMC System is safe for its intended use and met its specifications. Axial Tip Compression Force: 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: The AMC withstood the acceptance criteria for minimum pull-out force based on clinically relevant forces with safety factor.
- Test: Magnetic Resonance (MR) Safe Testing
- Test Method Summary: Testing was conducted to demonstrate MR Safety of the AMC and Extension Line Sets per the FDA guidance for MR Safety and Compatibility.
- Results: The AMC System is MR Safe for its intended use and substantially equivalent to the predicate device. MR Compatibility: The AMC is MR Safe in 1.5 Tesla and 3Tesla magnets.
- Test: Cytarabine Infusion Compatibility
- Test Method Summary: Testing was conducted to demonstrate compliance of AMC and Extension Lines with it specified requirements for Cytarabine concentration infusion (clinically relevant concentration). Testing evaluated effect of infusion of Cytarabine through the AMC System with respect to Cytarabine concentration post infusion and on device integrity after prolonged exposure to Cytarabine and acute infusion.
- Results: Testing passed and results demonstrate the AMC System is safe for its intended use and substantially equivalent to the predicate device. Cytarabine Compatibility: The materials of the fluid path of the AMC are compatible with Cytarabine infusion of a specified clinically relevant concentration. There was no visible degradation or reduction in strength below specifications of the AMC and Extension lines after prolonged exposure or acute infusion of Cytarabine at its maximum permitted clinical concentration and durations. There was no change in Cytarabine concentration post infusion.
- Test: Transit Testing (Packaging Qualification)
- Test Method Summary: Testing was conducted to demonstrate compliance of the AMC and Extension Lines with transit testing requirements per ISTA-2A.
- Results: Testing passed and results demonstrate that 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.
- Test: Accelerated Aging
- Test Method Summary: Protocol defines the methods and materials to conduct accelerated aging of AMC and Extension Lines and packaging materials
- Results: Testing demonstrates that the AMC System is safe for its labeled expiration dating and substantially equivalent to the predicate device.
- Test: Biocompatibility
- Test Method Summary: Testing was conducted to demonstrate compliance of the AMC and Extension Lines with ISO 10993 biocompatibility requirements.
- Results: All tissue contacting materials used in the AMC System are biocompatible per ISO 10993 –Biological evaluation of Medical Devices, Externally Communicating Device - Tissue contact, limited duration A
§ 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.
0
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
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
2
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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3
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 Name
Classification Name | Alcyone MEMS Cannula (AMC) System
Ventricular Cannula
Ventricular Cannula |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class I |
| Product Code and
Requlation: | 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.
4
Technological Characteristics
The AMC is equivalent in technological characteristics to its predicate device.
| | AMC System
Subject 510 (k) | SurgiVision Ventricular
Cannula (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 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." | The MR Compatible
Ventricular Cannula is
intended for injection of
Cytarabine or removal of
CSF from the ventricles
during intracranial
procedures. The device is
not 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 brain
ventricles | Equivalent to Predicate |
| | Allows injection of Cytarabine
into the ventricles | Allows injection of
Cytarabine into the
ventricles | Equivalent to Predicate |
| | Allows aspiration of CSF from
the ventricles | Allows aspiration of CSF
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
Cytarabine to the brain ventricles
or aspiration of CSF from the
ventricles | Pt. s needing injection of
Cytarabine to the brain
ventricles or aspiration of
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
Suite | Equivalent to Predicate |
| | MRI/Diagnostic / Surgical Room | MRI/Diagnostic / Surgical
Room | Equivalent to Predicate |
| Energy Used | N/A | N/A | Equivalent to Predicate |
| Human Factors | Labeling indicates size and
length | Labeling indicates size and
length | Equivalent to Predicate. |
| | Labeling indicates flowrates | Labeling indicates
flowrates | Equivalent to Predicate. |
| | Can be manipulated with gloved
hand | Can be manipulated with
gloved hand | Equivalent to Predicate |
5
| | AMC System
Subject 510 (k) | SurgiVision Ventricular
Cannula (VC)
K102101 | Discussion |
|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Designed to be placed through a
prepared opening through the
skull and the Dura into the brain
ventricle | Designed to be placed
through a prepared
opening through the skull
and the Dura into the brain
ventricle | Equivalent to Predicate |
| | Compatible with stereotactic
guidance systems equipped with
adapters possessing a 2.6mm
inner diameter. | Compatible with MRI
Interventions Stereotactic
Frame | Equivalent to Predicate |
| | Rigid section to enter the brain | Rigid section to enter the
brain | Equivalent to Predicate |
| | Straight section to enter the brain | Straight section to enter
the brain | Equivalent to Predicate |
| | Two holes at distal end for fluid
movement | Hole at distal end for fluid
movement | Equivalent to Predicate. One
hole per fluid channel. |
| Design | Distal holes | Distal holes | Equivalent to Predicate.
Distal holes openings are
towards the side designed to
prevent tissue blockage
during insertion. |
| | Body markings designed to
facilitate determination of
insertion depth | No marking on body of
device | Equivalent to Predicate.
Length marking on body to
help user determine depth of
insertion. Length markings
are common in these
devices to aid the user in
positioning. |
| | Length of rigid section 9" | Length of rigid section
10.5" (30cm) | Equivalent to Predicate.
Does not change user
interface or utility. This is
within the range of cleared
ventricular cannulas. |
| | Two lumens. Inside diameter of
each lumen in body: 0.010"
(.25mm).
Inside cross-section of each
lumen in tip: 0.002"x0.001" (.052
x.03mm) | One Lumen: Inside
diameter:
0.008" (0.2mm) to 0.021"
(0.53mm) | Equivalent to Predicate.
Both devices are moving
fluids and their different
inside/outside diameters
result in different flow rates.
This is within the range of
cleared 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) allows
remote (end of scanner bore)
injection/aspiration | Lumen extension (3 foot)
allows remote (end of
scanner bore)
injection/aspiration | Equivalent to Predicate.
Extensions allow for MR
compatibility. |
6
| | AMC System
Subject 510 (k) | SurgiVision Ventricular
Cannula (VC)
K102101 | Discussion |
|-------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Lumen extension (25 foot) allows
remote (outside of scanner 5
gauss) injection/aspiration using
a non-MRI safe pump | Lumen extension (9 foot)
allows remote (outside of
scanner 5 gauss)
injection/aspiration using a
non-MRI safe pump | Equivalent to Predicate.
Extensions allow for MR
compatibility. |
| | Tip Sheath | Tip Sheath | Equivalent to Predicate |
| | Depth-stop bushing to facilitated
setting of insertion depth | No depth stop | Equivalent to Predicate.
With the predicate device
the user uses generic stops
when using Predicate with
various frames. AMC
provides a stop for user
convenience. |
| | Standard luer | Standard luer | Equivalent to Predicate. |
| | Compatible with standard syringe
pumps for infusion. | Compatible with syringe
pumps for infusion. | Equivalent to Predicate |
| | Translucent luers | Translucent luers | Equivalent to Predicate. |
| Performance | Sufficiently rigid to pass through
brain tissue without additional
support. | Sufficiently rigid to pass
through brain tissue
without additional support. | Equivalent to Predicate |
| | Flow rate of:
3.0mL/hr. (1.5mL/hr. per
channel) at 1 year | Equivalent to Predicate |
8
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 | |
| Set (as a System) Line | ||
| were tested for leak | ||
| pressure and Infusion/ | ||
| Aspiration flow. | Testing passed and results demonstrate the AMC | |
| System is safe for its intended use and substantially | ||
| equivalent to the predicate device. | ||
| Leak Pressure | ||
| Testing | As applicable testing was | |
| done with room | ||
| temperature water, body | ||
| temperature Cytarabine | ||
| (for infusion), and body | ||
| temperature CSF (for | ||
| aspiration). | Leak Pressure | |
| AMC and Extension line systems withstood pressure | ||
| spikes with no leaks. | ||
| Infusion Flow | ||
| Testing | Infuse Flow Rate and Pressure | |
| AMC System reached specified flow rate within the | ||
| specified time and was capable of injecting fluid at it | ||
| maximum flow rate. | ||
| Aspiration Testing | Aspiration Rate | |
| The AMC was capable of aspirating at its maximum | ||
| aspiration rate. | ||
| Extension Line Set | ||
| patency Testing | ||
| Luer pull-off | ||
| testing | Extension Line Sets were | |
| tested for line patency | ||
| during bend and luer pull. | Testing passed and results demonstrate the Extension | |
| Line sets are safe for their intended use and | ||
| substantially equivalent to the predicate device. | ||
| Extension Line Patency | ||
| Extension lines remained patent with a worst case | ||
| expected bend radius |
Luer Pull-off
All units were above the maximum luer pull force
specification (worst case for clinical use plus safety
factor) |
Summary of AMC System Performance Testing
9
| Test | Test Method Summary | Results |
|---|---|---|
| AMC Brain | ||
| insertion, removal, | ||
| and lateral shift | ||
| testing | Testing was conducted to | |
| test compliance of AMC | ||
| with specified requirements | ||
| for brain insertion, removal, | ||
| and lateral shift strengths. | Testing passed and results demonstrate the AMC | |
| System is safe for its intended use and met its | ||
| specifications. | ||
| Brain Insertion and Removal | ||
| AMC withstood insertion and removal into a bovine | ||
| brain without breaking and detaching. | ||
| Brain Lateral Shift | ||
| AMC or AMC tip did not break or detach when laterally | ||
| shifted in bovine brain tissue in any direction from the | ||
| insertion location. | ||
| AMC tip- | ||
| compression, | ||
| bullet-nose pull- | ||
| out, and y- | ||
| connector pull-out | ||
| testing | Testing was conducted to | |
| demonstrate compliance of | ||
| AMC with requirements for | ||
| tip compression strength, | ||
| and pullout strengths of the | ||
| bullet-nose and y- | ||
| connector bond strengths. | Testing passed and results demonstrate the AMC | |
| System is safe for its intended use and met its | ||
| specifications. | ||
| Axial Tip Compression Force | ||
| 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 | ||
| The AMC withstood the acceptance criteria for | ||
| minimum pull-out force based on clinically relevant | ||
| forces with safety factor. | ||
| Magnetic | ||
| Resonance (MR) | ||
| Safe Testing | Testing was conducted to | |
| demonstrate MR Safety of | ||
| the AMC and Extension | ||
| Line Sets per the FDA | ||
| guidance for MR Safety | ||
| and Compatibility. | The AMC System is MR Safe for its intended use and | |
| substantially equivalent to the predicate device. | ||
| MR Compatibility | ||
| The AMC is MR Safe in 1.5 Tesla and 3Tesla magnets. | ||
| Test | Test Method Summary | Results |
| Cytarabine | ||
| Infusion | ||
| Compatibility | Testing was conducted to | |
| demonstrate compliance of | ||
| AMC and Extension Lines | ||
| with it specified | ||
| requirements for | ||
| Cytarabine concentration | ||
| infusion (clinically relevant | ||
| concentration). | ||
| Testing evaluated effect of | ||
| infusion of Cytarabine | ||
| through the AMC System | ||
| with respect to Cytarabine | ||
| concentration post infusion | ||
| and on device integrity | ||
| after prolonged exposure to | ||
| Cytarabine and acute | ||
| infusion. | Testing passed and results demonstrate the AMC | |
| System is safe for its intended use and substantially | ||
| equivalent to the predicate device. | ||
| Cytarabine Compatibility | ||
| The materials of the fluid path of the AMC are | ||
| compatible with Cytarabine infusion of a specified | ||
| clinically relevant concentration. There was no visible | ||
| degradation or reduction in strength below | ||
| specifications of the AMC and Extension lines after | ||
| prolonged exposure or acute infusion of Cytarabine at | ||
| its maximum permitted clinical concentration and | ||
| durations. There was no change in Cytarabine | ||
| concentration post infusion. | ||
| Transit Testing | ||
| (Packaging | ||
| Qualification) | Testing was conducted to | |
| demonstrate compliance of | ||
| the AMC and Extension | ||
| Lines with transit testing | ||
| requirements per ISTA-2A. | Testing passed and results demonstrate that 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 | Protocol defines the | |
| methods and materials to | ||
| conduct accelerated aging | ||
| of AMC and Extension | ||
| Lines and packaging | ||
| materials | Testing demonstrates that the AMC System is safe for | |
| its labeled expiration dating and substantially equivalent | ||
| to the predicate device. | ||
| Biocompatibility | Testing was conducted to | |
| demonstrate compliance of | ||
| the AMC and Extension | ||
| Lines with ISO 10993 | ||
| biocompatibility | ||
| requirements. | All tissue contacting materials used in the AMC System | |
| are biocompatible per ISO 10993 –Biological evaluation | ||
| of Medical Devices, Externally Communicating Device - | ||
| Tissue contact, limited duration A |