(277 days)
MRI SmartFlow Flex Ventricular Catheter #K123605
No
The device description explicitly states, "The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components." This indicates a purely mechanical device without the computational capabilities required for AI/ML.
Yes.
The device is used for removal of cerebrospinal fluid (CSF) or for injecting Cytarabine, which are therapeutic interventions.
No
The device is indicated for gaining access to the ventricles for the removal of CSF or for injecting Cytarabine, which are therapeutic and drug delivery actions, not diagnostic ones.
No
The device description explicitly states, "The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a catheter designed for physical access and fluid management within the brain ventricles. It does not perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Function: The device's function is to facilitate the removal of CSF or the injection of a drug. It does not analyze CSF or any other biological sample to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
Product codes (comma separated list FDA assigned to the subject device)
HCA
Device Description
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the micro-catheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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
Not Found
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 testing was conducted to demonstrate that the Cleveland Multiport Ventricular Catheter meets its design requirements and is substantially equivalent when compared to the predicable standards including verification and validation testing, and cadaver usability testing in a simulated clinical use.
- Joint and Bond Strength Tests: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. All joints bonds were above the minimum pull-off force requirement (worst-case usage force plus safety factor). Tip loading exceeded the minimum load requirements. Cleveland Multiport Ventricular Catheter withstood the pull forces based on clinically relevant forces with a safety factor.
- Viscosity Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. The kinematic viscosity of Cytarabine and saline are similar, (within 2%) therefore, bench testing using saline is acceptable.
- Depth Marking: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Testing for depth gauge marks were not altered.
- Pressure Testing (Flow Burst, Infusate Pressure Test With suture tab, Aspiration Flow Rate Test): Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Cleveland Multiport Ventricular Catheter reached specified flow rate within the specified time and was capable of injecting fluid at it maximum flow rate. Cleveland Multiport Ventricular Catheter reached a linear pressure profile across all flow rates without leakage and no kinking of catheter and withstood the maximum pressure/spikes. Testing passed pressure-flow with suture tab attached. The Cleveland Multiport Ventricular Catheter was capable Aspirating at its clinically acceptable aspiration rate.
- Pressure Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Reflux Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Deployment and Retraction Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Test results met the specified dimensional and maximum distance insertion and removal forces.
- Tissue Insertion Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Testing passed insertion and removal for bovine tissue.
- Bend Radius Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Dimensional Verification: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Micro-Catheter Strength Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Testing passed demonstrating the micro-catheter material exceeds the minimum force requirements.
- Syringe Drop Test: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Surface Inspection: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Particulate Testing: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Leakage under pressure: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Cadaver Assessment: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Testing passed using conventional techniques and was visualized on axial CT scan with successful infusion of CT dye.
- Stylet Strength: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices. Cleveland Multiport Ventricular Catheter withstood the pull forces based on clinically relevant forces with a safety factor.
- Stylet Corrosion Resistance: Testing passed and results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices.
- Biocompatibility: All tissues contacting materials used in the Cleveland Multiport Ventricular Catheter set are biocompatible per ISO 10993- Biological evaluation of Medical Devices, Externally Communicating Device - Tissue contact, limited exposure duration A
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2017
Parker Hannifin Corporation % Lisa L. Michels, J.D. Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K161731
Trade/Device Name: Cleveland Multiport Ventricular Catheter Set Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: HCA Dated: February 13, 2017 Received: February 21, 2017
Dear Dr. Lisa Michels:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
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) K161731
Device Name
Cleveland Multiport Ventricular Catheter Set
Indications for Use (Describe)
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Parker Hannifin Corporation. Medical Systems Division
3007 Bunsen Avenue. Unit K Ventura CA 93003 Telephone, 805-658-2984 Facsimile: 805-658-6720
| Contact Person: | Lisa L. Michels, J.D., M.S.O.L.Q. |
|---|---|
| Official Correspondent for Parker Hannifin | |
| Regulatory Compliance Associates® Inc. | |
| 10411 Corporate Drive, Suite 102 | |
| Pleasant Prairie, Wisconsin 53158 | |
| Phone: (928)-660-8570 (office) / (520)-704-2700 (mobile) | |
| Email: I.michels@rcainc.com |
Date Prepared: 13-February-2017
| Trade Name: | Cleveland Multiport Ventricular Catheter Set (CMC) |
|---|---|
| Common Name: | Ventricular Catheter |
| Product Code: | HCA |
| Device Classification: | 21 CFR 882.4100 |
| Regulatory Class: | Class II |
Predicate Device: MRI SmartFlow Flex Ventricular Catheter #K123605.
Intended Use / Indications for Use
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
Rx or OTC Device
The Cleveland Multiport Ventricular Catheter Set is an Rx prescription device per 21 CFR Part 801, Subpart D.
Description of Device
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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510(k) Traditional Summary
Parker Hannifin Corporation Cleveland Multiport Ventricular Catheter Set (CMC)
The catheter is available in one size; Ø2.5mm OD x 14.0 cm long, with four micro catheters that deploy at the distal tip.
The Cleveland Multiport Ventricular Catheter Set is supplied sterile. The set includes the insertion stylet which facilitates placement of the catheter into the ventricles of the brain, a suture tab for anchoring the catheter and preventing movement during aspiration of fluids and four female-to-female Luer adapters for connecting each proximal end micro-catheter.
The Cleveland Multiport Ventricular Cather verification activities are included in this 510(k) submission.
Technological Characteristics
The Cleveland Multiport Ventricular Catheter has the same intended use/indications for use along with similar technological characteristics to predicate devices on the market with the same intended use. The following tables show the similarities and differences between the Cleveland Multiport Ventricular Catheter and the predicate devices.
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| Topic | Subject Device
Parker Cleveland
Multiport Ventricular
Catheter Set | Predicate Device
MRII SmartFlow Flex
Ventricular Catheter,
K123605 | Reference Device
Alcyone MEMS
Cannula System,
K150660 | Reference Device
SurgiVision
Ventricular Cannula,
K102101 | Discussion |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4100 | 21 CFR 882.4100 | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent to Predicate. |
| Product Code | HCA, Class II | HCA, Class II | HCD, Class I | HCD, Class I | Equivalent to Predicate. |
| Intended Use/
Indications for Use | The Cleveland Multiport
Ventricular Catheter
Set is indicated for
gaining access to the
ventricles of the brain
for the removal of
cerebrospinal fluid
(CSF) or for injecting
Cytarabine. | The SmartFlow™ Flex
Ventricular Catheter 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." | 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.
The device is intended
for "single patient use
only." | Equivalent to Predicate. |
| Single Patient Use
Only | Yes | Yes | Yes | Yes | Equivalent to Predicate. |
| Target Patient
Population | Patients needing
injection of Cytarabine
into the brain ventricles | Any Pt's needing
aspiration of CSF and
other fluids of similar
physical characteristics | Pt.s needing injection of
Cytarabine into the
brain ventricles or | Pt.s needing injection of
Cytarabine to the brain
ventricles or aspiration | Equivalent to Predicate. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland
Multiport Ventricular
Catheter Set | MRII SmartFlow Flex
Ventricular Catheter,
K123605 | Alcyone MEMS
Cannula System,
K150660 | SurgiVision
Ventricular Cannula,
K102101 | |
| | or removal of CSF from
the brain ventricles | from the brain
ventricles | aspiration of CSF from
the brain ventricles | of CSF from the brain
ventricles | |
| Anatomical Sites | Brain ventricle | Brain ventricle | Brain ventricle | Brain ventricle | Equivalent to Predicate. |
| Where used | MRI Suite / Surgical
Room (OR) | MRI Suite / Surgical
Room (OR) | MRI Diagnostic/
Surgical Room (OR) | MRI Diagnostic/
Surgical Room (OR) | Equivalent to Predicate. |
| Human Factors | a) Labeling includes
size and length | a) Labeling includes
size and length | a) Labeling includes
size and length | a) Labeling includes
size and length | Equivalent to Predicate. |
| | b) Labeling shows flow
vs. pressure tables | b) Labeling shows flow
vs. pressure tables | b) Labeling shows flow
vs. pressure tables | b) Labeling shows flow
vs. pressure tables | Equivalent to Predicate. |
| | c) Can be manipulated
with gloved hand | c) Can be manipulated
with gloved hand | c) Can be manipulated
with gloved hand | c) Can be manipulated
with gloved hand | Equivalent to Predicate. |
| Design | a) Designed to be
placed through a
prepared opening
through the skull and
dura into the brain
ventricle | a) Designed to be
placed through a
prepared opening
through the skull and
dura into the brain
ventricle | a) Designed to be
placed through a
prepared opening
through the skull and
dura into the brain
ventricle | a) Designed to be
placed through a
prepared opening
through the skull and
dura into the brain
ventricle | Equivalent to Predicate. |
| | b) Main catheter
section to enter the
brain. | b) Rigid and straight
section to enter the
brain. | b) Rigid and straight
section to enter the
brain. | b) Rigid and straight
section to enter the
brain. | Equivalent to Predicate. |
| | c) Opening at distal end
of micro-catheters for
fluid movement | c) Opening at distal end
for fluid movement | c) Opening at distal end
for fluid movement | c) Opening at distal end
for fluid movement | Equivalent to Predicate.
One hole per fluid channel. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland
Multiport Ventricular
Catheter Set | MRII SmartFlow Flex
Ventricular Catheter,
K123605 | Alcyone MEMS
Cannula System,
K150660 | SurgiVision
Ventricular Cannula,
K102101 | |
| | d) Four openings, no
side holes, at distal end
for fluid movement | d) Central hole, no side
holes, at distal end for
fluid movement | d) Two holes, no side
holes, at distal end for
fluid movement | d) Central hole, no side
holes, at distal end for
fluid movement | 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 and
catheters. |
| | e) Reference side
markings on body of
device for depth
indication | e) No markings of
device body | e) Body markings
designed to facilitate
determination of the
insertion depth | e) No markings of
device body | 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. |
| Design | f) Total Length of
Catheter; 5.5" (14.0 cm)
long | f) Total length of rigid
section; 10.5" (30 cm)
long | f) Total Length of
Catheter; 9" (22.9 cm)
long | f) Length of rigid
section; 10.5" (30 cm)
long | Equivalent to Predicate.
Total length of catheter
does not impact the
intended usage of the
device. |
| | g) Main catheter Inside
Diameter: Ø.030"
(Ø0.76 mm) ID and
micro-catheters at tip
Ø.007" (Ø0.177 mm) ID | g) Inside diameter:
Ø.008" to .021" (Ø 0.2
mm to 0.53 mm) | g) Main catheter Inside
Diameter: Ø.010"
(Ø0.25 mm) with inside
cross-section at tip:
.002" x .001" (0.052 x
0.03mm) | g) Inside diameter:
Ø.008" to .021" (Ø 0.2
mm to 0.53 mm) | Equivalent to Predicate.
All devices are moving
fluids and their different
inside/outside diameters
result in different flow
rates. This is within the
range of cleared
ventricular cannulas and
catheters. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland
Multiport Ventricular
Catheter Set | MRII SmartFlow Flex
Ventricular Catheter,
K123605 | Alcyone MEMS
Cannula System,
K150660 | SurgiVision
Ventricular Cannula,
K102101 | ventricular cannulas and
catheters. |
| | h) Outside Diameter
Ø2.5mm | h) Outside Diameter: Ø
0.65" (1.6 mm) and
Ø0.080" (2.0 mm) | h) Outside Diameter: Ø
0.65" (1.6 mm) | h) Outside Diameter: Ø
0.65" (1.6 mm) and
Ø0.080" (2.0 mm) | Equivalent to Predicate. |
| | j) Insertion Stylet -
Stylet can be removed
after insertion | j) Insertion Stylet | j) No Stylet -
Sufficiently rigid to pass
through brain tissue
without additional
support. Rigid section
can be removed after
insertion | j) No Stylet -
sufficiently rigid for
insertion | Equivalent to Predicate.
Insertion Stylet and rigid
sections are removed after
insertion. |
| | k) Standard Luer | k) Standard Luer | k) Standard Luer | k) Standard Luer | Equivalent to Predicate. |
| Performance | Flow Rate: 4.93 mL/hr.
(1.97 mL/hr. per
channel) at