Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical catheter and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
Explanation: The device is intended for the injection of medication or removal of CSF, which are procedural functions rather than therapeutic ones directly treating a disease or condition. The medication itself would be therapeutic, but the device is merely a vehicle for its administration or removal of fluid.

Diagnostic

No
The device is described as being for injection of medication or removal of CSF from the ventricles, which are therapeutic or interventional actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with tubing and a stylet, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
Device Function: The SmartFlow™ Flex Ventricular Catheter is a device used within the body (intracranial) for the physical injection of substances or removal of fluids directly from the brain ventricles. It is a surgical/procedural device, not a diagnostic test performed on a sample.

The description clearly states its intended use is for "injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures," which are direct interventions within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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."

Product codes (comma separated list FDA assigned to the subject device)

HCA

Device Description

The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.

The Catheter will be marketed in the following sizes: Ventricular Catheter .008 x 7.5mm tip Ventricular Catheter .008 x 15mm tip Ventricular Cathcter .021 x 7.5mm tip Ventricular Catheter .021 x 15mm tip.

Each unit will provide for an approximate 23 inch tubing extension.

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

OR or MRI 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 testing including:

Sterilization and Shelf Life
Biocompatibility testing: Cytotoxicity, ISO Systemic Toxicity, Pyrogen Study, ISO Intracutaneous Study, ISO Maximization Sensitization Study, Drug/Device Compatibility Testing. All tests showed acceptable results (Non-cytotoxic, Non-toxic, Non-pyrogenic, No significant erythema or edema, Non-sensitizer, No leaching of materials or uptake of cytarabine respectively).
Performance Testing – Bench: Flow Rate Testing, Flow Rate Testing (constant pressure), High Pressure Flow Testing, Aspiration, Leak/Burst Testing, Distal Tip Compressive Strength, Distal Tip Lateral Load, Ceramic Stylet Lateral Load, Catheter Axial Tensile Load, Catheter Insertion into Bone Anchor, Catheter Retention in Bone Anchor, Stylet Removal from Bone Anchor, Catheter Tissue Insertion, Backflow, Tip Deflection at Max Pressure, Tip Deflection at Max Aspiration, Bend Radius Withstand, Syringe Dropping Test, Tip Deflection after Stylet Removal, Bone Anchor Insertion Force, Bone Anchor Insertion Torque, Bone Anchor Side Load Force, Bone Anchor Side Impact Force, Bone Anchor Retention Force, Bone Anchor-Driver Detachment Force.

Key Results: Bench testing included design verification testing and comparison testing with the predicate MRII Cannula, demonstrating the MR Compatible Ventricular Catheter functions as intended and is substantially equivalent to the legally marketed device. Flow rates for the device were greater than the predicate at 0.7 psi (4.0 mL/hr for .008" ID and 56 mL/hr for .021" ID vs 0.6 mL/hr and 34 mL/hr for predicate). High pressure flow and aspiration results were equivalent to or better than the predicate. All other performance tests showed equivalence to the predicate device and met specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MRII Ventricular Cannula, K102101

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII MR Compatible Ventricular Catheter.

1. Company Making the Submission:

Name of Owner:	MRII, Inc.
Address:	5 Musick
Irvine, CA 92618
Telephone:	949-900-6833
Fax:	949-900-6834
Contact:	Edward Waddell
E-mail:	ewaddell@mriinterventions.com

AUG 1 6 2013

2. Device Name:

Common Name:	Ventricular Catheter
Proprietary Name:	MR Compatible
Ventricular Catheter
Classification:	Class II
Regulation Number:	882.4100
Product Code:	HCA

3. Predicate Device:

MRII Ventricular Cannula, K102101

4. Intended Use Statement:

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."

Description of Device: S.

The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.

The Catheter will be marketed in the following sizes:

1

Ventricular Catheter .008 x 7.5mm tip Ventricular Catheter .008 x 15mm tip Ventricular Cathcter .021 x 7.5mm tip Ventricular Catheter .021 x 15mm tip

Each unit will provide for an approximate 23 inch tubing extension.

6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device

| | MRII
Ventricular Catheter | Predicate Device:
MRII Ventricular
Cannula | Discussion |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4100 | 21 CFR 882.4060 | Equivalent |
| Product Code | HCA | HCD | Equivalent |
| Premarket
Notification | TBD | K102101 | Equivalent |
| Intended Use | 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 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 |
| Target
Population | Any Pt's needing aspiration or
injection of fluids from the brain
ventricles | Any Pt's needing aspiration or
injection of fluids from the
brain ventricles | Equivalent |
| Anatomical Sites | Brain ventricle | Brain ventricle | Equivalent |
| Where Used | OR or MRI suite | OR or MRI Suite | Equivalent |
| Energy used | N/A | N/A | N/A |
| | Labeling indicates size and length | Labeling indicates size and
length | Equivalent |
| Human Factors | Can be manipulated with gloved
hand | Can be manipulated with gloved
hand | Equivalent |
| Design | Designed to be placed through a
prepared opening through the skull
and dura into the brain ventricle | Designed to be placed through a
prepared opening through the
skull and dura into the brain
ventricle | Equivalent |
| | Rigid and straight section to enter
the brain, rigid section can be
removed after insertion | Rigid and straight section to
enter the brain | Equivalent, except
the rigid section can
be removed after
insertion of the
catheter |
| | MRII
Ventricular Catheter | Predicate Device:
MRII Ventricular
Cannula | Discussion |
| | Hole at distal end for fluid
movement | Hole at distal end for fluid
movement | Equivalent |
| | Length of rigid section:
10.5" (30 cm) | Length of rigid section:
10.5" (30 cm) | Equivalent |
| | Tip design identical to that of the
Ventricular Cannula | Tip design as described in
K102101 | Equivalent |
| | Sufficiently rigid to pass through
brain tissue without additional
support | Sufficiently rigid to pass
through brain tissue without
additional support | Equivalent |
| | Contains a channel through which
fluids can be removed (aspiration)
or placed (injection) into the
ventricle
Flow rate of: | Contains a channel through
which fluids can be removed
(aspiration) or placed (injection)
into the ventricle
Flow rate of: | Equivalent. Flow
rates are higher for |
| | 4.0 ml/hr (.008" I.D.) to
56 ml/hr (.021" I.D.)
at 0.7 PSI | 0.6 ml/hr (.008" I.D.) to
34 ml/hr (.021" I.D.)
at 0.7 PSI | the catheter due to the
shorter tubing length. |
| | Rigid body:
Ceramic | Rigid body:
Ceramic | Equivalent |
| | Through lumen PEEK | Through lumen:
Polymer covered silica | Equivalent, both meet
biocompatibility
requirements |
| | MRI Safe | MRI Safe | Equivalent |
| Materials | Proximal Connector:
Female Luer adapter connector,
external to kit as described in IFU | Proximal Connector:
Female Luer connector | Equivalent, both can
be connected to a
syringe. Catheter
requires a user
supplied common
component to make
the connection. |
| Biocompatibility | Tissue contact tested per ISO
10993: Biological Evaluation of
Medical Devices | Tissue contact tested per ISO
10993: Biological Evaluation
of Medical Devices | Equivalent |
| Cytotoxicity | Acceptable | Acceptable | Equivalent |
| Systemic Toxicity, | Acceptable | Acceptable | Equivalent |
| SC & SO extracts
Pyrogen Material
Mediated | Acceptable | Acceptable | Equivalent |
| Intracutaneous
Study, SC & SO
extracts | Acceptable | Acceptable | Equivalent |
| ISO
Maximization SC
& SO extracts | Acceptable | Acceptable | Equivalent |
| Sterility | Yes per ANSI/AAMI/ISO 11137-
2: Sterilization of health care
products -- Radiation | Yes per ANSI/AAMI/ISO
11137-2: Sterilization of health
care products -- Radiation | Equivalent |
| Electrical Safety | N/A | N/A | Equivalent |

2

510(k) (Traditional) Submission

3

7. Summary of difference from the predicate

The MRII ventricular catheter differs from that of the cannula in four principal ways.

a) The fluid delivery tubing is composed of PEEK rather than the silica of the predicate
b) The fluid delivery tubing is shorter (23 inch nominal) versus 4 and 10 feet of the predicate.
c) The MRII ventricular cannula provides for a bone anchor, for subsequent infusions over a period of 24 hours.
d) The rigid component of the catheter can be removed after insertion so that the catheter is flexible along its whole length. The cannula's rigid section is integrated into the assembly.

8. Testing:

Testing to applicable standards has been completed with acceptable outcomes. The following testing has been performed:

. Sterilization and Shelf Life
Biocompatibility: Both the ventricular catheter and the bone anchor were . tested under conditions of Good Laboratory Practices in the following tests with acceptable results.

Study	Result	Conclusion
Cytotoxicity
Study, MEM
Elution	"The test article extract showed no
evidence of causing cell lysis or
toxicity. The test article extract
met the requirements of the test
since the grade was less than a
grade of 2 (mild reactivity)."	Non-cytotoxic
ISO Systemic
Toxicity, SC
and SO
Extracts	"There was no mortality or
evidence of systemic toxicity from
the extracts. The test article
extracts met the requirements of the
study."	Non-toxic

MRII, Inc.

4

| Pyrogen Study

Material
Mediated | "The total rise of rabbit
temperatures during the 3 hour
observation period was within
acceptable USP limits. The test
article was judged as
nonpyrogenic." | Non-pyrogenic |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| ISO
Intracutaneous
Study, SC and
SO Extracts | "The test article met the
requirements of the test since the
difference between each test extract
overall mean score and
corresponding control overall mean
score was 0.0 and 0.2 (0.4 bone
anchor) for the SC and SO test
extracts, respectively." | No significant erythema or
edema |
| ISO
Maximization
Sensitization
Study, SC and
SO Extracts | "The test article extracts showed no
evidence of causing delayed dermal
contact sensitization in the guinea
pig. The test article was not
considered a sensitizer in the
guinea pig maximization test." | Non-sensitizer |
| Drug/Device
Compatibility
Testing | HPLC using USP Monograph assay
for cytarabine concentration | No leaching of materials or
uptake of cytarabine |

. Performance Testing – Bench

Test	Methodology	Conclusions
Flow Rate Testing	Set flow rate on infusion
pump to specification rate.
Measure amount of fluid
collected over a set period of
time. Measure pressure for
reference.	Specified flow rates of 0.5 mL/hr and 0.3
mL/hr were achieved with the infusion
pump.
Flow Rate Testing,
constant pressure	Set flow rate on infusion
pump so that measured
pressure is 0.7 psi. Measure
amount of fluid collected over
a set period of time.	Flow rates at 0.7 psi for the device were
greater than the predicate as expected.
.008" ID Predicate 0.6 mL/hr
.008" ID Device 4.0 mL/hr
.021" ID Predicate 34 mL/hr
.021" ID Device 56 mL/hr

High Pressure
Flow Testing	Use hand held syringe to
apply very high pressure via
hand force. Measure amount
of fluid collected over a set
period of time.	High pressure flow is equivalent to or
better than the predicate. The main
difference comes from the shorter tubing
length of the device and different
applied pressure since hand force was
used.
Aspiration	Use hand held syringe and
apply vacuum to fixed amount
of fluid. Record time to
aspirate fluid.	Results were better than (higher
aspiration rates achievable) the
predicate. The main difference comes
from the shorter tubing length of the
device.
Leak/Burst Testing	Block the cannula tip. Use a
hand held syringe or manual
pump to apply 70 psi
minimum pressure to the
Catheter. Watch for leaks
anywhere along the length.	Results were equivalent to the predicate
device. The 70 psi specification is the
same. All samples withstood 70 psi
internal pressure without any leaks.
Distal Tip
Compressive
Strength	Apply axial compressive load
to distal tip on 50A durometer
material. Examine tip under
magnification to check for
damage.	Results were equivalent to the
predicate, which has the same
specification. All samples met the
requirement without damage to the tip.
Distal Tip Lateral
Load	Apply side load to distal tip
'section to a minimum force
limit.	Results were substantially equivalent to
the predicate, which had the same
specification. All samples met the
specification.
Ceramic Stylet
Lateral Load	Hold Catheter with Stylet
approximately 6 cm from the
distal end (5 cm from the
applied load). Apply lateral
load and measure force to
breakage.	Device met the specification, which is
the same specification as the predicate.
Predicate device has a fixed integrated
rigid tube, not a removable internal
stylet.
Catheter Axial
Tensile Load	Apply a tensile load to the
catheter. Pull to failure.
Catheter is held at the outer
capillary and at the PEEK
tubing. Catheter was then
held at the outer capillary and
the Pebax tubing.	Results were equivalent to the
predicate. The specification is the same
as the predicate. All devices met the
specification.
Catheter Insertion
into Bone Anchor	Insert the device into the bone
anchor. Observe for any
interference or difficulty.	The device was inserted into the Bone
Anchor without difficulty.
Catheter Retention
in Bone Anchor	Apply pull force to the
specified limit to determine if	All samples were retained to the
specification
	the Catheter remains in place
in the Bone Anchor
Stylet Removal
from Bone Anchor	Once the catheter is tightened
in the Bone Anchor, measure
the pull force required to
remove the Stylet from the
Catheter.	The device met the specification of
maximum pull force for Stylet removal.

The predicate device has an integrated
ceramic tube and does not have
removable Stylet. |
| Catheter Tissue
Insertion | Pass the device through
bovine brain tissue to a 4 inch
depth. Extract the device and
check for plugging or
damage. | Equivalent to the predicate device.
There was no tissue in or on the device
after insertion and removal. |
| Backflow | Insert the device into brain-
simulating gel. Use an
infusion pump at a set flow
rate to drive dyed fluid
through the device. Examine
the gel for any dye that runs
back up the sides of the
device. | Equivalent to predicate device. There
was no observed backflow. |
| Tip Deflection at
Max Pressure | Plug a catheter tip. Mark the
position of the tip. Apply 70
psi internal pressure to the
catheter. Mark the position of
the tip with pressure applied.
Determine the difference (if
any) between the marks. | Equivalent to the predicate device.
There was no movement of the tip at
applied intemal pressure of 70 psi. |
| Tip Deflection at
Max Aspiration | Plug a catheter tip. Mark the
position of the tip. Apply 2 psi
vacuum to the catheter. Mark
the position of the tip with
pressure applied. Determine
the difference (if any)
between the marks. | Equivalent to the predicate device.
There was no movement of the tip at
applied vacuum of 2.0 psi. |
| Bend Radius
Withstand | Wrap the device tubing for ½
turn around a specified
diameter rod. Examine the
tubing for kinks or other
damage. | Equivalent to the predicate device.
There was no kinking or damage to the
tubing at the specified bend radius. |
| Syringe Dropping
Test | Connect the device to a
syringe. Drop the syringe with
the device anchored in place.
After the syringe drop, check
the device for damage and
operation | Equivalent to the predicate device.
There was no damage sustained by the
device after the syringe was dropped
with the device connected. |
| Tip Deflection after | Insert Catheter with Stylet into | There was no tip movement upon Stylet |
| Stylet Removal | brain simulating gel in a clear
beaker. Mark the spot on the
beaker where the tip touches.
Lock the catheter in place.
Remove the Stylet and
observe for tip deflection
away from the mark. | removal. Device met specification. |
| Bone Anchor
Insertion Force | Insert Bone Anchor into drilled
hole and measure the amount
of downward force required
from beginning to end of
insertion. | All Bone Anchors were all inserted fully
with a downward force below the
requirement. |
| Bone Anchor
Insertion Torque | Insert Bone Anchor into drilled
hole and measure the amount
of torque required from
beginning to end of insertion. | All Bone Anchors were all inserted fully
with a torque below the requirement. |
| Bone Anchor Side
Load Force | Insert a Bone Anchor into a
drilled hole. Apply a side load
to the minimum specified level
to four points around the bone
anchor diameter. Inspect for
damage or yielding. | All Bone Anchors all withstood the
minimum load with no damage or
yielding. |
| Bone Anchor Side
Impact Force | Insert a Bone Anchor into a
drilled hole. Apply a lateral
impact load on four different
points around the bone
anchor diameter by dropping
a known weight from a
specified height to obtain an
applied energy. Inspect for
damage or yielding. | All Bone Anchors withstood the
minimum energy without damage or
yielding. |
| Bone Anchor
Retention Force | Insert a Bone Anchor into a
drilled hole. Tighten a
catheter into the Bone Anchor
and apply a tensile load to the
catheter to the minimum
specified limit. | All Bone Anchors remained in place
under the applied tensile load. |
| Bone Anchor-
Driver Detachment
Force | Insert a Bone Anchor into a
drilled hole using the Driver.
Measure the tensile force
required to remove the Driver
from the Bone Anchor. | All pairs of Bone Anchors and Drivers
were below the maximum limit for
detachment force. |

5

510(k) (Traditional) Submission

6

510(k) (Traditional) Submission

.

·

7

8

Bench testing included design verification testiny and comparison testing with the predicate MRII Cannula, demonstrating the MR Compatible Ventricular Catheter functions as intended and is substantially equivalent to the legally marketed device.

9. Rx or OTC:

The MR Compatible Ventricular Catheter is an Rx prescription device per 21 CFR Part 801, Subpart D.

10. Substantial Equivalence:

The MR Compatible Ventricular Catheter is as safe and effective as the predicate MRII Cannula. The MR Compatible Ventricular Catheter has the same intended uses and identical indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MR Compatible Ventricular Catheter and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MR Compatible Ventricular Catheter is as safe and offective as the MRI Cannula. Thus the MR Compatible Ventricular Catheter is substantially equivalent.

MRII, Inc.
C. Wartell

E. F. Waddell Director of Regulatory Affairs Date

MRII, Inc.

9

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a globe, conveying the department's mission of protecting the health of all Americans.

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

August 16, 2013

MRI Intervention Inc. Edward Waddell 5 Musick Irvine, CA 92618

Re: K123605

Trade/Device Name: SmartFlow Flex Ventricular Catheter Regulation Number: 21 CFR 882.4100 Regulation Name: Catheter, Ventricular Regulatory Class: Class II Product Code: HCA Dated: July 16, 2013 Received: July 17, 2013

Dear Mr. Waddell:

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 vour 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 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.

10

Page 2 - Mr. Waddell

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

Indications for Use

510(k) Number: K123605

Device Name: MRI Intervention, Inc. SmartFlow™ Flex Ventricular Catheter

Indications For Use:

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."

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123605

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