SMARTFLOW CATHETER

K123605 · Mri Interventions, Inc. · HCA · Aug 16, 2013 · Neurology

Device Facts

• Record ID: K123605
• Device Name: SMARTFLOW CATHETER
• Applicant: Mri Interventions, Inc.
• Product Code: HCA · Neurology
• Decision Date: Aug 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4100
• Device Class: Class 2
• Attributes: Therapeutic

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."

Device Story

SmartFlow Flex Ventricular Catheter is a sterile, single-use device for intracranial fluid management; used in OR or MRI suite by clinicians. Device features a stepped distal tip with a removable 30 cm rigid ceramic stylet to provide insertion rigidity; central fluid lumen is PEEK tubing. After insertion into brain ventricle, stylet is removed, leaving a flexible catheter. Device connects to external syringes or infusion pumps via female Luer adapter for CSF removal or Cytarabine injection. Shorter tubing length compared to predicate allows higher flow rates. Bench testing confirms biocompatibility, leak/burst resistance at 70 psi, and structural integrity during insertion/aspiration. Benefits include MRI compatibility and flexibility post-insertion for patient safety during intracranial procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility (cytotoxicity, systemic toxicity, pyrogenicity, sensitization, intracutaneous reactivity), drug/device compatibility (HPLC assay for Cytarabine), and mechanical performance testing (flow rate, leak/burst at 70 psi, tensile strength, insertion force, tip deflection, and stylet removal force).

Technological Characteristics

Materials: PEEK (lumen), ceramic (stylet). Dimensions: 23-inch tubing extension; .008" or .021" ID. Principle: Manual aspiration/injection via Luer connection. Energy: None. Connectivity: None. Sterilization: Radiation (ANSI/AAMI/ISO 11137-2). Form factor: Stepped distal tip with removable rigid stylet.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• MRII Ventricular Cannula (K102101)

Submission Summary (Full Text)

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### 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<br>Irvine, CA 92618 |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | [e-mail] |

## AUG 1 6 2013

#### 2. Device Name:

| Common Name: | Ventricular Catheter |
|--------------------|---------------------------------------|
| Proprietary Name: | MR Compatible<br>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:

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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<br>Ventricular Catheter | Predicate Device:<br>MRII Ventricular<br>Cannula | Discussion |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4100 | 21 CFR 882.4060 | Equivalent |
| Product Code | HCA | HCD | Equivalent |
| Premarket<br>Notification | TBD | K102101 | Equivalent |
| Intended Use | The SmartFlow™ Flex<br>Ventricular Catheter is intended for<br>injection of Cytarabine or removal<br>of CSF from the ventricles during<br>intracranial procedures. The device<br>is not intended for implant. This<br>device is intended for "single<br>patient use only." | The MR Compatible Ventricular<br>Cannula is intended for<br>injection of Cytarabine or<br>removal of CSF from the<br>ventricles during intracranial<br>procedures. The device is not<br>intended for implant. The<br>device is intended for "single<br>patient use only" | Equivalent |
| Target<br>Population | Any Pt's needing aspiration or<br>injection of fluids from the brain<br>ventricles | Any Pt's needing aspiration or<br>injection of fluids from the<br>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<br>length | Equivalent |
| Human Factors | Can be manipulated with gloved<br>hand | Can be manipulated with gloved<br>hand | Equivalent |
| Design | Designed to be placed through a<br>prepared opening through the skull<br>and dura into the brain ventricle | Designed to be placed through a<br>prepared opening through the<br>skull and dura into the brain<br>ventricle | Equivalent |
| | Rigid and straight section to enter<br>the brain, rigid section can be<br>removed after insertion | Rigid and straight section to<br>enter the brain | Equivalent, except<br>the rigid section can<br>be removed after<br>insertion of the<br>catheter |
| | MRII<br>Ventricular Catheter | Predicate Device:<br>MRII Ventricular<br>Cannula | Discussion |
| | Hole at distal end for fluid<br>movement | Hole at distal end for fluid<br>movement | Equivalent |
| | Length of rigid section:<br>10.5" (30 cm) | Length of rigid section:<br>10.5" (30 cm) | Equivalent |
| | Tip design identical to that of the<br>Ventricular Cannula | Tip design as described in<br>K102101 | Equivalent |
| | Sufficiently rigid to pass through<br>brain tissue without additional<br>support | Sufficiently rigid to pass<br>through brain tissue without<br>additional support | Equivalent |
| | Contains a channel through which<br>fluids can be removed (aspiration)<br>or placed (injection) into the<br>ventricle<br>Flow rate of: | Contains a channel through<br>which fluids can be removed<br>(aspiration) or placed (injection)<br>into the ventricle<br>Flow rate of: | Equivalent. Flow<br>rates are higher for |
| | 4.0 ml/hr (.008" I.D.) to<br>56 ml/hr (.021" I.D.)<br>at 0.7 PSI | 0.6 ml/hr (.008" I.D.) to<br>34 ml/hr (.021" I.D.)<br>at 0.7 PSI | the catheter due to the<br>shorter tubing length. |
| | Rigid body:<br>Ceramic | Rigid body:<br>Ceramic | Equivalent |
| | Through lumen PEEK | Through lumen:<br>Polymer covered silica | Equivalent, both meet<br>biocompatibility<br>requirements |
| | MRI Safe | MRI Safe | Equivalent |
| Materials | Proximal Connector:<br>Female Luer adapter connector,<br>external to kit as described in IFU | Proximal Connector:<br>Female Luer connector | Equivalent, both can<br>be connected to a<br>syringe. Catheter<br>requires a user<br>supplied common<br>component to make<br>the connection. |
| Biocompatibility | Tissue contact tested per ISO<br>10993: Biological Evaluation of<br>Medical Devices | Tissue contact tested per ISO<br>10993: Biological Evaluation<br>of Medical Devices | Equivalent |
| Cytotoxicity | Acceptable | Acceptable | Equivalent |
| Systemic Toxicity, | Acceptable | Acceptable | Equivalent |
| SC & SO extracts<br>Pyrogen Material<br>Mediated | Acceptable | Acceptable | Equivalent |
| Intracutaneous<br>Study, SC & SO<br>extracts | Acceptable | Acceptable | Equivalent |
| ISO<br>Maximization SC<br>& SO extracts | Acceptable | Acceptable | Equivalent |
| Sterility | Yes per ANSI/AAMI/ISO 11137-<br>2: Sterilization of health care<br>products -- Radiation | Yes per ANSI/AAMI/ISO<br>11137-2: Sterilization of health<br>care products -- Radiation | Equivalent |
| Electrical Safety | N/A | N/A | Equivalent |

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## 510(k) (Traditional) Submission

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

#### MRII, Inc.

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

#### . Performance Testing – Bench

| Test | Methodology | Conclusions |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate Testing | Set flow rate on infusion<br>pump to specification rate.<br>Measure amount of fluid<br>collected over a set period of<br>time. Measure pressure for<br>reference. | Specified flow rates of 0.5 mL/hr and 0.3<br>mL/hr were achieved with the infusion<br>pump. |
| Flow Rate Testing,<br>constant pressure | Set flow rate on infusion<br>pump so that measured<br>pressure is 0.7 psi. Measure<br>amount of fluid collected over<br>a set period of time. | Flow rates at 0.7 psi for the device were<br>greater than the predicate as expected.<br>.008" ID Predicate 0.6 mL/hr<br>.008" ID Device 4.0 mL/hr<br>.021" ID Predicate 34 mL/hr<br>.021" ID Device 56 mL/hr |
| | | |
| High Pressure<br>Flow Testing | Use hand held syringe to<br>apply very high pressure via<br>hand force. Measure amount<br>of fluid collected over a set<br>period of time. | High pressure flow is equivalent to or<br>better than the predicate. The main<br>difference comes from the shorter tubing<br>length of the device and different<br>applied pressure since hand force was<br>used. |
| Aspiration | Use hand held syringe and<br>apply vacuum to fixed amount<br>of fluid. Record time to<br>aspirate fluid. | Results were better than (higher<br>aspiration rates achievable) the<br>predicate. The main difference comes<br>from the shorter tubing length of the<br>device. |
| Leak/Burst Testing | Block the cannula tip. Use a<br>hand held syringe or manual<br>pump to apply 70 psi<br>minimum pressure to the<br>Catheter. Watch for leaks<br>anywhere along the length. | Results were equivalent to the predicate<br>device. The 70 psi specification is the<br>same. All samples withstood 70 psi<br>internal pressure without any leaks. |
| Distal Tip<br>Compressive<br>Strength | Apply axial compressive load<br>to distal tip on 50A durometer<br>material. Examine tip under<br>magnification to check for<br>damage. | Results were equivalent to the<br>predicate, which has the same<br>specification. All samples met the<br>requirement without damage to the tip. |
| Distal Tip Lateral<br>Load | Apply side load to distal tip<br>'section to a minimum force<br>limit. | Results were substantially equivalent to<br>the predicate, which had the same<br>specification. All samples met the<br>specification. |
| Ceramic Stylet<br>Lateral Load | Hold Catheter with Stylet<br>approximately 6 cm from the<br>distal end (5 cm from the<br>applied load). Apply lateral<br>load and measure force to<br>breakage. | Device met the specification, which is<br>the same specification as the predicate.<br>Predicate device has a fixed integrated<br>rigid tube, not a removable internal<br>stylet. |
| Catheter Axial<br>Tensile Load | Apply a tensile load to the<br>catheter. Pull to failure.<br>Catheter is held at the outer<br>capillary and at the PEEK<br>tubing. Catheter was then<br>held at the outer capillary and<br>the Pebax tubing. | Results were equivalent to the<br>predicate. The specification is the same<br>as the predicate. All devices met the<br>specification. |
| Catheter Insertion<br>into Bone Anchor | Insert the device into the bone<br>anchor. Observe for any<br>interference or difficulty. | The device was inserted into the Bone<br>Anchor without difficulty. |
| Catheter Retention<br>in Bone Anchor | Apply pull force to the<br>specified limit to determine if | All samples were retained to the<br>specification |
| | the Catheter remains in place<br>in the Bone Anchor | |
| Stylet Removal<br>from Bone Anchor | Once the catheter is tightened<br>in the Bone Anchor, measure<br>the pull force required to<br>remove the Stylet from the<br>Catheter. | The device met the specification of<br>maximum pull force for Stylet removal.<br><br>The predicate device has an integrated<br>ceramic tube and does not have<br>removable Stylet. |
| Catheter Tissue<br>Insertion | Pass the device through<br>bovine brain tissue to a 4 inch<br>depth. Extract the device and<br>check for plugging or<br>damage. | Equivalent to the predicate device.<br>There was no tissue in or on the device<br>after insertion and removal. |
| Backflow | Insert the device into brain-<br>simulating gel. Use an<br>infusion pump at a set flow<br>rate to drive dyed fluid<br>through the device. Examine<br>the gel for any dye that runs<br>back up the sides of the<br>device. | Equivalent to predicate device. There<br>was no observed backflow. |
| Tip Deflection at<br>Max Pressure | Plug a catheter tip. Mark the<br>position of the tip. Apply 70<br>psi internal pressure to the<br>catheter. Mark the position of<br>the tip with pressure applied.<br>Determine the difference (if<br>any) between the marks. | Equivalent to the predicate device.<br>There was no movement of the tip at<br>applied intemal pressure of 70 psi. |
| Tip Deflection at<br>Max Aspiration | Plug a catheter tip. Mark the<br>position of the tip. Apply 2 psi<br>vacuum to the catheter. Mark<br>the position of the tip with<br>pressure applied. Determine<br>the difference (if any)<br>between the marks. | Equivalent to the predicate device.<br>There was no movement of the tip at<br>applied vacuum of 2.0 psi. |
| Bend Radius<br>Withstand | Wrap the device tubing for ½<br>turn around a specified<br>diameter rod. Examine the<br>tubing for kinks or other<br>damage. | Equivalent to the predicate device.<br>There was no kinking or damage to the<br>tubing at the specified bend radius. |
| Syringe Dropping<br>Test | Connect the device to a<br>syringe. Drop the syringe with<br>the device anchored in place.<br>After the syringe drop, check<br>the device for damage and<br>operation | Equivalent to the predicate device.<br>There was no damage sustained by the<br>device after the syringe was dropped<br>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<br>beaker. Mark the spot on the<br>beaker where the tip touches.<br>Lock the catheter in place.<br>Remove the Stylet and<br>observe for tip deflection<br>away from the mark. | removal. Device met specification. |
| Bone Anchor<br>Insertion Force | Insert Bone Anchor into drilled<br>hole and measure the amount<br>of downward force required<br>from beginning to end of<br>insertion. | All Bone Anchors were all inserted fully<br>with a downward force below the<br>requirement. |
| Bone Anchor<br>Insertion Torque | Insert Bone Anchor into drilled<br>hole and measure the amount<br>of torque required from<br>beginning to end of insertion. | All Bone Anchors were all inserted fully<br>with a torque below the requirement. |
| Bone Anchor Side<br>Load Force | Insert a Bone Anchor into a<br>drilled hole. Apply a side load<br>to the minimum specified level<br>to four points around the bone<br>anchor diameter. Inspect for<br>damage or yielding. | All Bone Anchors all withstood the<br>minimum load with no damage or<br>yielding. |
| Bone Anchor Side<br>Impact Force | Insert a Bone Anchor into a<br>drilled hole. Apply a lateral<br>impact load on four different<br>points around the bone<br>anchor diameter by dropping<br>a known weight from a<br>specified height to obtain an<br>applied energy. Inspect for<br>damage or yielding. | All Bone Anchors withstood the<br>minimum energy without damage or<br>yielding. |
| Bone Anchor<br>Retention Force | Insert a Bone Anchor into a<br>drilled hole. Tighten a<br>catheter into the Bone Anchor<br>and apply a tensile load to the<br>catheter to the minimum<br>specified limit. | All Bone Anchors remained in place<br>under the applied tensile load. |
| Bone Anchor-<br>Driver Detachment<br>Force | Insert a Bone Anchor into a<br>drilled hole using the Driver.<br>Measure the tensile force<br>required to remove the Driver<br>from the Bone Anchor. | All pairs of Bone Anchors and Drivers<br>were below the maximum limit for<br>detachment force. |

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# 510(k) (Traditional) Submission

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## 510(k) (Traditional) Submission

.

.

·

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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.

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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.

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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 [phone] or [phone] or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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

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## 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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