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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.

Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.

However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Inferred)	Reported Device Performance
Flow Rate Testing (constant pressure)	Flow rates at 0.7 psi for the device to be greater than the predicate. (Predicate: .008" ID 0.6 mL/hr, .021" ID 34 mL/hr)	.008" ID Device 4.0 mL/hr.021" ID Device 56 mL/hr
High Pressure Flow Testing	Equivalent to or better than the predicate.	Equivalent to or better than the predicate.
Aspiration	Better than (higher aspiration rates achievable) the predicate.	Better than the predicate.
Leak/Burst Testing	Withstand 70 psi internal pressure without any leaks (same as predicate).	All samples withstood 70 psi internal pressure without any leaks. Equivalent to the predicate.
Distal Tip Compressive Strength	No damage to the tip (same as predicate's specification).	All samples met the requirement without damage to the tip. Equivalent to the predicate.
Distal Tip Lateral Load	Meet minimum force limit (same as predicate's specification).	All samples met the specification. Substantially equivalent to the predicate.
Ceramic Stylet Lateral Load	Device to meet specification (same as predicate's specification). (Note: Predicate has fixed, integrated rigid tube, not removable internal stylet).	Device met the specification.
Catheter Axial Tensile Load	Device to meet specification (same as predicate).	All devices met the specification. Equivalent to the predicate.
Catheter Insertion into Bone Anchor	Insert without difficulty.	The device was inserted into the Bone Anchor without difficulty.
Catheter Retention in Bone Anchor	Retained to the specified limit.	All samples were retained to the specification.
Stylet Removal from Bone Anchor	Meet specification of maximum pull force for Stylet removal.	The device met the specification of maximum pull force for Stylet removal.
Catheter Tissue Insertion	No tissue in or on the device, no plugging or damage (equivalent to predicate).	There was no tissue in or on the device after insertion and removal. Equivalent to the predicate device.
Backflow	No observed backflow (equivalent to predicate).	There was no observed backflow. Equivalent to predicate device.
Tip Deflection at Max Pressure	No movement of the tip at 70 psi internal pressure (equivalent to predicate).	There was no movement of the tip at applied internal pressure of 70 psi. Equivalent to the predicate device.
Tip Deflection at Max Aspiration	No movement of the tip at 2.0 psi vacuum (equivalent to predicate).	There was no movement of the tip at applied vacuum of 2.0 psi. Equivalent to the predicate device.
Bend Radius Withstand	No kinking or damage to the tubing at the specified bend radius (equivalent to predicate).	There was no kinking or damage to the tubing at the specified bend radius. Equivalent to the predicate device.
Syringe Dropping Test	No damage sustained by the device after the syringe was dropped with the device connected (equivalent to predicate).	There was no damage sustained by the device after the syringe was dropped with the device connected. Equivalent to the predicate device.
Tip Deflection after Stylet Removal	No tip movement upon Stylet removal.	There was no tip movement upon Stylet removal. Device met specification.
Bone Anchor Insertion Force	Insert fully with a downward force below the requirement.	All Bone Anchors were all inserted fully with a downward force below the requirement.
Bone Anchor Insertion Torque	Insert fully with a torque below the requirement.	All Bone Anchors were all inserted fully with a torque below the requirement.
Bone Anchor Side Load Force	Withstand minimum load with no damage or yielding.	All Bone Anchors all withstood the minimum load with no damage or yielding.
Bone Anchor Side Impact Force	Withstand minimum energy without damage or yielding.	All Bone Anchors withstood the minimum energy without damage or yielding.
Bone Anchor Retention Force	Remain in place under the applied tensile load.	All Bone Anchors remained in place under the applied tensile load.
Bone Anchor-Driver Detachment Force	Below the maximum limit for detachment force.	All pairs of Bone Anchors and Drivers were below the maximum limit for detachment force.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/software device. The device's "performance" is its physical function, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests is derived from:

Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
Comparative performance against the legally marketed predicate device.
Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).

8. The sample size for the training set

Not applicable. This is not an AI/software device and does not involve training data.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/software device.

Summary

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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 MusickIrvine, 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 CompatibleVentricular Catheter
Classification:	Class II
Regulation Number:	882.4100
Product Code:	HCA

3. Predicate Device:

MRII Ventricular Cannula, K102101

4. Intended Use Statement:

Description of Device: S.

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

	MRIIVentricular Catheter	Predicate Device:MRII VentricularCannula	Discussion
Classification	21 CFR 882.4100	21 CFR 882.4060	Equivalent
Product Code	HCA	HCD	Equivalent
PremarketNotification	TBD	K102101	Equivalent
Intended Use	The SmartFlow™ FlexVentricular Catheter is intended forinjection of Cytarabine or removalof CSF from the ventricles duringintracranial procedures. The deviceis not intended for implant. Thisdevice is intended for "singlepatient use only."	The MR Compatible VentricularCannula is intended forinjection of Cytarabine orremoval of CSF from theventricles during intracranialprocedures. The device is notintended for implant. Thedevice is intended for "singlepatient use only"	Equivalent
TargetPopulation	Any Pt's needing aspiration orinjection of fluids from the brainventricles	Any Pt's needing aspiration orinjection of fluids from thebrain 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 andlength	Equivalent
Human Factors	Can be manipulated with glovedhand	Can be manipulated with glovedhand	Equivalent
Design	Designed to be placed through aprepared opening through the skulland dura into the brain ventricle	Designed to be placed through aprepared opening through theskull and dura into the brainventricle	Equivalent
	Rigid and straight section to enterthe brain, rigid section can beremoved after insertion	Rigid and straight section toenter the brain	Equivalent, exceptthe rigid section canbe removed afterinsertion of thecatheter
	MRIIVentricular Catheter	Predicate Device:MRII VentricularCannula	Discussion
	Hole at distal end for fluidmovement	Hole at distal end for fluidmovement	Equivalent
	Length of rigid section:10.5" (30 cm)	Length of rigid section:10.5" (30 cm)	Equivalent
	Tip design identical to that of theVentricular Cannula	Tip design as described inK102101	Equivalent
	Sufficiently rigid to pass throughbrain tissue without additionalsupport	Sufficiently rigid to passthrough brain tissue withoutadditional support	Equivalent
	Contains a channel through whichfluids can be removed (aspiration)or placed (injection) into theventricleFlow rate of:	Contains a channel throughwhich fluids can be removed(aspiration) or placed (injection)into the ventricleFlow rate of:	Equivalent. Flowrates are higher for
	4.0 ml/hr (.008" I.D.) to56 ml/hr (.021" I.D.)at 0.7 PSI	0.6 ml/hr (.008" I.D.) to34 ml/hr (.021" I.D.)at 0.7 PSI	the catheter due to theshorter tubing length.
	Rigid body:Ceramic	Rigid body:Ceramic	Equivalent
	Through lumen PEEK	Through lumen:Polymer covered silica	Equivalent, both meetbiocompatibilityrequirements
	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 canbe connected to asyringe. Catheterrequires a usersupplied commoncomponent to makethe connection.
Biocompatibility	Tissue contact tested per ISO10993: Biological Evaluation ofMedical Devices	Tissue contact tested per ISO10993: Biological Evaluationof Medical Devices	Equivalent
Cytotoxicity	Acceptable	Acceptable	Equivalent
Systemic Toxicity,	Acceptable	Acceptable	Equivalent
SC & SO extractsPyrogen MaterialMediated	Acceptable	Acceptable	Equivalent
IntracutaneousStudy, SC & SOextracts	Acceptable	Acceptable	Equivalent
ISOMaximization SC& SO extracts	Acceptable	Acceptable	Equivalent
Sterility	Yes per ANSI/AAMI/ISO 11137-2: Sterilization of health careproducts -- Radiation	Yes per ANSI/AAMI/ISO11137-2: Sterilization of healthcare 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
CytotoxicityStudy, MEMElution	"The test article extract showed noevidence of causing cell lysis ortoxicity. The test article extractmet the requirements of the testsince the grade was less than agrade of 2 (mild reactivity)."	Non-cytotoxic
ISO SystemicToxicity, SCand SOExtracts	"There was no mortality orevidence of systemic toxicity fromthe extracts. The test articleextracts met the requirements of thestudy."	Non-toxic

MRII, Inc.

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Pyrogen Study- MaterialMediated	"The total rise of rabbittemperatures during the 3 hourobservation period was withinacceptable USP limits. The testarticle was judged asnonpyrogenic."	Non-pyrogenic
ISOIntracutaneousStudy, SC andSO Extracts	"The test article met therequirements of the test since thedifference between each test extractoverall mean score andcorresponding control overall meanscore was 0.0 and 0.2 (0.4 boneanchor) for the SC and SO testextracts, respectively."	No significant erythema oredema
ISOMaximizationSensitizationStudy, SC andSO Extracts	"The test article extracts showed noevidence of causing delayed dermalcontact sensitization in the guineapig. The test article was notconsidered a sensitizer in theguinea pig maximization test."	Non-sensitizer
Drug/DeviceCompatibilityTesting	HPLC using USP Monograph assayfor cytarabine concentration	No leaching of materials oruptake of cytarabine

. Performance Testing – Bench

Test	Methodology	Conclusions
Flow Rate Testing	Set flow rate on infusionpump to specification rate.Measure amount of fluidcollected over a set period oftime. Measure pressure forreference.	Specified flow rates of 0.5 mL/hr and 0.3mL/hr were achieved with the infusionpump.
Flow Rate Testing,constant pressure	Set flow rate on infusionpump so that measuredpressure is 0.7 psi. Measureamount of fluid collected overa set period of time.	Flow rates at 0.7 psi for the device weregreater 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 PressureFlow Testing	Use hand held syringe toapply very high pressure viahand force. Measure amountof fluid collected over a setperiod of time.	High pressure flow is equivalent to orbetter than the predicate. The maindifference comes from the shorter tubinglength of the device and differentapplied pressure since hand force wasused.
Aspiration	Use hand held syringe andapply vacuum to fixed amountof fluid. Record time toaspirate fluid.	Results were better than (higheraspiration rates achievable) thepredicate. The main difference comesfrom the shorter tubing length of thedevice.
Leak/Burst Testing	Block the cannula tip. Use ahand held syringe or manualpump to apply 70 psiminimum pressure to theCatheter. Watch for leaksanywhere along the length.	Results were equivalent to the predicatedevice. The 70 psi specification is thesame. All samples withstood 70 psiinternal pressure without any leaks.
Distal TipCompressiveStrength	Apply axial compressive loadto distal tip on 50A durometermaterial. Examine tip undermagnification to check fordamage.	Results were equivalent to thepredicate, which has the samespecification. All samples met therequirement without damage to the tip.
Distal Tip LateralLoad	Apply side load to distal tip'section to a minimum forcelimit.	Results were substantially equivalent tothe predicate, which had the samespecification. All samples met thespecification.
Ceramic StyletLateral Load	Hold Catheter with Styletapproximately 6 cm from thedistal end (5 cm from theapplied load). Apply lateralload and measure force tobreakage.	Device met the specification, which isthe same specification as the predicate.Predicate device has a fixed integratedrigid tube, not a removable internalstylet.
Catheter AxialTensile Load	Apply a tensile load to thecatheter. Pull to failure.Catheter is held at the outercapillary and at the PEEKtubing. Catheter was thenheld at the outer capillary andthe Pebax tubing.	Results were equivalent to thepredicate. The specification is the sameas the predicate. All devices met thespecification.
Catheter Insertioninto Bone Anchor	Insert the device into the boneanchor. Observe for anyinterference or difficulty.	The device was inserted into the BoneAnchor without difficulty.
Catheter Retentionin Bone Anchor	Apply pull force to thespecified limit to determine if	All samples were retained to thespecification
	the Catheter remains in placein the Bone Anchor
Stylet Removalfrom Bone Anchor	Once the catheter is tightenedin the Bone Anchor, measurethe pull force required toremove the Stylet from theCatheter.	The device met the specification ofmaximum pull force for Stylet removal.The predicate device has an integratedceramic tube and does not haveremovable Stylet.
Catheter TissueInsertion	Pass the device throughbovine brain tissue to a 4 inchdepth. Extract the device andcheck for plugging ordamage.	Equivalent to the predicate device.There was no tissue in or on the deviceafter insertion and removal.
Backflow	Insert the device into brain-simulating gel. Use aninfusion pump at a set flowrate to drive dyed fluidthrough the device. Examinethe gel for any dye that runsback up the sides of thedevice.	Equivalent to predicate device. Therewas no observed backflow.
Tip Deflection atMax Pressure	Plug a catheter tip. Mark theposition of the tip. Apply 70psi internal pressure to thecatheter. Mark the position ofthe tip with pressure applied.Determine the difference (ifany) between the marks.	Equivalent to the predicate device.There was no movement of the tip atapplied intemal pressure of 70 psi.
Tip Deflection atMax Aspiration	Plug a catheter tip. Mark theposition of the tip. Apply 2 psivacuum to the catheter. Markthe position of the tip withpressure applied. Determinethe difference (if any)between the marks.	Equivalent to the predicate device.There was no movement of the tip atapplied vacuum of 2.0 psi.
Bend RadiusWithstand	Wrap the device tubing for ½turn around a specifieddiameter rod. Examine thetubing for kinks or otherdamage.	Equivalent to the predicate device.There was no kinking or damage to thetubing at the specified bend radius.
Syringe DroppingTest	Connect the device to asyringe. Drop the syringe withthe device anchored in place.After the syringe drop, checkthe device for damage andoperation	Equivalent to the predicate device.There was no damage sustained by thedevice after the syringe was droppedwith 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 clearbeaker. Mark the spot on thebeaker where the tip touches.Lock the catheter in place.Remove the Stylet andobserve for tip deflectionaway from the mark.	removal. Device met specification.
Bone AnchorInsertion Force	Insert Bone Anchor into drilledhole and measure the amountof downward force requiredfrom beginning to end ofinsertion.	All Bone Anchors were all inserted fullywith a downward force below therequirement.
Bone AnchorInsertion Torque	Insert Bone Anchor into drilledhole and measure the amountof torque required frombeginning to end of insertion.	All Bone Anchors were all inserted fullywith a torque below the requirement.
Bone Anchor SideLoad Force	Insert a Bone Anchor into adrilled hole. Apply a side loadto the minimum specified levelto four points around the boneanchor diameter. Inspect fordamage or yielding.	All Bone Anchors all withstood theminimum load with no damage oryielding.
Bone Anchor SideImpact Force	Insert a Bone Anchor into adrilled hole. Apply a lateralimpact load on four differentpoints around the boneanchor diameter by droppinga known weight from aspecified height to obtain anapplied energy. Inspect fordamage or yielding.	All Bone Anchors withstood theminimum energy without damage oryielding.
Bone AnchorRetention Force	Insert a Bone Anchor into adrilled hole. Tighten acatheter into the Bone Anchorand apply a tensile load to thecatheter to the minimumspecified limit.	All Bone Anchors remained in placeunder the applied tensile load.
Bone Anchor-Driver DetachmentForce	Insert a Bone Anchor into adrilled hole using the Driver.Measure the tensile forcerequired to remove the Driverfrom the Bone Anchor.	All pairs of Bone Anchors and Driverswere below the maximum limit fordetachment force.

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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.

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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.

{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

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Indications for Use

510(k) Number: K123605

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

Indications For Use:

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

Page 1 of 1

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).