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."

Device Description

The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: 16 ga Ventricular Cannula, .008" ID x 4ft; 16 ga Ventricular Cannula. .008" ID x 10ft; 14 ga Ventricular Cannula, .021" ID x 4ft; 14 ga Ventricular Cannula, .021" ID x 10ft.

AI/ML Overview

The provided text describes the SurgiVision MR Compatible Ventricular Cannula and its substantial equivalence to a predicate device (Adson Cannula), but it does not contain information about the acceptance criteria or a study designed to prove the device meets those criteria in the context of typical AI/ML device evaluations. This document describes a traditional medical device submission (a cannula), not a diagnostic AI/ML device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance are not present because they are not applicable to this type of device submission.

However, I can extract the information relevant to the device's technical validation and comparison to the predicate device.

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

The document doesn't explicitly state "acceptance criteria" for performance metrics like those seen in AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, it describes performance and material characteristics that are either equivalent to the predicate or designed for specific needs (like MR compatibility). The "reported device performance" is essentially that it functions as intended and is safe and effective.

Characteristic Category	Acceptance Criteria (Implied)	Reported Device Performance	Discussion/Evidence (from the document)
Intended Use	Equivalent to predicate (injection/aspiration of fluids in ventricles).	Injection of Cytarabine or removal of CSF from ventricles.	Equivalent to predicate, validated using Cytarabine and primate CSF.
MR Compatibility	Safe in 1.5T MRI environment.	Safe in 1.5T MRI environment. Device is MR Compatible/MR Safe.	Designed for MR environment; not restricted to non-MRI environment. Predicate is not indicated for MR environments.
Material/Rigidity	Sufficiently rigid to pass through brain tissue.	Sufficiently rigid to pass through brain tissue.	Uses ceramic (VC) vs stainless steel (predicate); both rigid.
Fluid Movement	Contains a channel for fluid removal/placement.	Contains a channel for fluid removal/placement.	Equivalent to predicate.
Flow Rate	Capability to move fluids (differs due to diameter)	Flow rate of 0.3 ml/hr (0.008" I.D.) to 25.0 ml/hr (0.021" I.D.) at 0.7 PSI.	Both devices moving fluids; different flow rates result from different diameters. VC provides flow vs. pressure tables (additional information).
Biocompatibility	Meet ISO 10993 for tissue contact.	Tissue contact tested per ISO 10993: Biological Evaluation of Medical Devices with acceptable results.	Equivalent to predicate (presumed).
Sterility	Sterilized.	Yes, per ANSI/AAMI/ISO 11137-2.	Supplied sterile. Predicate is provided non-sterile and sterilized on-site, but both achieve sterility.
Mechanical Safety	Safe for intended use.	Performance Testing Bench, including design verification testing, comparison testing with the predicate Adson Cannula, pressure withstand testing and injection/aspiration testing, lateral tip deflection testing, transit testing in conformance to D4169 and accelerated aging testing. acceptable results.	Equivalent to predicate.

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

This information is not provided in the document. The testing described is bench testing, not a clinical study on human subjects where patient data provenance would be relevant.

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 medical device, not an AI/ML diagnostic algorithm requiring expert-established ground truth from images or data.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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 a medical device, not an AI/ML diagnostic algorithm.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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

For this type of device, "ground truth" is established through engineering and materials testing, demonstrating that the device physically performs as intended and meets safety standards. For example:

Biocompatibility: In vitro and in vivo (animal) studies to confirm material safety, assessed against ISO 10993 standards.
Performance (flow rates, rigidity): Bench testing using simulated conditions and fluids (e.g., Cytarabine, primate CSF).
MR Compatibility: Physical testing of the device in an MRI environment to confirm safety (e.g., no excessive heating, no significant image artifact).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:

The document describes several types of testing performed to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device:

Sterilization and Shelf Life Testing: Validation using the VDmax25 procedure of ISO 11137-2 to ensure the device remains sterile and functional over its shelf life.
Biocompatibility Testing: Conducted per ISO 10993 (Biological Evaluation of Medical Devices), including cytotoxicity, material mediated pyrogen, ISO maximization study, intracutaneous toxicity, and systemic toxicity. All tests yielded acceptable results.
Performance Testing Bench:
- Design verification testing.
- Comparison testing with the predicate Adson Cannula.
- Pressure withstand testing.
- Injection/aspiration testing.
- Lateral tip deflection testing.
- Transit testing in conformance to D4169.
- Accelerated aging testing.
Cytarabine Injection and Primate CSF Aspiration Testing: Completed with acceptable results, validating the device's intended use with specific fluids.
MR Compatibility Testing: The device is stated to be "Safe in a 1.5T MRI environment" and "MRI Safe. All brain contacting components tested safe in a 1.5T environment."

The conclusion from these tests was that the "MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device." The differences in design (e.g., single-patient use, MR compatibility, different materials, longer rigid section, no stylet, integral extension) are noted to "meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the 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 SurgiVision MR Compatible Ventricular Cannula.

1. Company Making the Submission:

JAN 2 6 2011

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

Device Name: 2.

Common Name:	Ventricular Cannula
Proprietary Name:	MR CompatibleVentricular Cannula
Classification:	Class I
Regulation Number:	882.4060
Product Code:	HCD

Predicate Device: 3.

Adson Cannula (9Fr x 14 cm; stainless steel) (class I, 510(k)-exempt)

Description of Device: 4.

The cannula will be marketed in the following sizes:

16 ga Ventricular Cannula, .008" ID x 4ft
16 ga Ventricular Cannula. .008" ID x 10ft
14 ga Ventricular Cannula, .021" ID x 4ft

14 ga Ventricular Cannula, .021" ID x 10ft

Surgi Vision, Inc.

Section 5 510(k) Submission Page #

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5. Intended Use Statement:

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

	SurgiVisionVentricular Cannula(VC)	Predicate Device:Adson VentricularCannula	Discussion
Classification	21 CFR 882.4060	21 CFR 882.4060	Equivalent
Product Code	HCD	HCD	Equivalent
Intended Use	Injection of Cytarabine to theventricles of the brain or aspirationof CSF from the ventricles of thebrain	Injection or aspiration of fluidin the ventricles of the brain	Equivalent
Indications forUse	Gains access to the brain ventricles	Gains access to the brainventricles	Equivalent
	Allows Injection of Cytarabine intothe brain ventricles	Allows injection of fluids intothe brain ventricles	VC validated usingCytarabine
	Allows aspiration of CSF from thebrain ventricles	Allows aspiration of fluids fromthe brain ventricles	VC validated usingprimate CSF
	Not implantable	Not implantable	Equivalent
	Single Patient Use	Reusable	VC is validated forsingle patient use.Component materialsdo not lend tomultiple use and re-sterilization
TargetPopulation	Pt.s needing injection ofCytarabine to the brain ventriclesor aspiration of CSF from the brainventricles	Pt.s needing aspiration orinjection of fluids from thebrain ventricles	VC validated usingCytarabine andprimate CSF
Anatomical Sites	Brain ventricle	Brain ventricle	Equivalent
	Operating Room	Operating Room	Equivalent
Where Used	MRI Diagnostic / Surgical Room	N/A	VC device is MRCompatible/ MRSafe, whereas thepredicate device isnot indicated for MRenvironments
Energy used	N/A	N/A	Equivalent
Human Factors	Labeling indicates size and length	Labeling indicates size andlength	Equivalent
	Labeling contains flow vs. pressuretables	No information provided	VC providesadditionalinformation to the
	SurgiVisionVentricular Cannula(VC)	Predicate Device:Adson VentricularCannula	Discussion
			physician regardingflow and pressuresfor the various sizes
	Can be manipulated with glovedhand	Can be manipulated with glovedhand	Equivalent
	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 section to enter the brain	Rigid section to enter the brain	Equivalent
Design	Straight section to enter the brain	Straight section to enter thebrain	Equivalent
	Hole at distal end for fluidmovement	Hole at distal end for fluidmovement	Equivalent
	No side holes	Three .055" (1.4 mm) sideholes located 11 mm to 21 mmfrom the distal end	The VC can onlytransfer fluids fromthe distal end
	No marking on body of device	CM markings on body	VC Device length isprovided with theinstructions
	Length of rigid section:10.5" (30 cm)	Length of rigid section:5.5" (14 cm)	The VC has a longerlength to facilitatehandling of thedevice when thepatient is within thebore of an MRscanner
	Inside diameter:.008" (0.2 mm) to.021" (0.53 mm)	Inside diameter:.079" (2.0 mm)	Both devices aremoving fluids andtheir different inside /outside diametersresult in differentflow rates.
	Outside diameter:.065" (1.6 mm)and .080" (2.0 mm)	Outside diameter:.120" (3.0 mm)
	No Stylet	Stylet	VC has steppedfeatures fordimensionaltransitions at the tipand the predicatedevice uses a stylet tocreate the transitions
	SurgiVisionVentricular Cannula(VC)	Predicate Device:Adson VentricularCannula	Discussion
			VC does not have astylet that would haveto be removed priorto assisted injectionor aspirationVC allows immediateun-assisted aspirationof CSF from ventricle(with visualization byphysician) duringplacement
	Lumen extension (3 foot) allowsremote (end of scanner bore)injection/aspiration	No Proximal Extension present	VC has anincorporatedproximal lumenextension, thisprovides a singlelumen extending fromthe rigid cannula tothe proximalconnector
	Lumen extension (9 foot) allowsremote (outside of scanner 5 gaussline) Injection/aspiration using anon-MRI safe pump	No Proximal Extension Present	VC has anincorporatedproximal lumenextension; thisprovides a singlelumen extending fromthe rigid cannula tothe proximalconnector. Thisextension provides acontinuous lumen thatis MR compatible andcan connect to aremote, not MR safepump forinjection/aspiration.
Performance	Sufficiently rigid to pass throughbrain tissue without additionalsupport	Sufficiently rigid to passthrough brain tissue withoutadditional support	Equivalent
Performance	Contains a channel through whichfluids can be removed (aspiration)or placed (injection) into theventricle	Contains a channel throughwhich fluids can be removed(aspiration) or placed (injection)into the ventricle	Equivalent
	Flow rate of:0.3 ml/hr (.008" I.D.) to25.0 ml/hr (.021" I.D.)at 0.7 PSI	Flow rate of 16,000 ml/hrat 0.7 PSI	Both devices aremoving fluids and thedifferent flow ratesresult only from theirdifferent diameters
Materials	Rigid body:Ceramic	Rigid body:Stainless Steel or Sterling Silver	Both devices userigid material for thebody, VC provides a
	SurgiVisionVentricular Cannula(VC)	Predicate Device:Adson VentricularCannula	Discussion
			rigid body that is MRCompatible due toceramic material
	Stylet: N/A	Stylet:Stainless Steel or Sterling Silver	VC has features thatprovide rigidity andtip transition whichare accomplished bythe stylet
	Through lumen:Polymer covered silica	Through lumen:Stainless Steel or Sterling Silver	Both devices have acontinuous throughlumen but the VC isMR compatible
	Lumen extension (outer supporttubing): PVC extrusion	No lumen extension.	VC is provided withlumen extension
	Proximal Connector:Female Luer connector	Proximal Connector:Female Luer connector	Equivalent
Biocompatibility	Tissue contact tested per ISO10993: Biological Evaluation ofMedical Devices	Presumed	Equivalent
Compatibilitywith environmentand other devices	Safe in a 1.5T MRI environment	Not safe in a 1.5T MRIenvironment	VC device isdesigned for MRenvironment
	Female Luer connector onproximal end fits all male luerconnectors (e.g. syringe tips)	Female Luer connector onproximal end fits all male luerslip connectors (e.g. syringetips)	Equivalent
Sterility	Yes per ANSI/AAMI/ISO 11137-2: Sterilization of health careproducts -- Radiation	Provided non-sterile andsterilized on-site	Equivalent
Electrical Safety	N/A	N/A	Equivalent
Mechanical safety	N/A	N/A	Equivalent
Chemical Safety	Silica lumen non-reactive	Stainless steel	Equivalent
Thermal Safety	MRI Safe. All brain contactingcomponents tested safe in a 1.5Tenvironment	Not MRI safe	VC use is notrestricted to non-MRIenvironment
Radiation safety	N/A	N/A	Equivalent

SurgiVision, Inc.

Section 5 510(k) Submission Page #

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K102101

510(k) (Traditional) Submission Section 5, 510(k) Summary

SurgiVision, Inc.

Section 5 510(k) Submission Page #

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K102101

510(k) (Traditional) Submission

SurgiVision, Inc.

Section 5 510(k) Submission Page #

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长10210 |

510(k) (Traditional) Submission Section 5, 510(k) Summary

Summarizing the differences noted above:

The SurgiVision MR Compatible Ventricular Cannula (VC) is single patient use and is . not re-sterilizable.
The VC is provided sterilized and pyrogen free in Tyvek packaging. .
The VC is MR safe and can be used within an MR environment. ●
The VC Is MN sale and can oe association to the physician regarding flow rates ● as a function of pressure. The predicate provides no such information.
The VC has no side holes in the lumen .
The VC has no depth marking on the barrel as the physician will be adjusting location . with direct visualization under MR using a stereotactic frame
While and the rigid section of the VC is longer than the predicate for ease of . handling within the MR bore.

SurgiVision, Inc.

Section 5 510(k) Submission Page #

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K102101

. The VC does not require a stylet for entry to the ventricles that requires removal prior to injection or aspiration.
The VC has an integral extension for injection or aspiration external to the bore. .
t The VC and predicate flow rates differ because of the different lumen sizes and extension.

These recognized differences between the VC and the predicate are intended to meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the device.

7. Testing:

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

Sterilization and Shelf Life, including sterilization validation using the . VDmax25 procedure of ISO 11137-2.
Biocompatibility Testing including cytotoxicity, material mediated . pyrogen, ISO maximization study, intracutaneous toxicity and systemic toxicity with acceptable results.
Performance Testing Bench, including design verification testing, . comparison testing with the predicate Adson Cannula, pressure withstand testing and injection/aspiration testing, lateral tip deflection testing, transit testing in conformance to D4169 and accelerated aging testing.
Cytarabine injection testing and aspiration of primate CSF was completed . with acceptable results..

These tests demonstrated that the MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device.

Rx or OTC: 8.

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

9. Substantial Equivalence:

The MR Compatible Ventricular Cannula has the same indications for use as the The Mice device, Adson Cannula. While there are technological differences between predical cornect, Notentricular Cannula and the Adson Cannula, such as the device matcrial, construction and dimensions, these differences do not raise new types of material, consultion and entions when all listed warnings and cautions are followed. The MR Compatible Ventricular Cannula is substantially equivalent to the marketed Adson Cannula.

SurgiVision, Inc.

Date: 1/22/21

Edward Waddell, Director of Regulatory Affairs

Surgi Vision, Inc.

Section 5 510(k) Submission Page #

006

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.

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

SurgiVision, Inc. c/o Mr. Edward Waddell Director, Regulatory Surgi Vision, Inc. 5 Musick Irvine, CA 92618

JAN 26 2011

Re: K102101

Trade/Device Name: SurgiVision MR Compatible Ventricular Cannula Regulation Number: 21 CFR 882.4060 Regulation Name: Ventricular cannula Regulatory Class: Class I Product Code: HCD Dated: January 17, 2011 Received: January 18, 2011

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 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.

. .

and the contraction of the comments of the comments of the comments of

. . . . . . . .

. . . . .

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Page 2 - Mr. Edward Waddell

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

. . . . . . . .

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

KI02101 510(k) Number (if known):

Device Name: SurgiVision, Inc. MR Compatible Ventricular Cannula Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Peterson

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102101

Page __ of _

Regulation Number and Section

§ 882.4060 Ventricular cannula.

(a)
Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.