The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).

AI/ML Overview

The provided document is a 510(k) Summary for the NICO Brain Port device, which is a medical device for neurosurgery. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing.

However, this document does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because such clinical study information is not present in the provided text.

The closest information related to testing and validation is found under the "Summary of Non-Clinical Testing/Statement of Equivalence" section:

Summary of Non-Clinical Testing (as described in the document):

The document states that "Multiple tests concerning product functionality, biocompatibility, packaging and sterilization have been performed to ensure that the Brain Port device is as safe and as effective as the predicate device."

Specific tests included:

Radiation sterilization validation on sterile components.
Cleaning method and sterilization validation of reusable components.
Packaging drop testing.
Simulated shipping, aging, and environmental stress testing.
In Vitro Cytotoxicity testing.
Irritation and Delayed-Type Hypersensitivity biocompatibility testing.
General functional, mechanical, dimensional, and performance testing against pre-determined specifications.
Simulated use testing consisting of inserting the Brain Port into a medium representative of brain tissue.

Ground Truth Used: The ground truth for this non-clinical testing would be the pre-determined specifications for the device's functionality, mechanical properties, dimensions, and performance, as well as established standards for biocompatibility, sterility, and packaging integrity. For simulated use, the "medium representative of brain tissue" served as the test environment.

Sample Sizes: The document does not specify sample sizes for any of these non-clinical tests.

Data Provenance: This is non-clinical, in-vitro, and simulated data, not human patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.

Expert Involvement: The document does not mention the number or qualifications of experts used to establish ground truth or conduct these non-clinical tests, beyond the general statement of "pre-determined specifications."

Adjudication Method: Not applicable to the described non-clinical testing.

MRMC Comparative Effectiveness Study: Not performed or mentioned in the document.

Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is inherent to its design and how it is used by a human surgeon.

Training Set: Not applicable to a physical medical device. The "training" for such a device comes from engineering design, material science, and prior knowledge of similar predicate devices.

In summary, the provided text details a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, rather than a clinical study with acceptance criteria for device performance in human subjects.

Summary

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K120691

JUN - 5 2012

510(k) Summary per 807.92(a)(1)

Date Prepared: January 24, 2012

Submitter's Information

Owner/Operator: NICO Corporation 9190 Priority Way West Dr. Suite 203 Indianapolis, IN 46240 Phone: 317-660-7118 Fax: 317-682-0305

Submission Contact Information

Name:	Jack Slovick
Title:	Quality and Regulatory
Phone:	(763) 639-0238
Email:	jack_slovick@yahoo.com

Proposed Device

Device Proprietary Name: Common Name:

Classification name: Class: Product Code:

Brain Port Self-retaining retractor for neurosurgery, Brain Retractor, Retractor Self-retaining retractor for neurosurgery Class II /21CFR 882.4800 GZT, HRX

Indications for Use

To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

Description of Device

The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths- see Table 1 below. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.

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Image /page/1/Picture/0 description: The image shows the logo for NICO Neuro and Spine. The word "NICO" is in large, bold, sans-serif font. Below the word "NICO" is the phrase "NEURO AND SPINE" in a smaller, sans-serif font. The logo is black and white.

The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).

Brain Port Component	Provided Sterile or Non-Sterile	Single Use or Reusable
Sheath (all sizes)	Sterile	Single Use
Obturators (all sizes)	Non-sterile	Reusable
Manipulation Tool	Non-sterile	Reusable
Sterilization Tray	Non-sterile	Reusable

Table 1: NICO Brain Port Sterile and Reusable Components

Product Materials

o Obturator: Anodized Aluminum
- Obturators available in three sizes which correspond to each sheath D
Thumb Screw: 316 Stainless Steel (part of obturator) o
Pin: 316 Stainless Steel (part of obturator) o
Sheath: Cyclic Olefin Copolymer o
- 1 Available sheath diameter is 13.5 mm (inner diameter).
- . Available sheath lengths are 50 mm, 60 mm, and 75 mm.
Medical Grade Ink (part of sheath) o
Manipulator: 316 Stainless Steel o
Reusable Tray: 304 Stainless Steel, Silicone o

Predicate Device

Vycor ViewSite™ Access System by Vycor Medical, LLC. (K060973)

Summary of Technical Characteristics

The Brain Port Device was compared to the predicate device in areas of components, packaging and compatibility with third party instruments, material, design, and size range. The Brain Port device is considered to be sustainably equivalent to the predicate device. Per 21 CFR Part 807.92(a)(5), the following shows where the Brain Port device is similar and different in terms of technological characteristics.

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Feature/	NICO Brain Port	Vycor ViewSite	Comparison
Characteristic		Surgical AccessSystem
510(k) #	TBD	K060973
Intended Use/Indications	To provide for accessand allow forvisualization of thesurgical field duringbrain and spinal	To provide for accessand allow forvisualization of thesurgical field duringbrain and spinal	Identical
	surgery.	surgery.
Principles ofUse	Device consists of anobturator componentand a sheath (or"sleeve") component.These two componentsare assembled (thesheath is slid over theobturator) and theninserted into andthrough intracranialneurological tissue(brain). The obturatoris then removed whilethe sheath is left inplace, providing accessor as is often referred toas a "portal" to thedesired site for surgicalpurposes	Device consists of anobturator componentand a sheath (or"sleeve") component.These two componentsare assembled (thesheath is slid over theobturator) and theninserted into andthrough intracranialneurological tissue(brain). The obturatoris then removed whilethe sheath is left inplace, providing accessor as is often referred toas a "portal" to thedesired site for surgical	Identical
FundamentalTechnology	"Sheath-like"componenttransparent/translucentfor visualization ofsurrounding tissue	purposes"Sheath-like"componenttransparent/translucentfor visualization ofsurrounding tissue	ldentical
Configuration /SystemComponents.	Two components: onereusable obturator andone sterile, disposablesheath. Sterilizationtray offered for onsitesterilization of reusableobturator.	Two components(obturator and sheath),both disposable andpackaged sterile.	Different: NICOprovides one singleuse sterile component(sheath) and onereusable non-sterilecomponent(obturator). Both ofthe predicatecomponents areprovided sterile forsingle use.Sterility validation forreusable component(including tray)demonstrates safety(TPR-3551; seeAppendix B).
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
Shippingconfiguration	Obturator and sheathpackaged and shippedseparately and pairedduring surgical case.	Obturator and Sheathare paired and shippedtogether within thesame packaging.	Simulated UseTesting of reusablecomponentdemonstrates efficacy(TPR-3549; seeAppendix B).Different: Brain Portsheath is sterilesingle use and isstocked within theOR. Brain PortObturator must besterilized onsite priorto each case and ispaired with sheath inOR immediately priorto case. Predicatecomponents arepaired prior topackaging by themanufacturer and arestored in the OR inthis configuration.Instructions for Use(LL-5918; seeAppendix E) coversafety and efficacy.Instruct user toconfirm that obturatorand sheath are pairedaccurately (i.e. 50mm sheath used witha 50 mm obturator).Packaging Validationfor reusables coveredby TPR-3552, BrainPort Packaging andShelf Life Validation.
Reusable orSingle PatientUse	Single Patient Use andReusable	Single Patient Use Only	Different: Brain Portcontains reusableobturator andmanipulation tool andsingle use sheath; thepredicatecomponents aresingle use only.
Method ofSterilization	Gamma for disposablecomponent (sheath)	Gamma	Different: Both theBrain Port andpredicate sheath are
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
	Autoclave/ hydrogenperoxide gas plasma forreusable components		sterilized via gammairradiation. However,the Brain Port Sheathis sterilized viaautoclave orhydrogen peroxidegas plasma while thepredicate sheath issterilized via gammairradiation.See TPR-3551 forevidence that thedifference in sterilitymethod for theobturator does notaffect safety orefficacy.
Biocompatible	ExternallyCommunicating Devicein Direct Contact withTissue/Bone/Dentin,Limited Duration	ExtemallyCommunicating Devicein Direct Contact withTissue/Bone/Dentin,Limited Duration	Identical
Device design	Consists of an"obturator-like"component and a"sheath-like"component which areassembled, insertedinto tissue, anddisassembled toprovide access.	Consists of an"obturator-like"component and a"sheath-like"component which areassembled, insertedinto tissue, anddisassembled toprovide access.	Identical
Obturator andSheathmaterials	Obturator is aluminum(reusable). Sheath(disposable) is CyclicOlefin Copolymer(COC).	Sheath and obturatorare both polycarbonate(disposable).	Different: Brain Portobturator and sheathmaterials arealuminum and COC,respectively.Predicate obturatorand sheath are bothpolycarbonate.BiocompatibilityTesting to coversafety for thisdifference (TPR-3553; see AppendixB).Simulated UseTesting to coverefficacy for thisdifference (TPR-
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
CrossSectionalanalysis ofObturator/Sheath	Obturator/Sheathcombination has acircular cross section.	Obturator/Sheathcombination has anovular cross section.	3549; see AppendixB).Different: Brain Portsheath/obturator havea circular crosssection whilepredicate has anovular cross section.Simulated UseTesting to prove thata circular crosssection safely andeffectively displaces(retracts) brain tissue(TPR-3549; seeAppendix B).
Depthmarkings	Incremental depthmarkings on bothsheath and obturator.	No depth markings.	Different: Brain Porthas incrementaldepth markings whilepredicate has nomarkings.BiocompatibilityTesting to addresssafety of markings(TPR-3553; seeAppendix B). Noimpact on efficacy.Depth markings arefor reference only anddo not impactfunctionality ofdevice.
Sheathdiameterdimensions	Available sheathdiameter is $13.5$ mm(inner diameter).Maximum tissuedisplacement as aresult of diameter ofsheath $15.8$ mm (outerdiameter).$*13.5$ mm dimensionreflects inner diameterof sheath. Outerdiameter, which iscorrelated with tissuedisplacement, is 15.8mm. Device size isdesignated by inner	Range of availablesheath diameters is $12$mm to $28$ mm.Maximum tissuedisplacement as aresult of diameter ofsheath is approximately$28$ mm.$All$ dimensions listedabove reflect innerdiameter of sheath andare slightly smaller thanthe outer diameter,which is most relevantfor tissue displacement.Device size is	Different: Brain Portonly available in onediameter (13.5 mm)while predicate isavailable in a range ofdiameters (12mm –28mm).Safety is addressedby the fact that thediameter of largestavailable version ofpredicate sheathexceeds the largestversion of the BrainPort sheath.Therefore, the
NEURO AND SPINE
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
	diameter because thisreflects the size of theopening through whichthe physician hasaccess during surgery.	designated by innerdiameter because thisreflects the size of theopening through whichthe physician hasaccess during surgery.	predicate will displacemore tissue than theBrain Port.Efficacy relative todiameter addressedby Simulated UseTesting (TPR-3549;see Appendix B).
Sheath lengths	Available sheathlengths are 5 cm, 6cm, and 7.5 cm.The sheath length iscalled out on thelabeling and is mostrelevant to the end userfrom a clinicalperspective. Thisdimension representsthe length of the portthrough which surgerywill occur. Theobturator is longer thanthe sheath byapproximately 1.0 cm.	Available sheathlengths are 3 cm, 5cm, and 7 cm.The sheath length iscalled out on thelabeling and is mostrelevant to the end userfrom a clinicalperspective. Thisdimension representsthe length of the portthrough which surgerywill occur. Theobturator is longer thanthe sheath byapproximately 0.75 cm.	Different: Brain Portavailable in lengths of5 cm, 6 cm and 7.5cm while predicate isavailable in lengths of3 cm, 5 cm, and 7cm.Additional length ofproposed device doesnot cause new issuesof safety relative topredicate. Theplacement of both thepredicate and theproposed device isentirely dependentupon the location ofdiseased tissue, notthe length of thedevices.Efficacy relative tolength addressed bySimulated UseTesting (TPR-3549;see Appendix B).
ManipulationTool	"Manipulation Tool"offered for manipulatingthe position of thesheath. Reusabledevice that will besterilized onsite withinthe tray.	No "Manipulation Tool"offered.	Different: Brain PortSystem includesmanipulation toolwhile predicate doesnot.The ManipulationTool is a class Idevice (product codeGEN) which isexempt frompremarket notificationrequirements.Although the same"manipulation tool"
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
			can be used with theVycor sheath, it wouldbe difficult since theVycor sheath doesnot have a ring at thetop with suture holes.The tip of themanipulation tool issized so that it will fitinto these sutureholes to makepositioningadjustments easier.Simulated Use testingto prove that tool iseffective and does notaffect efficacy ofBrain Port.
Handheldmanualoperation andplacement	Yes	Yes	Identical
Proximal Endof Sheath	Knurled ring on sheathincludes holes forsecuring to surroundingtissue via sutures afterinsertion.	Sheath does notinclude knurled ring ormechanism for securingplacement afterinsertion.	Different: Brain Portincludes knurled ringwith holes for easierhandling andsecurement tosurrounding tissue (ifdesired). Predicatedoes not includeknurled ring or sutureholes.Simulated UseTesting to provepresence of knurledring and suture holesdo not affect theability of the BrainPort to effectively beinserted into andretract tissue. (TPR-3549; see AppendixB).
Shape of distalend ofobturator	Distal end of obturatorhas a conical shapewith a rounded tip at itsend and no opening.	Distal end of obturatorhas a rounded shapewith an opening at itsend.	Different: Brain Portobturator has a distalend which is conicalin shape with arounded tip and noopening. Predicateobturator has a distal
Feature/Characteristic	NICO Brain Port	Vycor ViewSiteSurgical AccessSystem	Comparison
			end which is roundedin shape and has anopening.
			The obturators forboth the predicateand the proposeddevice displace braintissue duringinsertion. The conicalshape of theproposed deviceenables predictableand gradual serialdilation of brain tissueduring its insertion.
			Simulated UseTesting to coverefficacy (TPR-3549;see Appendix B).
3rd partyinstrumentation	Obturator componentinterfaces with thirdparty instruments.	Obturator componentnot designed tointerface with third partyinstruments.	Different: Brain Portobturator iscompatible with 3rdparty instrumentswhile predicate is not.Obturator includes acavity for receivingthird partyinstruments (ifdesired) and setscrew for securingthose instruments.These design aspects(cavity and set screw)do not affect theability of the end userto safely achieve theindications for use.Simulated UseTesting to cover

Table 2: Brain Port and Vycor (predicate) Comparison

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NEURO AND SPINE

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)

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Image /page/6/Picture/0 description: The image shows the logo for NICO Neuro and Spine. The word "NICO" is in large, bold, sans-serif font. Below the word "NICO" is the phrase "NEURO AND SPINE" in a smaller, sans-serif font.

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NIC NEURO AND SPINE

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Image /page/9/Picture/0 description: The image shows the logo for NICO Neuro and Spine. The word "NICO" is in large, bold, sans-serif font. Below the word "NICO" is the phrase "NEURO AND SPINE" in a smaller, sans-serif font. The logo is black and white.

Summary of Non-Clinical Testing/Statement of Equivalence

Multiple tests conceming product functionality, biocompatibility, packaging and sterilization have been performed to ensure that the Brain Port device is as safe and as effective as the predicate device. Specific testing included radiation sterilization validation on sterile components supplied, a cleaning method and sterilization validation of re-usable components supplied, packaging drop testing, simulated shipping, aging and environmental stress testing, In Vitro Cytotoxicity testing, Irritation and Delayed-Type Hypersensitivity biocompatibility testing, general functional, mechanical, dimensional and performance testing against pre-determined specifications and finally simulated use testing consisting of inserting the Brain Port into a medium representative of brain tissue.

The Brain Port system is very similar to the predicate device as both are considered "self-retaining retractors for neurosurgery" with identical indications for use. The Brain Port has very similar technological characteristics as both have the same general shape, size and identical principles of use. Both devices consist of an obturator type component that is paired with a sheath or sleeve and then inserted into the neurological tissue. The obturator component is then removed leaving the sheath in place which provides access to targeted tissues for surgery. Also, both are handheld manually placed devices and both have a means of securing the sheath and obturator so that they remain assembled during insertion. The minor technological differences such as shape, size, and compatibility with third party instruments have been evaluated through multiple verification and validation activities as well as critical analyses. Results of these evaluations demonstrate that these differences do not affect the ability of the Brain Port to achieve the indications for use. Concerning sterilization, the sheaths for both the Brain Port and the predicate are gamma-irradiated single use devices. Finally, both have identical patient contact per ISO 10993-1.

Conclusion

In conclusion, the data and information provided in this submission demonstrate that the Brain Port device is substantially equivalent to the predicate.

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Public Health Service

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

NICO Corporation c/o Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K120691

Trade/Device Name: Brain Port Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT, HRX Dated: March 4, 2012 Received: March 7, 2012

Dear Mr. Devine:

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.

5 2012

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Page 2 - Mr. Ned Devine

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.

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/ReportalProblem/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,

Kesia Alexander

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Malvina B. Evdelman, 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

510(k) Number (if known): __ K120691

Brain Port Device Name:_

Indications For Use: To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

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)

Quỳnh Hoang

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

Page 1 of 1

510(k) Number K120691

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).