Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, not data processing or algorithmic functions. There is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as providing access and visualization for surgery, and manipulating tissues, which are surgical tools, not therapeutic actions.

Diagnostic

No

The device is described as providing access and visualization for surgical procedures, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details multiple physical components including obturators, sheaths, a manipulation tool, and a sterilization tray, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "To provide for access and allow for visualization of the surgical field during brain and spinal surgery." This describes a surgical tool used during a procedure to facilitate access and visualization, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
Device Description: The description details a system of physical components (obturators, sheaths, manipulation tool, sterilization tray) used for creating and maintaining a surgical pathway. This aligns with a surgical access device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.

In summary, the NICO Brain Port is a surgical access device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GZT, HRX

Device Description

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.
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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

brain and spinal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

Not Found

Predicate Device(s)

K060973

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/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.

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
Characteristic		Surgical Access
System
510(k) #	TBD	K060973
Intended Use/
Indications	To provide for access
and allow for
visualization of the
surgical field during
brain and spinal	To provide for access
and allow for
visualization of the
surgical field during
brain and spinal	Identical
	surgery.	surgery.
Principles of
Use	Device consists of an
obturator component
and a sheath (or
"sleeve") component.
These two components
are assembled (the
sheath is slid over the
obturator) and then
inserted into and
through intracranial
neurological tissue
(brain). The obturator
is then removed while
the sheath is left in
place, providing access
or as is often referred to
as a "portal" to the
desired site for surgical
purposes	Device consists of an
obturator component
and a sheath (or
"sleeve") component.
These two components
are assembled (the
sheath is slid over the
obturator) and then
inserted into and
through intracranial
neurological tissue
(brain). The obturator
is then removed while
the sheath is left in
place, providing access
or as is often referred to
as a "portal" to the
desired site for surgical	Identical
Fundamental
Technology	"Sheath-like"
component
transparent/translucent
for visualization of
surrounding tissue	purposes
"Sheath-like"
component
transparent/translucent
for visualization of
surrounding tissue	ldentical
Configuration /
System
Components.	Two components: one
reusable obturator and
one sterile, disposable
sheath. Sterilization
tray offered for onsite
sterilization of reusable
obturator.	Two components
(obturator and sheath),
both disposable and
packaged sterile.	Different: NICO
provides one single
use sterile component
(sheath) and one
reusable non-sterile
component
(obturator). Both of
the predicate
components are
provided sterile for
single use.
Sterility validation for
reusable component
(including tray)
demonstrates safety
(TPR-3551; see
Appendix B).
Feature/
Characteristic	NICO Brain Port	Vycor ViewSite
Surgical Access
System	Comparison
Shipping
configuration	Obturator and sheath
packaged and shipped
separately and paired
during surgical case.	Obturator and Sheath
are paired and shipped
together within the
same packaging.	Simulated Use
Testing of reusable
component
demonstrates efficacy
(TPR-3549; see
Appendix B).
Different: Brain Port
sheath is sterile
single use and is
stocked within the
OR. Brain Port
Obturator must be
sterilized onsite prior
to each case and is
paired with sheath in
OR immediately prior
to case. Predicate
components are
paired prior to
packaging by the
manufacturer and are
stored in the OR in
this configuration.
Instructions for Use
(LL-5918; see
Appendix E) cover
safety and efficacy.
Instruct user to
confirm that obturator
and sheath are paired
accurately (i.e. 50
mm sheath used with
a 50 mm obturator).
Packaging Validation
for reusables covered
by TPR-3552, Brain
Port Packaging and
Shelf Life Validation.
Reusable or
Single Patient
Use	Single Patient Use and
Reusable	Single Patient Use Only	Different: Brain Port
contains reusable
obturator and
manipulation tool and
single use sheath; the
predicate
components are
single use only.
Method of
Sterilization	Gamma for disposable
component (sheath)	Gamma	Different: Both the
Brain Port and
predicate sheath are
Feature/
Characteristic	NICO Brain Port	Vycor ViewSite
Surgical Access
System	Comparison
	Autoclave/ hydrogen
peroxide gas plasma for
reusable components		sterilized via gamma
irradiation. However,
the Brain Port Sheath
is sterilized via
autoclave or
hydrogen peroxide
gas plasma while the
predicate sheath is
sterilized via gamma
irradiation.

See TPR-3551 for
evidence that the
difference in sterility
method for the
obturator does not
affect safety or
efficacy. |
| Biocompatible | Externally
Communicating Device
in Direct Contact with
Tissue/Bone/Dentin,
Limited Duration | Extemally
Communicating Device
in Direct Contact with
Tissue/Bone/Dentin,
Limited Duration | Identical |
| Device design | Consists of an
"obturator-like"
component and a
"sheath-like"
component which are
assembled, inserted
into tissue, and
disassembled to
provide access. | Consists of an
"obturator-like"
component and a
"sheath-like"
component which are
assembled, inserted
into tissue, and
disassembled to
provide access. | Identical |
| Obturator and
Sheath
materials | Obturator is aluminum
(reusable). Sheath
(disposable) is Cyclic
Olefin Copolymer
(COC). | Sheath and obturator
are both polycarbonate
(disposable). | Different: Brain Port
obturator and sheath
materials are
aluminum and COC,
respectively.
Predicate obturator
and sheath are both
polycarbonate.

Biocompatibility
Testing to cover
safety for this
difference (TPR-
3553; see Appendix
B).

Simulated Use
Testing to cover
efficacy for this
difference (TPR- |
| Feature/
Characteristic | NICO Brain Port | Vycor ViewSite
Surgical Access
System | Comparison |
| Cross
Sectional
analysis of
Obturator/
Sheath | Obturator/Sheath
combination has a
circular cross section. | Obturator/Sheath
combination has an
ovular cross section. | 3549; see Appendix
B).
Different: Brain Port
sheath/obturator have
a circular cross
section while
predicate has an
ovular cross section.

Simulated Use
Testing to prove that
a circular cross
section safely and
effectively displaces
(retracts) brain tissue
(TPR-3549; see
Appendix B). |
| Depth
markings | Incremental depth
markings on both
sheath and obturator. | No depth markings. | Different: Brain Port
has incremental
depth markings while
predicate has no
markings.

Biocompatibility
Testing to address
safety of markings
(TPR-3553; see
Appendix B). No
impact on efficacy.
Depth markings are
for reference only and
do not impact
functionality of
device. |
| Sheath
diameter
dimensions | Available sheath
diameter is $*13.5$ mm
(inner diameter).
Maximum tissue
displacement as a
result of diameter of
sheath $*15.8$ mm (outer
diameter).

$*13.5$ mm dimension
reflects inner diameter
of sheath. Outer
diameter, which is
correlated with tissue
displacement, is 15.8
mm. Device size is
designated by inner | Range of available
sheath diameters is $*12$
mm to $*28$ mm.
Maximum tissue
displacement as a
result of diameter of
sheath is approximately
$*28$ mm.

$*All$ dimensions listed
above reflect inner
diameter of sheath and
are slightly smaller than
the outer diameter,
which is most relevant
for tissue displacement.
Device size is | Different: Brain Port
only available in one
diameter (13.5 mm)
while predicate is
available in a range of
diameters (12mm –
28mm).

Safety is addressed
by the fact that the
diameter of largest
available version of
predicate sheath
exceeds the largest
version of the Brain
Port sheath.
Therefore, the |
| NEURO AND SPINE | | | |
| Feature/
Characteristic | NICO Brain Port | Vycor ViewSite
Surgical Access
System | Comparison |
| | diameter because this
reflects the size of the
opening through which
the physician has
access during surgery. | designated by inner
diameter because this
reflects the size of the
opening through which
the physician has
access during surgery. | predicate will displace
more tissue than the
Brain Port.
Efficacy relative to
diameter addressed
by Simulated Use
Testing (TPR-3549;
see Appendix B). |
| Sheath lengths | Available sheath
lengths are *5 cm, *6
cm, and *7.5 cm.
*The sheath length is
called out on the
labeling and is most
relevant to the end user
from a clinical
perspective. This
dimension represents
the length of the port
through which surgery
will occur. The
obturator is longer than
the sheath by
approximately 1.0 cm. | Available sheath
lengths are *3 cm, *5
cm, and *7 cm.
*The sheath length is
called out on the
labeling and is most
relevant to the end user
from a clinical
perspective. This
dimension represents
the length of the port
through which surgery
will occur. The
obturator is longer than
the sheath by
approximately 0.75 cm. | Different: Brain Port
available in lengths of
5 cm, 6 cm and 7.5
cm while predicate is
available in lengths of
3 cm, 5 cm, and 7
cm.
Additional length of
proposed device does
not cause new issues
of safety relative to
predicate. The
placement of both the
predicate and the
proposed device is
entirely dependent
upon the location of
diseased tissue, not
the length of the
devices.
Efficacy relative to
length addressed by
Simulated Use
Testing (TPR-3549;
see Appendix B). |
| Manipulation
Tool | "Manipulation Tool"
offered for manipulating
the position of the
sheath. Reusable
device that will be
sterilized onsite within
the tray. | No "Manipulation Tool"
offered. | Different: Brain Port
System includes
manipulation tool
while predicate does
not.
The Manipulation
Tool is a class I
device (product code
GEN) which is
exempt from
premarket notification
requirements.
Although the same
"manipulation tool" |
| Feature/
Characteristic | NICO Brain Port | Vycor ViewSite
Surgical Access
System | Comparison |
| | | | can be used with the
Vycor sheath, it would
be difficult since the
Vycor sheath does
not have a ring at the
top with suture holes.
The tip of the
manipulation tool is
sized so that it will fit
into these suture
holes to make
positioning
adjustments easier.

Simulated Use testing
to prove that tool is
effective and does not
affect efficacy of
Brain Port. |
| Handheld
manual
operation and
placement | Yes | Yes | Identical |
| Proximal End
of Sheath | Knurled ring on sheath
includes holes for
securing to surrounding
tissue via sutures after
insertion. | Sheath does not
include knurled ring or
mechanism for securing
placement after
insertion. | Different: Brain Port
includes knurled ring
with holes for easier
handling and
securement to
surrounding tissue (if
desired). Predicate
does not include
knurled ring or suture
holes.

Simulated Use
Testing to prove
presence of knurled
ring and suture holes
do not affect the
ability of the Brain
Port to effectively be
inserted into and
retract tissue. (TPR-
3549; see Appendix
B). |
| Shape of distal
end of
obturator | Distal end of obturator
has a conical shape
with a rounded tip at its
end and no opening. | Distal end of obturator
has a rounded shape
with an opening at its
end. | Different: Brain Port
obturator has a distal
end which is conical
in shape with a
rounded tip and no
opening. Predicate
obturator has a distal |
| Feature/
Characteristic | NICO Brain Port | Vycor ViewSite
Surgical Access
System | Comparison |
| | | | end which is rounded
in shape and has an
opening. |
| | | | The obturators for
both the predicate
and the proposed
device displace brain
tissue during
insertion. The conical
shape of the
proposed device
enables predictable
and gradual serial
dilation of brain tissue
during its insertion. |
| | | | Simulated Use
Testing to cover
efficacy (TPR-3549;
see Appendix B). |
| 3rd party
instrumentation | Obturator component
interfaces with third
party instruments. | Obturator component
not designed to
interface with third party
instruments. | Different: Brain Port
obturator is
compatible with 3rd
party instruments
while predicate is not.

Obturator includes a
cavity for receiving
third party
instruments (if
desired) and set
screw for securing
those instruments.
These design aspects
(cavity and set screw)
do not affect the
ability of the end user
to safely achieve the
indications for use.

Simulated Use
Testing 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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7

NIC NEURO AND SPINE

8

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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

11

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

12

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

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510(k) Number K120691