Who is the manufacturer of BRAIN PORT?

Nico Corporation filed the 510(k) submission for BRAIN PORT (K120691).

What is the FDA product code for BRAIN PORT?

GZT. It is classified under 21 CFR 882.4800 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for BRAIN PORT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BRAIN PORT?

Vycor ViewSite™ Access System (K060973).

Who can help prepare an FDA 510(k) submission like BRAIN PORT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BRAIN PORT

K120691 · Nico Corporation · GZT · Jun 5, 2012 · Neurology

Device Facts

Record ID	K120691
Device Name	BRAIN PORT
Applicant	Nico Corporation
Product Code	GZT · Neurology
Decision Date	Jun 5, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4800
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

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

Device Story

NICO Brain Port is a self-retaining neurosurgical retractor system. It consists of a reusable anodized aluminum obturator and a single-use, sterile cyclic olefin copolymer (COC) sheath. In the OR, the obturator is inserted into the sheath; the assembly is manually placed through intracranial or spinal tissue to the target site. The obturator is then removed, leaving the transparent/translucent sheath in place as a portal for surgical visualization and instrument access. A manual manipulation tool is provided to adjust sheath positioning. The device is intended for use by neurosurgeons in an OR setting. The obturator includes a cavity and set screw to interface with third-party surgical instruments. The system benefits patients by providing a stable, visualized access path to neurological tissues, facilitating surgical procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), sterilization validation (gamma for disposables, autoclave/gas plasma for reusables), packaging/shelf-life validation, and simulated use testing in a medium representative of brain tissue to confirm efficacy and safety of the circular design, depth markings, and manipulation tool.

Technological Characteristics

System components: Reusable obturator (anodized aluminum, 316 stainless steel), single-use sheath (cyclic olefin copolymer, medical grade ink), and manipulation tool (316 stainless steel). Sterilization: Gamma (sheath), autoclave/hydrogen peroxide gas plasma (reusables). Design: Circular cross-section, incremental depth markings, knurled ring with suture holes. Interface: Cavity/set screw for third-party instruments. Biocompatibility: Externally communicating, limited duration contact with tissue/bone/dentin.

Indications for Use

Indicated for patients undergoing brain or spinal surgery requiring surgical field access and visualization. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Predicate Devices

Vycor ViewSite™ Access System (K060973)

Related Devices

K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook · Nico Corporation · Jun 12, 2015
K172433 — NICO BrainPath · Nico Corporation · Sep 7, 2017
K202072 — MindsEye Expandable Port · Minnetronix Neuro, Inc. · Aug 26, 2020
K060973 — VYCOR SURGICAL ACCESS SYSTEMS · Vycor Medical, LLC · Jul 26, 2006
K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) · Vycor Medical, Inc. · Jan 14, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "NICO" in large, bold, sans-serif font. Below the word "NICO" are the words "NEURO AND SPINE" in a smaller, sans-serif font. The text is black and the background is white. | Feature/ | NICO Brain Port | Vycor ViewSite | Comparison | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "NICO" in large, bold, black letters. Below the word "NICO" are the words "NEURO AND SPINE" in smaller, black letters. The words "NEURO AND SPINE" are centered below the word "NICO". The image appears to be a logo or branding for a medical practice. {4}------------------------------------------------ # NEURO AND SPINE {5}------------------------------------------------ Image /page/5/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. ) . {6}------------------------------------------------ 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. {7}------------------------------------------------ ## NIC NEURO AND SPINE {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for NICO Neuro and Spine. The word "NICO" is in large, bold, sans-serif font. Below it, in a smaller font, are the words "NEURO AND SPINE". The logo is simple and professional. {9}------------------------------------------------ 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. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all caps. There is a logo to the left of the text that is made up of three diagonal lines. Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### 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 Image /page/11/Picture/8 description: The image shows a signature in black ink on a white background. The signature appears to be stylized, with looping strokes and a flourish at the end. The signature is vertically oriented and takes up most of the frame. The overall impression is that of a quick, practiced signature. 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 Page 1 of 1 510(k) Number K120691

BRAIN PORT

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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BRAIN PORT

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Device Story

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