MindsEye Expandable Port

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 26, 2020 Minnetronix Neuro, Inc. % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K202072 Trade/Device Name: MindsEye Expandable Port Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor For Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: July 24, 2020 Received: July 27, 2020 Dear Prithul Bom: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202072 Device Name MindsEye™ Expandable Port Indications for Use (Describe) The Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery. The device is indicated for use in surgery during which subcortical access is required. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY ln accordance with 21 CFR 807.92 and FDA Guidance Document The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014, Minnetronix Neuro provides this 510(k) Summary. 5. 510(k) NUMBER: K202072 #### 5.1 SUBMITTER INFORMATION | Company Name: | Minnetronix Neuro, Inc. | |------------------------|-------------------------------------------| | Company Address: | 1625 Energy Park Drive, St. Paul MN 55108 | | Company Phone: | (651) 917-4060 | | Company Facsimile: | (651) 917-4066 | | Contact Person: | Matt Adams, VP / GM | | Date Summary Prepared: | August 25, 2020 | #### 5.2 DEVICE IDENTIFICATION | Device Trade Name: | MindsEye™ Expandable Port | |----------------------|-------------------------------------------| | Common Name: | Neurological surgical port | | Classification Name: | Self-retaining retractor for neurosurgery | | | (21 CFR 882.4800, Product Code GZT) | | Device Class: | Class II | | Advisory Panel: | Neurological Devices Panel | #### 5.3 IDENTIFICATION OF PREDICATE DEVICE The predicate device for the MindsEye Expandable Port is the Nico® BrainPath® (K172433) with reference to the Vycor VBAS (K060973). #### 5.4 DEVICE DESCRIPTION The MindsEye Expandable Port is a single use, minimally invasive intracranial medical device designed to provide access and allow visualization to the surgical field while retracting subcortical soft tissues during neurological cranial surgery. Its design allows the user to place {4}------------------------------------------------ the port while collapsed in its minimal form for atraumatic access to the subcortical space. After placement, the port can be expanded radially to create a working channel to the target surgical location. The user is able to expand the port to the desired working channel diameter appropriate for the surgical plan then collapse the port upon surgical completion for safe removal. The working channel diameter may be adjusted as needed by the user throughout surgery. The MindsEye device is expected to be used in conjunction with other standard, commercially available intracranial medical devices, such as an aspirator, micro/endo/exoscope, irrigation, electrosurgical systems/tools and/or hemostatic agents. In addition, MindsEye is compatible with existing optical navigation systems for accurate target acquisition and may be attached to other commercial retraction systems according to user preference. The MindsEye device is made of biocompatible, medical grade materials (metals and polymers) with no software or electrical components. The MindsEye device and its components are provided sterile and not reusable. MindsEye is comprised of the following components and is available in three lengths (Table 1). - Port with attached Sheath - Obturator and Guide - · Optional Support System consisting of support clips, post, and legs ### Table 1: MindsEye Expandable Port Sizes | Model Number | Port Length (mm) | |--------------|------------------| | N-EXP1A-052 | 52 | | N-EXP1A-062 | 62 | | N-EXP1A-077 | 77 | #### 5.5 INDICATIONS FOR USE The Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery. The device is indicated for use in surgery during which subcortical access is required. {5}------------------------------------------------ #### TECHNOLOGICAL CHARACTERISTICS COMPARISON 5.6 While there are expected technological differences due to the ability of MindsEve to be placed in collapsed form then expanded (dilatable working channel) as compared to the static size working channel offered by the predicate; the overall indication for use, principles of operation and placement as well as general size of the device are similar to the predicate and reference devices. ### Similar Characteristics: Like the predicate and reference devices, the MindsEye port is placed using an obturator for atraumatic introduction. Placement can be performed using a commercial optical navigation system often utilized for surgical planning. The obturator is then removed leaving a working channel to allow for visualization and surgical access within the brain tissue. MindsEye can accommodate a minimum inner diameter (i.e. working channel) of 6mm to a maximum diameter of 21mm. The inner diameter range of MindsEye (6 - 21mm) is smaller then or within the diameter range of the predicate and references devices (11 – 28mm). Similarly, MindsEye is available in three port lengths (52 – 77mm) to accommodate various surgical locations which is also within the length range of the predicate and references devices (30 - 95mm). The transparent sheath allows users to see cerebral vasculature, structures and tissue adjacent to the sheath and accommodates the visualization preferences (i.e. use of an endoscope, microscope, loupes, etc.) of the user during surgery. Finally, MindsEye is compatible with typical adjunct surgical instruments such as larger retraction systems, aspirators, forceps, bipolar and other electrosurgical and hemostasis devices. ### Different Characteristics: To allow for the radial dilation of the MindsEye port, it was designed with a flexible, compliant sheath and controlled mechanism to expand and contract as intended. This is the primary difference from the predicate and reference devices which have a hard, static size sheath. To achieve this, different materials of manufacture are used as compared to the predicate and reference devices, however comprehensive biocompatibility testing was performed to maintain the safety profile of the device. Characterization and performance testing were completed to provide assurance that the sheath of the MindsEye device is robust enough to withstand the normal conditions of brain surgery. A summary of the predicate and reference device comparison is provided in Table 2. {6}------------------------------------------------ # Table 2: Predicate Comparison | | Predicate NICO BrainPath | MindsEye Expandable Port | Reference Vycor VBAS | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | 510(k)<br>Number | K172433 | Not yet assigned | K060973 | | Intended<br>Use | To provide for access and<br>allow for visualization of the<br>surgical field during brain<br>and spinal surgery. | Provide access and allow<br>visualization to the surgical<br>field and to retract soft tissue<br>during neurological cranial<br>surgery. | Same as predicate | | Device Components | | | | | Sheath<br>Lengths | L: 50, 60, 75, 95mm | L: 52, 62, 77mm | TC model:<br>L: 30, 50, 70, 90mm | | Sheath<br>Inner<br>Diameter<br>Options | ID: 11, 13.5mm | ID Expandable: 6 - 21mm | TC model:<br>ID: 12, 17, 21, 28mm | | Obturator<br>Tip Length | L: 8mm and 15mm | L: 9 mm | Unknown | | | Principle of Primary Operation | | | | | Consists of an "obturator-<br>like" component and a<br>"sheath-like" component<br>which are assembled,<br>inserted, and disassembled<br>to provide corridor access | Same as Predicate | Same | | Operation and Placement | | | | | | Handheld and can be<br>assisted by third-party<br>navigation (if desired) | Same as Predicate | Same | | Shipping Configuration | | | | | | Obturator and sheath<br>packaged and shipped<br>separately and paired during<br>surgical case | The obturator and sheath are<br>packaged and shipped<br>together ready for use | The port and introducer<br>are packaged<br>assembled ready for use | | Reusable or Single Patient Use | | | | | | Single patient use and<br>reusable | Single patient use only | Single patient use only | | Method of Sterilization | | | | | | Disposables: Gamma<br>Reusables:<br>Autoclave/hydrogen<br>peroxide gas plasma | EO<br>Reusables: None | Gamma<br>Reusables: None | | | Predicate NICO BrainPath | MindsEye Expandable Port | Reference Vycor VBAS | | Biocompatibility | Demonstrated based on<br>externally communicating<br>device in direct contact with<br>tissue/bone/dentin for a<br>limited duration | Same as Predicate | Same | | Materials of Manufacture | Obturator: Aluminum<br>Sheath: COC | Sheath - Chronoprene 5A<br>Guide - ABS<br>Obturator – 303 SS<br>Support system – 303 SS | Unknown | | Cross Sectional Analysis of Obturator / Sheath | Obturator / Sheath<br>combination has a circular<br>cross section | Obturator / sheath (port)<br>combination has a circular<br>cross section when placed<br>Sheath (port) has a hexagonal<br>cross section when dilated | Various depending on<br>model from circular to<br>elliptical | | General Shape of Obturator Tip | Distal end of obturator has a<br>conical shape with a<br>rounded tip and no opening | Same as Predicate | Various depending on<br>the model | | Third-Party Instrumentation | Obturator component<br>interfaces with third party<br>instruments | Same as Predicate | Same | | Navigation Locking Mechanism | Included as part of the<br>obturator | Same as Predicate | None | | Surface of Sheath | Inner diameter and<br>horizontal proximal surface<br>of the knurled ring are<br>textured | Inner and outer surface of<br>sheath is non-reflective,<br>transparent, and flexible | Port is transparent and<br>non-compliant | | Proximal End of Sheath | Updated knurled ring with<br>concave geometry to reduce<br>optical glare, still includes<br>holes, slots and tabs. | The proximal end has a non-<br>reflective head and dial for port<br>expansion with tabs that can<br>be used to connect to the<br>support system | Unknown | {7}------------------------------------------------ {8}------------------------------------------------ #### 5.7 SUMMARY OF TESTING A series of non-clinical tests, biocompatibility, sterility, and shelf life testing were performed to demonstrate that MindsEye met the applicable design and performance requirements to support a determination of substantial equivalence related to the safety and effectiveness of the MindsEye device as compared to the predicate and reference devices. | Non-Clinical Test | MindsEye Component | Result | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------| | Cytotoxicity: MEM elution | All potential patient<br>contacting components | Pass - non-cytotoxic | | Sensitization: (Maximum) | All potential patient<br>contacting components | Pass - non-sensitizer | | Irritation: (Intracutaneous Reactivity) | All potential patient<br>contacting components | Pass - non-irritant | | Acute System Toxicity | All potential patient<br>contacting components | Pass | | Material Mediated Pyrogenicity | All potential patient<br>contacting components | Pass | | Packaging and Shelf Life<br>• shipping/distribution simulation,<br>• environmental conditions, aging, visual<br>packaging inspection,<br>• bubble and seal strength packaging testing,<br>• environmental and shipping simulation | All | Pass | | Sterilization<br>• B&F testing,<br>• BI for SAL 10-6,<br>• Endotoxin testing | All | Pass | | Specification Review | All | Pass | | Damage Resistance | Sheath | Pass | ### Table 3: Non-Clinical Testing Summary #### 5.8 CONCLUSION A review of the risk assessment, biocompatibility and other non-clinical testing, in addition to demonstrated compliance with recognized standards, have established that the MindsEye Expandable Port does not raise different questions of safety or effectiveness for the described intended use when compared to the predicate and reference devices. Therefore, the results of these analyses provide reasonable assurance that the MindsEye Expandable Port has a similar safety and effectiveness profile as compared to the predicate and supports a determination of substantial equivalence.