Who is the manufacturer of Axonpen, Axonmonitor, Axonbox, Tablet?

Clearmind Biomedical filed the 510(k) submission for Axonpen, Axonmonitor, Axonbox, Tablet (K201308).

What is the FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet?

GWG. It is classified under 21 CFR 882.1480 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Axonpen, Axonmonitor, Axonbox, Tablet?

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

What are the predicate devices for Axonpen, Axonmonitor, Axonbox, Tablet?

Artemis™ Neuro Evacuation Device (K171332); Artemis™ Eye System (K190719).

Who can help prepare an FDA 510(k) submission like Axonpen, Axonmonitor, Axonbox, Tablet?

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.

Axonpen, Axonmonitor, Axonbox, Tablet

K201308 · Clearmind Biomedical · GWG · Nov 27, 2020 · Neurology

Device Facts

Record ID	K201308
Device Name	Axonpen, Axonmonitor, Axonbox, Tablet
Applicant	Clearmind Biomedical
Product Code	GWG · Neurology
Decision Date	Nov 27, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1480
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Axonpen System is indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

Device Story

Axonpen System comprises a steerable, single-use neuroendoscope (Axonpen) and a reusable monitor (Axonmonitor). Device inputs include visual data from an integrated distal camera and LED light source. Surgeon operates mechanical controls on the handle to steer the distal tip (horizontal plane), extend the distal tube, and manage irrigation/aspiration. Aspiration utilizes regulated hospital vacuum; irrigation uses third-party saline. Axonmonitor (Axonbox + tablet) processes camera signals for real-time display and recording. Used in neurosurgery to visualize and evacuate intracranial tissue/fluids. Output provides surgeons with direct visualization of the surgical field, facilitating controlled tissue/fluid removal. Benefits include improved visualization and efficient evacuation of intracranial targets without requiring repositioning of the entire endoscope.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), electrical safety (IEC 60601), and optical performance verification (noise reduction, contrast enhancement, resolution, distortion, dynamic range). Bench testing confirmed successful aspiration of fluid and clots without damaging adjacent tissue.

Technological Characteristics

Materials: 304 Stainless Steel, TPU, Polyurethane. Steerable neuroendoscope with integrated LED and camera. Connectivity: Wired connection to Axonmonitor (tablet-based). Power: Battery-operated monitor, hospital vacuum for aspiration. Software: Firmware for camera/light control and image processing. Sterilization: Single-use sterile endoscope; reusable monitor.

Indications for Use

Indicated for illumination, visualization, and controlled aspiration of intracranial tissue and fluids during surgery of the Ventricular System or Cerebrum.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

Artemis™ Neuro Evacuation Device (K171332)
Artemis™ Eye System (K190719)

Related Devices

K190719 — Artemis Eye System · Penumbra, Inc. · Aug 30, 2019
K020507 — OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 · Olympus Winter & Ibe GmbH · Oct 8, 2002
K223615 — Digital ClarusScope System, Digital NeuroPEN System · Clarus Medical, LLC · Nov 21, 2023
K182211 — Aurora Surgiscope System · Rebound Therapeutics Corporation · Jan 18, 2019
K230125 — Neuroblade System · Clearmind Biomedical · Oct 13, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ November 27, 2020 ClearMind Biomedical % Craig Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina. Suite 806 Alameda, California 94501 Re: K201308 Trade/Device Name: Axonpen, Axonmonitor, Axonbox, Tablet Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: October 27, 2020 Received: October 28, 2020 ### Dear Craig Coombs: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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) K201308 Device Name Axonpen System #### Indications for Use (Describe) The Axonpen System is indicated for the illumination of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | X 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 ## A. Device Information: | Category | Comments | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | ClearMind Biomedical 5F, No. 167, Fuxing N. Rd., Songshan Dist., Taipei City 105, Taiwan, R.O.C. +886-2-22697417 | | Correspondent Contact Information: | Craig Coombs Coombs Medical Device Consulting 1100 Pacific Marina, Suite 806 Alameda, CA 94501 Tel: 510-995-8499 | | Device Common Name: | Endoscope, neurological | | Device Classification & Name: | 21 CFR 882.1480, Neurological endoscope | | Device Classification & Product Code: | Class II, GWG | | Device Proprietary Name: | Axonpen™ System | ## Predicate Device Information: | Predicate Device: | Artemis™ Neuro Evacuation Device | |-------------------------------------------|----------------------------------| | Predicate Device Manufacturer: | Penumbra Inc. | | Predicate Device Premarket Notification # | K171332 | | Predicate Device Common Name: | Endoscope, neurological | | Predicate Device Classification & Name: | 21 CFR 882.1480, Neurological | | | endoscope | | Predicate Device Classification & | Class II, | | Product Code: | GWG | #### Predicate Device Information: | Predicate Device: | Artemis™ Eye System | |-------------------------------------------|-------------------------------| | Predicate Device Manufacturer: | Penumbra Inc. | | Predicate Device Premarket Notification # | K190719 | | Predicate Device Common Name: | Endoscope, neurological | | Predicate Device Classification & Name: | 21 CFR 882.1480, Neurological | | | endoscope | | Predicate Device Classification & | Class II, | | Product Code: | GWG | ## B. Date Summary Prepared 24 Nov 2020 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for ClearMind Biomedical. The logo consists of a blue abstract shape on the left, resembling a stylized letter "C" or a series of connected arrows. To the right of the shape is the company name "CLEARMIND" in gray, with the word "BIOMEDICAL" in smaller, lighter gray letters underneath. The overall design is clean and modern, suggesting a focus on clarity and innovation in the biomedical field. #### C. Description of Device The Axonpen System consists of a neuroendoscope (Axonpen) and a monitor (Axonmonitor) to view the image from the distal end of the Axonpen. The Axonpen is a steerable, single-use, neuroendoscope. It has an integrated camera and LED light source to allow the surgeon to view the surgical field at the distal end of the Axonpen. The Axonpen has a working channel that can accept third-party neuroendoscopic tools with an OD of ≤2.5mm and a length of at least 41cm. That same channel can be used for irrigation and aspiration of the surgical target site. The Axonpen is connected to a hospital source vacuum to provide the aspiration feature and is connected to a thirdparty saline infusion bag to provide irrigation solution. The distal 2.57cm of the Axonpen can be steered to the left or right of the axis in the horizontal plane. Additionally, the end of the distal tube of the Axonpen can be extended an additional 3.2mm to facilitate aspiration of fluid and tissue. The usable length of the Axonpen can be adjusted by setting the Stopper mechanism, which can limit the depth penetration of the device according to the physician's preference. The steering, irrigation, aspiration, and distal tube extension are all hand-controlled with mechanical features in the handle of the Axonpen. The Axonpen is connected by a cable to the Axonmonitor. The Axonmonitor is a combination of the Axonbox, which contains the firmware for the Axonpen camera and light, and a third-party tablet. The software on the tablet allows viewing of the camera image along with recording capabilities. The Axonmonitor is battery operated and provides all the electrical power needed by the Axonpen. The Axonmonitor is supplied with a battery charger that is plugged into the mains and can be charging when the Axonpen System is being used. #### D. Indications for Use The Axonpen™ System is indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum. {5}------------------------------------------------ K201308: Axonpen™ System 510(k) Summary ### E. Tabular Comparison of Application and Predicate Devices in Regard to Substantial Equivalence | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Axonpen™ System is indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum. | The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. | The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. | The application device Indications for Use is a combination of the two predicates. This combination does not raise new questions of safety or efficacy that were not raised in the predicates | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for ClearMind Biomedical. The logo consists of a blue abstract shape on the left, followed by the word "CLEARMIND" in gray, and the word "BIOMEDICAL" in a smaller font size below it. The abstract shape appears to be two stylized arrows pointing in opposite directions. | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technology | The Axonpen neuro- endoscope provides single channel for irrigation, aspiration and tool placement for neurosurgical field. The distal tip is steerable. Relies upon regulated Hospital vacuum for aspiration. The distal end of the scope has a camera + LED lighting. The reusable Axonmonitor displays and records live imaging captured by the Axonpen camera | Provides aspiration of neurosurgical targets via a tube that is placed in a neuroendoscope's working channel. The tube includes a macerator to facilitate the movement of tissue and fluids through tube. Provides proprietary vacuum pump for the aspiration | The Artemis Eye is a neuro-endoscope consisting of a camera, two channels for irrigation and aspiration/drainage, and a working channel for a surgical tool. Artemis Eye Tablet - a reusable component that connects to the Artemis Eye and displays live imaging captured by the Artemis Eye camera. | Technology is identical. The application device is a combination of the two Artemis predicates. The application device does not have an internal macerator, rather it relies on using a larger diameter aspiration tube to facilitate evacuation of tissue and fluids. | | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | | Manufacturer Provided System Components | Neuro endoscope (Axonpen™) that provides working channel for endoscopic tools, along with irrigation and aspiration. Handpiece has integrated camera & lighting. Reusable Axonmonitor tablet style display for camera image and recording. Battery Charger. | Hand piece that provides powered clot maceration within its aspiration tube. Aspiration pump & pump tubing to hand piece | A neuro endoscope that has an Artemis Eye camera at its distal end. Channels for suction and irrigation if required Working channel to allow passage of the Artemis Neuro Evacuation device. Tablet style display for camera image Battery Charger | Both the predicate devices (in combination) and the application device are neuroendoscopes. They both have distal cameras and lighting that are displayed on a tablet sized monitor. They both have at least one working channel for neuroendoscopic tools, irrigation and aspiration/drainage. The predicate device has a macerator in its aspiration device along with its own vacuum source. | | Hospital Supplied Components | Vacuum source Vacuum regulator Irrigation fluid Waste bucket | Endoscope Vacuum source Vacuum regulator | Camera Lighting Irrigation fluid drain | Achieves same clinical effect | {7}------------------------------------------------ {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Clearmind Biomedical. The logo consists of a blue abstract symbol on the left, followed by the word "CLEARMIND" in gray, and the word "BIOMEDICAL" in a smaller font size below it. The abstract symbol appears to be two stylized arrows pointing to the left. | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aspiration Source | Regulated hospital vacuum | Penumbra Aspiration Pump | Not described | The predicate and application devices have different sources of regulated vacuum. The source of the vacuum does not raise new questions of safety or efficacy. | | Aspiration Control | Fingertip controlled via pressing button on Axonpen handle. | Fingertip controlled via vacuum regulator hole on Wand handle. | Not Described | Vacuum activation controlled by user | | Aspiration regulation | Manually regulated at hospital vacuum regulator | Manually regulated at Artemis System Pump | Not Described | Vacuum regulated by user | | Mechanism of Clot Aspiration | Vacuum aspiration aided by large aspiration tube inner diameter (0.248" ID) and extender tube | Vacuum Aspiration aided by a battery-powered macerator in Evacuator and ability to advance 20mm beyond distal end of Artemis Eye neuro endoscope | None | Both devices use vacuum to aspirate clots and tissue. The predicate uses a macerator to facilitate passage of debris from the surgical field. The application device uses a larger diameter tube (i.e. 0.248" ID vs 0.048" — 0.100″ ID) to facilitate debris passage. | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Clearmind Biomedical. The logo consists of a blue abstract shape on the left, resembling a stylized letter C or a pair of overlapping arrows. To the right of the shape is the company name, "CLEARMIND," in a bold, gray sans-serif font. Below "CLEARMIND" is the word "BIOMEDICAL" in a smaller, lighter blue font. | 510(k) Summary | |----------------| |----------------| | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |----------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Power Source for Clot Aspiration | Hospital sourced regulated vacuum | Primary Cell Lithium Ion Battery, 1.5 Volt DC Motor contained within the handle to power the macerator Proprietary vacuum source | None | Same as previous | | Steering | 10° Steerable in both directions from axis along horizontal plane. | Non steerable | Non steerable | Steerable application device may allow for clean-up of larger surgical field without requiring repositioning of the entire endoscope. May pose less risk than predicate neuroendoscope. | | Camera | Integrated, 80° visualization at distal end. | None | Integrated, visualization at distal end | Clinically identical | | Lighting | Fiber optic Integrated LED light source in Axonpen handle. | None | Fiber optic Integrated LED light source in handle | Identical | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for CLEARMIND BIOMEDICAL. To the left of the text is a blue icon that looks like two arrows pointing in opposite directions. The text "CLEARMIND" is in gray, and the text "BIOMEDICAL" is in a smaller, light blue font below the word CLEARMIND. | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Display | Axonmonitor component controls lighting and visualization. Direct electrical/ data connection to Axonpen. Video and still picture recording. Battery powered. | None | Artemis Eye Tablet - a reusable component that connects to the Artemis Eye and displays live imaging captured by the Artemis Eye camera. Battery powered. | Functionally identical | | Handpiece Dimensions | L: 33.0 cm ID: 0.248" OD: 0.256" (6.6mm) | L: 26.1 cm - 27.0 cm ID: 0.048″ — 0.100″ OD: 00.058″ —0.109″ | Length: 25 cm OD: 6 mm | The Axonpen and the Artemis Eye neuroendoscopes are nearly the same outside diameter | | Wand Usable Length | 5.0 to 10.0cm (12.0cm with the adjustable Stopper mechanism fully compressed); 20.0cm with the Stopper mechanism removed. | Increases usable length of Artemis Eye by 2cm because the Device can extend beyond the distal tip of the scope by 2cm. | 15cm | Application neuroendoscope has a shorter potential usable length than the predicate. No new questions of safety or efficacy raised by this 3cm difference. | | Patient contacting Wand Materials | 304 Stainless Steel. Polyurethane Fiber optic line, TPU | 304 Stainless Stee | 304 Stainless Steel Fiber optic line | Clinically identical; all materials in all devices have passed appropriate biocompatibility testing. | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for ClearMind Biomedical. The logo consists of a stylized blue symbol on the left, resembling a stylized letter "C" or a curved arrow. To the right of the symbol is the text "CLEARMIND" in gray, with the word "BIOMEDICAL" in smaller, lighter gray letters underneath. The logo has a clean and modern design. | Characteristic | Application Device: Clearmind Axonpen™ System | Predicate Device: Penumbra Artemis™ Neuro Evacuation Device (K171332) | Predicate Device: Penumbra Artemis™ Eye System (K190719) | Impact on Substantial Equivalence | |----------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aspiration Tubing Material | Polymers | Polymer | Not applicable | Clinically identical; all materials in all devices have passed appropriate biocompatibility testing. | | Irrigation Tubing Material | PVC | None, provided via endoscope | Not applicable | Clinically identical; all materials in all devices have passed appropriate biocompatibility testing. | | Single use? Sterile? | Axonpen- single use, sterile Display- reusable, nonsterile | Hand Piece-single use, sterile Vacuum pump- reusable, nonsterile. | Artemis Eye- single use, sterile Artemis Eye tablet- reusable, nonsterile | In both cases the components that are inserted into the patient's brain are single-use and provided sterile and the image monitors are reusable. The predicate's vacuum pump is also reusable. | {12}------------------------------------------------ #### F. Summary of Supporting Data Biocompatibility data demonstrates that the device is in compliance with ISO 10993. Testing was conducted with fully manufactured Axonpen devices. The following tests were conducted and passed to demonstrate substantial equivalence with the predicate devices: | Test Name | Standard | Methodology | |--------------------------------------|-------------------|-----------------------------------------------------------------| | Cytotoxicity | ISO 10993-5:2009 | L929 Mem Elution | | Sensitization | ISO 10993-10:2010 | Kligman Maximization | | Irritation | ISO 10993-10:2010 | Intracutaneous Injection: NaCl, CSO extracts | | Systemic toxicity | ISO 10993-11:2017 | Intravenous or intraperitoneal Injection: NaCl, CSO extracts | | Material Mediated pyrogenicity | ISO 10993-5:2009 | Rabbit pyrogen | | Hemolysis | ASTM F756-17 | Rabbit blood | The Axonpen System was demonstrated to be in compliance with all pertinent FDA recognized consensus standards including the ISO 8600 series (Endoscopes- Medical endoscopes and endotherapy devices), the ISO 60601 series (Medical electrical equipment- Part 1: General requirements for safety and essential performance) including IEC 60601-2-18 for endoscopes. Bench testing demonstrated that the Axonpen System could successfully aspirate fluid and clots without damaging adjacent tissue. #### Additional Testing included: Optical Performance including: - Image processing architecture verification Noise Reduction Contrast Enhancement Color Management (Performance) Display Nonlinear Transformations Image Intensity Uniformity Image Resolution Depth of Field Quantification of Geometric Distortion Dynamic Range of Visualization Photobiological Safety Validation Water Ingress IPX Rating Packaging Verification Shelf life testing {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for Clearmind Biomedical. The logo consists of a blue abstract symbol on the left, followed by the word "CLEARMIND" in gray. Below "CLEARMIND" is the word "BIOMEDICAL" in a smaller, lighter gray font. The abstract symbol appears to be two stylized arrows pointing in opposite directions. #### G. Conclusion Based on intended use, performance, and supporting documentation, Clearmind concludes that the Axonpen™ System is substantially equivalent in intended use, Indications for Use, technology, design, materials, physician use, and energy source as a combination of the predicate Artemis Eye System (K190719) and the Artemis Neuro Evacuation Device (K171332).