(196 days)
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.
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 with an integrated camera and LED light source. It has a working channel for third-party tools, irrigation, and aspiration. The distal end is steerable and can be extended. The Axonmonitor is a combination of the Axonbox (firmware) and a third-party tablet for viewing and recording images. It is battery operated.
This document is a 510(k) summary for the Axonpen System, which is a neurological endoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically proving the device meets those acceptance criteria in the way described in the request using clinical performance metrics. The provided information is primarily focused on design, materials, and safety testing to support equivalence.
However, based on the provided text, here's an attempt to extract and infer the requested information, acknowledging that a full clinical study with specific performance acceptance criteria for diagnostic/treatment efficacy is not detailed in this 510(k) summary.
Acceptance Criteria and Study for ClearMind Biomedical's Axonpen System (K201308)
The provided 510(k) summary for the Axonpen System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various bench and biocompatibility tests. It does not detail specific performance acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or clinical outcomes that would typically be found in a clinical study proving a device meets such criteria. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful completion of bench testing to demonstrate functionality and safety.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) summary, specific numerical performance metrics are not explicitly stated as "acceptance criteria" for clinical efficacy. The performance reported primarily relates to safety, functionality, and compliance with standards.
| Acceptance Criteria Category (Implied) | Specific Criterion (Implied/Stated from Text) | Reported Device Performance (from Text) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 series for patient contact materials. | Passed Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis tests per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ASTM F756-17. |
| Electrical Safety & Essential Performance | Compliance with ISO 60601 series and IEC 60601-2-18 for endoscopes. | Demonstrated compliance with all pertinent FDA recognized consensus standards, including ISO 8600 series and ISO 60601 series (including IEC 60601-2-18). |
| Aspiration Functionality | Ability to successfully aspirate fluid and clots without damaging adjacent tissue. | Bench testing demonstrated that the Axonpen System could successfully aspirate fluid and clots without damaging adjacent tissue. |
| Optical Performance | Verification of image processing architecture, noise reduction, contrast enhancement, color management, image intensity uniformity, image resolution, depth of field, quantification of geometric distortion, dynamic range of visualization. | Optical Performance tests conducted and verified. No specific values provided. |
| Photobiological Safety | Validation of photobiological safety. | Photobiological Safety Validation conducted. |
| Environmental/Durability | Water Ingress IPX Rating, Packaging Verification, Shelf life testing. | These tests were included. No specific results or ratings provided within this summary for these categories. |
| Sterilization | Axonpen (single-use) must be sterile upon use. | Axonpen indicated as single use, sterile. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a clinical test set with human subjects. The "test set" primarily refers to bench tests and in-vitro studies. Therefore:
- Sample Size for Test Set: Not applicable for a clinical test set. For bench/material tests, specific sample sizes are not provided in this summary.
- Data Provenance: The tests conducted (biocompatibility, electrical safety, aspiration, optical, etc.) are generally laboratory-based studies. The document does not specify country of origin for this testing, nor does it specify "retrospective or prospective" as these are not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is typically relevant for clinical studies involving expert review of images or interpretations. Since no human-based clinical test set is described, this section is not applicable to the provided document.
4. Adjudication Method for the Test Set
As no clinical test set requiring expert interpretation is detailed, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence based on design, materials, and engineering performance, not on direct comparison of reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Axonpen system includes an integrated camera and display (Axonmonitor) for visualization, implying a human-in-the-loop for interpretation and surgical decisions. There's no indication of an "algorithm-only" standalone performance evaluation in the context of diagnostic or treatment decision-making (e.g., using AI for automated pathology detection).
7. The Type of Ground Truth Used
For the various bench and material tests mentioned:
- Biocompatibility: Ground truth is established by standardized testing methodologies (e.g., cell viability in cytotoxicity, immune response in sensitization) and established regulatory limits defined by ISO standards.
- Aspiration Functionality: Ground truth is the observable outcome of successful aspiration of fluid and clots without damage, assessed by direct observation in bench models.
- Optical Performance: Ground truth for optical quality refers to measurable physical properties related to image quality (e.g., resolution targets, color accuracy charts).
There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this document since it doesn't describe a clinical study where such ground truths would be applied to a diagnostic or treatment outcome.
8. The Sample Size for the Training Set
The Axonpen system, as described, does not appear to be an AI/machine learning device that would typically have a "training set" of data in the manner of deep learning algorithms for image analysis. Its functions (illumination, visualization, aspiration) are mechanically and optically driven. Therefore, this is not applicable.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set for an AI/machine learning component, this question is not applicable.
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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
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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
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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) |
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510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | ClearMind Biomedical5F, No. 167, Fuxing N. Rd., Songshan Dist., Taipei City105, Taiwan, R.O.C.+886-2-22697417 |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1100 Pacific Marina, Suite 806Alameda, CA 94501Tel: 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
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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.
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K201308: Axonpen™ System
510(k) Summary
E. Tabular Comparison of Application and Predicate Devices in Regard to Substantial Equivalence
| Characteristic | Application Device:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| Indicationsfor Use | The Axonpen™ System isindicated for theillumination andvisualization of intracranialtissue and fluids and thecontrolled aspiration oftissue and/or fluid duringsurgery of the VentricularSystem or Cerebrum. | The Artemis™ NeuroEvacuation Device is usedfor the controlledaspiration of tissue and/orfluid during surgery of theVentricular System orCerebrum in conjunctionwith a PenumbraAspiration Pump. | The Artemis™ Eye Systemis indicated to providevisualization andillumination of intracranialtissue and fluids duringdiagnostic andtherapeutic procedures. | The application deviceIndications for Use is acombination of the twopredicates. Thiscombination does notraise new questions ofsafety or efficacy thatwere not raised in thepredicates |
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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:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| Technology | The Axonpen neuro-endoscope provides singlechannel for irrigation,aspiration and toolplacement forneurosurgical field. Thedistal tip is steerable.Relies upon regulatedHospital vacuum foraspiration.The distal end of thescope has a camera + LEDlighting.The reusable Axonmonitordisplays and records liveimaging captured by theAxonpen camera | Provides aspiration ofneurosurgical targets via atube that is placed in aneuroendoscope'sworking channel. Thetube includes a maceratorto facilitate themovement of tissue andfluids through tube.Provides proprietaryvacuum pump for theaspiration | The Artemis Eye is aneuro-endoscopeconsisting of a camera,two channels for irrigationand aspiration/drainage,and a working channel fora surgical tool.Artemis Eye Tablet - areusable component thatconnects to the ArtemisEye and displays liveimaging captured by theArtemis Eye camera. | Technology is identical.The application device is acombination of the twoArtemis predicates. Theapplication device doesnot have an internalmacerator, rather it relieson using a larger diameteraspiration tube tofacilitate evacuation oftissue and fluids. |
| Characteristic | Application Device:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
| ManufacturerProvidedSystemComponents | Neuro endoscope(Axonpen™) that providesworking channel forendoscopic tools, alongwith irrigation andaspiration.Handpiece has integratedcamera & lighting.Reusable Axonmonitortablet style display forcamera image andrecording.Battery Charger. | Hand piece that providespowered clot macerationwithin its aspiration tube.Aspiration pump &pump tubing to handpiece | A neuro endoscope thathas an Artemis Eyecamera at its distal end.Channels for suction andirrigation if requiredWorking channel to allowpassage of the ArtemisNeuro Evacuation device.Tablet style display forcamera imageBattery Charger | Both the predicatedevices (in combination)and the application deviceare neuroendoscopes.They both have distalcameras and lighting thatare displayed on a tabletsized monitor. They bothhave at least one workingchannel forneuroendoscopic tools,irrigation andaspiration/drainage.The predicate device has amacerator in its aspirationdevice along with its ownvacuum source. |
| HospitalSuppliedComponents | Vacuum sourceVacuum regulatorIrrigation fluidWaste bucket | EndoscopeVacuum sourceVacuum regulator | CameraLightingIrrigation fluiddrain | Achieves same clinicaleffect |
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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:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| AspirationSource | Regulated hospitalvacuum | Penumbra AspirationPump | Not described | The predicate andapplication devices havedifferent sources ofregulated vacuum. Thesource of the vacuumdoes not raise newquestions of safety orefficacy. |
| AspirationControl | Fingertip controlled viapressing button onAxonpen handle. | Fingertip controlled viavacuum regulator hole onWand handle. | Not Described | Vacuum activationcontrolled by user |
| Aspirationregulation | Manually regulated athospital vacuum regulator | Manually regulated atArtemis System Pump | Not Described | Vacuum regulated by user |
| Mechanismof ClotAspiration | Vacuum aspiration aidedby large aspiration tubeinner diameter (0.248" ID)and extender tube | Vacuum Aspiration aidedby a battery-poweredmacerator in Evacuatorand ability to advance20mm beyond distal endof Artemis Eye neuroendoscope | None | Both devices use vacuumto aspirate clots andtissue. The predicate usesa macerator to facilitatepassage of debris fromthe surgical field. Theapplication device uses alarger diameter tube (i.e.0.248" ID vs 0.048" —0.100″ ID) to facilitatedebris passage. |
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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:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| Power Sourcefor ClotAspiration | Hospital sourcedregulated vacuum | Primary Cell Lithium IonBattery, 1.5 Volt DC Motorcontained within thehandle to power themaceratorProprietary vacuumsource | None | Same as previous |
| Steering | 10° Steerable in bothdirections from axis alonghorizontal plane. | Non steerable | Non steerable | Steerable applicationdevice may allow forclean-up of larger surgicalfield without requiringrepositioning of the entireendoscope. May poseless risk than predicateneuroendoscope. |
| Camera | Integrated, 80°visualization at distal end. | None | Integrated, visualization atdistal end | Clinically identical |
| Lighting | Fiber optic Integrated LEDlight source in Axonpenhandle. | None | Fiber optic Integrated LEDlight source in handle | Identical |
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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:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| Display | Axonmonitor componentcontrols lighting andvisualization.Direct electrical/ dataconnection to Axonpen.Video and still picturerecording.Battery powered. | None | Artemis Eye Tablet - areusable component thatconnects to the ArtemisEye and displays liveimaging captured by theArtemis Eye camera.Battery powered. | Functionally identical |
| HandpieceDimensions | L: 33.0 cmID: 0.248"OD: 0.256" (6.6mm) | L: 26.1 cm - 27.0 cmID: 0.048″ — 0.100″OD: 00.058″ —0.109″ | Length: 25 cmOD: 6 mm | The Axonpen and theArtemis Eyeneuroendoscopes arenearly the same outsidediameter |
| Wand UsableLength | 5.0 to 10.0cm (12.0cmwith the adjustableStopper mechanism fullycompressed);20.0cm with the Stoppermechanism removed. | Increases usable length ofArtemis Eye by 2cmbecause the Device canextend beyond the distaltip of the scope by 2cm. | 15cm | Applicationneuroendoscope has ashorter potential usablelength than the predicate.No new questions of safetyor efficacy raised by this3cm difference. |
| PatientcontactingWandMaterials | 304 Stainless Steel.Polyurethane Fiber opticline, TPU | 304 Stainless Stee | 304 Stainless SteelFiber optic line | Clinically identical; allmaterials in all deviceshave passed appropriatebiocompatibility testing. |
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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:ClearmindAxonpen™ System | Predicate Device:PenumbraArtemis™ NeuroEvacuation Device(K171332) | Predicate Device:PenumbraArtemis™ Eye System(K190719) | Impact onSubstantial Equivalence |
|---|---|---|---|---|
| AspirationTubingMaterial | Polymers | Polymer | Not applicable | Clinically identical; allmaterials in all deviceshave passed appropriatebiocompatibility testing. |
| IrrigationTubingMaterial | PVC | None,provided via endoscope | Not applicable | Clinically identical; allmaterials in all deviceshave passed appropriatebiocompatibility testing. |
| Single use?Sterile? | Axonpen- single use,sterileDisplay- reusable,nonsterile | Hand Piece-single use,sterileVacuum pump- reusable,nonsterile. | Artemis Eye- single use,sterileArtemis Eye tablet-reusable, nonsterile | In both cases thecomponents that areinserted into the patient'sbrain are single-use andprovided sterile and theimage monitors arereusable.The predicate's vacuumpump is also reusable. |
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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, CSOextracts |
| Systemic toxicity | ISO 10993-11:2017 | Intravenous or intraperitoneal Injection:NaCl, CSO extracts |
| MaterialMediatedpyrogenicity | 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
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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).
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).