(196 days)
Not Found
No
The summary describes a neuroendoscope system with image viewing and recording capabilities, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The "Image processing architecture verification" likely refers to standard digital image processing, not AI/ML.
No
The device is used for illumination and aspiration during surgery, which are interventional procedures, not therapeutic. Its function is to aid the surgeon, not to directly treat a disease or condition.
No
The device is described as being indicated for illumination and controlled aspiration during surgery, and its description highlights its function as a surgical tool (neuroendoscope with integrated camera and working channel for third-party tools, irrigation, and aspiration). It aids in performing a procedure, not in diagnosing a condition.
No
The device description explicitly includes hardware components such as a neuroendoscope with an integrated camera and LED light source, and a monitor which is a combination of firmware and a third-party tablet. The performance studies also include hardware-specific testing like biocompatibility, bench testing for aspiration, optical performance, photobiological safety, water ingress, packaging, and shelf life.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "illumination of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery." This describes a surgical tool used directly on the patient during a procedure.
- Device Description: The description details a neuroendoscope, monitor, camera, light source, and working channel for surgical tools, irrigation, and aspiration. These are all components of a surgical device used for visualization and manipulation within the body.
- Anatomical Site: The anatomical site is "Intracranial tissue and fluids, Ventricular System or Cerebrum," which are internal parts of the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
The Axonpen System is a surgical device used in vivo (within the living body) for visualization and manipulation during surgery, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (camera)
Anatomical Site
Intracranial tissue and fluids, Ventricular System, Cerebrum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing demonstrated that the Axonpen System could successfully aspirate fluid and clots without damaging adjacent tissue. Additional testing included Optical Performance (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, and Shelf life testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
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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).