(269 days)
No
The summary describes a standard neuroendoscopy system with imaging, irrigation, aspiration, and coagulation capabilities. While it mentions "image processing chip," there is no indication of AI or ML being used for analysis, interpretation, or decision-making. The performance studies focus on standard medical device testing, not AI/ML model validation.
Yes
The Neuroblade System is used for illumination, visualization, aspiration, cutting, and coagulation of tissue during intracranial surgery, directly treating or modifying the body.
No
The device is primarily intended for visualization, illumination, aspiration, cutting, and coagulation of tissue during surgical procedures. While it provides visualization, its primary function is not to diagnose a condition but to facilitate surgical intervention.
No
The device description clearly states that the Neuroblade System is comprised of three physical components: Neuroblade (a hand-held neuroendoscope with camera, lighting, irrigation, aspiration, and bipolar electrode), Neuropad (a display and control unit), and Cart. It also mentions connections to third-party hardware like RF generators, saline bags, vacuum systems, and flexible endoscopic surgical devices. This indicates a significant hardware component, not a software-only device.
Based on the provided information, the Neuroblade System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- Neuroblade System Function: The Neuroblade System is a surgical tool used directly within the patient's body during neurosurgery. Its functions include visualization, aspiration, cutting, and coagulation of tissue and fluids in situ.
- Intended Use: The intended use clearly states "illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery". This describes a surgical procedure, not laboratory testing of specimens.
The Neuroblade System is a surgical instrument used for direct intervention and manipulation within the body, which is the opposite of the in vitro nature of IVD devices.
N/A
Intended Use / Indications for Use
The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and/or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.
Product codes
GWG, GEI
Device Description
The Neuroblade System is comprised of three components: Neuroblade, Neuropad and Cart.
The Neuroblade is a hand-held, sterile neuroendoscope with lighting and camera at its distal end. The camera images are displayed on the Neuropad via a connecting cable that extends from the proximal end of the Neuroblade. It has integrated irrigation and aspiration functions. The distal bipolar electrode allows the application of RF energy from a third-party radiofrequency (RF) generator for coagulation of bleeding vessels in the neuro space. A cutting window on the side of distal end is for the removal of blood clots.
The Neuroblade System, like other neuroendoscopes, is advanced into the brain through a burr hole created in the patient's skull. The tip of the Neuroblade is advanced under visualization via the illuminated camera image transmitted from the distal tip of the Neuroblade to the Neuropad.
The Neuroblade has irrigation and vacuum tubing (2.0 m) that allows for connection to a third party saline infusion bag and a vacuum waste bucket, respectively. The waste bucket is connected to a vacuum regulator which is attached to the hospital's vacuum system.
The bipolar electrode is incorporated into the distal tip of the Neuroblade and has a bipolar plug (20 cm) on the proximal end that allows for connection to a third-party bipolar cord. The proximal end of that bipolar cord connects to the RF Generator. An RF Generator and bipolar cord are common accessories in the operating room.
The Neuroblade has a working channel that will facilitate the introduction of flexible endoscopic surgical devices (
§ 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2023
ClearMind Biomedical % Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda, California 94501
Re: K230125
Trade/Device Name: Neuroblade System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, GEI Dated: September 11, 2023 Received: September 12, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Digitally signed by Adam D. Pierce -S Pierce - S 09:19:04-04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
2
and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230125
Device Name Neuroblade System
Indications for Use (Describe)
The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization 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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4
510(k) Summary
A. Device Information
| Category | Comments | ||
|---|---|---|---|
| Date Prepared: | October 12, 2023 | ||
| Applicant | ClearMind Biomedical | ||
| 5F., No. 167, Fuxing N. Rd., Songshan Dist., Taipei | |||
| City 105, Taiwan, R.O.C. | |||
| +886-2-2269-7417 | |||
| Primary Correspondent | Shaun Lin | ||
| Senior Regulatory Affairs Specialist | |||
| Clearmind Biomedical | |||
| 5F., No. 167, Fuxing N. Rd., Songshan Dist., Taipei | |||
| City 105, Taiwan, R.O.C. | |||
| Phone: +886-2-2269-7417-108 | |||
| E-mail: Shaun@theclearmindgroup.com | |||
| (preferred) | |||
| Secondary Correspondent | Craig Coombs | ||
| Coombs Medical Device Consulting | |||
| 427 14th Ave, | |||
| San Francisco, CA 94118 | |||
| Tel: 650-380-2474 | |||
| Device Classification & Name | 21 CFR 882.1480, Neurological endoscope | ||
| 21 CFR 878.4400, Electrosurgical cutting and | |||
| coagulation device and accessories | |||
| Device Classification & Product | |||
| Code | |||
| Secondary Product Code | GEI | ||
| Device Proprietary Name | Neuroblade System |
Predicate Device Information
| Predicate Device (Primary) | Axonpen System |
|---|---|
| Predicate Device Manufacturer | ClearMind Biomedical |
| Predicate Device Premarket Notification # | K201308 |
| Predicate Device Classification & Name | 21 CFR 882.1480, Neurological endoscope |
| Predicate Device Classification & Product Code | Class II, GWG |
5
Predicate Device Information
| Predicate Device | AURORA Evacuator + Coag |
|---|---|
| Predicate Device Manufacturer | Rebound Therapeutics |
| Predicate Device Premarket Notification # | K203745 |
| Predicate Device Classification & Name | 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories |
| Predicate Device Classification & Product Code | Class II, GEI |
Reference Device Information
| Reference Device | Kirwan Bipolar Suction Coagulator |
|---|---|
| Reference Device Manufacturer | Kirwan Surgical Products |
| Reference Device Premarket | |
| Notification # | K960455 |
| Reference Device Classification & | |
| Name | 21 CFR 878.4400, Electrosurgical cutting and |
| coagulation device and accessories | |
| Reference Device Classification & | |
| Product Code | Class II, GEI |
B. Description of Device
The Neuroblade System is comprised of three components: Neuroblade, Neuropad and Cart.
The Neuroblade is a hand-held, sterile neuroendoscope with lighting and camera at its distal end. The camera images are displayed on the Neuropad via a connecting cable that extends from the proximal end of the Neuroblade. It has integrated irrigation and aspiration functions. The distal bipolar electrode allows the application of RF energy from a third-party radiofrequency (RF) generator for coagulation of bleeding vessels in the neuro space. A cutting window on the side of distal end is for the removal of blood clots.
The Neuroblade System, like other neuroendoscopes, is advanced into the brain through a burr hole created in the patient's skull. The tip of the Neuroblade is advanced under visualization via the illuminated camera image transmitted from the distal tip of the Neuroblade to the Neuropad.
The Neuroblade has irrigation and vacuum tubing (2.0 m) that allows for connection to a third party saline infusion bag and a vacuum waste bucket, respectively. The waste bucket is
6
connected to a vacuum regulator which is attached to the hospital's vacuum system.
The bipolar electrode is incorporated into the distal tip of the Neuroblade and has a bipolar plug (20 cm) on the proximal end that allows for connection to a third-party bipolar cord. The proximal end of that bipolar cord connects to the RF Generator. An RF Generator and bipolar cord are common accessories in the operating room.
The Neuroblade has a working channel that will facilitate the introduction of flexible endoscopic surgical devices (≤1.7 mm outer diameter) into the surgical site. That same working channel will also facilitate irrigation of the target site and is the channel that supports the aspiration of fluid and tissues.
The Neuropad can be installed onto the Cart and adjusted by the user for height and tilt. The Neuropad allows the user to input patient data, control some aspects of the image, and record the case.
- C. Indications for Use
The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and/or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.
7
D. Tabular Comparison of Subject and Predicate Devices
| Characteristic | Application Device | Predicate Devices | | Impact on
Substantial
Equivalence |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| 510(k) | K230125 | K201308 | K203745 | |
| Regulation Number | 882.1480 | 882.1480 | 878.4400 | |
| Regulation Class | Class II | Class II | Class II | Same |
| Product Code | GWG | GWG | GEI | |
| Secondary Product Code | GEI | --- | --- | |
| Indications for Use | The Neuroblade System is a
neuroendoscopy system
indicated for the
illumination and
visualization of intracranial
tissue and fluids, controlled
aspiration of tissue and/or
fluid, powered cutting of
soft tissue, and coagulation
of tissue under direct
visualization during surgery
of the ventricular system or
cerebrum. | 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 and Cerebrum. | The AURORA Evacuator +
Coag is a powered
instrument with a
handpiece intended for
removal of soft tissue and
fluids, and coagulation of
tissue under direct
visualization.
Types of direct visualization
may include laparoscopic,
pelviscopic, endoscopic,
percutaneous, and open.
Applications include those
when access to the surgical
site is limited, such as
neurosurgical. | Same |
| Technology | - Endoscope provides
single channel for
irrigation, aspiration,
cutting along with tool
placement for
neurosurgical field
-
The distal end of the
scope has a camera + LED
lighting | - Endoscope provides
single channel for
irrigation, aspiration
along with tool
placement for
neurosurgical field -
The distal end of the
scope has a camera +
LED lighting | | Similar |
| Characteristic | Application Device | | Predicate Devices | Impact on
Substantial
Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| | - The reusable monitor
displays and records the
live imaging captured by
the endoscope camera -
Irrigation | - The reusable monitor
displays and records the
live imaging captured by
the endoscope camera -
Irrigation | - Irrigation lumen for
saline drip | |
| | - Removal of fluid by
suction lumen and relies
upon regulation hospital
vacuum for aspiration. | - Removal of fluid by
suction lumen and relies
upon regulated hospital
vacuum for aspiration. | - Removal of fluid by
suction lumen (wall
vacuum source) | |
| | - Rotating debrider
incorporated into the
suction lumen at distal
tip for removal of soft
tissue (i.e., blood clot)
powered by an electric
motor in the handle. -
Bipolar electrodes at | | - Rotating debrider
incorporated into the
suction lumen at distal
tip for removal of soft
tissue (i.e., blood clot)
powered by an electric
motor in the handle. -
Bipolar electrodes at | |
| | distal tip for coagulation
of tissue | | distal tip for coagulation
of tissue | |
| Available Modes | - Irrigation -
Suction/Aspiration
-
Suction with Cutting
Internal to Channel -
RF Coagulation | - Irrigation
-
Suction/Aspiration | - Irrigation
-
Suction/Aspiration
-
Suction with Cutting
Internal to Channel -
RF Coagulation | Same
All
Application
Modes can
be found in
the
predicate
devices |
| Patient Contacting Wand
Materials | SUS 304 | SUS 304, TPU | SUS 304 | Similar |
| Characteristic | Application Device | Predicate Devices | | Impact on
Substantial
Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| Working Length | 16.4 cm | Up to 20.0 cm with the
stopper mechanism
removed. | 7 – 13 cm | Different |
| Outside
Diameter (OD) | 18F
(6.1 mm) | 20F
(6.6 mm) | 12F
(4 mm) | Different |
| Aspiration Window | Window at side of distal end | Window at the distal end of
the distal tip | Window at side of distal end | Similar |
| Debrider | - Located internal at
aspiration window -
Scissoring action between
rotational inner cannula
and stationary outer
cannula -
SUS 304 | N/A | - Located and fully
contained rotating
debrider within inner
lumen at aspiration
window -
Flat member with
notches -
SUS 301 | Different |
| Power Source for Motor
for Internal Debrider | Electrically powered by
Neuroblade system | N/A | Battery located in handle-
one 6V Alkaline | Different |
| Vacuum Source | Endoscope vacuum tubing
connects to Operating Room
suction machine. | Endoscope vacuum tubing
connects to Operating Room
suction machine. | Connect to barb on device
handle to Operating Room
suction (i.e., wall) | Identical |
| Vacuum Control | Suction button on
handpiece that is fingertip
controlled. | Same | Same | Identical |
| Type | Bipolar | Not Applicable | Bipolar | |
| Shape | 2 rectangular components | --- | 2 rectangular components | |
| Material | Stainless steel with coating | --- | Silver | Same |
| Insulation | Polyphenylsulfone | --- | Polyphenylsulfone | |
| Rated Voltage | 450 Vp-p | --- | 450 Vp-p | |
| Power Source for Bipolar
Electrodes | Cable to electrosurgical
generator (external)
connected to AC mains.
Cable will include in the
system and Electrosurgical | Not Applicable | Cable to electrosurgical
generator (external)
connected to AC mains.
Cable and Electrosurgical
generator are third party | Similar |
| Characteristic | Application Device | Predicate Devices | | Impact on
Substantial
Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| | generator is third party
devices. | | devices. | |
| Irrigation | Capability for saline
irrigation delivery to distal
tip.
Irrigation rate controlled on
handle. | Capability for saline
irrigation delivery to distal
tip.
Irrigation rate controlled on
handle. | Capability for saline drip
irrigation delivery to distal
tip.
Connection on device
handle to saline bag with
line clamp for clinician to
control irrigation rate. | Similar |
| Main Components | Handpiece - Single Use
Display - Reusable
Cart - Reusable | Handpiece - Single Use
Display - Reusable
Cart - None | Single use | Same |
| Sterile | Handpiece- Sterile
Display - Nonsterile
Cart - Nonsterile | Handpiece - Sterile
Display - Nonsterile | Sterile | |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
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K230125 Page 5 of 10
9
10
11
E. Summary of Supporting Data
The following biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, bench testing, usability testing and animal testing have been conducted to provide evidence in support of the substantial equivalence determination.
| Test | Test Method Summary | Results |
|---|---|---|
| Biocompatibility: |
- Cytotoxicity (MEM Elution)
- Sensitization (Kligman Maximization)
- Irritation (intracutaneous Injection)
- Systemic toxicity (Systemic Injection)
- Materials Mediated Pyrogenicity
- Hemocompatibility s (Indirect Contact) | ISO 10993-1 Biological evaluation of medical devices –
Part 1: Evaluation and testing within a risk
management process per FDA biocompatibility
guidance | Pass |
| Electrical safety and Enclosure
Protection | IEC 60601-1 Medical electrical equipment — Part 1-
11: General requirements for basic safety and
essential performance — Collateral standard:
Requirements for medical electrical equipment and
medical electrical systems used in the home
healthcare environment.
IEC 60601-2-2 Medical electrical equipment
Part 2: Particular requirements for the basic safety
and essential performance of high frequency surgical
equipment and high frequency surgical accessories
IEC 60601-2-18 Medical electrical equipment - Part 2-
18: Particular requirements for the basic safety and
essential performance of endoscopic equipment
IEC 62471 Photobiological Safety of Lamps and Lamp
Systems | Pass |
| Emissions and Immunity | IEC 60601-1-2:2020 Medical electrical equipment -
Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and
tests
IEC 61000-4-39 Electromagnetic compatibility (EMC) -
Part 4-39: Testing and measurement techniques -
Radiated fields in close proximity - Immunity test | Pass |
| Sterilization Validation (SAL of 10-6) | ISO 11135-1 Sterilization of health care products –
Ethylene Oxide — Part 1: Requirements for
development, validation and routine control of a
sterilization process for medical devices | Pass |
| Packaging and Shelf Life | ISTA 2A simulation performance test procedure
ASTM F1980-16 Standard Guide for Accelerated Aging
of Sterile Barrier Systems for Medical Devices | Pass |
| Ex-vivo tissue studies (porcine brain, liver,
and kidney) | Demonstrated equivalent performance to the
predicate device by evaluating the correlation
between the power setting and the lesion size/tissue | Pass |
| | time to tissue temperature per power setting for the
subject device and predicate device. | |
| Software Test | In accordance with IEC 62304:2015, and FDA guidance
documents:
– "Guidance for the Content of Premarket
Submissions for Software Contained in Medical
Devices,"
– "Content of Premarket submissions for
Management of Cybersecurity in Medical
Devices,"
– "Off-the-Shelf Software Use in Medical Devices." | Pass |
| Bench Testing | Suction/Irrigation functionality
Debridement efficiency
Image orientation
Durability of feature
IPX testing
Evaluated device performance and demonstrated that
the subject device can accurately and consistently
deliver varying power across a range of power
settings. | Pass |
| Image Quality Test | ISO 12233:2017, Photography— Electronic still picture
imaging — Resolution and spatial frequency
responses
ISO 15739:2017, Photography — Electronic still-
picture imaging— Noise measurements
ISO 8600-1:2015 Endoscopes — Medical endoscopes
and endotherapy devices — Part 1: General
requirements
ISO 8600-3:2019 Endoscopes — Medical endoscopes
and endotherapy devices — Part 3: Determination of
field of view and direction of view of endoscopes with
optics
ISO 8600-4: Endoscopes — Medical endoscopes and
endotherapy devices — Part 4: Determination of
maximum width of insertion portion
ISO 8600-6: Endoscopes — Medical endoscopes and
endotherapy devices — Part 6: Vocabulary
FDA guidance: Color Performance Review Tool for
Endoscopy Devices
Demonstrated comparable color performance using
camera, optical system, image processing chip and
monitor when compared with predicate device. | Pass |
| Usability Study | Evaluated use for neurosurgeons of all integrated
functions of the Neuroblade System in a simulated
use model | Pass |
12
13
Animal Study
An animal study was conducted in accordance with the provisions of FDA Good Laboratory Practice (GLP) Regulations, 21 CFR 58, in a kaolin-induced experimental hydrocephalus porcine model. A hydrocephalus model was necessary to increase the volume of cerebrospinal fluid (CSF) to permit endoscopic neurosurgical procedures to be evaluated in the ventricles. Magnetic resonance imaging (MRI) was used to verify the increase in CSF volume prior to surgical procedures, which were performed 3-4 weeks after hydrocephalus induction. The safety and performance of the Neuroblade System was based on successful management of hemorrhage under endoscopic visualization in the cortex and ventricles. Five neurosurgeons evaluated the performance and handling of the Neuroblade System by manipulating various features simultaneously under bleeding conditions. The participants gave high scores to the usability elements included in the study survey. Necropsy and histopathology of the brain confirmed that the effects of using the Neuroblade System were limited to the surgical areas. The study results support the safety and performance of the Neuroblade System for the proposed intended use.
F. Conclusion
Based on intended use, performance and supporting documentation, the Neuroblade System is substantially equivalent in intended use, indications for use, technology, design, materials, physician use, and energy source to the predicate Axonpen System (K201308) and the AURORA Evacuator + Coag (K203745).