(269 days)
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 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 (≤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.
I am sorry, but the provided text does not contain the specific acceptance criteria for the device, nor the detailed results of a study that proves the device meets those criteria in a format that would allow me to populate the requested table directly. The document primarily describes the device, compares it to predicate devices, and lists various tests performed (biocompatibility, electrical safety, bench testing, an animal study, etc.) with a "Pass" result, but without specifying the quantitative or qualitative acceptance criteria for each of those tests or linking them to a comprehensive performance evaluation in the way requested.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance: While tests are listed, the specific criteria for "Pass" are not detailed, nor are numerical or descriptive performance metrics provided for each criterion.
- Sample size used for the test set and data provenance: A general animal study is mentioned, but specific sample sizes for particular performance tests are not given.
- Number of experts used to establish ground truth and their qualifications: Not explicitly stated for any specific test.
- Adjudication method: Not discussed.
- MRMC comparative effectiveness study: No mention of such a study or effect sizes of human reader improvement with AI. The device is a neuroendoscopy system, not an AI-assisted diagnostic tool.
- Standalone performance: The tests are generally standalone device performance evaluations, but the specific metrics are not provided as requested.
- Type of ground truth: For the animal study, necropsy and histopathology were used for confirmation, but for other tests, "ground truth" in the requested sense is not clearly defined.
- Sample size for the training set: Not applicable as this is not an AI/ML device with a separate training set.
- How ground truth for the training set was established: Not applicable.
The document mainly focuses on proving substantial equivalence to predicate devices through various engineering and safety tests, rather than presenting a clinical performance study with detailed acceptance criteria and results.
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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"
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(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
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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) 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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510(k) Summary
A. Device Information
| Category | Comments | ||
|---|---|---|---|
| Date Prepared: | October 12, 2023 | ||
| Applicant | ClearMind Biomedical5F., No. 167, Fuxing N. Rd., Songshan Dist., TaipeiCity 105, Taiwan, R.O.C.+886-2-2269-7417 | ||
| Primary Correspondent | Shaun LinSenior Regulatory Affairs SpecialistClearmind Biomedical5F., No. 167, Fuxing N. Rd., Songshan Dist., TaipeiCity 105, Taiwan, R.O.C.Phone: +886-2-2269-7417-108E-mail: Shaun@theclearmindgroup.com(preferred) | ||
| Secondary Correspondent | Craig CoombsCoombs Medical Device Consulting427 14th Ave,San Francisco, CA 94118Tel: 650-380-2474 | ||
| Device Classification & Name | 21 CFR 882.1480, Neurological endoscope21 CFR 878.4400, Electrosurgical cutting andcoagulation device and accessories | ||
| Device Classification & ProductCode | |||
| 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 |
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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 PremarketNotification # | K960455 |
| Reference Device Classification &Name | 21 CFR 878.4400, Electrosurgical cutting andcoagulation 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
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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.
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D. Tabular Comparison of Subject and Predicate Devices
| Characteristic | Application Device | Predicate Devices | Impact onSubstantialEquivalence | |
|---|---|---|---|---|
| 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 aneuroendoscopy systemindicated for theillumination andvisualization of intracranialtissue and fluids, controlledaspiration of tissue and/orfluid, powered cutting ofsoft tissue, and coagulationof tissue under directvisualization during surgeryof the ventricular system orcerebrum. | The Axonpen System isindicated for theillumination andvisualization of intracranialtissue and fluids and thecontrolled aspiration oftissue and/or fluid duringsurgery of the VentricularSystem and Cerebrum. | The AURORA Evacuator +Coag is a poweredinstrument with ahandpiece intended forremoval of soft tissue andfluids, and coagulation oftissue under directvisualization.Types of direct visualizationmay include laparoscopic,pelviscopic, endoscopic,percutaneous, and open.Applications include thosewhen access to the surgicalsite is limited, such asneurosurgical. | Same |
| Technology | - Endoscope providessingle channel forirrigation, aspiration,cutting along with toolplacement forneurosurgical field- The distal end of thescope has a camera + LEDlighting | - Endoscope providessingle channel forirrigation, aspirationalong with toolplacement forneurosurgical field- The distal end of thescope has a camera +LED lighting | Similar | |
| Characteristic | Application Device | Predicate Devices | Impact onSubstantialEquivalence | |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| - The reusable monitordisplays and records thelive imaging captured bythe endoscope camera- Irrigation | - The reusable monitordisplays and records thelive imaging captured bythe endoscope camera- Irrigation | - Irrigation lumen forsaline drip | ||
| - Removal of fluid bysuction lumen and reliesupon regulation hospitalvacuum for aspiration. | - Removal of fluid bysuction lumen and reliesupon regulated hospitalvacuum for aspiration. | - Removal of fluid bysuction lumen (wallvacuum source) | ||
| - Rotating debriderincorporated into thesuction lumen at distaltip for removal of softtissue (i.e., blood clot)powered by an electricmotor in the handle.- Bipolar electrodes at | - Rotating debriderincorporated into thesuction lumen at distaltip for removal of softtissue (i.e., blood clot)powered by an electricmotor in the handle.- Bipolar electrodes at | |||
| distal tip for coagulationof tissue | distal tip for coagulationof tissue | |||
| Available Modes | - Irrigation- Suction/Aspiration- Suction with CuttingInternal to Channel- RF Coagulation | - Irrigation- Suction/Aspiration | - Irrigation- Suction/Aspiration- Suction with CuttingInternal to Channel- RF Coagulation | SameAllApplicationModes canbe found inthepredicatedevices |
| Patient Contacting WandMaterials | SUS 304 | SUS 304, TPU | SUS 304 | Similar |
| Characteristic | Application Device | Predicate Devices | Impact onSubstantialEquivalence | |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| Working Length | 16.4 cm | Up to 20.0 cm with thestopper mechanismremoved. | 7 – 13 cm | Different |
| OutsideDiameter (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 ofthe distal tip | Window at side of distal end | Similar |
| Debrider | - Located internal ataspiration window- Scissoring action betweenrotational inner cannulaand stationary outercannula- SUS 304 | N/A | - Located and fullycontained rotatingdebrider within innerlumen at aspirationwindow- Flat member withnotches- SUS 301 | Different |
| Power Source for Motorfor Internal Debrider | Electrically powered byNeuroblade system | N/A | Battery located in handle-one 6V Alkaline | Different |
| Vacuum Source | Endoscope vacuum tubingconnects to Operating Roomsuction machine. | Endoscope vacuum tubingconnects to Operating Roomsuction machine. | Connect to barb on devicehandle to Operating Roomsuction (i.e., wall) | Identical |
| Vacuum Control | Suction button onhandpiece that is fingertipcontrolled. | 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 BipolarElectrodes | Cable to electrosurgicalgenerator (external)connected to AC mains.Cable will include in thesystem and Electrosurgical | Not Applicable | Cable to electrosurgicalgenerator (external)connected to AC mains.Cable and Electrosurgicalgenerator are third party | Similar |
| Characteristic | Application Device | Predicate Devices | Impact onSubstantialEquivalence | |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| generator is third partydevices. | devices. | |||
| Irrigation | Capability for salineirrigation delivery to distaltip.Irrigation rate controlled onhandle. | Capability for salineirrigation delivery to distaltip.Irrigation rate controlled onhandle. | Capability for saline dripirrigation delivery to distaltip.Connection on devicehandle to saline bag withline clamp for clinician tocontrol irrigation rate. | Similar |
| Main Components | Handpiece - Single UseDisplay - ReusableCart - Reusable | Handpiece - Single UseDisplay - ReusableCart - None | Single use | Same |
| Sterile | Handpiece- SterileDisplay - NonsterileCart - Nonsterile | Handpiece - SterileDisplay - Nonsterile | Sterile | |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
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K230125 Page 5 of 10
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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 riskmanagement process per FDA biocompatibilityguidance | Pass |
| Electrical safety and EnclosureProtection | IEC 60601-1 Medical electrical equipment — Part 1-11: General requirements for basic safety andessential performance — Collateral standard:Requirements for medical electrical equipment andmedical electrical systems used in the homehealthcare environment.IEC 60601-2-2 Medical electrical equipmentPart 2: Particular requirements for the basic safetyand essential performance of high frequency surgicalequipment and high frequency surgical accessoriesIEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety andessential performance of endoscopic equipmentIEC 62471 Photobiological Safety of Lamps and LampSystems | Pass |
| Emissions and Immunity | IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirements andtestsIEC 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 fordevelopment, validation and routine control of asterilization process for medical devices | Pass |
| Packaging and Shelf Life | ISTA 2A simulation performance test procedureASTM F1980-16 Standard Guide for Accelerated Agingof Sterile Barrier Systems for Medical Devices | Pass |
| Ex-vivo tissue studies (porcine brain, liver,and kidney) | Demonstrated equivalent performance to thepredicate device by evaluating the correlationbetween the power setting and the lesion size/tissue | Pass |
| time to tissue temperature per power setting for thesubject device and predicate device. | ||
| Software Test | In accordance with IEC 62304:2015, and FDA guidancedocuments:– "Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevices,"– "Content of Premarket submissions forManagement of Cybersecurity in MedicalDevices,"– "Off-the-Shelf Software Use in Medical Devices." | Pass |
| Bench Testing | Suction/Irrigation functionalityDebridement efficiencyImage orientationDurability of featureIPX testingEvaluated device performance and demonstrated thatthe subject device can accurately and consistentlydeliver varying power across a range of powersettings. | Pass |
| Image Quality Test | ISO 12233:2017, Photography— Electronic still pictureimaging — Resolution and spatial frequencyresponsesISO 15739:2017, Photography — Electronic still-picture imaging— Noise measurementsISO 8600-1:2015 Endoscopes — Medical endoscopesand endotherapy devices — Part 1: GeneralrequirementsISO 8600-3:2019 Endoscopes — Medical endoscopesand endotherapy devices — Part 3: Determination offield of view and direction of view of endoscopes withopticsISO 8600-4: Endoscopes — Medical endoscopes andendotherapy devices — Part 4: Determination ofmaximum width of insertion portionISO 8600-6: Endoscopes — Medical endoscopes andendotherapy devices — Part 6: VocabularyFDA guidance: Color Performance Review Tool forEndoscopy DevicesDemonstrated comparable color performance usingcamera, optical system, image processing chip andmonitor when compared with predicate device. | Pass |
| Usability Study | Evaluated use for neurosurgeons of all integratedfunctions of the Neuroblade System in a simulateduse model | Pass |
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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).
§ 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).