Neuroblade System

K230125 · Clearmind Biomedical · GWG · Oct 13, 2023 · Neurology

Device Facts

• Record ID: K230125
• Device Name: Neuroblade System
• Applicant: Clearmind Biomedical
• Product Code: GWG · Neurology
• Decision Date: Oct 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Neuroblade System is a hand-held, sterile neuroendoscope for intracranial surgery. Device inputs include visual data from a distal camera/LED and manual control of irrigation/aspiration/cutting/coagulation. The system transforms visual inputs into live images displayed on a reusable Neuropad monitor. It features an integrated bipolar electrode for RF coagulation (via third-party generator) and a rotating debrider for soft tissue removal. Used in the OR by neurosurgeons, the device is inserted through a burr hole. The Neuropad allows for patient data input, image control, and case recording. The system facilitates surgical site visualization and tissue management, potentially improving surgical outcomes by enabling precise, minimally invasive intracranial procedures.

Clinical Evidence

Evidence includes bench testing (biocompatibility, electrical safety, sterilization, image quality, and mechanical functionality) and a GLP-compliant animal study. The porcine hydrocephalus model study (n=5 neurosurgeons) evaluated safety and performance during simulated hemorrhage management. Results confirmed successful visualization and tissue handling, with histopathology showing effects limited to surgical areas. No human clinical data provided.

Technological Characteristics

Components: Handpiece (sterile, single-use), Neuropad (reusable), Cart. Materials: SUS 304, Polyphenylsulfone. Sensing: CMOS camera, LED illumination. Energy: RF (bipolar, 450 Vp-p), electric motor for debrider. Connectivity: Wired connection to Neuropad and third-party RF generator. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for illumination, visualization, aspiration, powered soft tissue cutting, and coagulation during surgery of the ventricular system or cerebrum.

Regulatory Classification

Identification

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

Predicate Devices

• Axonpen System (K201308)
• AURORA Evacuator + Coag (K203745)

Reference Devices

• Kirwan Bipolar Suction Coagulator (K960455)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
|------------------------------------------------------------------------------------------------|---------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) Summary

# A. Device Information

| Category | Comments | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 12, 2023 | | |
| Applicant | ClearMind Biomedical<br>5F., No. 167, Fuxing N. Rd., Songshan Dist., Taipei<br>City 105, Taiwan, R.O.C.<br>[phone] | | |
| | Primary Correspondent | Shaun Lin<br>Senior Regulatory Affairs Specialist<br>Clearmind Biomedical<br>5F., No. 167, Fuxing N. Rd., Songshan Dist., Taipei<br>City 105, Taiwan, R.O.C.<br>Phone: [phone]<br>E-mail: [e-mail]<br>(preferred) | |
| | | Secondary Correspondent | Craig Coombs<br>Coombs Medical Device Consulting<br>427 14th Ave,<br>San Francisco, CA 94118<br>Tel: [phone] |
| Device Classification & Name | | | 21 CFR 882.1480, Neurological endoscope<br>21 CFR 878.4400, Electrosurgical cutting and<br>coagulation device and accessories |
| | | | Device Classification & Product<br>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<br>Notification # | K960455 |
| Reference Device Classification &<br>Name | 21 CFR 878.4400, Electrosurgical cutting and<br>coagulation device and accessories |
| Reference Device Classification &<br>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<br>Substantial<br>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<br>neuroendoscopy system<br>indicated for the<br>illumination and<br>visualization of intracranial<br>tissue and fluids, controlled<br>aspiration of tissue and/or<br>fluid, powered cutting of<br>soft tissue, and coagulation<br>of tissue under direct<br>visualization during surgery<br>of the ventricular system or<br>cerebrum. | The Axonpen System is<br>indicated for the<br>illumination and<br>visualization of intracranial<br>tissue and fluids and the<br>controlled aspiration of<br>tissue and/or fluid during<br>surgery of the Ventricular<br>System and Cerebrum. | The AURORA Evacuator +<br>Coag is a powered<br>instrument with a<br>handpiece intended for<br>removal of soft tissue and<br>fluids, and coagulation of<br>tissue under direct<br>visualization.<br>Types of direct visualization<br>may include laparoscopic,<br>pelviscopic, endoscopic,<br>percutaneous, and open.<br>Applications include those<br>when access to the surgical<br>site is limited, such as<br>neurosurgical. | Same |
| Technology | - Endoscope provides<br>single channel for<br>irrigation, aspiration,<br>cutting along with tool<br>placement for<br>neurosurgical field<br><br>- The distal end of the<br>scope has a camera + LED<br>lighting | - Endoscope provides<br>single channel for<br>irrigation, aspiration<br>along with tool<br>placement for<br>neurosurgical field<br><br>- The distal end of the<br>scope has a camera +<br>LED lighting | | Similar |
| Characteristic | Application Device | | Predicate Devices | Impact on<br>Substantial<br>Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| | - The reusable monitor<br>displays and records the<br>live imaging captured by<br>the endoscope camera<br>- Irrigation | - The reusable monitor<br>displays and records the<br>live imaging captured by<br>the endoscope camera<br>- Irrigation | - Irrigation lumen for<br>saline drip | |
| | - Removal of fluid by<br>suction lumen and relies<br>upon regulation hospital<br>vacuum for aspiration. | - Removal of fluid by<br>suction lumen and relies<br>upon regulated hospital<br>vacuum for aspiration. | - Removal of fluid by<br>suction lumen (wall<br>vacuum source) | |
| | - Rotating debrider<br>incorporated into the<br>suction lumen at distal<br>tip for removal of soft<br>tissue (i.e., blood clot)<br>powered by an electric<br>motor in the handle.<br>- Bipolar electrodes at | | - Rotating debrider<br>incorporated into the<br>suction lumen at distal<br>tip for removal of soft<br>tissue (i.e., blood clot)<br>powered by an electric<br>motor in the handle.<br>- Bipolar electrodes at | |
| | distal tip for coagulation<br>of tissue | | distal tip for coagulation<br>of tissue | |
| Available Modes | - Irrigation<br>- Suction/Aspiration<br>- Suction with Cutting<br>Internal to Channel<br>- RF Coagulation | - Irrigation<br>- Suction/Aspiration | - Irrigation<br>- Suction/Aspiration<br>- Suction with Cutting<br>Internal to Channel<br>- RF Coagulation | Same<br>All<br>Application<br>Modes can<br>be found in<br>the<br>predicate<br>devices |
| Patient Contacting Wand<br>Materials | SUS 304 | SUS 304, TPU | SUS 304 | Similar |
| Characteristic | Application Device | Predicate Devices | | Impact on<br>Substantial<br>Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| Working Length | 16.4 cm | Up to 20.0 cm with the<br>stopper mechanism<br>removed. | 7 – 13 cm | Different |
| Outside<br>Diameter (OD) | 18F<br>(6.1 mm) | 20F<br>(6.6 mm) | 12F<br>(4 mm) | Different |
| Aspiration Window | Window at side of distal end | Window at the distal end of<br>the distal tip | Window at side of distal end | Similar |
| Debrider | - Located internal at<br>aspiration window<br>- Scissoring action between<br>rotational inner cannula<br>and stationary outer<br>cannula<br>- SUS 304 | N/A | - Located and fully<br>contained rotating<br>debrider within inner<br>lumen at aspiration<br>window<br>- Flat member with<br>notches<br>- SUS 301 | Different |
| Power Source for Motor<br>for Internal Debrider | Electrically powered by<br>Neuroblade system | N/A | Battery located in handle-<br>one 6V Alkaline | Different |
| Vacuum Source | Endoscope vacuum tubing<br>connects to Operating Room<br>suction machine. | Endoscope vacuum tubing<br>connects to Operating Room<br>suction machine. | Connect to barb on device<br>handle to Operating Room<br>suction (i.e., wall) | Identical |
| Vacuum Control | Suction button on<br>handpiece that is fingertip<br>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<br>Electrodes | Cable to electrosurgical<br>generator (external)<br>connected to AC mains.<br>Cable will include in the<br>system and Electrosurgical | Not Applicable | Cable to electrosurgical<br>generator (external)<br>connected to AC mains.<br>Cable and Electrosurgical<br>generator are third party | Similar |
| Characteristic | Application Device | Predicate Devices | | Impact on<br>Substantial<br>Equivalence |
| Device | Neuroblade System | Axonpen System | AURORA Evacuator + Coag | |
| | generator is third party<br>devices. | | devices. | |
| Irrigation | Capability for saline<br>irrigation delivery to distal<br>tip.<br>Irrigation rate controlled on<br>handle. | Capability for saline<br>irrigation delivery to distal<br>tip.<br>Irrigation rate controlled on<br>handle. | Capability for saline drip<br>irrigation delivery to distal<br>tip.<br>Connection on device<br>handle to saline bag with<br>line clamp for clinician to<br>control irrigation rate. | Similar |
| Main Components | Handpiece - Single Use<br>Display - Reusable<br>Cart - Reusable | Handpiece - Single Use<br>Display - Reusable<br>Cart - None | Single use | Same |
| Sterile | Handpiece- Sterile<br>Display - Nonsterile<br>Cart - Nonsterile | Handpiece - Sterile<br>Display - Nonsterile | Sterile | |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |

{8}------------------------------------------------

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:<br>- Cytotoxicity (MEM Elution)<br>- Sensitization (Kligman Maximization)<br>- Irritation (intracutaneous Injection)<br>- Systemic toxicity (Systemic Injection)<br>- Materials Mediated Pyrogenicity<br>- Hemocompatibility s (Indirect Contact) | ISO 10993-1 Biological evaluation of medical devices –<br>Part 1: Evaluation and testing within a risk<br>management process per FDA biocompatibility<br>guidance | Pass |
| Electrical safety and Enclosure<br>Protection | IEC 60601-1 Medical electrical equipment — Part 1-<br>11: General requirements for basic safety and<br>essential performance — Collateral standard:<br>Requirements for medical electrical equipment and<br>medical electrical systems used in the home<br>healthcare environment.<br><br>IEC 60601-2-2 Medical electrical equipment<br>Part 2: Particular requirements for the basic safety<br>and essential performance of high frequency surgical<br>equipment and high frequency surgical accessories<br><br>IEC 60601-2-18 Medical electrical equipment - Part 2-<br>18: Particular requirements for the basic safety and<br>essential performance of endoscopic equipment<br>IEC 62471 Photobiological Safety of Lamps and Lamp<br>Systems | Pass |
| Emissions and Immunity | IEC 60601-1-2:2020 Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and<br>tests<br><br>IEC 61000-4-39 Electromagnetic compatibility (EMC) -<br>Part 4-39: Testing and measurement techniques -<br>Radiated fields in close proximity - Immunity test | Pass |
| Sterilization Validation (SAL of 10-6) | ISO 11135-1 Sterilization of health care products –<br>Ethylene Oxide — Part 1: Requirements for<br>development, validation and routine control of a<br>sterilization process for medical devices | Pass |
| Packaging and Shelf Life | ISTA 2A simulation performance test procedure<br>ASTM F1980-16 Standard Guide for Accelerated Aging<br>of Sterile Barrier Systems for Medical Devices | Pass |
| Ex-vivo tissue studies (porcine brain, liver,<br>and kidney) | Demonstrated equivalent performance to the<br>predicate device by evaluating the correlation<br>between the power setting and the lesion size/tissue | Pass |
| | time to tissue temperature per power setting for the<br>subject device and predicate device. | |
| Software Test | In accordance with IEC 62304:2015, and FDA guidance<br>documents:<br>– "Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical<br>Devices,"<br>– "Content of Premarket submissions for<br>Management of Cybersecurity in Medical<br>Devices,"<br>– "Off-the-Shelf Software Use in Medical Devices." | Pass |
| Bench Testing | Suction/Irrigation functionality<br>Debridement efficiency<br>Image orientation<br>Durability of feature<br>IPX testing<br>Evaluated device performance and demonstrated that<br>the subject device can accurately and consistently<br>deliver varying power across a range of power<br>settings. | Pass |
| Image Quality Test | ISO 12233:2017, Photography— Electronic still picture<br>imaging — Resolution and spatial frequency<br>responses<br><br>ISO 15739:2017, Photography — Electronic still-<br>picture imaging— Noise measurements<br><br>ISO 8600-1:2015 Endoscopes — Medical endoscopes<br>and endotherapy devices — Part 1: General<br>requirements<br><br>ISO 8600-3:2019 Endoscopes — Medical endoscopes<br>and endotherapy devices — Part 3: Determination of<br>field of view and direction of view of endoscopes with<br>optics<br><br>ISO 8600-4: Endoscopes — Medical endoscopes and<br>endotherapy devices — Part 4: Determination of<br>maximum width of insertion portion<br><br>ISO 8600-6: Endoscopes — Medical endoscopes and<br>endotherapy devices — Part 6: Vocabulary<br><br>FDA guidance: Color Performance Review Tool for<br>Endoscopy Devices<br><br>Demonstrated comparable color performance using<br…