cCeLL - In vivo

K233391 · VPIX Medical, Inc. · GWG · Aug 21, 2024 · Neurology

Device Facts

• Record ID: K233391
• Device Name: cCeLL - In vivo
• Applicant: VPIX Medical, Inc.
• Product Code: GWG · Neurology
• Decision Date: Aug 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.

Device Story

cCeLL - In vivo is an optic scanner probe for real-time NIR fluorescence imaging during adult neurosurgery. System components: 6 mm Pixection ICG/NIR Endoscope (0°), NIR light source, photo-multiplier tube, and sterile probe sheath. Operation: probe contacts tissue/bone; irradiates tissue with laser; measures fluorescence intensity from ICG-injected tissue; generates 2D images of internal microstructure (depth of several hundred µm). Output: real-time HD images displayed on medical-grade monitor (DVI-D/RGB input). Used by neurosurgeons to visualize vessels and blood flow; aids in identifying tumor sites and surrounding tissue during biopsy/resection. Benefits: provides intraoperative visualization of micro- and macro-vasculature to guide surgical decision-making.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including image sensitivity analysis in a small animal model, detection linearity, geometric distortion, dynamic range, illumination/detection uniformity, SNR, sensitivity, and video latency. Biocompatibility, sterility, shelf-life, and electrical safety/EMC testing were performed per recognized standards.

Technological Characteristics

System includes 6 mm Pixection ICG/NIR Endoscope (0°), NIR light source, photo-multiplier tube, and sterile probe sheath. Connectivity: DVI-D or RGB input for HD monitors. Sterilization: Ethylene Oxide (ISO 11135). Biocompatibility: ISO 10993-1. Electrical safety: IEC 60601-1, IEC 60601-1-2. Software: Enhanced level of concern.

Indications for Use

Indicated for adult patients undergoing cranial diagnostic and therapeutic procedures (e.g., tumor biopsy, resection) to visualize cerebrovasculature (micro- and macro-vasculature) and blood flow using indocyanine green (ICG) fluorescence imaging.

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

• KARL STORZ ICG Imaging System (K180146)

Submission Summary (Full Text)

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August 21, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

VPIX Medical, Inc. % Dawn N. Norman, M.S. Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112

Re: K233391

Trade/Device Name: cCeLL - In vivo Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: July 18, 2024 Received: July 22, 2024

Dear Dawn Norman:

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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Adam D Pierce -S

Digitally signed by Adam D. Pierce -S Date: 2024.08.21 15:25:30 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices

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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) K233391

Device Name cCeLL - In vivo

### Indications for Use (Describe)

The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# K233391 510(k) Summary

### i. Submitter Information

ii.

iii.

| Submitter: | VPIX Medical, Inc. |
|-------------------------|-------------------------------------|
| | 774, Gyeryong-ro, Jung-gu |
| | Daejeon, 34873 |
| | Republic of Korea |
| Contact Person: | Kyungmin Hwang, President |
| Submitter: | Jin Hee Byon, RA Team Leader |
| Email: | [e-mail] |
| Phone: | [phone] |
| Official Correspondent: | Dawn Norman, MS |
| Email: | [e-mail] |
| Phone: | 01-618-604-3064 |
| Date Prepared: | August 17, 2024 |
| Device Name | |
| Proprietary Name: | cCeLL - In vivo |
| Manufacturer: | VPIX Medical, Inc. |
| Common Name: | Neurological Endoscope |
| Classification Name: | Endoscope, Neurological |
| Regulation Number: | 21 CFR 882.1480; 21 CFR 876.1500 |
| Device Class: | Class II |
| Product Code: | GWG (Primary) |
| | OWN (Secondary) |
| | |
| Predicate Devices | |
| 510(k) Number: | K180146 |
| Proprietary Name: | KARL STORZ ICG Imaging System |
| Manufacturer | KARL STORZ Endoskopie-America, Inc. |

Manufacturer: Common Name: Classification Name: Regulation Number: Device Class: Product Code:

KARL STORZ Endoscopy-America, Inc. Neurological Endoscope Endoscope, Neurological 21 CFR 882.1480; 21 CFR 876.1500 Class II GWG, OWN

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#### iv. Device Description

The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.

The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.

### V. Principle of Operation / Mechanism of Action

This product irradiates the tissue with a laser by contacting the probe to the suspected tumor site of a patient injected with indocyanine green. It is a medical fluorescence imaging device that measures the intensity of the fluorescence signal emitted from the tissue and images the cells of the tissue. It has a function to acquire an image of a part corresponding to an area of several hundred um of tissue at a depth of several to several hundred um by using fluorescence and shows a two-dimensional image through the provided software.

#### vi. Indications for Use

The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.

#### vii. Summary of Substantial Equivalence

The similarities between subject device and predicate device are as follows: Both devices provide images of NIR Indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.

Both can be used with any medical grade HD monitor with a DVI-D input.

The differences between subject device and predicate device are as follows:

The predicate also provides fluorescence during plastic, micro- and reconstructive surgical procedures in adults and pediatric populations. The predicate allows use of a medical grade HD monitor with 3G-SDI input. The predicate device is supplied with an ICG kit while the subject device is not.

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# Substantial Equivalence Table:

| | Subject Device | Predicate Device | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233391 | K180146 | N/A |
| Device<br>Identification | Trade Name: cCeLL - In vivo<br>Classification Name: Neurological Endoscope | Trade Name: KARL STORZ ICG Imaging System<br>Classification Name: Neurological Endoscope | N/A |
| Product Code | GWG, OWN | GWG, OWN | Identical |
| Regulation | 21 CFR 876.1480<br>(Neurological Endoscope) | 21 CFR 876.1480<br>(Neurological Endoscope) | Identical |
| Device<br>Description | The cCeLL - In vivo is used to provide real-time<br>high-definition (HD) endoscopic images of near-<br>infrared (NIR) indocyanine green (ICG) dye<br>fluorescence during minimally invasive,<br>neurosurgery in adults.<br><br>The overall system includes a 6 mm Pixection<br>ICG/NIR Endoscope (0°) for use in<br>neurosurgery, a light source for emission of NIR<br>illumination, a photo-multiplier tube capable of<br>capturing NIR imaging, and a sterile probe<br>sheath. | The KARL STORZ ICG Imaging System is used to<br>provide real-time high-definition (HD)<br>endoscopic or telescopic images of visible (VIS)<br>and near-infrared (NIR) indocyanine green (ICG)<br>dye fluorescence during minimally invasive,<br>neuro- and endonasal skull base surgery as well<br>as plastic, micro- and reconstructive surgical<br>procedures in general and pediatric populations.<br><br>The overall system includes a 4mm HOPKINS<br>ICG/NIR Endoscope (0°, 30° or 45°) for use in<br>neuro- and endonasal skull base surgery, a 5mm<br>& 10mm HOPKINS ICG/NIR Endoscope (0° or<br>30°) for use in minimally invasive procedures<br>and a VITOM II ICG/NIR Telescope for use in<br>plastic, micro- and reconstructive surgical<br>procedures for VIS and NIR illumination and<br>imaging, a light source with foot switch for<br>emission of VIS and NIR illumination, a color<br>video camera head capable of capturing both<br>VIS and NIR imaging, and a KARL STORZ ICG Kit.<br>Additional accessories used with the KARL<br>STORZ ICG Imaging System include two<br>standards fiber-optic light cables for<br>transmission of VIS and NIR light and the<br>Image1 S Camera Control Unit (CCU). | Similarities<br>Both devices provide HD<br>images of NIR<br>Indocyanine green (ICG)<br>dye fluorescence during<br>minimally invasive,<br>neuro- and endonasal<br>skull base surgery in<br>adults.<br><br>Both can be used with<br>any medical grade HD<br>monitor with a DVI-D<br>input.<br><br>Differences<br>The predicate also<br>provides fluorescence<br>during plastic, micro-<br>and reconstructive<br>surgical procedures in<br>pediatric populations.<br><br>The predicate allows use<br>of a medical grade HD<br>monitor with 3G-SDI<br>input. |
| | Subject Device | Predicate Device | Comparison |
| | The cCeLL - In vivo can be used with any<br>medical grade HD monitor with a DVI-D or RGB<br>input. | The KARL STORZ ICG Imaging System can be<br>used with any medical grade HD monitor with a<br>DVI-D or 3G-SDI input. | The predicate device is<br>supplied with an ICG kit<br>while the subject device<br>is not. |
| Intended Use | The cCeLL - In vivo is intended to provide real-<br>time near-infrared fluorescence imaging. | The KARL STORZ ICG Imaging System is intended<br>to provide real-time visible and near-infrared<br>fluorescence imaging. | Identical except the<br>predicate provides<br>visible fluorescence<br>imaging. |
| Indications for<br>Use | The cCeLL - In vivo is an optic scanner probe<br>placed in direct contact with tissue to create<br>images of the internal microstructure of tissues<br>and is indicated for use with indocyanine green<br>(ICG) for fluorescence imaging as an aid in the<br>visualization of vessels (micro- and macro-<br>vasculature) blood flow in the<br>cerebrovasculature before, during or after<br>cranial diagnostic and therapeutic procedures,<br>such as tumor biopsy and resection. | The KARL STORZ Endoscopic ICG System enables<br>surgeons to perform minimally invasive surgery<br>using standard endoscopic visible light as well as<br>visual assessment of vessels, blood flow and<br>related tissue perfusion, or at least one of the<br>major extra-hepatic bile ducts (cystic duct,<br>common bile duct and common hepatic duct),<br>using near infrared imaging. Fluorescence<br>imaging of biliary ducts with the KARL STORZ<br>Endoscopic ICG System is intended for use with<br>standard of care white light and, when<br>indicated, intraoperative cholangiography. The<br>device is not intended for standalone use for<br>biliary duct visualization. | Similarities<br>Both use HD images of<br>NIR Indocyanine green<br>(ICG) dye fluorescence<br>during minimally<br>invasive, neuro- and<br>endonasal skull base<br>surgery in adults.<br>Both can be used with<br>any medical grade HD<br>monitor with a DVI-D<br>input. |
| | | Additionally, the KARL STORZ Endoscopic ICG<br>System enables surgeon to perform minimally<br>invasive cranial neurosurgery in adults and<br>pediatrics and endonasal skull base surgery in<br>adults and pediatrics > 6 years of age using<br>standard endoscopic visible light as well as<br>visual assessment of vessels, blood flow and<br>related tissue perfusion using near infrared<br>imaging.<br>The KARL STORZ VITOM II ICG System is<br>intended for capturing and viewing fluorescent<br>images for the visual assessment of blood flow, | Differences<br>The predicate is<br>indicated for pediatrics<br>cranial neurosurgery and<br>endonasal skull base<br>surgery in adults and<br>pediatrics > 6 years of<br>age.<br>The predicate has<br>multiple light and<br>visualization options.<br>The predicate also |
| | | as an adjunctive method for the evaluation of | The predicate also |
| | Subject Device | Predicate Device | Comparison |
| | | tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light. | provides fluorescence during plastic, micro- and reconstructive surgical procedures in general and pediatric populations.<br>The predicate allows use of a medical grade HD monitor with 3G-SDI input. |
| | The cCeLL - In vivo includes the following components and accessories: | The KARL STORZ ICG Imaging System includes the following components and accessories: | Similarities<br>Both devices use a camera and optical fiber light source to process images. |
| | Main Unit<br>(for NIR illumination and capturing) Pixection (for endoscope) Sterile Probe Sheath | 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes VITOM II ICG Telescope Camera Head (H3Z-FI) Fiber optic Light Cables Light Source Image1 S CCU | |
| Technological<br>Characteristics | The Pixection is intended to be connected to the Main Unit, which connects to the PC for image processing, as well as to the light source via optical fiber as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed using NIR imaging for visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed initially using VIS imaging. NIR imaging is selected when visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | Differences<br>The predicate uses VIS while the subject device uses NIR for Visualization and navigation. |

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#### viiii. Performance Testing

Verification and validation testing demonstrated that the subject device conforms to the recognized safety standards, design input specifications and intended use consistent with the predicate device.

| Test | Test Method Summary | Results |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Sensitivity<br>Analysis | Validate the device's ability to visualize cerebral microstructures and<br>vascular systems, including tumor tissue, surrounding normal tissue, blood<br>vessels using clinically relevant ICG concentrations in a small animal model. | The study confirmed that the device effectively<br>visualized cerebral microstructures and vascular<br>systems across a range of clinically relevant ICG<br>concentrations. PASS |
| Image<br>Comparison<br>Analysis | Comparison of the fluorescence signal between the subject and predicate<br>device, following ICG injection in a small animal model, was conducted to<br>determine if the subject device performs equivalently to the predicate<br>device in visualizing vessels of various sizes and changes in blood flow. | The study confirmed that the subject device can<br>visualize vessels of various sizes and changes in<br>blood flow with image quality comparable to the<br>predicate device, as assessed across users with a<br>range of experience. PASS |
| Detection<br>Linearity | To verify the device's accuracy and reliability in capturing fluorescence<br>intensity, detection linearity was assessed by measuring optical power and<br>brightness at various increments for both the predicate and subject<br>devices. | The detection linearity test demonstrated<br>equivalent performance to the predicate device.<br>PASS |
| Geometric<br>Distortion | To verify the device's accuracy and reliability in capturing fluorescence<br>intensity with respect to geometric distortion, the power was measured<br>using an optical power meter and radial distortion was calculated from the<br>acquired image. Performance testing conducted with the predicate and<br>subject devices. | The geometric distortion test demonstrated<br>equivalent performance to the predicate device.<br>PASS |
| Dynamic Range | To verify the device's gradation performance in capturing fluorescence<br>intensity across its dynamic range, optical power and brightness were set,<br>fluorescent target removed and the dynamic range was calculated using<br>the acquired image. Performance testing conducted with the predicate and<br>subject devices. | The dynamic range test demonstrated equivalent<br>performance to the predicate device. PASS |
| Illumination &<br>Detection<br>Uniformity | To verify the device's accuracy and reliability in capturing fluorescence<br>intensity, illumination and detection uniformity, the average intensity of<br>each fluorescent dot in the region of interest [diagnostic area] and the | Testing measuring illumination and detection<br>uniformity demonstrated equivalent performance<br>to the predicate device. PASS |
| Test | Test Method Summary | Results |
| | illumination uniformity were calculated using the acquired image.<br>Performance testing conducted with the predicate and subject devices. | |
| SNR &<br>Sensitivity | To verify the device's sensing ability in capturing fluorescence intensity,<br>images were acquired and the signal to noise ratio (SNR) and sensitivity<br>were calculated. Performance testing conducted with the predicate and<br>subject devices. | SNR & sensitivity test demonstrated equivalent<br>performance to the predicate device. PASS |
| Video Latency | To verify the device's dynamic vision capability in capturing fluorescence<br>intensity, video latency was assessed by recoding the initialization and<br>stoppage of motion on the screen and calculating the latency. Performance<br>testing conducted with the predicate and subject devices. | The test results demonstrated equivalent<br>performance to the predicate device.<br>PASS |
| Sterile Probe<br>Sheath Tear<br>Resistance | To verify the robustness of SPS (Sterile Probe Sheath) tear resistance of the<br>SPS was tested for breaking strength at different join interfaces on aged<br>samples. | The test resutls demonstrated that the SPS can<br>withstand forces greater than those expected<br>during clinical use. PASS |
| Electrical Safety<br>/ EMC | IEC 60601-1:2005 + A1:2012 + A2:2021 Medical electrical equipment – Part<br>1: General requirements for basic safety and essential performance<br>IEC 60601-1-2 : 2014 + A1:2020, Medical Electrical Equipment - Part 1-2:<br>General requirements for basic safety and essential performance -<br>Electromagnetic Compatibility | PASS |
| Software /<br>Cybersecurity<br>(Enhanced Level) | FDA's Guidance for Industry and FDA Staff, "Content of Premarket<br>Submissions for Device Software Functions" issued June 14, 2023.<br>FDA guidance's Cybersecurity in Medical Devices: Quality System<br>Considerations and Content of Premarket Submissions, Postmarket<br>Management of Cybersecurity in Medical Devices. | PASS |
| Biocompatibility | Per FDA's Guidance "Use of International Standard ISO 10993-1, "Biological<br>evaluation of medical devices - Part 1: Evaluation and testing within a risk<br>management process", the single use Sterile Probe Sheath (SPS) is<br>categorized as an external communicating device in contact with<br>tissue/bone/dentin for <24 hours. | Biocompatibility testing in accordance with FDA's<br>biocompatibility guidance demonstrated that the<br>patient-contacting components are<br>biocompatible. PASS |
| Test | Test Method Summary | Results |
| | The following biocompatibility endpoints were evaluated: | |
| | Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Material medicated pyrogenicity<br>Hemocompatibility (indirect)<br>Neurotoxicity | |
| Sterility / Shelf<br>Life | ISO 11135:2014 + Amd1:2018 Sterilization of health care product –<br>Ethylene Oxide – Requirements for development, validation and routine<br>control of a sterilization process for medical devices | Sterilization and shelf-life testing of the Sterile<br>Probe Sheath (SPS) demonstrated the device is<br>and can remain sterile and functional for the<br>documented shelf life. PASS |
| | ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier<br>Systems and Medical Devices | |
| | ISO 11607–1:2019 Packaging for terminally sterilized medical devices - Part<br>1: Requirements for materials, sterile barrier systems and packaging<br>systems were used to validate the shelf life. | |

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#### ix. Conclusion

Based on the similarities of the indications for use, device design, principles of operation, technological characteristics and the results of the non-clinical performance testing, the substantially equivalent to the legally marketed predicate device and does not raise new concerns of safety and effectiveness.