Clear Guide SCENERGY

K234030 · Clear Guide Medical · JAK · Jan 17, 2024 · Radiology

Device Facts

• Record ID: K234030
• Device Name: Clear Guide SCENERGY
• Applicant: Clear Guide Medical
• Product Code: JAK · Radiology
• Decision Date: Jan 17, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The device is a stereotaxic accessory intended to provide fusion of images from certain imaging modalities. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

Device Story

Software system for image-guided procedures; inputs include real-time ultrasound stream, static CT/MRI volumes, and video feed from Clear Guide Optical Head. Uses optical detection of rigid instruments and fiducial markers to track position. Proprietary algorithms perform automated segmentation and registration to fuse static volumetric data with real-time imaging. Displays fused images and guidance overlays on a clinical monitor. Used by physicians in clinical settings for needle-based interventions (e.g., biopsy, ablation). Provides real-time visual feedback of target regions and instrument path, accounting for patient movement/deformation. Benefits include improved accuracy and navigation during interventional procedures.

Clinical Evidence

Clinical validation study (NCT05573048) with 10 patients. Evaluated workflow, intervention accuracy, and safety of modifications (transperineal grid support). Results confirmed device accurately achieved intended use; no adverse effects or new risks observed compared to cadaveric prostate ablation experiments.

Technological Characteristics

Optical detection via stereo cameras; software-based image fusion of static (CT/MRI) and real-time (US) data. Hardware: Clear Guide CORE and Optical Head (compliant with ES60601-1, IEC 60601-1-2). Connectivity: Integrated with ultrasound machines. Accessories: SteriMASK, VisiMARKER, TP Access tool, SteriGRID. Software: Automated segmentation and registration algorithms. Non-sterile.

Indications for Use

Indicated for fusion of CT, MR, and US images in patients ≥ 25 kg. US images can be fused with CT or MR. Used in interventional/diagnostic procedures (excluding brain) to display target regions and projected path of interventional instruments (e.g., biopsy/ablation needles) using Clear Guide CORE and Optical Head platform, accounting for patient movement/deformation.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Clear Guide SCENERGY (K201188)

Submission Summary (Full Text)

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January 17, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

Clear Guide Medical % Alican Demir Principal Engineer / Director of Quality Systems 3600 Clipper Mill Road, Suite 400 BALTIMORE, MD 21211

Re: K234030

Trade/Device Name: Clear Guide SCENERGY Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, IYO, LLZ, ITX Dated: November 12, 2023 Received: December 20, 2023

Dear Alican Demir:

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" (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).

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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 QS 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).

Sincerelv.

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K234030

Device Name Clear Guide SCENERGY

#### Indications for Use (Describe)

The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT). Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the intervent, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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# K234030

Image /page/3/Picture/1 description: The image is a logo for Clear Guide Medical. The logo consists of a stylized image of a needle and the words "CLEAR GUIDE MEDICAL" in bold, sans-serif font. The words "CLEAR GUIDE" are in black, and the word "MEDICAL" is in gray.

# 510(k) Summary

(per 21 CFR § 807.92)

# Submitter's Information

| Name | Clear Guide Medical, Inc. |
|----------------|-----------------------------------------------------------------------|
| Address | 3600 Clipper Mill Road, Suite 400<br>Baltimore, MD 21211 USA |
| Phone Number | [phone] |
| Contact Person | Alican Demir, PhD<br>Principal Engineer / Director of Quality Systems |
| Date Prepared | January 15, 2024 |

# Device Information

| Trade Name | | Clear Guide SCENERGY | | |
|-------------------|-----|----------------------------------------------------------------------------------|--|--|
| Common Name | | System, Imaging Software | | |
| Classification(s) | JAK | Computed tomography x-ray system<br>Class II under 21 CFR 892.1750 | | |
| | | Subsequent/Secondary Classification(s) are: | | |
| | IYO | Ultrasonic pulsed echo imaging system<br>Class II under 21 CFR 892.1560 | | |
| | LLZ | Medical image management and processing system<br>Class II under 21 CFR 892.2050 | | |
| | ITX | Diagnostic ultrasound transducer<br>Class II under 21 CFR 892.1570 | | |
| | | | | |

# Predicate Device Information

| Device Name | Clear Guide SCENERGY (Clear Guide Medical, Inc.) |
|-------------------|--------------------------------------------------------------------------------------|
| 510(k) Number | K201188 |
| Common Name | System, Imaging Software |
| Classification(s) | JAK Computed tomography x-ray system<br>Class II under 21 CFR 892.1750 |
| | Subsequent/Secondary Classification(s) for all predicate devices are. |
| | IYO Ultrasonic pulsed echo imaging system<br>Class II under 21 CFR 892.1560 |
| | LLZ Medical image management and processing system<br>Class II under 21 CFR 892.2050 |

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Image /page/4/Picture/1 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized letter "L" formed by a thick black line intersecting with two thinner gray lines. To the right of the "L" is the text "CLEAR GUIDE" in bold, black letters, with the word "MEDICAL" underneath in a smaller, gray font.

# Device Description

The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).

The CLEAR GUIDE SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data. the CLEAR GUIDE SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are ning that new inputs (e.g., a new CT or MRI) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

### Intended Use

The device is a stereotaxic accessory intended to provide fusion of images from certain imaging modalities. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

## Indications For Use

The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument. while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).

## Technological Characteristics

Real-time marker tracking and instrument guidance is achieved by optical detection of needle-like rigid instrumentation by means of stereo cameras, and overlay of graphical indicators on the input imaging modality (Ultrasound, CT, or MR). Optionally, fiducial markers are attached to the patient and/or instrument to facilitate tracking.

Image fusion is the joining of static, volumetric, high-resolution imaging data (e.g., CT or MRI scans) with real-time, streamed image data (e.g., ultrasound). CLEAR GUIDE SCENERGY uses proprietary algorithms capable of combining three input sources (image stream from an ultrasound machine, a static CT/MRI volume, and video feed from the CLEAR GUIDE Optical Head) to provide an accurate visual feedback for the underlying image-guided procedure. Fusion of static imaging data (CT/MRI) is facilitated by the application of multi-modality fiducial markers prior the imaging. When Ultrasound and CT/MR fusion is enabled, the real-time ultrasound image stream is shown on the display together with dynamically computed CT/MB slices from the volumetric data, and guidance overlays.

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Image /page/5/Picture/1 description: The image is a logo for Clear Guide Medical. The logo consists of two parts: a stylized graphic on the left and the company name on the right. The graphic on the left features a thick, black vertical line with two thinner, gray lines curving away from it. To the right of the graphic, the words "CLEAR GUIDE" are stacked on top of each other in bold, black letters, and below them, the word "MEDICAL" is written in gray.

A comparison of CLEAR GUIDE SCENERGY's technological characteristics to its predicate device is provided below.

| Category | Modified Device:<br>Clear Guide SCENERGY | Predicate Device:<br>Clear Guide SCENERGY |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K234030 | K201188 |
| Product Code | JAK | JAK |
| Classification Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Regulatory Class | Class II | Class II |
| Classification Name | Computed tomography x-ray system | Computed tomography x-ray system |
| Subsequent<br>Product Code(s) | IYO, LLZ, ITX | IYO, LLZ |
| Intended Use(s)<br>(i.e., List of Main Functions) | - Image Fusion<br>- Instrument Tracking and Guidance | - Image Fusion<br>- Instrument Tracking and Guidance |
| Indications for Use | The Clear Guide SCENERGY is software that provides<br>fusion of images from Computed Tomography (CT), Mag-<br>netic Resonance (MR), and Ultrasound (US) modalities.<br>US images can be fused with either CT or MR.<br>The Clear Guide SCENERGY utilizes the Clear Guide<br>CORE and Clear Guide Optical Head platform to display<br>images of the target regions and the projected path of<br>the interventional instrument, while taking into account<br>patient movement and deformation. Instrumentation used<br>with the Clear Guide SCENERGY might include an in-<br>terventional needle or needle-like rigid device, such as<br>a biopsy needle, an aspiration needle, or an ablation<br>needle. The device is intended to be used in any inter-<br>ventional or diagnostic procedure where the combination<br>of these modalities is used for visualization, except for<br>procedures on the brain. The device is intended for use<br>in a clinical setting, in patients of sufficient size (at least<br>25 kg). | The Clear Guide SCENERGY is software that provides<br>fusion of images from Computed Tomography (CT), Mag-<br>netic Resonance (MR), and Ultrasound (US) modalities.<br>US images can be fused with either CT or MR.<br>The Clear Guide SCENERGY utilizes the Clear Guide<br>CORE and Clear Guide SuperPROBE platform to display<br>images of the target regions and the projected path of<br>the interventional instrument, while taking into account<br>patient movement and deformation. Instrumentation used<br>with the Clear Guide SCENERGY might include an in-<br>terventional needle or needle-like rigid device, such as<br>a biopsy needle, an aspiration needle, or an ablation<br>needle. The device is intended to be used in any inter-<br>ventional or diagnostic procedure where the combination<br>of these modalities is used for visualization, except for<br>procedures on the brain. The device is intended for use<br>in a clinical setting, in patients of sufficient size (at least<br>25 kg). |
| Principle of Operation<br>(i.e., Mechanism of Action) | Optical Detection & Software | Optical Detection & Software |
| Hardware Components | Clear Guide CORE and Optical Head | Clear Guide CORE and Optical Head |
| Conditions of Use | Image-guided Procedures | Image-guided Procedures |
| Fusion Capabilities | US-CT & US-MR | US-CT & US-MR |
| Input Imaging Data | CT, MR, or Ultrasound | CT, MR, or Ultrasound |
| Device Interactions | Connected/Anchored to Transducer | Connected/Anchored to Transducer |
| Segmentation Process | Automatic | Automatic |
| Registration Process | Automatic | Automatic |
| Fusion Algorithms | Automatic | Automatic |
| Tracking/Guidance<br>Algorithms | Automatic | Automatic |
| User Interface Modes | SETUP (3D), PLAN, NAVIGATION | SETUP (3D), NAVIGATION<br>continued |
| Category | Modified Device:<br>Clear Guide SCENERGY | Predicate Device:<br>Clear Guide SCENERGY |
| Supported Accessories<br>(Marketed separately) | - SteriMASK transducer cover kit<br>- VisiMARKER fiducial markers<br>- TP Access tool with SteriGRID needle guide grid | - SteriMASK transducer cover kit<br>- VisiMARKER fiducial markers |
| Intended User | Physician | Physician |
| Environment of Use | Clinical Setting | Clinical Setting |
| Duration of Use | ≤ 24 Hours | ≤ 24 Hours |
| Number of Uses | Reusable | Reusable |
| Sterility | Non-Sterile | Non-Sterile |
| Bench Testing | N/A (no modifications) | N/A (no modifications) |
| Animal Testing | N/A | N/A |
| Clinical Testing | Yes | Yes |
| Standards | N/A (for software) | N/A (for software)…