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 SuperPROBE 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, an aspiration 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.

Device Description

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). 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 deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Clear Guide SCENERGY device based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the types of testing performed but does not explicitly state quantitative acceptance criteria or reported device performance metrics in a clear, tabular format. It states that "Performance testing of the Clear Guide SCENERGY device demonstrates that the product accurately achieves its intended use, while also showing that differences in technological features from the predicate device did not affect device performance." And, "Results of performance testing show that the subject device is as safe and as effective as the predicate device."

However, it describes the metrics used for evaluation:

Test Type	Metric	Reported Device Performance
Segmentation Testing	Comparison of software outputs to manual selection of fiducial markers.	Demonstrated satisfactory performance (implied by conclusion of substantial equivalence)
Fusion Testing	Tissue Registration Error (TRE): Distance measurements between identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR.	Demonstrated satisfactory performance (implied by conclusion of substantial equivalence)
Systematic Error (Tip-to-Tip) Testing	"Tip-to-Tip" distance: From the needle point seen by ground truth CT (or MR) to the same needle point seen by Clear Guide SCENERGY's displayed guidance. (Also referred to as "tracking error" in literature for the predicate device.)	Demonstrated satisfactory performance (implied by conclusion of substantial equivalence)

Important Note: The document does not provide specific numerical values for TRE, "tip-to-tip" distance, or segmentation accuracy. It relies on a qualitative statement of meeting its intended function and being "as safe and as effective as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document states that "Phantom datasets were utilized for this evaluation" for Systematic Error Testing, and "phantom datasets" were also used for Segmentation Testing. However, no specific number or size of these phantom datasets is provided.
Data Provenance: "Phantom datasets" were used. This indicates simulated or artificial data, not human patient data. The document does not specify the country of origin for these phantom datasets, nor whether they are retrospective or prospective. Given they are phantoms, the latter distinction is less relevant.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document mentions "manual selection" for segmentation testing and "ground truth CT (or MR)" for systematic error testing. It implies that these "ground truths" are objective measures or expert-derived, but it does not specify the number of experts, their qualifications, or how they established the ground truth.

4. Adjudication Method:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document primarily focuses on technical performance testing against a predicate device's established safety and effectiveness. It does not mention human reader performance or improvements with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, standalone performance testing was done. The described "Segmentation Testing," "Fusion Testing," and "Systematic Error (Tip-to-Tip) Testing" evaluate the device's algorithmic performance (e.g., software outputs compared to manual selection, distance measurements for fusion and guidance accuracy) directly without human-in-the-loop interaction for the reported metrics. The device's segmentation and registration algorithms are described as "automated."

7. Type of Ground Truth Used:

For Segmentation Testing: "Manual selection in phantom datasets." This implies an expert-derived ground truth.
For Fusion Testing: "Identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR." This suggests comparison against established anatomical structures or markers within the imaging modalities.
For Systematic Error (Tip-to-Tip) Testing: "Ground truth CT (or MR)." This indicates reference imaging data as the standard.

Overall, the ground truth appears to be a combination of expert-derived measurements/selections and reference imaging data (CT/MR).

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set. It focuses on the validation of the device.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide any information regarding how the ground truth for the training set was established, as it does not discuss the training phase of the algorithms.

Summary

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July 31, 2020

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

Clear Guide Medical % Jack Kent, MPH, MBA Director of Regulatory Affairs and Quality Systems 3600 Clipper Mill Road, Suite 400 BALTIMORE MD 21211

Re: K201898

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 Dated: June 23, 2020 Received: July 2, 2020

Dear Mr. Kent:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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)

K201898

Device Name Clear Guide SCENERGY

Indications for Use (Describe)

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE play 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Clear Guide Medical. The logo consists of two parts: a stylized image of a needle and the words "CLEAR GUIDE MEDICAL". The needle is black and is pointing downwards. The words "CLEAR GUIDE" are in black, and the word "MEDICAL" is in gray.

510(k) Summary (per 21 CFR § 807.92)

K201898

Submitter's Information

Name	Clear Guide Medical, Inc.
Address	3600 Clipper Mill Rd., Suite 400Baltimore, MD 21211
Phone Number	(443) 602-8950
Contact Person	Jack Kent, Director of Regulatory Affairs and Quality System
Date Prepared	July 27, 2020

Device Information

Trade Name	Clear Guide SCENERGY
Common Name	System, Imaging Software
Classification	Computed Tomography X-Ray System
	21 CFR § 892.1750 (Product Code JAK)

Predicate Device Information

Device Name	Clear Guide SCENERGY
510(k) Number	K171677

Device Description

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). 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 reqistration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the seqmentation output. Registration can be reset by the user at any time during use.

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Image /page/4/Picture/0 description: The image contains the logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with two horizontal lines extending from it. To the right of the "L" is the text "CLEAR GUIDE" stacked on top of each other in bold, black letters, with the word "MEDICAL" underneath in a lighter gray font.

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

Comparison to Predicate: This indications for use statement is exactly the same as the predicate device.

Technological Characteristics

The Clear Guide SCENERGY operates using optical detection technology. The Clear Guide SCENERGY enables fusion with two difference image volumes: CT and MRI. Fusion with ultrasound is available with both types, versus just CT for the predicate device. Optical detection technology does not require specialized instruments or calibration at the point of use. As with the predicate device, the Clear Guide SCENERGY overlays instrument positioning data onto an existing ultrasound image through proprietary software algorithms. For certain software algorithms (specifically segmentation and registration), these functions are automated. A comparison of Clear Guide SCENERGY's technological characteristics to its predicate device is provided below.

This 510(k) specifically adds the CORETABLET ("CORE 13") to the hardware platform. This medical grade PC provides the necessary processing power and touchscreen inputs to properly execute the Clear Guide SCENERGY software.

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Image /page/5/Picture/0 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with two curved lines extending from the bottom of the "L". To the right of the "L" are the words "CLEAR GUIDE" stacked on top of each other in bold, black letters. Below "GUIDE" is the word "MEDICAL" in gray letters.

Category	Modified Clear Guide SCENERGY	Original Clear Guide SCENERGY
Product Name (Full)	Clear Guide SCENERGY	Clear Guide SCENERGY
510(k) Number	K201898	K171677
Product Code(s)	JAK	JAK
Classification Regulation	21 CFR 892.1750	21 CFR 892.1750
Regulatory Class	ll	ll
Intended Use	Image FusionInstrument Tracking and Guidance	Image FusionInstrument Tracking and Guidance
Indications for Use	The Clear Guide SCENERGY is softwarethat provides fusion of images fromComputed Tomography (CT), MagneticResonance (MR), and Ultrasound (US)modalities. US images can be fused witheither CT or MR.	The Clear Guide SCENERGY is softwarethat provides fusion of images fromComputed Tomography (CT), MagneticResonance (MR), and Ultrasound (US)modalities. US images can be fused witheither CT or MR.
	The Clear Guide SCENERGY utilizes theClear Guide CORE and Clear GuideSuperPROBE platform to display imagesof the target regions and the projectedpath of the interventional instrument,while taking into account patientmovement and deformation.Instrumentation used with the ClearGuide SCENERGY might include aninterventional needle or needle-like rigiddevice, such as a biopsy needle, anaspiration needle, or an ablation needle.The device is intended to be used in anyinterventional or diagnostic procedurewhere the combination of thesemodalities is used for visualization,except for procedures on the brain. Thedevice is intended for use in a clinicalsetting.	The Clear Guide SCENERGY utilizes theClear Guide CORE and Clear GuideSuperPROBE platform to display imagesof the target regions and the projectedpath of the interventional instrument,while taking into account patientmovement and deformation.Instrumentation used with the ClearGuide SCENERGY might include aninterventional needle or needle-like rigiddevice, such as a biopsy needle, anaspiration needle, or an ablation needle.The device is intended to be used in anyinterventional or diagnostic procedurewhere the combination of thesemodalities is used for visualization,except for procedures on the brain. Thedevice is intended for use in a clinicalsetting.
Fundamental Technology(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
Operating Principle	Optical Detection	Optical Detection
Conditions of Use	Optical Detection	Optical Detection
Fusion Capabilities	US-CT & US-MR	US-CT & US-MR
Signal Receiver	Connected/Anchored to Transducer	Connected/Anchored to Transducer
Segmentation Process	Automatic	Automatic
Registration Process	Automatic	Automatic
Category	Modified Clear Guide SCENERGY	Original Clear Guide SCENERGY
Fusion Algorithms	Automatic	Automatic
Tracking/Guidance Algorithms	Automatic	Automatic
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	Yes (V&V on modification)	Yes (V&V on modification)
Animal Testing	N/A	N/A
Clinical Testing	N/A	N/A
Standards	IEC 60601-1 & IEC 60601-1-2	N/A (for software)

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Image /page/6/Picture/0 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized image of a needle on the left, with the words "CLEAR GUIDE" stacked on top of each other in bold, black letters on the right. Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller, gray font.

Performance data was collected to demonstrate that the Clear Guide SCENERGY achieves its intended function in a manner that is as safe and as effective as the predicate device.

Performance Data

Performance testing of the Clear Guide SCENERGY device demonstrates that the product accurately achieves its intended use, while also showing that differences in technological features from the predicate device did not affect device performance. Results of performance testing show that the subject device is as safe and as effective as the predicate device.

Hardware Verification and Validation Testing

Tests were completed in accordance with the CORE V&V testing plan. This includes any necessary testing to achieve compliance with IEC 60601-1 and IEC 60601-1-2 standards. Hardware testing includes component verification, system infrastructure and architecture testing, and general system operation testing.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for the Clear Guide SCENERGY was considered as a "moderate" level of concern, since a failure or latent flaw in the software could

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Image /page/7/Picture/0 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized image of a needle on the left, with the words "CLEAR GUIDE" stacked on top of each other in bold, black letters on the right. Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller, gray font.

directly result in minor injury to the patient or operator, or indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Segmentation Testing

The automatic segmentation of fiducial markers by the Clear Guide SCENERGY was evaluated by comparing software outputs to manual selection in phantom datasets.

Fusion Testing

The Clear Guide SCENERGY's ability to provide fused images from ultrasound and CT/MR modalities was evaluated using fusion testing. Fusion quality was assessed by taking distance measurements between identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR. This metric is known as Tissue Registration Error (TRE).

Systematic Error (Tip-to-Tip) Testing

Systematic error in the Clear Guide SCENERGY is defined as the cumulative error that would be observed within the entire system, which includes segmentation. registration, fusion, and guidance errors. This performance metric is a "tip-to-tip" distance from the needle point seen by ground truth CT (or MR) to the same needle point seen by Clear Guide SCENERGY's displayed guidance. This metric has been called "tracking error" in literature for the predicate device. Phantom datasets were utilized for this evaluation.

Conclusions

The Clear Guide SCENERGY has the same intended use as the predicate device. There are no differences in the product's feature offerings (from the predicate device), and therefore no new or different questions of safety or effectiveness are raised. Additionally, performance tests confirm that the Clear Guide SCENERGY is as safe and as effective as the predicate device. Therefore, the Clear Guide SCENERGY is substantially equivalent to its predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.