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

Acceptance Criteria and Study for Clear Guide SCENERGY

This document describes the acceptance criteria and the study that demonstrates the Clear Guide SCENERGY device meets these criteria. The information is extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing without explicitly stating numerical acceptance criteria with pass/fail thresholds. However, it indicates that the device's performance was evaluated against the intended function and compared to the predicate device. The performance categories are inferred from the "Performance Data" and "Software Verification and Validation Testing" sections.

Performance Category	Acceptance Criteria (Implied)	Reported Device Performance
Overall Performance	Achieve intended function, safe and effective as predicate.	"Accurately achieves its intended use," "as safe and as effective as the predicate device."
Software Functionality	Software operates without latent flaws leading to minor injury.	Software verification and validation conducted; considered "moderate" level of concern. No specific failure rates or bug counts are provided.
Segmentation Accuracy	Software outputs for fiducial markers match manual selection.	Evaluated by comparing software output to manual selection in phantom datasets. No specific accuracy metrics (e.g., percentage, distance) are given.
Fusion Quality (Tissue Registration Error)	Distance measurements between identifiable landmarks/surfaces in fused images are acceptable.	Assessed by Tissue Registration Error (TRE) using identifiable landmarks or surfaces. No specific TRE threshold or measured values are given.
Systematic Error (Tip-to-Tip)	Cumulative error (segmentation, registration, fusion, guidance) is acceptable, ensuring accurate needle-point guidance.	Measured as "tip-to-tip" distance from ground truth CT/MR needle point to Clear Guide SCENERGY's displayed guidance. No specific error threshold or measured values are given.

Study Details:

The provided text details various performance tests conducted to demonstrate the substantial equivalence of the Clear Guide SCENERGY to its predicate device. This appears to be a standalone performance study focused on the device's functional capabilities.

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

Sample Size for Test Set:
- Segmentation Testing: "phantom datasets" (specific number not provided).
- Fusion Testing: No specific number of datasets mentioned, but "identifiable landmarks or surfaces" were used.
- Systematic Error (Tip-to-Tip) Testing: "Phantom datasets were utilized" (specific number not provided).
Data Provenance: The study primarily used phantom datasets. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.

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

Segmentation Testing: "manual selection in phantom datasets" was used as ground truth. The number and qualifications of experts performing this manual selection are not provided.
Fusion Testing: "identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR" were used for TRE assessment. It is not specified how these identifiable landmarks were established or if expert input was involved in defining them.
Systematic Error (Tip-to-Tip) Testing: "ground truth CT (or MR)" was used to define the actual needle point. It is not specified how this ground truth was established or if experts were involved.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating disagreements, as expert consensus is not explicitly detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on technical performance rather than human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The described "Performance Data" and "Software Verification and Validation Testing," including "Segmentation Testing," "Fusion Testing," and "Systematic Error (Tip-to-Tip) Testing," all evaluate the algorithm's performance directly against established ground truth (e.g., manual selection, identifiable landmarks, ground truth CT/MR needle point) without human interaction being part of the primary measurement of the device's accuracy.

7. The Type of Ground Truth Used

Segmentation Testing: Ground truth was established by manual selection in phantom datasets.
Fusion Testing: Ground truth for TRE assessment relied on identifiable landmarks or surfaces within fused images.
Systematic Error (Tip-to-Tip) Testing: Ground truth was based on the needle point seen by ground truth CT (or MR) in phantom datasets.

In all cases, the ground truth was based on objective measurements or established references within phantom models, rather than pathology or patient outcomes.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The descriptions focus solely on performance "testing" using phantom datasets.

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

Since information regarding a training set is not provided, the method for establishing its ground truth is also not specified. The details are centered on the evaluation of the device as a pre-trained system.

Summary

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December 8, 2017

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 & Human Services seal on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Clear Guide Medical, Inc. % Dorothee Heisenberg, Ph.D. Executive Vice President 3600 Clipper Mill Road. Suite 400 BALTIMORE MD 21211

Re: K171677

Trade/Device Name: Clear Guide SCENERGY Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 3, 2017 Received: November 6, 2017

Dear Dr. Heisenberg:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171677

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, an aspiration 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.

X 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 contains the logo for Clear Guide Medical. The logo consists of a stylized letter "L" formed by a thick black line and two thin gray lines, followed by the words "CLEAR GUIDE" stacked on top of each other in bold black letters. Below "GUIDE" is the word "MEDICAL" in gray letters.

510(k) Summary (per 21 CFR § 807.92)

Submitter's Information

Name	Clear Guide Medical, Inc.
Address	3600 Clipper Mill Rd., Suite 400Baltimore, MD 21211
Phone Number	(410) 504-6540
Contact Person	Dorothee Heisenberg, Executive Vice President
Date Prepared	November 1, 2017

Device Information

Trade Name	Clear Guide SCENERGY
Common Name	System, Imaging Software
Classification	Computed Tomography X-Ray System21 CFR § 892.1750 (Product Code JAK)

Predicate Device Information

Device Name	Clear Guide SCENERGY
510(k) Number	K153004

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left and the words "CLEAR GUIDE MEDICAL" on the right. The words "CLEAR GUIDE" are in bold black letters, and the word "MEDICAL" is in gray letters.

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: The indications for use statement for the Clear Guide SCENERGY differs from the predicate device to account for feature-level differences and to provide additional clarity. These changes do not represent a difference in the overall intended use of the product compared to the predicate device.

Technological Characteristics

The Clear Guide SCENERGY operates using optical detection technology. The modified 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.

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Image /page/5/Picture/0 description: The image contains the logo for Clear Guide Medical. The logo consists of a stylized "L" shape on the left, with two horizontal lines extending from it. To the right of the "L" shape, the words "CLEAR GUIDE" are stacked on top of each other in bold, black letters, and below that, the word "MEDICAL" is written in gray.

Category	Modified Clear Guide SCENERGY	Original Clear Guide SCENERGY
Product Name (Full)	Clear Guide SCENERGY	Clear Guide SCENERGY
510(k) Number	[not assigned]	K153004
Product Code(s)	JAK	JAK
Classification Regulation	21 CFR 892.1750	21 CFR 892.1750
Regulatory Class	II	II
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 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 is astereotaxic accessory for the fusion ofimages from multiple modalities -including Computed Tomography (CT)and Ultrasound (US).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. Imagingmodalities may be fused in variouscombinations. Instrumentation usedwith the Clear Guide SCENERGY mightinclude an interventional needle orneedle-like rigid device, such as a biopsyneedle, an aspiration needle, or anablation needle. The device is intendedto be used in any interventional ordiagnostic procedure where thecombination of these modalities is usedfor visualization. The device is intendedfor use in a clinical setting.
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
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
Animal Testing	N/A	Yes
Clinical Testing	N/A	Yes
Standards	N/A (for software)	N/A (for software)

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Image /page/6/Picture/0 description: The image contains the logo for Clear Guide Medical. On the left side of the logo is a stylized letter "L" with two horizontal lines running through it. To the right of the "L" is the text "CLEAR GUIDE MEDICAL" in a stacked format, with "CLEAR GUIDE" in black and "MEDICAL" in gray.

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.

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 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.

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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 letter "L" on the left and the words "CLEAR GUIDE" stacked on top of each other on the right. The word "MEDICAL" is located below the words "CLEAR GUIDE" and is a different color than the other words.

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. Changes to the specific indications for use statement were made to account for technological differences, without impacting intended use. Differences in the product's feature offerings do not raise different questions of safety or effectiveness. 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.