(152 days)
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, in patients of sufficient size (at least 25 kg).
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.q., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
The Clear Guide SCENERGY is a software device that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. The device utilizes optical detection technology to identify and track objects, overlaying instrument positioning data onto existing ultrasound images through proprietary software algorithms for segmentation and registration.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the type of tests performed rather than specific numerical acceptance criteria. However, it indicates that the device's performance was evaluated to ensure its safe and effective operation compared to its predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Segmentation Accuracy | The automatic segmentation of fiducial markers was evaluated by comparing software outputs to manual selection in phantom datasets. (The specific accuracy metrics or thresholds met are not detailed in this summary.) |
| Fusion Quality (TRE) | The device's ability to provide fused US and CT/MR images was assessed using Tissue Registration Error (TRE). This involved taking distance measurements between identifiable landmarks or surfaces on ultrasound and CT, or ultrasound and MR. (Specific TRE thresholds or results are not provided.) |
| Systematic Error ("Tip-to-Tip" Tracking Error) | This metric, also known as "tracking error" for the predicate device, measures the cumulative error across segmentation, registration, fusion, and guidance. It's defined as the "tip-to-tip" distance from the needle point seen by ground truth CT (or MR) to the same needle point displayed by the Clear Guide SCENERGY's guidance. Phantom datasets were used for this evaluation. (Specific error ranges or maximum deviations are not provided.) |
| Clinical Safety in Pediatric Patients | A small safety study was conducted to demonstrate the safe usability of the Clear Guide SCENERGY in pediatric patients without raising new safety or effectiveness concerns. The study included patients aged 5 to 17 and weighing 11.9 to 78.9 kg, to represent children and adolescents. (Specific safety endpoints or results are not detailed, but the conclusion states no new or different questions of safety or effectiveness were raised). |
| Overall Safety and Effectiveness | "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." "Results of performance testing show that the subject device is as safe and as effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Segmentation Testing: "phantom datasets" (specific number not provided). Data provenance is synthetic (phantom).
- Fusion Testing: Utilized phantoms. (Specific number of phantom datasets not provided). Data provenance is synthetic (phantom).
- Systematic Error (Tip-to-Tip) Testing: "Phantom datasets were utilized for this evaluation." (Specific number not provided). Data provenance is synthetic (phantom).
- Clinical Testing: "A small safety study was run... The study included patients ranging in age (5 to 17) and weight (11.9 to 78.9 kg) to demonstrate use in children and adolescents." (Specific number of patients not provided, but implies a prospective clinical study involving human subjects). The country of origin for this clinical data is not specified. It's a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts used for establishing ground truth or their qualifications.
- For Segmentation Testing, ground truth for fiducial markers was established by "manual selection." It's implied this was done by human experts, but their number and qualifications are not provided.
- For Fusion Testing and Systematic Error Testing, ground truth was based on measurements from phantom datasets and comparison to "ground truth CT (or MR)." The process for establishing this phantom-based ground truth or any expert involvement in verifying it is not detailed.
- For the Clinical Testing, the safety assessment would have involved clinicians, but their role in establishing ground truth for device performance measurements (if any were taken) is not specified.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. For tests involving "manual selection" or comparison to "ground truth CT/MR," it implies a singular reference standard rather than an adjudicated consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The studies focus on the standalone performance of the device and its safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, standalone performance (algorithm only) was assessed for:
- Segmentation Testing: Comparison of software outputs to manual selection in phantom datasets.
- Fusion Testing: Evaluation of the device's ability to provide fused images and assessment of Tissue Registration Error (TRE) using phantom datasets.
- Systematic Error (Tip-to-Tip) Testing: Measurement of cumulative error by comparing the device's displayed guidance to ground truth CT/MR needle points in phantom datasets.
These tests evaluate the device's algorithmic performance in isolation.
7. The Type of Ground Truth Used:
- Segmentation Testing: Ground truth was established by "manual selection" in phantom datasets, implying expert human judgment on fiducial markers.
- Fusion Testing: Ground truth was based on identifiable landmarks or surfaces on ultrasound and CT/MR in phantom datasets.
- Systematic Error (Tip-to-Tip) Testing: Ground truth was based on the "needle point seen by ground truth CT (or MR)" in phantom datasets.
- Clinical Testing: The "small safety study" would likely have relied on clinical observations and assessments by healthcare professionals for safety endpoints.
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for the training set for the segmentation, registration, or fusion algorithms.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide details on how the ground truth for the training set was established, as no information on the training set itself is given.
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September 30, 2020
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Clear Guide Medical % Mr. Jack Kent Director of Regulatory Affairs and Quality Systems 3600 Clipper Mill Road, Suite 400 BALTIMORE MD 21211
Re: K201188
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: August 21, 2020 Received: August 25, 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/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.
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) K201188
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 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, in patients of sufficient size (at least 25 kg).
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 shows the logo for Clear Guide Medical. The logo consists of a stylized image of a needle and two lines on the left side. On the right side of the image, the words "CLEAR GUIDE" are stacked on top of each other in large, bold, black letters, and the word "MEDICAL" is below them in smaller, 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 | (443) 602-8950 |
| Contact Person | Jack Kent, Director of Regulatory Affairs and Quality System |
| Date Prepared | September 17, 2020 |
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 | K171677 |
| Common Name | System, Imaging Software |
| Classification | Computed Tomography X-Ray System21 CFR § 892.1750 (Product Code JAK) |
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
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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 "L" shape 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.
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.q., new CT or MR) 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 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, in patients of sufficient size (at least 25 kg).
Comparison to Predicate: This indications for use statement is exactly the same as the predicate device, except for language specific to the minimum size for a patient.
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
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Image /page/5/Picture/0 description: The image is a logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with the words "CLEAR GUIDE" stacked on top of each other in bold, black letters on the right. Below "GUIDE" is the word "MEDICAL" in a smaller, gray font. The "L" is formed by a thick, black line intersecting two curved, gray lines.
automated. A comparison of Clear Guide SCENERGY's technological characteristics to its predicate device is provided below.
| Category | Modified Clear Guide SCENERGY | Original Clear Guide SCENERGY |
|---|---|---|
| Product Name (Full) | Clear Guide SCENERGY | Clear Guide SCENERGY |
| 510(k) Number | K201188 | K171677 |
| 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 these | 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 these |
| modalities is used for visualization,except for procedures on the brain. Thedevice is intended for use in a clinicalsetting, in patients of sufficient size (atleast 25 kg). | modalities is used for visualization,except for procedures on the brain. Thedevice is intended for use in a clinicalsetting. | |
| Fundamental Technology | Optical Detection & Software | Optical Detection & Software |
| (i.e., Mechanism of Action) | ||
| 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 |
| Category | Modified Clear Guide SCENERGY | Original Clear Guide SCENERGY |
| Signal Receiver | Connected/Anchored to Transducer | Connected/Anchored to Transducer |
| Segmentation Process | Automatic | Automatic |
| Registration Process | Automatic | Automatic |
| 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 | N/A (no modifications) | Yes (V&V on modification) |
| Animal Testing | N/A | N/A |
| Clinical Testing | Yes | N/A |
| Standards | N/A (for software) | 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 letter "L" on the left, with the words "CLEAR GUIDE" stacked on top of each other to the right of the "L". Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller font size. The "L" is made up of a thick black vertical line and two thin gray curved lines.
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. 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 is a 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 "CLEAR GUIDE" text is in bold black letters, while the "MEDICAL" text is in gray.
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 quidance. This metric has been called "tracking error" in literature for the predicate device. Phantom datasets were utilized for this evaluation.
Clinical Testing
A small safety study was run to demonstrate that the Clear Guide SCENERGY could be utilized safely in pediatric patients without creating new or different questions of safety or effectiveness. The study included patients ranging in age (5 to 17) and weight (11.9 to 78.9 kg) to demonstrate use in children and adolescents.
Conclusions
The Clear Guide SCENERGY has the same intended use as the predicate device, with a minor change to its indications for use. 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 for the intended patient population. Therefore, the Clear Guide SCENERGY is substantially equivalent to its predicate device.
§ 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.