(185 days)
Not Found
No
The description mentions "proprietary software algorithms" for segmentation and registration, but explicitly states these are "deterministic" and does not use terms like AI, ML, deep learning, or neural networks. The performance testing also focuses on traditional metrics like registration error and tip-to-tip distance, not metrics typically associated with AI/ML model evaluation (e.g., AUC, sensitivity/specificity on clinical data).
No
This device is a software for image fusion and guidance during interventional procedures; it does not directly treat or diagnose a disease state, but rather assists in visualization and guidance for other medical instruments that perform the therapeutic or diagnostic action.
No
The device is intended for visualization during interventional or diagnostic procedures to guide instruments, not to establish a diagnosis itself. It fuses images and tracks instruments to aid the clinician, who then performs the diagnostic or interventional procedure.
No
The device description explicitly states that the Clear Guide SCENERGY uses "optical detection technology to identify and track objects in the field of view." This indicates the presence of hardware components beyond just software.
Based on the provided information, the Clear Guide SCENERGY is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Clear Guide SCENERGY's Function: The Clear Guide SCENERGY is a software and hardware system that provides image fusion, instrument tracking, and guidance during medical interventions. It works with existing imaging modalities (CT, MR, US) and helps guide instruments like needles within the patient's body. It does not analyze specimens taken from the body.
Therefore, the Clear Guide SCENERGY falls under the category of a medical device used for image guidance and navigation during procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US)
Anatomical Site
Not specified, except "except for procedures on the brain."
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Clinical Setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Results of performance testing show that the subject device is as safe and as effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K171677
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 400 |
| Baltimore, 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 System |
| 21 CFR § 892.1750 (Product Code JAK) |
Predicate Device Information
| Device Name | Clear Guide SCENERGY |
|---|---|
| 510(k) Number | K153004 |
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.
4
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
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.
- 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.
5
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 Fusion | |
| Instrument Tracking and Guidance | Image Fusion | |
| Instrument Tracking and Guidance | ||
| 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. | The Clear Guide SCENERGY is a
stereotaxic accessory for the fusion of
images from multiple modalities -
including Computed Tomography (CT)
and Ultrasound (US).
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. Imaging
modalities may be fused in various
combinations. 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. The device is intended
for 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) |
6
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.
7
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.