(122 days)
Not Found
No
The description mentions "proprietary software algorithms" for segmentation and registration, but explicitly states these are "automated" and "deterministic," which are not characteristic of typical AI/ML approaches that involve learning from data and can exhibit variability. The lack of mention of AI, DNN, or ML, and the description of deterministic algorithms, suggest the technology is not AI/ML.
No.
This device is an accessory that provides image fusion, instrument tracking, and guidance functionalities for interventional procedures, but it does not directly treat a medical condition or restore health.
Yes
The intended use explicitly states that the device is for use in "any interventional or diagnostic procedure where the combination of these modalities is used for visualization." While it also mentions interventional procedures, the inclusion of "diagnostic procedure" confirms its diagnostic capability.
No
The device description explicitly states it "uses optical detection technology to identify and track objects in the field of view," indicating 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 examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Clear Guide Scenergy's Function: The Clear Guide Scenergy is a stereotaxic accessory used during medical procedures to guide instruments based on fused imaging data (CT and Ultrasound). It provides real-time visualization and guidance for interventional or diagnostic procedures performed on the patient's body.
- Intended Use: The intended use clearly states it's for "image-guided medical interventions" and "diagnostic procedure where the combination of these modalities is used for visualization," not for analyzing specimens.
- Device Description: The description focuses on image fusion, instrument tracking, and guidance functionality, all of which are performed in conjunction with imaging systems and instruments used directly on the patient.
The device is a medical device used for image guidance during procedures, but it does not perform diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The Clear Guide Scenergy is a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities.
The Clear Guide Scenergy utilizes the 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. 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 (comma separated list FDA assigned to the subject device)
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 ultrasound and CT modalities. 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 seqmentation and registration algorithms are automated, and the user cannot modify either result. Segmentation results are deterministic, meaning that new inputs (e.g., a new CT) 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) and Ultrasound (US)
Anatomical Site
Not 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, animal, and human datasets.
Registration Testing: Using phantom, animal, and human datasets, the FRE (fiducial registration error) metric was within acceptable limits, and there were no instances of misregistration.
Guidance (Tip-to-Target) Testing: Bench testing was performed to evaluate the performance of the instrument guidance feature of the Clear Guide SCENERGY.
Fusion Testing: Using phantom, animal, and human datasets, fusion quality was assessed by taking distance measurements between identifiable landmarks seen on ultrasound and CT. This metric is known as Tissue Registration Error (TRE). Multiple images per dataset were evaluated by sampling across the entire run.
Systematic Error (Tip-to-Tip) Testing: Phantom datasets were utilized for this evaluation.
Deformation Testing: In silicone liver and in-vivo porcine datasets, percent recovery metrics demonstrated a positive effect compared to no deformation simulation.
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: 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.
Segmentation Testing: Segmentation error and detection rate were analyzed, with passing results (per acceptability criteria).
Registration Testing: The FRE metric was within acceptable limits, and there were no instances of misregistration.
Guidance (Tip-to-Target) Testing: Guidance performance (tip-to-target distance) yielded a passing test result.
Fusion Testing: TRE was analyzed, with passing test results (per acceptability criteria).
Systematic Error (Tip-to-Tip) Testing: For the Clear Guide SCENERGY, the total systematic error was found to be within test acceptance criteria (passing test result).
Deformation Testing: In silicone liver and in-vivo porcine datasets, percent recovery metrics demonstrated a positive effect compared to no deformation simulation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
fiducial registration error (FRE), tip-to-target distance, Tissue Registration Error (TRE), systematic error (tip-to-tip distance), percent recovery
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Clear Guide Medical % Mr. Jack Kent Director of Regulatory Affairs and Quality System 3600 Clipper Mill Road, Suite 400 BALTIMORE MD 21211
Re: K153004
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: January 18, 2016 Received: January 19, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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) K153004
Device Name Clear Guide SCENERGY
Indications for Use (Describe)
The Clear Guide Scenergy is a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities.
The Clear Guide Scenergy utilizes the 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. 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)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" on the left, with the words "CLEAR GUIDE" stacked on top of each other in bold, black letters to the right of the "L". Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller, gray font. The "L" is formed by a thick, black vertical line and two thin, gray horizontal lines.
510(k) Summary (per 21 CFR § 807.92)
Submitter's Information
| Name | Clear Guide Medical |
|---|---|
| Address | 3600 Clipper Mill Rd., Suite 400 |
| Baltimore, MD 21211 | |
| Phone Number | (443) 602-8950 |
| Contact Person | Jack Kent, Director of Regulatory Affairs and Quality System |
| Date Prepared | February 10, 2016 |
Device Information
| Trade Name | Clear Guide SCENERGY |
|---|---|
| Common Name | Computer Assisted, Image-Guided Surgery System |
| Classification | Computed Tomography X-Ray System |
| 21 CFR § 892.1750 (Product Code JAK) |
Predicate Device Information
| Device Name | PercuNav |
|---|---|
| 510(k) Number | K132087 |
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 ultrasound and CT modalities. 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 seqmentation and registration algorithms are automated, and the user cannot modify either result. Segmentation results are deterministic, meaning that new inputs (e.g., a new CT) 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 graphic on the left and the company name on the right. The graphic is a black line intersecting two gray lines. The company name is stacked, with "CLEAR GUIDE" in black and "MEDICAL" in gray.
Intended Use
The device is a stereotaxic accessory intended to provide fusion of images from certain imaging modalities (see indications for use). 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 a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities.
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 technological 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, instead of electromagnetic (EM) technology employed by the predicate device. Although both technologies can be used to achieve the intended use (provide image fusion, track instrumentation, and provide quidance), the 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, where the predicate device relies upon manual entry. 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 image of a writing utensil 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.
| Category | Clear Guide SCENERGY | PercuNav |
|---|---|---|
| Product Name (Full) | Clear Guide SCENERGY | PercuNav |
| 510(k) Number | K153004 | K132087 |
| Product Code(s) | JAK | JAK, IYO, LLZ |
| 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 a | |
| stereotaxic accessory for the fusion of | ||
| images from Computed Tomography | ||
| (CT) and Ultrasound (US) modalities. |
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. | PercuNav is a stereotaxic accessory
for Computed Tomography (CT),
Magnetic Resonance (MR),
Ultrasound (US), Positron Emission
Tomography (PET), Single Photon
Emission Computed Tomography
(SPECT), Rotational Fluoroscopy,
Endoscopy, and other imaging
systems. CT, Ultrasound, PET, MR,
and Rotational Fluoroscopy may be
fused in various combinations, such
as CT with MR, MR with ultrasound,
etc. It may include instrumentation to
display the simulated image of a
tracked insertion tool such as a biopsy
needle, guidewire or probe on a
computer monitor screen that shows
images of the target organs and the
current and the projected future path
of the interventional instrument taking
into account patient movement. This
is intended for treatment planning and
guidance for clinical, interventional,
and/or diagnostic procedures. The
device also supports an image-free
mode in which the proximity of the
interventional device is displayed
relative to another device.
The device is intended to be used in
interventional and diagnostic
procedures in a clinical setting. The
device is also intended for use in
clinical interventions to determine the
proximity of one device relative to
another.
Example procedures include, but are
not limited to: [...] |
| Fundamental Technology | Optical Detection | Electromagnetic (EM) |
| Signal Receiver | Connected/Anchored to Transducer | Connected/Anchored to Transducer
and Instrument |
| Segmentation Process | Automatic | Manual |
| Registration Process | Automatic | Manual |
| Fusion Algorithms | Automatic | Automatic |
| Category | Clear Guide SCENERGY | PercuNav |
| 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 | Yes |
| Animal Testing | Yes | N/A |
| Clinical Testing | Yes | None |
| 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 two horizontal lines extending to the right. To the right of the "L" are the words "CLEAR GUIDE" stacked on top of each other in bold, black letters, with the word "MEDICAL" underneath in gray letters.
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 characteristics from the predicate device did not affect device performance. Results of performance testing show that the subject device, the Clear Guide SCENERGY, 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.
Segmentation Testing
The automatic segmentation of fiducial markers by the Clear Guide SCENERGY was evaluated by comparing software outputs to manual selection in phantom, animal, and human datasets. Segmentation error and detection rate were analyzed, with passing results (per acceptability criteria).
7
Image /page/7/Picture/0 description: The image contains 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 in bold, black letters on the right. Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller, gray font.
Registration Testing
The automatic registration of the dynamic imaging modality (ultrasound) to the static imaging modality (CT) was evaluated in terms of fiducial registration error (FRE). Using phantom, animal, and human datasets, the FRE metric was within acceptable limits, and there were no instances of misregistration.
Guidance (Tip-to-Target) Testing
Bench testing was performed to evaluate the performance of the instrument guidance feature of the Clear Guide SCENERGY. Specifically, guidance testing evaluated the end user's ability to hit a desired target, so a "tip-to-target" distance metric evaluated this performance aspect. Guidance performance (tip-to-target distance) yielded a passing test result.
Fusion Testing
The Clear Guide SCENERGY's ability to provide fused images from ultrasound and CT modalities was evaluated using fusion testing. Using phantom, animal, and human datasets, fusion quality was assessed by taking distance measurements between identifiable landmarks seen on ultrasound and CT. This metric is known as Tissue Registration Error (TRE). Multiple images per dataset were evaluated by sampling across the entire run. TRE was analyzed, with passing test results (per acceptability criteria).
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 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. For the Clear Guide SCENERGY, the total systematic error was found to be within test acceptance criteria (passing test result).
Deformation Testing
The Clear Guide SCENERGY simulates deformation of the static CT image to compensate for compression error caused by pressing the probe onto the patient tissue. Performance testing for this feature measured the estimated recovery (i.e., simulated distance from target divided by original compression error, reported as a percent). In silicone liver and in-vivo porcine datasets, percent recovery metrics demonstrated a positive effect compared to no deformation simulation.
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Image /page/8/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 MEDICAL" on the right. The words "CLEAR GUIDE" are in black, and the word "MEDICAL" is in gray.
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 technology 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.