(122 days)
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.
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 segmentation 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.
Here's a breakdown of the acceptance criteria and study information for the Clear Guide SCENERGY, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it generally states that tests yielded "passing results" or were "within acceptable limits/criteria." However, it does describe the metrics used and confirms successful performance.
| Test Category | Metric Used | Reported Device Performance | Acceptance Criteria (Implicitly Met) |
|---|---|---|---|
| Segmentation Testing | Segmentation error, Detection rate | Passing results | Software outputs match manual selection within acceptable error and detection rates. |
| Registration Testing | Fiducial Registration Error (FRE) | FRE within acceptable limits; no instances of misregistration. | FRE within acceptable limits, misregistration instances are zero. |
| Guidance (Tip-to-Target) Testing | Tip-to-target distance | Passing test result | End user's ability to hit a desired target within acceptable distance. |
| Fusion Testing | Tissue Registration Error (TRE) | Passing test results | TRE within acceptable limits. |
| Systematic Error (Tip-to-Tip) Testing | Cumulative "tip-to-tip" distance | Within test acceptance criteria (passing test result) | Cumulative error (segmentation, registration, fusion, guidance) within acceptable limits. |
| Deformation Testing | Estimated recovery (percent) | Positive effect compared to no deformation simulation. | Demonstrate a positive and effective compensation for compression error. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that phantom, animal, and human datasets were used for various tests (Segmentation, Registration, Fusion, Deformation). However, it does not specify the exact sample sizes for each of these categories (e.g., number of CT scans, number of animals, number of human subjects).
The data provenance is generally described as:
- Phantom datasets: Used for Segmentation, Registration, Fusion, Systematic Error testing.
- Animal datasets (in-vivo porcine): Used for Segmentation, Registration, Fusion, Deformation testing.
- Human datasets: Used for Segmentation, Registration, Fusion testing.
The country of origin is not explicitly stated, nor is whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the use of animal and human datasets, it's likely a mix of prospective (as part of the validation study) and potentially some retrospective data, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "manual selection" as the ground truth for segmentation testing but does not specify the number of experts who performed this manual selection, nor their qualifications (e.g., radiologist with X years of experience).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies, beyond stating that software outputs were compared to "manual selection" for segmentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
The document does not report a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how human readers improve with AI vs. without AI assistance. The performance data focuses on the device's accuracy and functionality in performing its tasks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be largely standalone algorithm performance from the perspective of accuracy of segmentation, registration, guidance, and fusion. For example, "Segmentation error and detection rate were analyzed, with passing results (per acceptability criteria)" directly assesses algorithms' outputs against ground truth. The "Guidance (Tip-to-Target) Testing" also assesses the device's ability to facilitate hitting a desired target. The entire section on "Performance Data" describes how the device itself (its software algorithms) performs.
7. The Type of Ground Truth Used
The types of ground truth used include:
- Manual Selection: Mentioned for Segmentation Testing (comparing software outputs to manual selection in phantom, animal, and human datasets).
- CT: Implied as the reference for "tip-to-tip" distance in Systematic Error Testing ("needle point seen by ground truth CT").
- Identifiable landmarks seen on ultrasound and CT: Used for Fusion Testing (Tissue Registration Error (TRE)).
It does not explicitly mention pathology or outcomes data as ground truth for these specific performance tests.
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 Clear Guide SCENERGY's algorithms.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information on how the ground truth for the training set was established. It only discusses the ground truth used for the validation/test sets.
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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.
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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
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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 400Baltimore, 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 System21 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.
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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 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 FusionInstrument Tracking and Guidance | Image FusionInstrument Tracking and Guidance |
| Indications for Use | The Clear Guide SCENERGY is astereotaxic accessory for the fusion ofimages from Computed Tomography(CT) and Ultrasound (US) modalities.The Clear Guide SCENERGY utilizesthe Clear Guide CORE and ClearGuide SuperPROBE platform todisplay images of the target regionsand the projected path of theinterventional instrument, while takinginto account patient movement anddeformation. Instrumentation usedwith the Clear Guide SCENERGYmight include an interventional needleor needle-like rigid device, such as abiopsy needle, an aspiration needle,or an ablation needle. The device isintended to be used in anyinterventional or diagnostic procedurewhere the combination of thesemodalities is used for visualization,except for procedures on the brain.The device is intended for use in aclinical setting. | PercuNav is a stereotaxic accessoryfor Computed Tomography (CT),Magnetic Resonance (MR),Ultrasound (US), Positron EmissionTomography (PET), Single PhotonEmission Computed Tomography(SPECT), Rotational Fluoroscopy,Endoscopy, and other imagingsystems. CT, Ultrasound, PET, MR,and Rotational Fluoroscopy may befused in various combinations, suchas CT with MR, MR with ultrasound,etc. It may include instrumentation todisplay the simulated image of atracked insertion tool such as a biopsyneedle, guidewire or probe on acomputer monitor screen that showsimages of the target organs and thecurrent and the projected future pathof the interventional instrument takinginto account patient movement. Thisis intended for treatment planning andguidance for clinical, interventional,and/or diagnostic procedures. Thedevice also supports an image-freemode in which the proximity of theinterventional device is displayedrelative to another device.The device is intended to be used ininterventional and diagnosticprocedures in a clinical setting. Thedevice is also intended for use inclinical interventions to determine theproximity of one device relative toanother.Example procedures include, but arenot limited to: [...] |
| Fundamental Technology | Optical Detection | Electromagnetic (EM) |
| Signal Receiver | Connected/Anchored to Transducer | Connected/Anchored to Transducerand 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).
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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.
§ 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.