(28 days)
Not Found
No
The document describes "proprietary software algorithms" for segmentation and registration, but does not mention AI, ML, or related terms like neural networks or deep learning. The description of the algorithms being "automated" and requiring new inputs to change segmentation output suggests deterministic, rule-based processing rather than adaptive learning.
No.
The device is a medical guidance and navigation software system that assists in diagnostic and interventional procedures by providing image fusion and tracking, but it does not directly treat a condition. It is a tool used during therapeutic or diagnostic procedures.
Yes
The "Intended Use / Indications for Use" section states: "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."
No
The device description explicitly states that the system "uses optical detection technology to identify and track objects in the field of view" and utilizes the "Clear Guide Optical Head platform". 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 examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Clear Guide SCENERGY's Function: The Clear Guide SCENERGY is a medical guidance and navigation software system that uses image fusion and tracking to assist clinicians during interventional and diagnostic procedures. It works with imaging modalities (CT, MR, US) and tracks instruments and patient movement.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is based on processing and displaying medical images and tracking physical objects in real-time.
Therefore, the Clear Guide SCENERGY falls under the category of a medical device used for image-guided 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 Optical Head platform to display images of the target regions and the projected path of the intervent, 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, 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).
Product codes (comma separated list FDA assigned to the subject device)
JAK, IYO, LLZ, ITX
Device Description
The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).
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 ning that new inputs (e.g., a new CT or MRI) 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
Any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain.
Indicated Patient Age Range
patients of sufficient size (at least 25 kg)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
Software V&V testing were conducted and documented based on the risks of software functions in the context of the intended use as recommended by FDA's Guidance titled "Content of Premarket Submissions for Device Software Functions". For the CLEAR GUIDE SCENERGY. the "enhanced" documentation level was considered as appropriate, since a failure or flaw of any device software functions could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.
Clinical Testing:
A small (10 patient) clinical validation study (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid") was run to further test the safety and effectiveness of the modifications to CLEAR GUIDE SCENERGY. The study validated the workflow, characterized the intervention accuracy within the existing device performance, and confirmed safety as compared to that demonstrated in experiments performed using a perineal template to facilitate needle localization for focal laser ablation of cadaveric prostate. No adverse effects or new risks were observed and CLEAR GUIDE SCENERGY accurately achieved its intended use throughout the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
January 17, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
Clear Guide Medical % Alican Demir Principal Engineer / Director of Quality Systems 3600 Clipper Mill Road, Suite 400 BALTIMORE, MD 21211
Re: K234030
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, IYO, LLZ, ITX Dated: November 12, 2023 Received: December 20, 2023
Dear Alican Demir:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K234030
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 Optical Head platform to display images of the target regions and the projected path of the intervent, 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, 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).
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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K234030
Image /page/3/Picture/1 description: The image is a logo for Clear Guide Medical. The logo consists of a stylized image of a needle and the words "CLEAR GUIDE MEDICAL" in bold, sans-serif font. The words "CLEAR GUIDE" are in black, and the word "MEDICAL" is in gray.
510(k) Summary
(per 21 CFR § 807.92)
Submitter's Information
| Name | Clear Guide Medical, Inc. |
|---|---|
| Address | 3600 Clipper Mill Road, Suite 400 |
| Baltimore, MD 21211 USA | |
| Phone Number | +1 (443) 602-8950 |
| Contact Person | Alican Demir, PhD |
| Principal Engineer / Director of Quality Systems | |
| Date Prepared | January 15, 2024 |
Device Information
| Trade Name | Clear Guide SCENERGY | |||
|---|---|---|---|---|
| Common Name | System, Imaging Software | |||
| Classification(s) | JAK | Computed tomography x-ray system | ||
| Class II under 21 CFR 892.1750 | ||||
| Subsequent/Secondary Classification(s) are: | ||||
| IYO | Ultrasonic pulsed echo imaging system | |||
| Class II under 21 CFR 892.1560 | ||||
| LLZ | Medical image management and processing system | |||
| Class II under 21 CFR 892.2050 | ||||
| ITX | Diagnostic ultrasound transducer | |||
| Class II under 21 CFR 892.1570 | ||||
Predicate Device Information
| Device Name | Clear Guide SCENERGY (Clear Guide Medical, Inc.) |
|---|---|
| 510(k) Number | K201188 |
| Common Name | System, Imaging Software |
| Classification(s) | JAK Computed tomography x-ray system |
| Class II under 21 CFR 892.1750 | |
| Subsequent/Secondary Classification(s) for all predicate devices are. | |
| IYO Ultrasonic pulsed echo imaging system | |
| Class II under 21 CFR 892.1560 | |
| LLZ Medical image management and processing system | |
| Class II under 21 CFR 892.2050 |
4
Image /page/4/Picture/1 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized letter "L" formed by a thick black line intersecting with two thinner gray lines. To the right of the "L" is the text "CLEAR GUIDE" in bold, black letters, with the word "MEDICAL" underneath in a smaller, gray font.
Device Description
The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).
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 ning that new inputs (e.g., a new CT or MRI) 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 Optical Head 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, 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).
Technological Characteristics
Real-time marker tracking and instrument guidance is achieved by optical detection of needle-like rigid instrumentation by means of stereo cameras, and overlay of graphical indicators on the input imaging modality (Ultrasound, CT, or MR). Optionally, fiducial markers are attached to the patient and/or instrument to facilitate tracking.
Image fusion is the joining of static, volumetric, high-resolution imaging data (e.g., CT or MRI scans) with real-time, streamed image data (e.g., ultrasound). CLEAR GUIDE SCENERGY uses proprietary algorithms capable of combining three input sources (image stream from an ultrasound machine, a static CT/MRI volume, and video feed from the CLEAR GUIDE Optical Head) to provide an accurate visual feedback for the underlying image-guided procedure. Fusion of static imaging data (CT/MRI) is facilitated by the application of multi-modality fiducial markers prior the imaging. When Ultrasound and CT/MR fusion is enabled, the real-time ultrasound image stream is shown on the display together with dynamically computed CT/MB slices from the volumetric data, and guidance overlays.
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Image /page/5/Picture/1 description: The image is a logo for Clear Guide Medical. The logo consists of two parts: a stylized graphic on the left and the company name on the right. The graphic on the left features a thick, black vertical line with two thinner, gray lines curving away from it. To the right of the graphic, the words "CLEAR GUIDE" are stacked on top of each other in bold, black letters, and below them, the word "MEDICAL" is written in gray.
A comparison of CLEAR GUIDE SCENERGY's technological characteristics to its predicate device is provided below.
| Category | Modified Device:
Clear Guide SCENERGY | Predicate Device:
Clear Guide SCENERGY |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K234030 | K201188 |
| Product Code | JAK | JAK |
| Classification Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 |
| Regulatory Class | Class II | Class II |
| Classification Name | Computed tomography x-ray system | Computed tomography x-ray system |
| Subsequent
Product Code(s) | IYO, LLZ, ITX | IYO, LLZ |
| Intended Use(s)
(i.e., List of Main Functions) | - 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), Mag-
netic 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 Optical Head 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 in-
terventional 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 inter-
ventional 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 is software that provides
fusion of images from Computed Tomography (CT), Mag-
netic 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 in-
terventional 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 inter-
ventional 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). |
| Principle of Operation
(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 |
| Conditions of Use | Image-guided Procedures | Image-guided Procedures |
| Fusion Capabilities | US-CT & US-MR | US-CT & US-MR |
| Input Imaging Data | CT, MR, or Ultrasound | CT, MR, or Ultrasound |
| Device Interactions | 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 |
| User Interface Modes | SETUP (3D), PLAN, NAVIGATION | SETUP (3D), NAVIGATION
continued |
| Category | Modified Device:
Clear Guide SCENERGY | Predicate Device:
Clear Guide SCENERGY |
| Supported Accessories
(Marketed separately) | - SteriMASK transducer cover kit - VisiMARKER fiducial markers
- TP Access tool with SteriGRID needle guide grid | - SteriMASK transducer cover kit
- VisiMARKER fiducial markers |
| 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) | N/A (no modifications) |
| Animal Testing | N/A | N/A |
| Clinical Testing | Yes | Yes |
| Standards | N/A (for software) | N/A (for software) |
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510(k) Summary Clear Guide SCENERGY
Image /page/6/Picture/1 description: The image is a logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with two horizontal lines extending from the "L" to the right. To the right of the "L" is the text "CLEAR GUIDE MEDICAL" in black and gray letters. The words "CLEAR" and "GUIDE" are in black, while the word "MEDICAL" is in gray.
The fundamental optical detection technology used for marker tracking and instrument guidance is unaffected by the change, and thus identical to the predicate version of CLEAR GUIDE SCENERGY. Similarly, the image fusion technology developed for the predicate CLEAR GUIDE SCENERGY is not modified. Instead, existing technologies for marker detection (i.e. segmentation), target selection, and quidance overlay mechanisms were reused to show visualizations pertaining to the newly supported CLEAR GUIDE SteriGRID needle guide grid accessory on the static MR/CT images. The software takes advantage of the permanent CLEAR GUIDE VisiMARKER fiducial markers on the CLEAR GUIDE TP Access frame to accurately register it to the loaded static image volume. This static guidance information is presented on a new graphical user interface called "PLAN", which is only enabled if CLEAR GUIDE SCENERGY is configured for transperineal procedures. Any other changes to the technological characteristic descriptions are editorial in nature for clarity, and subtantially equivalence is further supported by the comparison table.
Performance Data
No new performance data were needed to evaluate the "software" device modification as the intended use, indications for use, underlying device technology, principles of operation, as well as the device components (Clear Guide CORE, Clear Guide Optical Head) were not changed. For the CLEAR GUIDE TP Access tool with the CLEAR GUIDE SteriGRID accessorry, functional tests as well as evaluation of sterility, packaging, stability, and biocompatibility were performed. The newly added "PLAN" user interface and added support for the registration of "SteriGRID" (Transperineal Guide Grid) accessory did not affect the safety and effectiveness of the device, which is supported by the execution of well-established CLEAR GUIDE SCENERGY Verification and Validation (V&V) methods as part of the CLEAR GUIDE MEDICAL's design control activities. In addition, a small clinical testing was performed to demonstrate that CLEAR GUIDE SCENERGY accurately achieves its intended use.
Hardware Verification and Validation Testing
Hardware V&V tests were not performed since those components were not changed. CLEAR GUIDE Optical Head and CLEAR GUDE CORE are in compliance with ES60601-1 and IEC 60601-1-2 standards. Necessary software/hardware integration tests with the new CLEAR GUIDE TP Access (with CLEAR GUIDE SteriGRID) acessory devices were performed.
7
Image /page/7/Picture/1 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 MEDICAL" on the right. The words "CLEAR GUIDE" are stacked on top of each other in black, and the word "MEDICAL" is in gray below them.
Software Verification and Validation Testing
Software V&V testing were conducted and documented based on the risks of software functions in the context of the intended use as recommended by FDA's Guidance titled "Content of Premarket Submissions for Device Software Functions". For the CLEAR GUIDE SCENERGY. the "enhanced" documentation level was considered as appropriate, since a failure or flaw of any device software functions could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.
Clinical Testing
A small (10 patient) clinical validation study (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid") was run to further test the safety and effectiveness of the modifications to CLEAR GUIDE SCENERGY. The study validated the workflow, characterized the intervention accuracy within the existing device performance, and confirmed safety as compared to that demonstrated in experiments performed using a perineal template to facilitate needle localization for focal laser ablation of cadaveric prostate. No adverse effects or new risks were observed and CLEAR GUIDE SCENERGY accurately achieved its intended use throughout the study.
Conclusions
Based on the comparison presented above, therere are no differences in the product's technological characteristics with respect to the its predicate device, and therefore no new or different questions of safety or effectiveness are raised. Additionally, verification & validation tests confirm that the CLEAR GUIDE SCENERGY is as safe and as effective as the predicate device for the intended use. For this particular device modification, therefore, the CLEAR GUIDE SCENERGY is substantially equivalent to its predicate device.