(34 days)
No
The summary describes image processing algorithms for segmentation, registration, and probe identification, but does not explicitly mention or imply the use of AI or ML techniques. The segmentation is described as "semi-automatic" and initiated by the physician, which is not typical of autonomous AI/ML segmentation.
No
The device is an image processing software package that assists physicians during ablation procedures but does not perform the therapy itself. It is explicitly stated that it is used with an "Ablation System," implying it's a tool for the therapeutic device, not the therapeutic device itself.
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis." It aims to assist physicians in identifying targets, assessing probe placement, and confirming ablation zones, which are procedural support functions rather than diagnostic ones.
No
The device is described as an optional feature for use with the Certus® 140 2.45 GHz Ablation System and is resident on that system, implying a dependency on the hardware of the ablation system. While it has a separate user interface, it is not presented as a standalone software product independent of the Certus 140 hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ablation Confirmation™ software processes medical images (CT and MR) taken from the patient's body to assist physicians during an ablation procedure. It helps with identifying targets, assessing probe placement, and confirming the ablation zone.
- Intended Use: The intended use explicitly states that the software is "not intended for diagnosis." While it provides information to the physician, it does not perform a diagnostic test on a biological sample.
- Input: The input is medical imaging data, not biological samples.
Therefore, the Ablation Confirmation™ software falls under the category of medical image processing software used for procedural guidance and assessment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.
Product codes
JAK
Device Description
AC is resident on the Certus® 140 system and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT and MR images via the DICOM protocol.
AC contains a wide range of image processing tools, including:
- 2D image manipulation
- 3D image generation (from 2D images)
- 3D image manipulation
- Region of interest (ROI) identification, segmentation and measurement
- Automatic identification of ablation probes
- . Registration of multiple images into a single view
Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image.
Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure probe(s) placement prior to starting the ablation.
Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semiautomatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure.
All AC processing and viewing is accomplished at the Certus® 140 Ablation System without the physician having to leave the procedure area to utilize separate image processing tools.
Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), MR images
Anatomical Site
soft tissue including liver, lung and kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / procedure area
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)
Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks arising from the expansion of the Tissue Contraction feature were analyzed and satisfactorily mitigated in the device design and labeling.
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
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
NeuWave Medical, Inc. % Mr. Dan Kosednar Director of Regulatory Affairs and Quality Assurance 3529 Anderson Street MADISON WI 53704
Re: K171022
Trade/Device Name: Ablation Confirmation™ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 2, 2017 Received: May 3, 2017
Dear Mr. Kosednar:
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
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1
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.
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/ResourcesforYou/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,
Michael D'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) K171022
Device Name Ablation Confirmation™
Indications for Use (Describe)
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.
| 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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3
| Date: | 05/02/2017 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information for NeuWave |
| Medical's Ablation Confirmation™ image processing software | |
| Company: | NeuWave Medical, Inc. |
| 3529 Anderson Street | |
| Madison, WI 53704 | |
| FDA Establishment# | 3008769756 |
| Contact: | Dan Kosednar, Director of Regulatory Affairs |
| P – 608-512-1592 | |
| F – 608-512-1509 | |
| Proprietary: | |
| Classification: | Ablation Confirmation™ Common: Computed Tomography X-ray System |
| Radiology, JAK, 21 CFR 892.1750 |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
Predicate Devices
Ablation Confirmation™ is substantially equivalent to the following currently marketed device:
- . Ablation Confirmation Software - Class II - 21CFR892.1750, Radiology, JAK, which has been the subject of a cleared 510(k) with the FDA log number K161285.
Indications For Use
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.
Device Description
AC is resident on the Certus® 140 system and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT and MR images via the DICOM protocol.
AC contains a wide range of image processing tools, including:
- 2D image manipulation
- 3D image generation (from 2D images)
- 3D image manipulation
- Region of interest (ROI) identification, segmentation and measurement
- Automatic identification of ablation probes
- . Registration of multiple images into a single view
Ablation Confirmation 510(k) Submission Safety Summary Page 1 of 2
4
Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image.
Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure probe(s) placement prior to starting the ablation.
Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semiautomatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure.
All AC processing and viewing is accomplished at the Certus® 140 Ablation System without the physician having to leave the procedure area to utilize separate image processing tools.
Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.
Modifications
This 510(k) was submitted to update the Ablation Confirmation software with the following modifications:
- . The available tissue contraction percentages vary by tissue type and have been expanded versus the predicate while remaining within the values supported by various peer-reviewed literature
- . The user can configure the AC software so that tissue contraction is automatically applied when reaching the "Evaluate Ablation" page in the workflow rather than requiring a separate distinct action and additional processing time.
Performance Data
Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks arising from the expansion of the Tissue Contraction feature were analyzed and satisfactorily mitigated in the device design and labeling.
Substantial Equivalence Discussion
Ablation Confirmation™ is substantially equivalent in design concepts, technologies and materials to the identified predicate. AC does not present any new questions of safety or effectiveness.