(29 days)
Unknown
The summary mentions "Automated tools for target tissue and ablation zone segmentation" and "several algorithms" including "Segmentation post-processing" and "Automatic ROI definition for Local Rigid Registration". While these could potentially utilize AI/ML, the summary does not explicitly state the use of AI, DNN, or ML, nor does it provide details about training or test sets which are common indicators of ML use. Therefore, it is not possible to definitively confirm the presence of AI/ML based on this summary alone.
No
The device is described as image processing software used to assist physicians in planning ablation procedures and confirming ablation zones, but it is not directly involved in performing the ablation or treating the patient.
No.
The "Intended Use / Indications for Use" section explicitly states: "The software is not intended for diagnosis."
Yes
The device is described as a "stand-alone desktop software application" that imports images and provides tools for planning and evaluating ablation procedures. While it runs on a workstation and interacts with imaging systems, the core medical device functionality is entirely within the software itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this software processes medical images (CT and MR) of the patient's body, not biological samples.
- The intended use is for image processing and planning/confirmation of ablation procedures. This is a medical device used in the context of a surgical or interventional procedure, not a diagnostic test performed on a specimen.
- The device description focuses on image manipulation, segmentation, and measurement within the images. These are functions related to medical imaging analysis, not in vitro testing.
- The "Intended Use / Indications for Use" explicitly states "The software is not intended for diagnosis." While IVDs are used for diagnosis, this device is specifically stated as not being for diagnosis.
Therefore, based on the definition and typical use cases of IVDs, this device, which processes medical images for procedural planning and confirmation, does not fit the criteria of an In Vitro Diagnostic. It is a medical device used in the context of image-guided procedures.
N/A
Intended Use / Indications for Use
Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
Aline Ablation Intelligence is controlled by the user via a user interface on a workstation.
Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Aline Ablation Intelligence 1.0.0, is a stand-alone desktop software application with tools and features designed to assist users in planning ablation procedures as well as tools for evaluating ablation procedure's outcome.
The use environment for Aline Ablation Intelligence is the Operating Room and the hospital healthcare environment such as interventional radiology control room.
Aline Ablation Intelligence has five distinct workflow steps:
- . Data assignment
- Tumor segmentation
- Needle planning ●
- . Ablation zone segmentation
- Treatment confirmation ●
Of these workflow steps two (Tumor Segmentation and Needle Planning) make use of the planning image volume. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Segmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's outcome in the confirmation image volume.
Key features of the Aline Ablation Intelligence Software include: - Workflow steps availability
- Manual and Automated tools for target tissue and ablation zone segmentation
- Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images
- Multimodal image fusion and registration
- Compute achieved margins and missed volumes to help the user assess the coverage of the target tissue by the ablation zone
- Data saving and secondary capture generation
The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the target tissues and ablation zones.
The software system runs on a dedicated workstation and is intended for display and processing, of a Computed Tomography (CT) and/or Magnetic Resonance (MR) image, including contrast enhanced images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Computed Tomography (CT) and Magnetic Resonance (MR)
Anatomical Site
Soft tissue lesions.
Indicated Patient Age Range
The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment.
Intended User / Care Setting
Physicians in the Operating Room and the hospital healthcare environment such as interventional radiology control room.
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)
Aline Ablation Intelligence is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission.
The results of performance, functional and algorithmic testing demonstrate that Aline Ablation Intelligence meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.
Test planning was performed in accordance with standard testing procedures and guidelines as listed in internal development processes.
Human factors testing has been performed in line with Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 and IEC 62366-1:2015.
Verification and validation testing were carried out as per planned arrangements in the Project Test Plan and Phase Test Plan(s) to ensure that design outputs meet design inputs and that this edition of Aline Ablation Intelligence meets the product acceptance criteria. These are 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" and adherence to the DICOM standard.
Potential risks were analyzed and satisfactorily mitigated in the device design.
Performance testing (Bench) was performed, including on the following features, to ensure that performance and accuracy was as expected:
- Segmentation post-processing Testing
- . Automatic ROI definition for Local Rigid Registration Testing
- Measurement and Quantification Testing
Aline Ablation Intelligence 1.0.0 provides functions including linear distance measurements and volumetric measurements. The resolution of the medical image data directly affects the ability of the user to make definitive measurements, especially when the sizes of structures to identify, segment or measure are near the resolution of the image data. The software's functions are dependent on the user actions as well as on the available information in the provided medical image data.
Segmentation tools provided within Aline Ablation Intelligence 1.0.0 include manual and semiautomated segmentation, and system post-processing of segmentations to remove 2D-holes and/or disconnected 3D regions present. The use of the segmentation tools to achieve a satisfactory delineation of tumor or ablated tissue is a user operation and the clinical accuracy of segmentation is the responsibility of the user and not an Aline Ablation Intelligence function.
Registration tools provided within Aline Ablation Intelligence 1.0.0 include automated local rigid registration within a region of interest around user-segmentations of tumors and ablation zones. Final accuracy of registration is dependent on user assessment and manual modification of the registration prior to acceptance, and not an Aline Ablation Intelligence function.
Measurements of the achieved margins and missed volumes, calculated by comparing the segmentations, are presented by the system following user acceptance of segmentations and registration as clinically accurate. Accuracy of linear distance measures calculated by Aline Ablation Intelligence 1.0.0 are dependent on the image resolution; these are accurate to ¼ of a voxel width and are reported to 0.1mm precision. Volume calculations by Aline Ablation Intelligence 1.0.0 are dependent on the image resolution; these are at whole-voxel resolution and voxel inclusion/exclusion is determined by whether the voxel center is inside or outside the displayed contour. Volume is reported to 0.001cm3 precision.
It is the responsibility of the user to determine if the results of image visualization are satisfactory and allow the accurate use of the functions provided.
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.
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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September 11, 2020
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Mirada Medical Ltd % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. WARREN NJ 07059
Re: K202297
Trade/Device Name: Aline Ablation Intelligence Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 12, 2020 Received: August 13, 2020
Dear Mr. Yungvirt:
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. 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 located 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Mirada. The logo consists of the word "MIRADA" in a bold, sans-serif font, with the "M" in a lighter blue color than the rest of the letters. Below the word "MIRADA" is the tagline "The Imaging Software People" in a smaller, lighter blue font. The logo is simple and modern, and it conveys a sense of professionalism and expertise.
SECTION 4. INDICATIONS FOR USE STATEMENT
The completed Form FDA 3881 Indications for Use is provided here (page 1 of 1).
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K202297 |
| Device Name | Aline Ablation Intelligence |
| Indications for Use (Describe) | Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
Aline Ablation Intelligence is controlled by the user via a user interface on a workstation.
Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for MIRADA. The logo is in blue and consists of the word "MIRADA" in a bold, sans-serif font. The "I" in MIRADA is a lighter shade of blue than the rest of the letters. Below the word "MIRADA" is the tagline "The Imaging Software People" in a smaller, lighter blue font.
SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(The following information is in conformance with 21 CFR 807.92)
| 510(k) Number | K202297 |
|---|---|
| Date of summary: | September 9th 2020 |
| Submitter's name: | Mirada Medical Ltd |
| Submitter's address: | New Barclay House, 234 Botley Rd, Oxford OX2 |
| OHP. United Kingdom United Kingdom | |
| Submitter's contact: | David Clafton |
| Telephone number: | +44(0)1865 817600 |
| Device Proprietary Name: | Aline Ablation Intelligence |
| Device Common Name(s): | Aline Ablation Intelligence |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system. |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
Predicate Device
| 510(k) Number | K150313 |
|---|---|
| Trade Name | Ablation Confirmation (AC) |
| Manufacturer | NeuWave Medical, Inc. |
| Device Name | Ablation Confirmation |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system. |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
Reference Devices
The following reference devices are used within this submission to support the substantial equivalence discussion regarding performance evaluation. These devices have been selected as they share common features and technological characteristics with the proposed device.
| 510(k) Number | K102687 |
|---|---|
| Trade Name | Mirada RT |
Copyright © Mirada Medical Ltd, 2020
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Image /page/4/Picture/0 description: The image shows the logo for Mirada. The logo has the word "MIRADA" in large, bold, blue letters. Below the word "MIRADA" is the phrase "The Imaging Software People" in a smaller, lighter blue font.
| Manufacturer | Mirada Medical Ltd |
|---|---|
| Device Name | Mirada RT |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system. |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
| 510(k) Number | K130393 |
|---|---|
| Trade Name | Mirada RTX |
| Manufacturer | Mirada Medical Ltd |
| Device Name | Mirada RTX |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system. |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
| 510(k) Number | K101228 |
|---|---|
| Trade Name | Mirada XD |
| Manufacturer | Mirada Medical Ltd |
| Device Name | Mirada XD |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system. |
| Regulatory Class | Class II |
| Primary Product Code | LLZ |
5.1 Device Description
Aline Ablation Intelligence 1.0.0, is a stand-alone desktop software application with tools and features designed to assist users in planning ablation procedures as well as tools for evaluating ablation procedure's outcome.
The use environment for Aline Ablation Intelligence is the Operating Room and the hospital healthcare environment such as interventional radiology control room.
Aline Ablation Intelligence has five distinct workflow steps:
- . Data assignment
- Tumor segmentation
- Needle planning ●
- . Ablation zone segmentation
- Treatment confirmation ●
Of these workflow steps two (Tumor Segmentation and Needle Planning) make use of the planning image volume. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Segmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools
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Image /page/5/Picture/0 description: The image shows the logo for Mirada, a company that specializes in imaging software. The logo is composed of the company name in a bold, sans-serif font, with the "I" in "MIRADA" colored in a lighter blue than the rest of the name. Below the company name is the tagline "The Imaging Software People" in a smaller, lighter font.
designed to support the evaluation of the ablation procedure's outcome in the confirmation image volume.
Key features of the Aline Ablation Intelligence Software include:
- Workflow steps availability
- Manual and Automated tools for target tissue and ablation zone segmentation
- Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images
- Multimodal image fusion and registration
- Compute achieved margins and missed volumes to help the user assess the coverage of the target tissue by the ablation zone
- Data saving and secondary capture generation
The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the target tissues and ablation zones.
The software system runs on a dedicated workstation and is intended for display and processing, of a Computed Tomography (CT) and/or Magnetic Resonance (MR) image, including contrast enhanced images.
The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment.
Aline Ablation Intelligence uses several algorithms to perform operations to present information to the user in order for them to evaluate the planned and post ablation zones. These include:
- Segmentation post-processing
- Automatic ROI definition for Local Rigid Registration
- Measurement and Quantification
Indications for Use 5.2
Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
Aline Ablation Intelligence is controlled by the user interface on a workstation.
Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
5.3 Technical characteristic comparison
| Characteristic | Aline Ablation Intelligence | NeuWave – Ablation
Confirmation | Equivalence |
|----------------|-----------------------------|------------------------------------|-------------|
| 510(k) number | K202297 | K150313 | n/a |
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Image /page/6/Picture/0 description: The image shows the logo for MIRADA. The logo is in blue and features the word "MIRADA" in bold letters. Below the word "MIRADA" is the phrase "The Imaging Software People" in a smaller font, also in blue.
| Classification | Class II. 892.2050 LLZ | Class II. 892.2050 LLZ | n/a |
|---|---|---|---|
| Target | |||
| Population | The intended patient | ||
| population of the Aline | |||
| Ablation Intelligence software | |||
| is the patient demographic | |||
| chosen by interventional | |||
| radiologists to undergo | |||
| ablation treatment (including | |||
| patient with soft tissue | |||
| lesions). | Patient with soft tissue lesions. | Equivalent | |
| Where Used | The application's use | ||
| environment is the Operating | |||
| Room and the hospital | |||
| healthcare environment such | |||
| as interventional radiology | |||
| control room. | 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. 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. | Substantially | ||
| Equivalent | |||
| Energy Used | |||
| and/or | |||
| Delivered | None - software only | ||
| application. The software | |||
| application does not deliver or | |||
| depend on energy delivered to | |||
| or from patients | None - software only | ||
| application. The software | |||
| application does not deliver or | |||
| depend on energy delivered to | |||
| or from patients, this image | |||
| processing software package is | |||
| an optional for use with the | |||
| Certus® 140 2.45 GHz Ablation | |||
| System | Equivalent | ||
| Intended Users | Physicians | Physicians | Equivalent |
| Design: | |||
| Supported | |||
| modalities | CT, MRI. | CT, MRI. | Equivalent |
| Design: Data | |||
| Visualization | Window and level, pan, zoom, | ||
| cross-hairs, slice navigation | Window and level, pan, zoom, | ||
| cross-hairs, slice navigation | Equivalent | ||
| Design: Image | |||
| Segmentation | Tools for segmenting 3D VOIs, | ||
| including target tissues and | |||
| ablation zones. | Tools for segmenting 3D VOIs, | ||
| including target lesions and | |||
| ablation zones. | Equivalent | ||
| Design: Image | |||
| registration | Registration of multiple | ||
| images into a single view. | Registration of multiple | ||
| images into a single view. | Equivalent | ||
| Design: | |||
| Ablation zone | |||
| confirmation | Aline Ablation Intelligence can | ||
| perform a registration of the | |||
| planning scan, containing the | |||
| identified target tissue, with | |||
| the confirmation scan showing | |||
| the ablation zone. The | |||
| delineated target tissue on the | |||
| planning scan is then | |||
| projected onto the | |||
| confirmation scan and overlaid | |||
| onto the delineated ablation | |||
| zone segmentation. This to | |||
| help the user in analyzing if | |||
| the ablation zone covers the | |||
| target tissue with the desired | |||
| amount of margin. | AC can then perform a | ||
| registration of the initial CT | |||
| scan, containing the identified | |||
| target, with the final CECT scan | |||
| containing the segmented | |||
| ablation zone. The resulting | |||
| image set includes the ablation | |||
| zone overlaid onto the initial | |||
| target lesion segmentation to | |||
| help physicians determine the | |||
| technical success (ablation | |||
| zone covers target lesion with | |||
| desired amount of margin) of | |||
| the ablation procedure. | Substantially | ||
| Equivalent | |||
| Design: Save | |||
| key images to | |||
| PACS | Key images can be acquired | ||
| which may be saved back to | |||
| PACS or any DICOM nodes. | All snapshot taken during | ||
| procedure are stored to PACS. | Substantially | ||
| Equivalent | |||
| Human Factors | Intended to be used safely and | ||
| effectively by trained | |||
| physicians and a human | |||
| factors engineering process | |||
| has been undertaken, | |||
| adhering to IEC 62366-1:2015 | Unknown | Substantially | |
| Equivalent | |||
| Materials | Not applicable - software | ||
| device only | Not applicable - software | ||
| device only | n/a | ||
| Biocompatibility | Not applicable - software | ||
| device only | Not applicable - software | ||
| device only | n/a | ||
| Sterility | Not applicable - software | ||
| device only | Not applicable - software | ||
| device only | n/a | ||
| Electrical safety | Not applicable - software | ||
| device only | Not applicable - software | ||
| device only | n/a | ||
| Mechanical | |||
| Safety | Not applicable - software | ||
| device only | Not applicable - software | ||
| device only | n/a | ||
| Chemical Safety | Not applicable - software device only | Not applicable - software device only | n/a |
| Thermal Safety | Not applicable - software device only | Not applicable - software device only | n/a |
| Radiation Safety | Not applicable - software device only | Not applicable - software device only | n/a |
| Computer platform & operating system | Microsoft Windows compatible machine. 64-bit Windows 7 and 10. | Installed on the Certus 140 system, OS unknown. | Substantially Equivalent |
| Labelling | Labelling complies with 21 CFR 801/830 | Requirements should be met based on 510(k) submission | Substantially Equivalent |
| Instructions for Use | Help Guide, Installation Guide, Release Notes | Requirements should be met based on 510(k) submission | Substantially Equivalent |
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Image /page/7/Picture/0 description: The image shows the logo for Mirada, a company that specializes in imaging software. The logo consists of the word "MIRADA" in a bold, sans-serif font. The letters are primarily dark blue, except for the "I", which is a lighter blue color. Below the word "MIRADA" is the tagline "The Imaging Software People" in a smaller, lighter blue font.
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Image /page/8/Picture/0 description: The image shows the logo for Mirada. The logo is in blue and consists of the word "MIRADA" in large, bold letters. Below the word "MIRADA" is the phrase "The Imaging Software People" in a smaller, lighter blue font.
5.4 Substantial Equivalence
When compared to the indications listed for the predicate device and applicable to the proposed device, the proposed device is substantially equivalent to the predicate device.
Both devices provide similar tools with which to register and segment images for planning (pretreatment) and confirmation (post-treatment).
The key differences between the predicate device and the proposed device is that the proposed device is not indicated for the identification of ablation probes in order to ensure proper ablation placement.
Additionally, the proposed device is indicated for placement of virtual ablation needles on the planning image volumes so to visualize size and location of the ablation regions created by the needles.
The needle planning features of the proposed device support the user in enhancing the evaluation of the needle planning procedure, performed in accordance with its intended use, and do not result in any new potential safety risks.
The above analysis of the characteristics of the Mirada Medical Aline Ablation Intelligence and the Predicate Device demonstrate that the proposed device is substantially equivalent, and the differences do not introduce additional risks that could affect safety or effectiveness.
There are no new indications for use for Aline Ablation Intelligence and therefore by following the FDA guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", Aline Ablation Intelligence is determined to be substantially equivalent to the predicate device.
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Image /page/9/Picture/0 description: The image shows the logo for Mirada. The logo is in blue and consists of the word "MIRADA" in a sans-serif font. The "I" in Mirada is a lighter shade of blue than the rest of the letters. Below the word "MIRADA" is the tagline "The Imaging Software People" in a smaller, lighter blue font.
5.5 Performance
Aline Ablation Intelligence is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission.
The results of performance, functional and algorithmic testing demonstrate that Aline Ablation Intelligence meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.
Test planning was performed in accordance with standard testing procedures and guidelines as listed in internal development processes.
Human factors testing has been performed in line with Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 and IEC 62366-1:2015.
Verification and validation testing were carried out as per planned arrangements in the Project Test Plan and Phase Test Plan(s) to ensure that design outputs meet design inputs and that this edition of Aline Ablation Intelligence meets the product acceptance criteria. These are 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" and adherence to the DICOM standard.
Potential risks were analyzed and satisfactorily mitigated in the device design.
Performance testing (Bench) was performed, including on the following features, to ensure that performance and accuracy was as expected:
- Segmentation post-processing Testing
- . Automatic ROI definition for Local Rigid Registration Testing
- Measurement and Quantification Testing
Aline Ablation Intelligence 1.0.0 provides functions including linear distance measurements and volumetric measurements. The resolution of the medical image data directly affects the ability of the user to make definitive measurements, especially when the sizes of structures to identify, segment or measure are near the resolution of the image data. The software's functions are dependent on the user actions as well as on the available information in the provided medical image data.
Segmentation tools provided within Aline Ablation Intelligence 1.0.0 include manual and semiautomated segmentation, and system post-processing of segmentations to remove 2D-holes and/or disconnected 3D regions present. The use of the segmentation tools to achieve a satisfactory delineation of tumor or ablated tissue is a user operation and the clinical accuracy of segmentation is the responsibility of the user and not an Aline Ablation Intelligence function.
Registration tools provided within Aline Ablation Intelligence 1.0.0 include automated local rigid registration within a region of interest around user-segmentations of tumors and ablation zones. Final accuracy of registration is dependent on user assessment and manual modification of the registration prior to acceptance, and not an Aline Ablation Intelligence function.
Measurements of the achieved margins and missed volumes, calculated by comparing the segmentations, are presented by the system following user acceptance of segmentations and registration as clinically accurate. Accuracy of linear distance measures calculated by Aline Ablation Intelligence 1.0.0 are dependent on the image resolution; these are accurate to ¼ of a
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Image /page/10/Picture/0 description: The image contains the logo for Mirada. The logo is in blue and features the company name in a bold, sans-serif font. The "I" in Mirada is a lighter shade of blue than the rest of the letters. Below the company name is the tagline "The Imaging Software People" in a smaller, lighter blue font.
voxel width and are reported to 0.1mm precision. Volume calculations by Aline Ablation Intelligence 1.0.0 are dependent on the image resolution; these are at whole-voxel resolution and voxel inclusion/exclusion is determined by whether the voxel center is inside or outside the displayed contour. Volume is reported to 0.001cm3 precision.
It is the responsibility of the user to determine if the results of image visualization are satisfactory and allow the accurate use of the functions provided.
5.6 Standards and guidelines
Aline Ablation Intelligence complies to the following FDA recognized standards:
- IEC 62304:2006+A1:2015
- IEC 62366-1:2015
- NEMA PS 3.1 3.20 (2016) DICOM 3.0 ●
The following other Standards were used during development of Aline Ablation Intelligence:
- ISO 14971:2012
- ISO 13485:2016
The following guidelines were used during development of Aline Ablation Intelligence:
- How to Prepare a Traditional 510(k)" and "eCopy Program for Medical Device submissions" dated October 10, 2013.
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k), July 28, 2014
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, December 20, 2019.
- Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2, 2014.
- . Guidance for the content of premarket submissions for software contained in medical devices, May 11, 2005
- Format for Traditional and Abbreviated 510(k)s, September 13, 2019.
5.7 Conclusion
In conclusion, performance testing demonstrates that Aline Ablation Intelligence is substantially equivalent to, and performs at least as safely and effectively as, the listed predicate device. Aline Ablation Intelligence meets requirements for safety and effectiveness and does not introduce any new potential safety risks.