The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle.

The system supports a workflow based on automated image registration of spatial mapping from image space to physical space.

The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where is currently used for visualizing such procedures.

The system is not intended for guidance for the head, nervous system and central circulatory system (heart included).

Device Description

The IMACTIS® CT-NAVIGATION system consists of a navigation station, specific software and a dedicated instrumentation set used in an interventional radiology room during percutaneous interventional radiological procedures performed under Computed Tomography.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance metric explicitly stated for the IMACTIS CT-NAVIGATION system is accuracy. The document compares this to the predicate device.

Acceptance Criteria (Stated or Implied)	Reported Device Performance (IMACTIS® CT-NAVIGATION system)
Non-Clinical Accuracy (Rigid conditions): Accuracy of the complete measurement chain (localization, calibration, registration). Implied: Needs to be comparable or better than the predicate device.	Non-Clinical Accuracy (Rigid conditions): "The system accuracy is always smaller than 2° and 2 mm." Conclusion: "IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device in terms of accuracy in rigid conditions."
Clinical Accuracy: Accuracy of the complete measurement chain on patients. Implied: Needs to provide sufficient guidance for interventional procedures.	Clinical Accuracy: Median Accuracy (IMACTIS® CT-NAVIGATION system): - Per Protocol: 3.8 mm [2.1; 9.9] (Median [P16%; P84%]) - Intention To Treat: 4.1 mm [2.1; 11.7] (Median [P16%; P84%]) Conclusion: "Regarding system registration performance of the predicate device, and the IMACTIS® CT-NAVIGATION system accuracy performance measured on the complete measurement chain, the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device."
Electromagnetic Compatibility & Electrical Safety: Compliance with relevant standards.	Tested according to IEC 60601-1 and IEC 60601-1-2 standards.
Biocompatibility: Device components.	Tested according to ISO10993 standards.
Sterility: Sterilization of delivered components.	Tested according to ISO11737 and ISO11607 standards.
CT Imaging Requirements: Maintained performance across different CT resolutions.	Performance maintained for axial resolutions of 0.5mm/pixel (1mm slice spacing) and 1mm/pixel (2mm slice spacing).

2. Sample Size Used for the Test Set and Data Provenance

Clinical Test Set Sample Size: 60 patients.
Data Provenance: The study was a "clinical testing on patients," implying it was real-world patient data. The country of origin is not explicitly stated, but the manufacturer is based in France, suggesting the study might have been conducted there or in a nearby region. It is prospective in nature, as it collected data during interventions performed with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish a ground truth for the test set, nor their specific qualifications. The clinical study collected "system accuracy results" by physicians using the system for procedures. The reported accuracy metrics (median, P16%, P84%) suggest that the "ground truth" for the test was likely the actual achieved position during the intervention, which was then compared to the device's measurement. The "ground truth" wasn't established via expert consensus on imagery, but rather by the inherent precision of the physical measurements derived from the actual clinical use. The document does state the system is "intended for use by trained physicians in clinical intervention."

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. Given that the clinical study focused on measuring the system's accuracy during interventions, and not on interpreting images, an adjudication method in the traditional sense (for diagnostic studies) would not be applicable here. The "accuracy" itself is the outcome measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned. The device provides "intra-operative guidance" to trained physicians, but the study described is a performance/accuracy validation, not a study evaluating human reader performance with or without AI assistance. The device is the assistance in this context, guiding the needle.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The primary performance metric (accuracy) for the IMACTIS® CT-NAVIGATION system was evaluated for the system as a whole, including the localization system, calibration, and registration, and its use in clinical settings. This implies a standalone performance of the device's guidance capabilities output, which the physician then uses. The non-clinical testing performed on a "dedicated test bench" does represent a standalone evaluation of the system's inherent accuracy in a controlled environment, without a human actively making interpretive decisions based on the output.

7. The Type of Ground Truth Used

Non-Clinical (Rigid conditions): The ground truth was established by comparing the device's measured position to the "known position of the cylindrical hole" on the dedicated test bench. This is an objective, physical measurement-based ground truth.
Clinical: The "achieved accuracy" was collected for 60 patients. While not explicitly defined as a "ground truth" in the diagnostic sense, it refers to the accuracy of the device's guidance during actual procedures. This implies the ground truth for "accuracy" was the difference between the intended/known target and the actual achieved position after guidance by the system in a real clinical scenario.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This device is an image-guided navigation system, not an AI/machine learning diagnostic tool that requires a separate training set in the conventional sense for model development. Its software design is based on algorithms for image registration and spatial mapping.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of typical AI/ML model development, there's no information on how its ground truth would have been established. The device design and software were developed according to internal design control procedures, which would involve verification and validation against specified requirements.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The FDA acronym is in a blue square, and the words "U.S. Food & Drug Administration" are in blue text.

April 24, 2018

IMACTIS® SAS % Mady Batailh Quality Manager 5 avenue du Grand Sablon 38700 La Tronche FRANCE

Re: K162314

Trade/Device Name: IMACTIS CT-NAVIGATION system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 12, 2018 Received: April 16, 2018

Dear Mady Batailh:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K162314

Device Name IMACTIS® CT-NAVIGATION system

The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle.

The system supports a workflow based on automated image registration of spatial mapping from image space to physical space.

The system is not intended for guidance for the head, nervous system and central circulatory system (heart included).

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 shows the logo for IMACTIS. The logo consists of a stylized eye symbol to the left of the word "IMACTIS". The eye symbol is a dark blue color, and the word "IMACTIS" is also dark blue. There is a registered trademark symbol to the right of the word "IMACTIS".

Traditional 510(k) Premarket Notification for IMACTIS® CT-NAVIGATION system

510(k) SUMMARY

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

Date Prepared: October, 4th 2017.

Owner's information:

IMACTIS® SAS 5 avenue du Grand Sablon 38700 LA TRONCHE - FRANCE Phone: +334 76 54 95 40 Fax: +334 76 54 95 61

Contact person:

Mady Batailh Phone: +33 4 76 54 95 40 Email: quality@imactis.com

Device information:

Trade name:	IMACTIS® CT-NAVIGATION system
Common name:	CT stereotactic accessory
Classification name:	Computed tomography x-ray system (21 CFR 892.1750)
Product code:	JAK
Class:	II

Panel:

Radiology devices

Legally-marketed predicate device:

Manufacturer	System Name	510(k)number	Product code
EDDA-technology	IQQA® Guide	K151414	JAK

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Image /page/4/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye-shaped symbol on the left, followed by the word "IMACTIS" in a sans-serif font. The symbol and the text are in a muted blue color. There is a registered trademark symbol to the right of the word "IMACTIS".

Device Description:

Intended Use

The IMACTIS® CT-NAVIGATION system is a stereotaxic accessory for Computed Tomography systems. It displays simulated image of interventional instrument on a computer monitor screen that also shows images of the targeted organ(s) and the current and the projected future path of the interventional instrument.

Indications for use

The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space.

The system is not intended for quidance for the head, neck, central nervous system and central circulatory system (heart included).

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Image /page/5/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye graphic on the left, followed by the word "IMACTIS" in a sans-serif font. The eye graphic is a blue-gray color, and the text is the same color. There is a registered trademark symbol to the right of the word "IMACTIS".

Summary of technological characteristics:

Item	IMACTIS® CT-NAVIGATION system	IQQA® Guide	SE
Trackingtechnology	Electromagnetic tracking technology	Same	YES
ComputerHardwareconfiguration	Standard PC hardware	Same	YES
Used by	Trained physicians	Same
User Interface	A graphical user interface to interactwith the software	Same	YES
Patient imagingdisplay duringintervention	Use of acquired patient imaging foranatomy structure:- CT during intervention- Previously acquired CT	Use of acquired patientimaging for anatomy structure:-CT during intervention-CT pre-proceduralPreviously acquired CT, MRUltrasound during interventionwhen available	YES
CombinedDisplay	Combine the display of simulatedinstrument and display of patientimaging/anatomy model	Same	YES
Clinicalenvironment tobe used in	Used in clinical interventions and foranatomical structure where imaging iscurrently used for visualizing suchprocedures	Same	YES

Table 2: Summary of technological characteristics

Testing Information and performance:

The design of the device, including software, was realized according to internal design controls procedures to ensure that specified design requirements are met.

Non clinical testing

The IMACTIS® CT-NAVIGATION system was tested for electromagnetic compatibility and electrical safety according to the IEC 60601-1 and IEC 60601-1-2 standards.

Biocompatibility testing was performed on components according to ISO10993 standards.

Sterility of components delivered sterile was tested according to ISO11737 and ISO11607 standards.

CT imaging requirements for the IMACTIS® CT-NAVIGATION system were challenged during the verification phase of the design process using 2 CT-scan series resolutions:

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Image /page/6/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized letter "m" inside of a circle on the left, followed by the word "IMACTIS" in all capital letters. The color of the logo is a muted blue.

First resolution corresponds to an axial image resolution of 0.5mm/pixel and a spacing of 1mm between slices
Second resolution corresponds to the worst accepted case, an axial image resolution of 1mm/pixel (corresponds to a field of view of 512mm) and a spacing of 2mm between images.

The verification testing demonstrates that the IMACTIS® CT-NAVIGATION system performances are maintained in both cases.

Regarding the system accuracy performance on the complete measurement chain (including localization system, calibration and registration accuracy), the IMACTIS® CT-NAVIGATION system was tested in rigid conditions during the verification phase of the design process, on a dedicated test bench. This bench has cylindrical holes at different positions and with different angles. A needle tool, localized by the navigation system, is positioned in those cylindrical holes. For each cylindrical hole, the accuracy is computed as the difference between the known position of the cylindrical hole and the position measured by the medical device. The system accuracy is always smaller than 2° and 2 mm.

While comparing the results of the predicate device and the results of the submitted device as described above, we conclude that the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device in terms of accuracy in rigid conditions.

Clinical testing

Additionally, a clinical testing on patients was conducted with the IMACTIS® CT-NAVIGATION system to provide feedback on the intended use and validate major functionalities by physicians. The system accuracy results on the complete measurement chain was collected on 60 patients for which the intervention was done with IMACTIS® CT-NAVIGATION system. As an information, during a clinical testing, the achieved accuracy of the IMACTIS® CT-NAVIGATION system (using the convention Median [P16%; P84%]) was of 3.8 mm [2.1; 9.9] in Per Protocol and of 4.1 mm [2.1; 11.7] in Intention To Treat.

Regarding system registration performance of the predicate device, and the IMACTIS® CT-NAVIGATION system accuracy performance measured on the complete measurement chain, the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device

Testing drawn from the nonclinical and clinical tests demonstrate that the actual device performance is substantially equivalent to the predicate device performance. The IMACTIS® CT-NAVIGATION system is as safe, as effective and performs as well as the legally marketed device.

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Image /page/7/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye on the left and the word "IMACTIS" on the right. The eye is a teal color, and the word "IMACTIS" is also teal. The logo is simple and modern.

Conclusion on substantial equivalence:

The IMACTIS® CT-NAVIGATION system has the same intended use as the predicate device IQQA® Guide. It is substantially equivalent in the areas of technical characteristics, principles of operations and functional features. It does not raise any new questions of safety and effectiveness.

The IMACTIS® CT-NAVIGATION system is substantially equivalent to IQQA® Guide.

Regulation Number and Section

§ 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.