SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.

SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

Device Description

SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures.

SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously acquired CT images by means of a semiautomatic algorithm.

The system components are:

the patient tool
the needle tool
direction tool
guide for needle
a visualization /elaboration unit
an infrared optical sensor mounted either on the ceiling of the CT room or on the visualization /elaboration unit

All the tools in contact both with the skin of the patient and with the surgical instruments are sterile disposable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety	Conforms to IEC 60601-1
EMC Compatibility	Conforms to IEC 60601-1-2
Dimensional & Visual Inspections	Performed (outcome not explicitly stated but implied to be acceptable)
Mechanical and Performance	Accuracy: ≤ 2mm / 100mm (difference between the position of the sensitized real needle and the tip of the figure-guided needle in a phantom simulation). This criterion was met. The system "performed as intended in 3D imaging, patient tool use, needle localization, and tracking system operation" in a clinical evaluation.
Sterilization	ETO (Ethylene Oxide) sterilization validated. Disposable components are supplied sterile.
Biocompatibility	Materials used are biocompatible.
Shelf Life	5 years
Intended Use	Device successfully assisted in planning, navigation, manual advancement, and verification of instrument position during CT-guided procedures.

2. Sample size used for the test set and the data provenance

Sample Size for Clinical Evaluation (Test Set): 40 patients.
Data Provenance: The clinical evaluation was conducted by the Department of Diagnostic Imaging of the University Campus of Bio-Medico of Rome. This indicates the data is prospective and from Italy (Rome).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states "interventional procedures performed by physicians trained for CT procedures." It doesn't explicitly state the number of experts used for establishing ground truth specifically for the test set or their detailed qualifications (e.g., years of experience). However, it implies that the physicians performing the procedures in the clinical evaluation served as the ultimate arbiters of successful "performance as intended."

4. Adjudication method for the test set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical evaluation implicitly relies on the judgment of the performing physicians.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this submission. The device is a "CT navigation system" (stereotactic accessory) and not a diagnostic AI interpretation tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a form of "standalone" performance testing was done in the form of phantom testing for mechanical accuracy. The "Accuracy test that evaluated needle insertion configurations of SIRIO H3 was conducted on a phantom simulation of clinical use and was shown to be accurate. Accuracy is defined as the difference between the position of the sensitized real needle and the tip of the figure-guided needle. The accuracy is ≤ 2mm / 100mm." This evaluates the algorithm's guidance and the system's mechanical precision independently of patient variability.

7. The type of ground truth used

For Mechanical and Performance (Accuracy): The ground truth was based on the "sensitized real needle" position in a phantom simulation. This is a simulated/engineered ground truth.
For Clinical Evaluation: The ground truth was implicit from the device "performing as intended" during actual CT-guided lung biopsy procedures in 40 patients. This relies on clinical outcomes and expert observation during the procedure.

8. The sample size for the training set

The document does not provide any information regarding a training set size or if machine learning was used in a way that required a distinct training set. The device assists in planning and navigation, and reconstructs 3D models using a "semiautomatic algorithm," but it doesn't specify if this algorithm utilized a large training dataset in the modern machine learning sense. The primary performance evaluation focuses on the system's accuracy and its ability to function as intended in real-world scenarios.

9. How the ground truth for the training set was established

As no training set is mentioned, there is no information on how its ground truth might have been established. If the "semiautomatic algorithm" involves traditional image processing or rule-based logic, a formal "training set" with ground truth in the typical AI sense might not have been applicable or necessary.

Summary

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November 16, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name written out to the right of the square.

MASMEC S.p.A. % Gregory Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, Minnesota 55612

Re: K163643

Trade/Device Name: SIRIO H3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 17, 2017 Received: October 24, 2017

Dear Mr. Gregory Mathison:

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 (QS) regulation (21 CFR Part 820);

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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 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 mediation-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,

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) K163643

Device Name SIRIO H3

Indications for Use (Describe)

SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

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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510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Applicant:	MASMEC S.p.A.
Trade Name:	SIRIO H3
Common Name:	CT navigation system
Classification Name:	Computed Tomography X-ray System
21CFR Number:	892.1750
Device Classification:	Class II
Product Code:	JAK - System, X-ray, Tomography, Computed
Predicate Devices:	CAS-One IR from CAScination AG(K152473)
Contact	Domenico MarinoDirector of Regulatory Affairs
Date:	October 15, 2017

Substantially Equivalent to:

The SIRIO H3 is equivalent in intended use, principal of operation and technological characteristics to the CAS-One IR submitted as K152473 with Product Code JAK under 21CFR892.1750.

Description of the device subject to premarket notification

SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously

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acquired CT images by means of a semiautomatic algorithm.

The system components are:

the patient tool ●
the needle tool ●
direction tool
guide for needle ●
a visualization /elaboration unit ●
an infrared optical sensor mounted either on the ceiling of the CT room or on the ● visualization /elaboration unit

All the tools in contact both with the skin of the patient and with the surgical instruments are sterile disposable.

Indications for Use

SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

Materials

All materials used in the manufacture of the SIRIO H3 Disposable Kit are suitable for this use and have been used in numerous previously cleared products.

Non-Clinical Testing

Product testing was completed and met all of the acceptance criteria. Testing included:

Electrical safety & EMC compatibility according to IEC 60601-1 and IEC 60601-1-2 were . conducted. The system was found to conform.
Dimensional & Visual inspections of the product was performed
Mechanical and Performance An accuracy test that evaluated needle insertion ● configurations of SIRIO H3 was conducted on a phantom simulation of clinical use and was shown to be accurate. Accuracy is defined as the difference between the position of the sensitized real needle and the tip of the figure-guided needle. The accuracy is ≤ 2mm / 100mm.

Clinical Evaluation

A clinical evaluation of the SIRIO H3 System was completed by the Department of Diagnostic Imaging of the University Campus of Bio-Medico of Rome. A total of 40 patients were evaluated for lung biopsy procedures. The study concluded the SIRIO H3 System performed as intended in 3D imaging, patient tool use, needle localization, and tracking system operation.

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Performance Data

All necessary verification and validation testing has been performed for the SIRIO H3 to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SIRIO H3 is determined to be substantially equivalent to existing legally marketed devices.

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Comparison of Product Features

Trade name	SIRIO H3	CAS-One IR	SE Discussion
Product code	JAK	JAK	Same product code
510(k) number	K163643	K152473
21CFR	892.1750	892.1750	Same CFR number
Device Classification	II	II	Same - Class II
Device description	SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures.SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously acquired CT images by means of a semiautomatic algorithm. The system components are:the patient tool the needle tool direction tool guide for needle a visualization /elaboration unit an infrared optical sensor	The system consists of three main components:A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera and a computer. Aiming device with trackable aiming insert: To aim the needles to their correct locations, the system uses an aiming device. The aiming device is attached to a multi-axis mechanical arm that can align the position of the aiming device around the expected needle entry position. The aiming device is first aligned to the desired entry point (translational alignment) and then alignment to the desired needle insertion angle is performed using a remote center of rotation principle (rotational alignment). There are two possible configurations of the aiming device. Instrument adapter	The device description is the same.
	mountedeither on theceiling of theCT room oron thevisualization/elaborationunitAll the tools in contactboth with the skin ofthe patient and with thesurgical instrumentsare sterile disposable.	clamp with trackablemarker shield: As analternative to the aimingdevice, trackablemarkershields can beattached directly to rigidneedles by means of aninstrument adapter.Calibration of theneedle geometry isperformed with acalibration unit suppliedby CAScination.- CAS-One IR software:The software provides thestep-by-step workflowassistance for needlenavigation. It provides ameans for users toprecisely plan a single ormultiple needletrajectories, navigate aneedle to this exactposition and validate theinserted needle's positionto the planned position.
Intended Use	SIRIO H3 is a usercontrolled, stereotacticaccessory intended toassist in planning,navigation and manualadvancement of one ormore instruments, aswell as in verificationof instrument positionand performanceduring ComputedTomography (CT)guided procedures.SIRIO H3 is indicatedfor use with rigidstraight instrumentssuch as needles andprobes used in CTguided interventionalprocedures performedby physicians trainedfor CT procedures.	CAS-One IR is a usercontrolled, stereotacticaccessory intended toassist in planning,navigation and manualadvancement of one ormore instruments, aswell as in verification ofinstrument position andperformance duringComputed Tomography(CT) guidedprocedures.In planning, the desiredneedle configurationand performance isdefined relative to thetarget anatomy.In navigation, theinstrument position isdisplayed relative to thepatient and guidance forneedle alignment isprovidedwhile respiratory levelsare monitored.	Equivalent
		In verification, theachieved instrumentconfiguration andperformance aredisplayed relative to thepreviously defined planthrough an overlay ofthe pre- and post-treatment image data.
ElectricalSafety	IEC 60601-1:2005	IEC 60601-1:2005/A12012
EMC	IEC 60601-1-2:2007	IEC 60601-1-2:2007	Equivalent
Procedureplanning	Yes	Yes	Equivalent
Navigation	Yes	Yes	Equivalent
Respiratorymotioncontrol	Yes	Yes	Equivalent
PhysicianIntra-interventionalverification	Yes	Yes	Equivalent
Interventionalinstrumentcompatibility	Yes	Yes	Equivalent
Sterilization	Yes - ETO	Yes - ETO	Both disposablecomponents aresupplied sterile.
Single usedisposables	Y	Y	Equivalent
Shelf life	5 years	Not indicated insummary	Expiry date is on theproduct label
Packaging	Tyvek / Poly pouch	Tyvek / Poly pouch	Equivalent
Materials	Biocompatible	Biocompatible	Equivalent

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Conclusion

The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.

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.