(328 days)
No
The description mentions a "semiautomatic algorithm" for 3D reconstruction, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on stereotactic guidance and image processing, not AI/ML-driven analysis or decision-making.
No
The device is an accessory that assists in planning, navigation, and manual advancement of instruments for CT-guided procedures; it does not directly treat a disease or condition.
No
The device is intended to assist in planning, navigation, and manual advancement of instruments during CT-guided procedures, and in verification of instrument position, rather than for diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including a patient tool, needle tool, direction tool, guide for needle, visualization/elaboration unit, and an infrared optical sensor.
Based on the provided information, the SIRIO H3 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that SIRIO H3 is a stereotactic accessory used during CT-guided procedures on the patient's body. It assists in planning, navigation, and instrument placement within the patient.
- IVDs are used to provide information about a physiological or pathological state. While SIRIO H3 assists in procedures that might be related to diagnosing or treating a condition, the device itself is a surgical guidance tool, not a diagnostic test performed on a sample.
The SIRIO H3 is a surgical guidance system or stereotactic navigation system used in conjunction with imaging (CT) to assist physicians in performing interventional procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained for CT procedures.
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)
Non-Clinical Testing:
- 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
§ 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.
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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);
1
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 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.
| 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 Marino |
| Director 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 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
4
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 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.
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. |
| | 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. | clamp with trackable
marker shield: As an
alternative to the aiming
device, trackable
markershields can be
attached directly to rigid
needles by means of an
instrument adapter.
Calibration of the
needle geometry is
performed with a
calibration unit supplied
by CAScination.
- CAS-One IR software:
The software provides the
step-by-step workflow
assistance for needle
navigation. It provides a
means for users to
precisely plan a single or
multiple needle
trajectories, navigate a
needle to this exact
position and validate the
inserted needle's position
to the planned position. | |
| Intended Use | 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. | CAS-One IR 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.
In planning, the desired
needle configuration
and performance is
defined relative to the
target anatomy.
In navigation, the
instrument position is
displayed relative to the
patient and guidance for
needle alignment is
provided
while respiratory levels
are monitored. | Equivalent |
| | | In verification, the
achieved instrument
configuration and
performance are
displayed relative to the
previously defined plan
through an overlay of
the pre- and post-
treatment image data. | |
| Electrical
Safety | IEC 60601-1:2005 | IEC 60601-1:2005/A1
2012 | |
| EMC | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 | Equivalent |
| Procedure
planning | Yes | Yes | Equivalent |
| Navigation | Yes | Yes | Equivalent |
| Respiratory
motion
control | Yes | Yes | Equivalent |
| Physician
Intra-
interventional
verification | Yes | Yes | Equivalent |
| Interventional
instrument
compatibility | Yes | Yes | Equivalent |
| Sterilization | Yes - ETO | Yes - ETO | Both disposable
components are
supplied sterile. |
| Single use
disposables | Y | Y | Equivalent |
| Shelf life | 5 years | Not indicated in
summary | Expiry date is on the
product 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.