(129 days)
No
The description focuses on automated mechanical positioning based on user-selected points and real-time fluoroscopy, without mentioning AI/ML algorithms for image analysis, decision-making, or trajectory planning. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is an automated needle positioning system used to aid in needle placement during percutaneous nephrolithotomy (PCNL) procedures. Its primary function is guidance and alignment, not direct treatment of a disease or condition. While it supports a therapeutic procedure, it is not therapeutic itself.
No
The ANT-X System is indicated for use in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment. It is a robotic device that assists in surgical intervention rather than providing a diagnosis.
No
The device description explicitly lists multiple hardware components (ANT-X Device, ANT-X Controller Box, ANT-X Needle Holder) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- ANT-X System Function: The ANT-X System is a surgical assistance device used during a procedure (PCNL) to aid in needle positioning and alignment within the patient's body. It uses imaging (fluoroscopy) to guide a physical action (needle insertion).
The ANT-X System is a surgical guidance and assistance device, not a device that performs tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.
Product codes
OWB
Device Description
The ANT-X System is an automated needle positioning medical device that is used in conjunction with fluoroscopy to support percutaneous interventions (PCNL). There are 4 main components to the system - the ANT-X Device. ANT-X Controller Box. ANT- X Needle Holder, and ANT-X Software. It is intended to be used in an operating theatre equipped with standard surgical equipment which are generally found in operating rooms.
The ANT-X Device holds a sterile, disposable needle-guide kit, the ANT-X Needle Holder. The main bulk of ANT-X Device is made of biocompatible polyetheretherketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The Device has a fixed base made of three pairs of high stiffness parallel linkages allow millimetric planar needle adjustment. The targeted insertion point will act as a pivot point for the needle. The device will be mounted onto the operating table with a 6-DOF instrument holder (FISSO Articulated arm) such that it can be precisely oriented to the area of interest on the patient.
The ANT-X Controller Box powers the ANT-X Device and is the integrating point for the whole ANT-X System. Images from the C-arm fluoroscopy machine will be passed into the ANT-X Controller Box and then to the ANT-X Software, in real-time. The user will then use the ANT-X Software to command the ANT-X Device to commence needle alignment between the chosen insertion point on the skin surface, and the desired target point within the body. Validation of the puncture trajectory and the final needle insertion will be performed by the surgeon.
Accessory:
The FISSO Articulated Arm is used as an accessory to the ANT-X System. It functions to hold or position the ANT-X Device over the patient's body to allow for needle positioning and alignment during the surgical procedure. The base of the articulated arm is mounted onto the operating bed while the head component is attached to the ANT-X Device. The joints of the articulated arm can be maneuvered to any desired position and comes with a mechanical central locking mechanism, a knob, which can be tightened to lock the arm in place. The FISSO Articulated Arm is delivered non-sterile and must be cleaned, disinfected and sterilized before each use as per manufacturer's Instructions for Use.
The FISSO Articulated Arm device is exempt from Premarket Submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
kidneys
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians / operating theatre
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)
Performance Data:
Biocompatibility: Biocompatibility tests in accordance with Annex A of ISO 10993-1:2018 were conducted for the ANT-X Needle Holder, including Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, and Acute systemic toxicity. The ANT-X Needle Holder was found to be biologically safe for surgical use and biocompatible.
Sterilization: The ANT-X Needle Holder is supplied sterile and designed for single-use. Sterilization via Ethylene Oxide was validated per ISO 11135 to achieve an SAL of 10-6. ETO and ECH sterilant residual levels were within acceptable limits.
Shelf Life: Real-time studies validated a one-year shelf life for the ANT-X Needle Holder, confirming sterility, packaging integrity, and functional quality.
Electrical Safety and Electromagnetic Compatibility (EMC): The ANT-X System (controller box, device, software, and third-party instrument holder) complies with IEC 60601-1 for Safety and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing: Documentation for software verification and validation was provided as recommended by FDA guidance. The software was deemed a "moderate" level of concern.
Bench Testing:
Software Tracking Accuracy including marker detection: Verified that the ANT-X System software provides accurate tracking of individual points under C-arm fluoroscopy. Results met design acceptance criteria.
Positional Repeatability: Verified the robot's ability to achieve positional repeatability. Met specifications, and repeatability accuracy was within acceptable limits.
Bullseye Alignment Accuracy: Verified the ANT-X System's ability to provide accurate bullseye alignment between user-selected points under C-arm fluoroscopy. Met specifications.
Puncture Accuracy: Verified the ANT-X System's ability to achieve a successful puncture of a specific target size. Met specifications.
Animal Study:
Pre-clinical animal testing demonstrated the functionality and performance of the ANT-X System by comparing percutaneous access to kidneys (PAK) using ANT-X versus conventional free-hand procedures. Animal trials were successful, and the performance was satisfactory, concluding that the ANT-X System can be used safely in fluoroscopy-guided procedures.
Clinical Study:
Study type: A feasibility randomized, single-blind clinical trial comparing Robotic Assisted Fluoroscopy (RAF)- and Ultrasound (US)-guided renal access in mini-PCNL was conducted in Japan.
Sample size: 71 patients (35 in USG group, 36 in RAFG group).
Primary objective: Stone-free rate (SFR) at 3 months after surgery.
Secondary objectives: Overall complication rate, Clavien-Dindo classification complication rates, Renal puncture time, Total operation time, Number of successful punctures, Fluoroscopy time.
Efficacy evaluation:
SFR at 3 months: US group 70.6%, RAF group 83.3% (p=0.26). Results were comparable.
The mean number of needle punctures: significantly fewer in RAF group (1.83 times) than USG group (2.51 times, p=0.025).
Median needle puncture duration: significantly shorter in RAF group (5.5 minutes) than USG group (8.0 minutes, p=0.049).
Puncture surgeon change was not required in the RAF group (p=0.025).
No statistical differences in other intraoperative parameters (e.g., percutaneous tract size, tubeless cases, device set/ access/ fragmentation/ surgery/ fluoroscopy durations).
ANT-X System was as easy to use as ultrasound-guided PCNLs for resident doctors in training.
Safety evaluation:
No significant differences in overall complication rates (p=0.396) or complications within the first month (p=0.88) between RAFG and USG groups.
Complications were associated with renal tract dilation after needle insertion, not directly with ANT-X device use.
The study supported the safety of the ANT-X System as an adjunctive method for fluoroscopy-guided PCNL procedures.
Summary:
The study indicated that ANT-X is a feasible, safe, and comparable method to ultrasound-guided PCNL for kidney stone procedures, with comparable safety and efficacy evaluations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
June 1, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NDR Medical Technology Pte. Ltd. % Ainoa Forteza Vice Director of Regulatory Affairs Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) Barcelona 08029 SPAIN
Re: K230185
Trade/Device Name: ANT-X System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: May 5, 2023 Received: May 5, 2023
Dear Ainoa Forteza:
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
1
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 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 medical devices and radiation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K230185
Device Name ANT-X System
Indications for Use (Describe)
The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K230185
510(k) Summary for the ANT-X System (per 21CFR 807.92)
Date: May 5, 2023
1. 510K Applicant / Submitter:
NDR Medical Technology Pte Ltd 75 Ayer Rajah Crescent, #02-19 Singapore 139953 Tel: +65 6908 5497 CTO: Jason Ng Ka Wei Email: jason(@ndrmedical.com
2. Submission Contact Person
Ainoa Forteza Vice President of Regulatory Affairs Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) 08029 Barcelona, Spain Email: ainoa.forteza@alirahealth.com
3. Subject Device
Name of Device: ANT-X System Common or Usual Name: Robotic Needle Positioning Unit Classification Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1650 Regulatory Class: II Product Code: OWB
4. Predicate and Reference Device
Predicate Device: Device Name: Nuvasive LessRay with Enhanced Tracking 510(k) Number: K170800 Classification Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1650 Regulatory Class: II Product Code: OWB
4
Reference Device: Device Name: iSYS 1 510(k) Number: K131433 Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Regulatory Class: II Product Code: JAK
5. Device Description:
The ANT-X System is an automated needle positioning medical device that is used in conjunction with fluoroscopy to support percutaneous interventions (PCNL). There are 4 main components to the system - the ANT-X Device. ANT-X Controller Box. ANT- X Needle Holder, and ANT-X Software. It is intended to be used in an operating theatre equipped with standard surgical equipment which are generally found in operating rooms.
The ANT-X Device holds a sterile, disposable needle-guide kit, the ANT-X Needle Holder. The main bulk of ANT-X Device is made of biocompatible polyetheretherketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The Device has a fixed base made of three pairs of high stiffness parallel linkages allow millimetric planar needle adjustment. The targeted insertion point will act as a pivot point for the needle. The device will be mounted onto the operating table with a 6-DOF instrument holder (FISSO Articulated arm) such that it can be precisely oriented to the area of interest on the patient.
The ANT-X Controller Box powers the ANT-X Device and is the integrating point for the whole ANT-X System. Images from the C-arm fluoroscopy machine will be passed into the ANT-X Controller Box and then to the ANT-X Software, in real-time. The user will then use the ANT-X Software to command the ANT-X Device to commence needle alignment between the chosen insertion point on the skin surface, and the desired target point within the body. Validation of the puncture trajectory and the final needle insertion will be performed by the surgeon.
Accessorv:
The FISSO Articulated Arm is used as an accessory to the ANT-X System. It functions to hold or position the ANT-X Device over the patient's body to allow for needle positioning and alignment during the surgical procedure. The base of the articulated arm is mounted onto the operating bed while the head component is attached to the ANT-X Device. The joints of the articulated arm can be maneuvered to any desired position and comes with a mechanical central locking mechanism, a knob, which can be tightened to lock the arm in place. The FISSO Articulated Arm is delivered non-sterile and must be cleaned, disinfected and sterilized before each use as per manufacturer's Instructions for Use.
The FISSO Articulated Arm device is exempt from Premarket Submission.
5
6. Indications for Use
The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.
7. Substantial Equivalence Discussion:
The ANT-X System is designed to assist interventional radiologists and clinicians in the manual advancement of interventional trocar needles, during fluoroscopic image guided percutaneous nephrolithotomy (PCNL). The ANT-X has the same intended use as its predicate device NuVasive LessRay with Enhanced Tracking, and the reference device iSYS 1. The devices are designed to assist interventional radiologists and clinicians in the positioning of instruments, such as needles in the case of the ANT-X System, for percutaneous procedures that are fluoroscopy-guided. All the three devices require the physician to execute the final gesture, that is, to advance the needle by physically pushing the instrument into the patient.
The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process, while the NuVasive LessRay with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated. The indications of the ANT-X are the same as the indications of the predicate device, in that fluoroscopy-guided PCNL procedures are a subset of any fluoroscopy-guided treatment applications in which the predicate device is intended for use.
The ANT-X System subject of this submission, the predicate device NuVasive LessRay with Enhanced Tracking, and the reference device iSYS 1 are all powered, computer controlled devices that provide the position of the instrument for the procedure in real time.
The ANT-X System subject of this submission and the NuVasive LessRay with Enhanced Tracking predicate device not only use the image acquired from interventional fluoroscopic Xray system (2D X-Ray video input), as the intraoperative guidance, but they are both passive devices to the fluoroscope and they do not perform instrument advancement into the patient, which is left as manual task to the clinician.
The ANT-X System differs from the predicate NuVasive LessRay with Enhanced Tracking in the locations of marker placement that is on the robotic system in the ANT-X, as opposed to the markers placed on the fluoroscope and the tracking clip in the predicate device. Moreover, the type of markers used as reference points during image registration represent another difference between the ANT-X System and the predicate device. The ANT-X System uses fiducial markers which differ from the optical gray markers in the NuVasive LessRay with Enhanced Tracking device. Instead, the ANT-X System and the reference device iSYS 1 both use fiducial markers as reference points. their software duplicates 2D fluoroscopy images onto the software UI to provide navigational assistance and monitoring of device deployment during procedure without performing tracking.
6
Although there are other minor differences in technological characteristics between the ANT-X System and the predicate device, such as the instrumentation, the instrument fixation method, the calibration, the immobilization of the system between patient and device and whether the instrument positioning is done automatically or manually, these minor differences do not raise any additional safety and effectiveness concerns. As the reference device, the ANT-X System serves as a mechanical guide to ensure desired end-effector (needle) trajectory is fixed during puncture. Furthermore, performance tests were conducted on ANT-X to ensure that it is safe and effective for its intended use.
Table 5-1 below compares the intended uses, the indications for use and the technological characteristics of the ANT-X System with the predicate and reference devices.
Differences in technological characteristics between the ANT-X System and the NuVasive LessRay with Enhanced Tracking were evaluated through performance and safety tests (bench studies and animal studies). A feasibility clinical trial was conducted as a reference study for the use of ANT-X System. No new questions of safety and effectiveness was raised, and therefore, it can be concluded that the ANT-X System is substantially equivalent to the selected predicate NuVasive LessRay with Enhanced Tracking device.
7
| Characteristic | Automated Needle Targeting
(ANT-X) | Predicate | Reference Device | Comparison | |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K230185 | K170800 | K131433 | | |
| Primary Product Code | OWB | OWB | JAK | | |
| Manufacturer | NDR Medical Technology Pte. Ltd. | NuVasive, Incorporated | ISYS Medizintechnik GmbH | | |
| General Description | Computer controlled automatic needle alignment robot used during fluoroscopy guided percutaneous procedures. | Software based device used to provide computer display systems interfaced to fluoroscope through a video cable. | Computer controlled electromechanical multi-joined arm indicated for CT and fluoroscopy guided invasive procedures. | | |
| Intended Use | The ANT-X System assists interventional radiologists and clinicians in the manual advancement of trocar needles during image guided (C-arm fluoroscopy) percutaneous procedures (PCNL). It is a low-risk medical device that helps to create a keyhole access accurately by carrying out automated specific needle targeting while using image guiding with fluoroscopy system. Its primary aim is to carry out accurate needle positioning. | Intended for use with a standard C-arm or fluoroscope during a surgical or interventional procedure. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user may improve the quality (clarity, contrast, noise level and usability) of a noisy (low-quality) image. LessRay with Enhanced Tracking | The intended use of the iSYS1 device is to function as a remote- operated positioning and guidance system during interventional procedures. Positioning is done in remote control manner; planning of the position/ angulation is done based on 2D/3D patient data (CT, cone- beam CT, fluoroscopy) by external planning software for example using an external navigation system or planning software coming | Same Intended Use as the predicate and reference devices, in the sense that the devices are intended to use C-arm fluoroscopic images to aid the clinician in positioning the instrumentation for percutaneous procedures. | |
| | | Enhanced
Tracking has
additional
capability of
instrument
tracking to
aid the user in
positioning
an instrument
using prior
baseline x-
rays. | with the used
imaging device.
Also, verification
of the correct
position and
orientation of the
tool prior
to/during/after the
intervention is
done by means of
these external
devices. The
iSYS1- System is
then acting as a
guideway during
the manual
insertion of the
interventional
tool - usually a
needle type
device, and the
like. | | |
| Indication for Use | | The ANT-X System is
indicated for use in
conjunction with
fluoroscopy imaging in
percutaneous
nephrolithotomy (PCNL)
procedures to aid in
needle positioning and
alignment process. | Indicated for
use in any
application
where a
fluoroscope
is
incorporated
to aid in
diagnosis and
treatment of
disease. | The iSYS 1
device is a user
controlled
electromechanical
arm with a needle
guide. It is
intended to assist
the surgeon in the
positioning of a
needle or
electrode where
both computed
tomography (CT)
and fluoroscopic
imaging can be
used for target
trajectory
planning and
intraoperative
tracking. The
needle or
electrode is then
manually
advanced by the
surgeon.
Trajectory
planning is made
with software that
is not part of the
iSYS device.
Applications
include, but are
not limited to,
interventions like | Same Indications for
use as the predicate
device, as the PCNL
procedures where the
ANT-X is intended for
use are a subset of any
fluoroscopic guided
procedure in which the
predicate device is
intended to be used. |
| | | | biopsy
procedures, tumor
ablation, nerve
blocking,
electrode
placement, etc | | |
| Intended User(s) | Trained physicians | Trained physicians | Trained physicians | Same to the predicate
and reference devices | |
| Used with imaging
Guidance | Yes | Yes | Yes | Same to the predicate
and reference devices. | |
| Powered | Yes | Yes | Yes | Same. | |
| Computer
controlled | Yes | Yes | Yes | Same | |
| Real-time
Instrument Position | Yes | Yes | Yes | Same. | |
| Imaging Modality | Fluoroscopy | Fluoroscopy | Fluoroscopy and
computed
tomography | Same to the predicate
and reference devices. | |
| Video Input Image | 2D X-ray | 2D X-ray | N.A. iSYS 1 uses
an external third-
party software
that is not part of
the system. | Same to the predicate
device. Different to the
reference device. | |
| Localization means | Fiducial
markers on
robotic device | Optic
markers on
the tracking
clip fitted on
the
instrument
and the
fluoroscope. | Fiducial markers
on tool holder | Different Locations of
Markers
placement
from both the
predicate and the
reference device. | |
| Registration Method | Fiducial Markers | Optical
Markers | Fiducial Markers | Same to the reference
device, as the same
type of marker
(fiducial) are used..
Different from the
predicate device. | |
| Planning
and
navigation software | Directly duplicates 2D
fluoroscopy images onto
software UI to provide
navigational
assistance
and monitoring of device
deployment
during
procedure. | N.A.
Nuvasive
LessRay uses
an off-the-
shelf tracking
system to
guide the user
in positioning
the
instrument | N.A. iSYS 1 uses
an external third-
party software for
planning
and
monitoring
of
device
deployment
during procedure. | Different to
both
predicate and
reference device. | |
| Instrumentation | ANT-X Device | Computer
Screen
Camera | Robotic
Positioning Unit | Different
instrumentation
to
both the predicate and
reference devices. | |
| | ANT-X Needle Holder
ANT-X Software
ANT-X Controller Box
FISSO Instrument Holder
(Model 3840.40) | Table arrays
C-arm collar
arrays C-arm
collar
Tracking
Snaps | Instrument Guide
Control Unit
Handheld Control
Unit
Table Adapter
Gross Positioning
Arm | | |
| Instrument Fixation | Robot is mounted
to
operating table using a
FISSO
Instrument
Holder, Model 3840.40
(US FDA Class I
Exempt). It does not have
direct contact with the
patient's body | C-arm collar
arrays and
table arrays
are used in
order to
mount the
off-the-shelf
tracking
hardware to
the C-arm
and to the
operating
table. It does
not have
direct contact
with the
patient's
body. | Robot is mounted
to operating table
using a gross
positioning arm
and table adapter.
It does not have
direct contact
with the patient's
body | Different
mounting
instruments to
both
predicate and
reference device. | |
| System
immobilization | Yes | No | Yes | Same to the reference
device. Different from
the predicate device. | |
| Device
Instrument
Calibration | Intraoperative | Not required | Intraoperative | Same to the reference device. Different from the predicate device. | |
| Device end effector
trajectory alignment | Auto alignment to desired trajectory | Manual alignment to desired trajectory via manual freehand technique | Manual alignment to desired trajectory using handheld control unit | Different to both predicate and reference device. | |
| Execution of final gesture after
trajectory alignment | Physician executes final gesture via manual advancement of device end effector | Physician executes final gesture via manual advancement of the instrument | Physician executes final gesture via manual advancement of device end effector | Same to both predicate and reference device. | |
| Mechanical
Guidance For Device
End-effector | Yes, the device serves as a mechanical guide to ensure desired needle (end-effector) trajectory is fixed during puncture. | No, the instrument is manipulated via manual freehand technique | Yes, the device serves as a mechanical guide to ensure desired needle (end-effector) trajectory is fixed during puncture. | Same mechanical guidance principle as the reference device. Different from the predicate device. | |
| Image Registration
Error | 0.01-0.45mm | Unknown | $0.38 \pm 0.18$ mm | Similar. The ANT-X image registration error (mean) is comparable to the reference device's error. | |
| Alignment Accuracy
Range (Target
error) | 0.14-0.97mm | Unknown | 0.1-4mm | Similar. The subject device alignment accuracy range is within the range of the reference device's target error. | |
| Sterility Assurance
Level | SAL 10-6 | Unknown | SAL 10-6 | Same as the reference device. | |
| Biocompatibility | -Cytotoxicity
-Sensitization
-Irritation
-Material-mediated
-Pyrogenicity
-Acute systemic toxicity | NA- no patient contacting components | NA- no patient contacting components | Different to both predicate and reference device, due to the presence of an indirect patient contacting component (Needle Holder) in the subject device. | |
Table 5-1: Side by Side Comparison Table of ANT-X System with Nuvasive LessRay with Enhanced Tracking and iSYS 1
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8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Biocompatibility tests in accordance with Annex A of ISO 10993-1:2018 was conducted to evaluate the potential biological risks arising from the use of the ANT-X Needle Holder. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- · Material-mediated pyrogenicity
- Acute systemic toxicity
The ANT-X Needle Holder is considered an externally communicating medical device which has indirect contact with the internal body tissues. The duration of contact, when used as intended, is ≤ 24 h. The ANT-X Needle Holder has been validated to be biologically safe for use in a surgical setting and is considered to be biocompatible.
Sterilization
The only component of the ANT-X System that is supplied sterile is the ANT-X Needle Holder, which is intended to be attached to the ANT-X Device during use. ANT-X Needle Holders are for single-use only and are sterilized using Ethylene Oxide sterilization. The sterilization method has been validated in accordance with ISO 11135 Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices to demonstrate a Sterility Assurance Level (SAL) of 106. The ETO and ECH sterilant residual levels are also found to be within acceptable levels.
Shelf Life
Real time studies were conducted to validate a one-year shelf life of the ANT-X Needle Holder. Sterility and packaging validation testing and functional testing demonstrated that the ANT-X Needle Holder sterility and quality are maintained at 1 year of real time storage conditions.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on ANT-X System consisting of the controller box, device, software and third-party instrument holder. The system complies with the IEC 60601-1 standard for Safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this
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subject device was considered as a "moderate" level of concern.
Bench Testing
Software Tracking Accuracy including marker detection
The purpose of this testing was to verify that the ANT-X System software is able to provide accurate tracking of individual points in plane under C-arm fluoroscopy imaging. The test results showed that the tracking accuracy of ANT-X Software meet the design acceptance criteria.
Positional Repeatability
The purpose of this testing was to verify that the robot can achieve positional repeatability when instructed to move to specific locations from the home position repeatedly over multiple trials. The test demonstrated that the system met specifications and the repeatability accuracy is within the acceptable limit.
Bullseye Alignment Accuracy
The purpose of this testing was to verify that the ANT-X System is able to provide an accurate bullseye alignment between two points selected by the user under C-arm fluoroscopy. The testing demonstrated that ANT-X System met specifications.
Puncture Accuracy
The purpose of this testing was to verify that the ANT-X System can ultimately achieve a successful puncture of a specific target size. The test demonstrated that the ANT-X System met its specifications.
Animal Study
Pre-clinical animal testing was conducted on the ANT-X System to demonstrate the functionality and performance of the device. Percutaneous access to the target site, the kidneys (PAK), using the ANT-X System are compared to the conventional free-hand, unassisted procedure performed by fellowship-trained surgeons. Animal trials were successful and the performance of the ANT-X System were satisfactory. The performance of ANT-X System is concluded to be consistent and that it can be used in fluoroscopy guided procedure safely.
Clinical Study
A feasibility clinical study was conducted as a reference study for the safe use of the ANT-X System in PCNL procedures.
A randomized, single-blind clinical trial comparing the surgical outcomes of Robotic Assisted Fluoroscopy (RAF)- and Ultrasound (US)-guided renal access in mini-PCNL was conducted in Japan. The intention of the study was to prove the non-inferiority of ANT-X over US-guided Endoscopic combined intrarenal surgery (ECIRS), one of the most ideal methods currently utilized for PCNL. A total of 71 patients were randomized for the study, 35 in the USG group and 36 in the RAFG group. No significant differences were observed between the two groups in terms of other preoperative factors, including patient background, hydronephrosis and stone characteristics.
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Primary objective:
Stone-free rate (SFR) at 3 months after surgery. SFR is defined as following: no residual fragments larger than 4 mm detected in kidney ureter bladder (KUB) radiography at 1 month after surgery and no residual fragments larger than 2 mm detected by computed tomography (CT) 3 months after surgery.
Secondary objectives:
- Overall complication rate and Clavien-Dindo classification complication rates.
- Renal puncture time -
- Total operation time -
- Number of successful punctures -
- Fluoroscopy time ।
Efficacy evaluation
The SFR at 3 months after surgery in the US and RAF groups was 70.6% and 83.3 %, respectively (p=0.26). Overall, the results were comparable for both ANT-X and ultrasoundguided access procedures.
The RAFG and US groups showed similar trends in the selection of renal calyces for percutaneous access. In the US group, 14.3% of patients had a puncture surgeon change, whereas puncture surgeon change during percutaneous renal access was not required in the RAF group (p=0.025). The mean number of needle punctures was significantly fewer in the RAF group than that in the USG group (1.83 times vs. 2.51 times, p=0.025). The median needle puncture duration was also significantly shorter in the RAF group than in the USG group (5.5 minutes vs. 8.0 minutes, p=0.049). Moreover, there were no statistical differences in other intraoperative parameters, such as percutaneous tract size, tubeless cases, and device set/ percutaneous access/ fragmentation/ surgery/ fluoroscopy durations. The ANT-X System resulted to be as easy to use as the ultrasound-guided PCNLs to resident doctors still in training and demonstrated to require less puncture surgeon changes, fewer punctures attempts and reduced puncturing time.
Safety evaluation
The study demonstrated that the robotic assisted fluoroscopy-guided PCNL procedure is as safe as the control ultrasound-guided PCNL, as no significant differences were observed between the RAFG and USG groups in overall complication rates, complications within the first month after the surgery, or between the complications within 1 and 3 months. The results of the regression analysis demonstrates that the complications in the study are not related to or caused by the use of the ANT-X device, as they are directly associated with the dilation of the renal tract after needle insertion is performed by the surgeon after the ANT-X System is used and removed from the operating area.
It is noted that the overall complication rates between the robotic-assisted fluoroscopic-guided procedures and ultrasound-guided procedures presented in this study are not statistically significant (p-value = 0.396) and also the rates of complications within one month are not statistically significant (p=0.88). Even if this study showed only that the use of the ANT-X device did not have effect on the adverse events for the entire PCNL procedure as opposed to
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use of the ANT-X system alone, it allowed to answer the basic question of the relationship between the occurring complications and the use of the ANT-X System, and to exclude that complications arise from the use of the ANT-X System. These results support the safety of the ANT-X System as adjunctive method to perform safe fluoroscopy-guided PCNL procedures.
Summary
The results of the study indicated that ANT-X is a feasible, safe, and comparable as the control ultrasound-guided PCNL method of percutaneous nephrolithotomy (PCNL) for kidney stone procedure. Its safety and efficacy evaluations are comparable to the control.
9. Conclusion:
Based on the information provided in this 510(k) premarket notification, NDR Medical Technology Pte Ltd. concludes that the ANT-X is substantially equivalent to the Nuvasive LessRay with Enhanced Tracking predicate device.