Who is the manufacturer of ANT-X System?

Ndr Medical Technology Pte. , Ltd. filed the 510(k) submission for ANT-X System (K230185).

What is the FDA product code for ANT-X System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ANT-X System?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for ANT-X System?

Nuvasive LessRay with Enhanced Tracking (K170800).

Who can help prepare an FDA 510(k) submission like ANT-X System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANT-X System

K230185 · Ndr Medical Technology Pte. , Ltd. · OWB · Jun 1, 2023 · Radiology

Device Facts

Record ID	K230185
Device Name	ANT-X System
Applicant	Ndr Medical Technology Pte. , Ltd.
Product Code	OWB · Radiology
Decision Date	Jun 1, 2023
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1650
Device Class	Class 2

Intended 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.

Device Story

ANT-X System is an automated robotic needle positioning unit used in operating rooms to assist clinicians during percutaneous nephrolithotomy (PCNL). The system comprises a robotic device, controller box, needle holder, and software. It accepts real-time 2D X-ray video input from a C-arm fluoroscope. The software processes these images to provide navigational assistance, allowing the user to command the robot to align the needle trajectory between a selected skin insertion point and an internal target. The robot acts as a mechanical guide, fixing the trajectory for the surgeon, who performs the final manual needle advancement. The device is mounted to the operating table via an articulated arm. By automating the alignment process, the system aims to improve puncture accuracy, reduce the number of needle attempts, and decrease puncture duration, potentially benefiting patients by minimizing procedural time and trauma.

Clinical Evidence

A randomized, single-blind feasibility clinical trial (n=71) compared robotic-assisted fluoroscopy (RAFG) to ultrasound-guided (USG) PCNL. Primary endpoint: Stone-free rate (SFR) at 3 months (RAFG 83.3% vs. USG 70.6%, p=0.26). Secondary endpoints: RAFG showed significantly fewer needle punctures (1.83 vs. 2.51, p=0.025) and shorter median puncture duration (5.5 vs. 8.0 min, p=0.049). Complication rates were not statistically different (p=0.396). Bench testing verified tracking accuracy, positional repeatability, and bullseye alignment.

Technological Characteristics

Materials: Biocompatible PEEK (radiolucent). Sensing/Actuation: Robotic arm with three pairs of high-stiffness parallel linkages for planar adjustment. Energy: Powered controller box. Connectivity: Real-time video input from C-arm fluoroscope. Sterilization: Ethylene Oxide (SAL 10^-6) for single-use needle holder. Software: Moderate level of concern. Mounting: FISSO articulated arm (Class I exempt).

Indications for Use

Indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Nuvasive LessRay with Enhanced Tracking (K170800)

Reference Devices

iSYS 1 (K131433)

Related Devices

K191332 — XACT Robotic System · Xact Robotics, Ltd. · Oct 3, 2019
K201586 — XACT Robotic System · Xact Robotics, Ltd. · Jul 9, 2020
K230130 — Micromate Navi+ · Isys Medizintechnik GmbH · Oct 10, 2023
K221116 — XACT ACE Robotic System · Xact Robotics, Ltd. · May 13, 2022
K213759 — XACT Robotic System, ACE Model · Xact Robotics, Ltd. · Sep 23, 2022

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {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…