(214 days)
No
The summary mentions image processing and reconstruction but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of performance studies focuses on traditional bench testing and clinical evaluation against a predicate device and standard of care, without detailing AI/ML model training or validation.
No
The device is an imaging system designed to produce tomographic images (diagnose), not to provide treatment (therapeutic).
Yes
The device is described as an "X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography". The "Summary of Performance Studies" further states that a clinical evaluation was conducted "to define whether Nanox.ARC Tomosynthesis...is of diagnostic quality," confirming its role in providing images for diagnosis.
No
The device description explicitly states that Nanox.ARC is a "tomographic and solid-state X-ray system" and lists hardware components such as a user control console, gantry, patient table, and flatpanel detector. While it includes software packages, it is not solely software.
Based on the provided text, the Nanox.ARC device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Nanox.ARC Function: The description clearly states that Nanox.ARC is an X-ray system that produces tomographic images of the human musculoskeletal system directly from the patient. It does not analyze samples taken from the body.
The device is an imaging system used for diagnostic purposes, but it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Product codes (comma separated list FDA assigned to the subject device)
IZF, MQB
Device Description
Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients.
Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages.
Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.
The acquired projection imaging data is automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The image reconstruction service, as well as the system's protocol database and DICOMization services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human musculoskeletal system
Indicated Patient Age Range
adult patients. This device is not intended for imaging pediatric or neonatal patients.
Intended User / Care Setting
professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists.
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
A clinical sample evaluation by an ABR-certified radiologist was completed to evaluate the imaging performance of Nanox.ARC. The objective of the evaluation was to define whether Nanox.ARC Tomosynthesis, when performed as an adjunct to conventional radiography of the musculoskeletal system, is of diagnostic quality. This evaluation was done against a reference comparison which was the standard of care radiographies. Nine (9) Digital Tomosynthesis image cases were acquired from healthy adult human subjects (patients) from a clinical study conducted at Shamir Medical Center in Israel. In addition, twelve (12) Digital Tomosynthesis phantom performance exams were captured. The acquired clinical exams met the inclusion/exclusion criteria. X-ray images were acquired using appropriate device dependent exposure for Digital Tomosynthesis acquisitions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Bench tests were performed in a laboratory setup, demonstrating that the Nanox.ARC device meets all specifications as required for intended use. All tests were performed in accordance with written protocols using calibrated equipment. The set of non-clinical evaluations was conducted on assembled Nanox.ARC device units or (where applicable) system components. The bench tests were based on applicable standards and guidance documents and Company-conducted risk analysis activities. All design control documents, including test reports, are referenced on file at Nano-X Ltd. in accordance with 21 CFR 820.30.
- Test Results (all PASS): System Electrical Qualification, System Performance, System Longevity & Consistency, Tube Longevity and Reliability, Functional Verification, Motion Control, Detector and image acquisition, Usability Summative, Transportation, Dimensional and Mechanical Properties, Image Quality, Phantom Validation, Software verification and validation using FDA Guidance; IEC 62304, 21 CFR 1020.30 and 21 CFR 1020.31, Electrical Safety & EMC IEC 60601-1 IEC 60601-1-2, Radiation Safety IEC 60601-1-3 IEC 60601-2-28 IEC 60601-2-54, Biocompatibility using FDA guidance, ISO 10993-1.
Clinical Sample Evaluation:
- Study Type: Clinical sample evaluation by an ABR-certified radiologist.
- Sample Size: Nine (9) Digital Tomosynthesis image cases from healthy adult human subjects (patients).
- Data Source: Clinical study conducted at Shamir Medical Center in Israel.
- Annotation Protocol: Not explicitly stated, but images were acquired.
- Key Results: The objective was to define whether Nanox.ARC Tomosynthesis, when performed as an adjunct to conventional radiography of the musculoskeletal system, is of diagnostic quality. This evaluation was done against a reference comparison which was the standard of care radiographies. The acquired clinical exams met the inclusion/exclusion criteria.
Phantom Performance Exams:
- Sample Size: Twelve (12) Digital Tomosynthesis phantom performance exams.
- Key Results: These exams, along with descriptive characteristics demonstrated substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
April 28, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nano-X Imaging Ltd. % Odelia Maron VP QA & RA Communications Center, Bldg. C. Entrance 1 Neve Ilan. 9085000 ISRAEL
Re: K222934
Trade/Device Name: Nanox.ARC Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, MQB Dated: March 27, 2023 Received: March 27, 2023
Dear Odelia Maron:
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 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
1
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 mediation-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
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Indications for Use
510(k) Number (if known) K22934
Device Name Nanox.ARC
Indications for Use (Describe)
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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Nanox.ARC 510(k) Summary
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Submission Sponsor 1
Nano-x Imaging Ltd. Communications Center, Bldg. C, Entrance 1, Neve Ilan, Israel 9085000 Establishment Registration Number: The Company will register following FDA clearance
2 Submission Correspondent
Odelia Maron, Ph.D. VP QA & RA Phone: +972-50-5733837 E-mail: Odelia.m@nanox.vision
3 Date Prepared
March 24, 2023
4 Device identification
| Name of Device: | Nanox.ARC |
|---|---|
| Classification Name: | Tomographic X-ray System |
| Regulation: | 21 CFR §892.1740 |
| Regulatory Classification: | Class II |
| Product Classification Code: | IZF and MQB |
| Classification panel: | Radiology |
5 Legally Marketed Predicate and Reference Device
| Predicate Manufacturer: | AGFA NV. |
|---|---|
| Predicate Trade Name: | DR 600 with Tomosynthesis |
| Predicate Classification Code: | IZF and MQB |
| Predicate 510(k): | K193262 |
| Reference Manufacturer: | AGFA NV. |
| Reference Trade Name: | DR 800 with Tomosynthesis |
| Reference Classification Code: | IZF and JAA |
| Reference 510(k): | K183275 |
6 Device description
Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients.
Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages.
Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.
The acquired projection imaging data is automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The image reconstruction service, as well as the system's protocol database and DICOMization
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Image /page/6/Picture/0 description: The image features the logo for Nanox, a company specializing in medical imaging technology. The logo consists of a stylized, abstract design in blue, resembling a symmetrical, curved pattern. Below the graphic is the word "NANOX" in a bold, sans-serif font, also in blue, clearly identifying the company.
services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.
7 Indications for Use
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients.
This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists.
Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.
This device is not intended for mammographic, angiographic, cardiac, pulmonary, intraabdominal, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
8 Technological Characteristics
Nanox.ARC is a stationary X-ray tomographic system utilizes predefined protocols with predefined optimal acquisition parameters depending on the anatomy being imaged. The System allows the user to further configure these parameters for each examination type.
The acquired projection imaging data is automatically reconstructed to form tomographic imaged object.
A reconstruction engine converts the 2D images from the detector into Tomographical layers data. This reconstruction engine, as well as the system's protocol database and DICOMization services, can be hosted either locally, or as part of the Nanox.CLOUD.
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Image /page/7/Picture/0 description: The image features the logo for Nanox. The logo consists of a stylized blue graphic above the word "NANOX" in a simple sans-serif font. The graphic is composed of curved lines that intersect to form a pattern resembling a stylized eye or a network of interconnected pathways.
9 Substantial Equivalence
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence with respect to indications for use, principles of operation, technological characteristics, materials, and performance.
The comparison of the devices in Table 1 below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new or different questions of safety or effectiveness based on the similarities to the predicate device.
| Table 1 – Comparison of Subject Device with Predicate Device | ||
|---|---|---|
| Item | Subject Device | |
| Nanox.ARC | Predicate Device | |
| DR 600 with Tomosynthesis | ||
| Name | Nanox.ARC | DR 600 with Tomosynthesis |
| Manufacturer | Nano-x Imaging Ltd. | AGFA NV |
| 510(k) | K222934 | K193262 |
| Date of clearance | To be assigned | March 9, 2020 |
| Indications for use | Nanox.ARC is a stationary X-ray | |
| system intended to produce | ||
| tomographic images of the human | ||
| musculoskeletal system adjunctive | ||
| to conventional radiography, on | ||
| adult patients. |
This device is intended to be used
in professional healthcare facilities
or radiological environments, such
as hospitals, clinics, imaging
centers, and other medical
practices by trained radiographers,
radiologists, and physicists.
Digital Tomosynthesis is used to
synthesize tomographic slices from
a single tomographic sweep.
Applications can be performed
with the patient in prone, supine,
and lateral positions.
This device is not intended for
mammographic, angiographic,
cardiac, pulmonary, intra-
abdominal, intra-cranial,
interventional, or fluoroscopic
applications. This device is not
intended for imaging pediatric or
neonatal patients. | The DR 600 System is a general
radiography X-ray imaging system used
in hospitals, clinics and medical
practices by radiographers, radiologists
and physicists to make, process and
view static X-ray radiographic images
of the skeleton (including skull, spinal
column and extremities), chest,
abdomen and other body parts on adult,
pediatric or neonatal patients. In
addition, the System provides the
AGFA tomosynthesis option, intended
to acquire tomographic slices of human
anatomy and to be used with AGFA DR
X-ray systems. Digital Tomosynthesis
is used to synthesize tomographic slices
from a single tomographic sweep.
Applications can be performed with the
patient in a sitting, standing or lying
position. This System is not intended
for mammography applications. |
| Intended users | Radiographers, radiologists, and
physicists | Radiographers, radiologists, and
physicists |
| Intended use environment | Hospitals, clinics, imaging centers,
and other healthcare facilities | Hospitals, clinics, imaging centers, and
other healthcare facilities |
| Classification Name | Tomographic X-ray system | Tomographic X-ray system |
| Regulation number | 21 CFR § 892.1740 | 21 CFR § 892.1740 |
| Regulatory class | II | II |
| Product code | IZF, MQB | IZF, MQB |
| Item | Subject Device | Predicate Device |
| | Nanox.ARC | DR 600 with Tomosynthesis |
| Communications with | DICOM | DICOM |
| external storage devices | | |
| Patient positioning options | | |
| Vertical stand | Not included | Included as an Option |
| Table stand | Included | Included as an Option |
| Patient Table | | |
| Patient table height | 48cm
(motorized w/fixed height) | 55-90 cm
(motorized w/ height adjustment) |
| Patient weight allowance
(kg/lbs.) | 150kg / 330 lbs. | 320 Kg / 705 lbs. |
| Table length (mm) | 2600 | 2200 |
| Table width (mm) | 720 | 810 |
| Tabletop material | PMMA | Resopal HPL (DIN EN438) |
| Generator | | |
| Tube voltage range (kVp) | 40-110 | 40-150 |
| Nominal electric power
(kW) | 1.8 | Selectable 50, 65 or 80 |
| Total mAs range per
Tomosynthesis study | 12-90 mAs | 12-90 mAs |
| X-ray accuracy | Fulfills the X-ray radiation
accuracy according to EN IEC
60601-2-54 with a variation of
max. 0.05 (5%). | Fulfills the X-ray radiation accuracy
according to EN IEC 60601-2-54 with a
variation of max. 0.05 (5%). |
| X-ray source | | |
| Electron stream source | MEMS chip | Tungsten filament |
| Physical phenomena
generating electron
stream | Quantum tunneling via an applied
External electrical field (cold
cathode) | Thermionic excitation (Hot Cathode) |
| Focal spot size (nominal
FS value large/small
focus) | 0.7 | E7884X: 0.6/1.2
E7252X: 0.6/1.2
E7254FX: 0.6/1.2
E7869XX: 0.6/1.2 |
| Anode design | Stationary Anode | Rotating Anode |
| Target angle | 19 deg | 12 deg |
| Source to Image
Distance (SID) | Fixed (at 100cm) | Selectable (110cm/115cm) for
Tomosynthesis. Other SIDs available
for other procedures |
| X-ray source position | Table mounted | Ceiling or table mounted |
| Number of X-ray
sources | Five (5) X-ray sources | One (1) X-ray source |
| Sweep angle during
Tomosynthesis | Longitudinal: up to ±18°
Lateral: up to ±15° | Longitudinal: selectable at ±15° or ±22° |
| Tilt mode | Automatic | Automatic |
| X-ray Field size | | |
| X-ray field size | Fixed, 43x43 cm | Variable, between
1-43cm by 1-43cm |
| Visual indication of the
X-ray field | Indication by a Graphical User
Interface | Indication by a light-field indicator |
| Image Processing | | |
| Detector | Flat-panel detector | Flat-panel detector |
| Operating System | Ubuntu 20.04 LTS | Windows® 7, 8, 8.1, 10 |
| Operator Console | Tablet device (iPad) | PC |
| Imaging Protocols
location | Either Local (hardware-based) or
Cloud-based | Local (hardware-based) |
| Image processing
location | Either Local (hardware-based) or
Cloud-based | Local (hardware-based) |
| Item | Subject Device
Nanox.ARC | Predicate Device
DR 600 with Tomosynthesis |
| DICOM encapsulation
service location | Either Local (hardware-based) or
Cloud-based | Local (hardware-based) |
| Image processing
package | Proprietary | AGFA's MUSICA2 TM image processing and AGFA's MUSICA Digital Tomosynthesis software (K193262) image processing |
| Compliance | | |
| Human factors | IEC 62366 and FDA guidance | IEC 62366
IEC 60601-1-6 |
| Biocompatibility | ISO 10993-1 and FDA guidance | ISO 10993-1 and FDA guidance |
| Electrical safety | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Radiation safety | IEC 60601-1-3
IEC 60601-2-54
IEC 60601-2-28 | IEC 60601-1-3
IEC 60601-2-54
IEC 60601-2-28 |
| Other standards | ISO 13485
ISO 14971
ISO 14155 | ISO 13485
ISO 14971 |
Table 1 - Comparison of Subiect Device with Predicate Device
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Image /page/8/Picture/0 description: The image contains the logo for NANOX. The logo consists of a blue, abstract design that resembles a network or interconnected structure, positioned above the word "NANOX" in bold, blue letters. The design is symmetrical and evokes a sense of technology and connectivity.
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Image /page/9/Picture/0 description: The image shows the logo for Nanox. The logo features a blue, abstract design resembling a globe or interconnected network, with curved lines forming a spherical shape. Below the design, the word "NANOX" is written in blue, block letters. The logo appears clean and modern, suggesting a focus on technology and global connectivity.
10 Summary of Technical Characteristics comparison
The Nanox. ARC and the predicate device have similar intended use with regard to their respective indications for the production of Tomosynthesis images. Both have similar technological characteristics, again, with regard to their respective indications for the production of Tomosynthesis images, and use the same principles of operation and are also identical in the following ways:
- · Regulation number 21 CFR §892.1740
- Product Code IZF and MQB
- · Regulatory Class Class II
In addition, both devices have equivalent technological characteristics, with the exception of:
- The Nanox.ARC utilizes five individual small-sized X-ray tubes, whilst the predicate utilizes . one larger general-purpose X-ray tube. Both Systems share a similar dose range.
- In the Nanox.ARC, irradiations are done in a spherical path geometry, whereas in the predicate, irradiations are done in a linear path geometry.
- . In the Nanox.ARC, table and gantry movements are limited to specific angles, SID, and positions, while in the predicate, the tube moves in tomographic sequence in the room.
- . In the Nanox.ARC. The field size of the Nanox.ARC is non-adjustable and fixed at 43x43cm (17x17"), whereas the predicate X-ray field can be varied by the operator from 1x1cm to up to 43x43cm.
- . In the Nanox.ARC, the generator has a lower power output (1.8kW) than the predicate's (50/65/80kW) and lower kVp and mAs ratings.
- . In the Nanox.ARC, the mAs range per each tomosynthesis projection is lower than the predicate.
- . In the Nanox.ARC, the protocol database, the image reconstruction and DICOMization services - are either based on local hardware or cloud-based, whereas for the predicate protocol database, these services are based on local hardware.
- . In the Nanox.ARC, the control console is an off-the-shelf Tablet device, where in the predicate, the operator console is installed on an off-the-shelf PC.
These minor differences, both individually and as accumulated differences - do not present any new or different questions of safety or effectiveness as confirmed by the completed testing discussed in more detail below.
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Image /page/10/Picture/0 description: The image shows the logo for Nanox. The logo consists of a blue, stylized globe-like design made up of intersecting curved lines, resembling a lattice or mesh. Below the design, the word "NANOX" is written in a bold, sans-serif font, also in blue.
Thus, the Nanox.ARC is substantially equivalent to the DR 600 with Tomosynthesis by AGFA NV (K193262).
11 Performance Data
Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols were evaluated by qualified individuals to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. Results were verified and validated.
The performance characteristics and operation / usability of Nanox.ARC were evaluated in nonclinical (bench) testing. These studies have demonstrated the device related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements.
Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
A clinical sample evaluation by an ABR-certified radiologist was completed to evaluate the imaging performance of Nanox.ARC.
The objective of the evaluation was to define whether Nanox.ARC Tomosynthesis, when performed as an adjunct to conventional radiography of the musculoskeletal system, is of diagnostic quality.
This evaluation was done against a reference comparison which was the standard of care radiographies.
Nine (9) Digital Tomosynthesis image cases were acquired from healthy adult human subjects (patients) from a clinical study conducted at Shamir Medical Center in Israel.
In addition, twelve (12) Digital Tomosynthesis phantom performance exams were captured. The acquired clinical exams met the inclusion/exclusion criteria. X-ray images were acquired using appropriate device dependent exposure for Digital Tomosynthesis acquisitions.
12 Bench Testing
Bench tests were performed in a laboratory setup, demonstrating that the Nanox. ARC device meets all specifications as required for intended use. All tests were performed in accordance with written protocols using calibrated equipment.
The set of non-clinical evaluations was conducted on assembled Nanox.ARC device units or (where applicable) system components. The bench tests were based on applicable standards and guidance documents and Company-conducted risk analysis activities.
The tests summarized below include methods, procedures, acceptance criteria, results, and conclusions. All design control documents, including test reports, are referenced on file at Nano-X Ltd. in accordance with 21 CFR 820.30.
The following tests were performed:
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Image /page/11/Picture/0 description: The image shows the logo for Nanox. The logo consists of a blue, abstract design that resembles two curved, interconnected grids facing each other, creating a symmetrical pattern. Below the design, the word "NANOX" is written in a bold, sans-serif font, also in blue.
Table 2: Non-clinical Performance Data
| Test | Test description | Result |
|---|---|---|
| System Electrical | ||
| Qualification | Verify that Nanox.ARC electrical qualification is according to system | PASS |
| System Performance | Evaluate Nanox.ARC motion resolution and accuracy performance | PASS |
| System Longevity & | ||
| Consistency | Verify that the Nanox.ARC Table and ARC lifetime and consistency is according to system spec. | PASS |
| Tube Longevity and | ||
| Reliability | Verify that the Nanox.ARC Tubes lifetime and consistency is according to System spec. | PASS |
| Functional Verification | Verify that the Nanox.ARC Tubes' lifetime and consistency are according to system spec. | PASS |
| Motion Control | Verify the stability of Nanox.ARC motion in precise linear and angular movements is according to specification | PASS |
| Detector and image | ||
| acquisition | Verify the key functionality of the detector as well as the system imaging properties. | PASS |
| Usability Summative | Demonstrate that after training, when used by intended users in the expected use environment, the Nanox.ARC system can be used safely and effectively without producing patterns of failures that could result in negative clinical impact, injury to patients and users, or damage to the device. Tested using FDA guidance, IEC 62366-1 and ISO 14971 | PASS |
| Transportation | Ensure the packing allows for safe transportation of the Nanox ARC while preventing damage to it, using ASTM D4169; ISTA 1H; IEC 60068-2; IEC 60068-2-64 | PASS |
| Dimensional and | ||
| Mechanical Properties | Verify Dimensional and Mechanical properties of Nanox.ARC system as defined in System requirement Specification documentation. | PASS |
| Image Quality | Verify that the key functionality of the detector as well as the system imaging properties is as defined in System requirement Specification documentation: | PASS |
| Phantom Validation | Evaluation of the system performance in comparison with the predicate system in terms of diagnostic quality. | PASS |
| Software verification and | ||
| validation using FDA | ||
| Guidance; IEC 62304 | The device meets design and cybersecurity requirements | PASS |
| 21 CFR 1020.30 and | ||
| 21 CFR 1020.31 | Nanox.ARC is compliant to the FDA Subchapter J mandated performance standard | PASS |
| Electrical Safety & EMC | ||
| IEC 60601-1 | ||
| IEC 60601-1-2 | Conformance to electromagnetic compatibility standards, accompanied by certificate | PASS |
| Radiation Safety | ||
| IEC 60601-1-3 | ||
| IEC 60601-2-28 | ||
| IEC 60601-2-54 | Conformance to electromagnetic compatibility standards, accompanied by certificate | PASS |
| Biocompatibility using FDA | ||
| guidance, ISO 10993-1 | Conformance to recognized biocompatibility standards supported by Biological Risk Assessment. | PASS |
13 Substantial Equivalence Conclusions
Utilizing FDA's Substantial Equivalence Decision Flowchart, the following was concluded:
- . The subject device has the same intended use and similar indications for use as the predicate device
- . The subject device has similar technological characteristics to the predicate device
- The different characteristics do not raise new or different safety or effectiveness questions .
- Acceptable scientific methods exist for assessing the new characteristics .
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Image /page/12/Picture/0 description: The image contains the logo for Nanox. The logo features a stylized, interconnected grid pattern in blue, resembling a globe or a network. Below the graphic is the word "NANOX" in a bold, sans-serif font, also in blue.
- . Performance data are available to assess the effects of the new characteristics
- . Performance data and phantom testing (together with descriptive characteristics) demonstrate substantial equivalence
Review of performance lab, bench, and user testing results, as well as comparison of the device classification, indication for use, operating principles, and technological characteristics, demonstrate that the subject device is substantially equivalent to the predicate DR 600 with Tomosynthesis by AGFA NV (K193262). Any differences between the subject and predicate device do not raise new questions of safety or effectiveness.