(117 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard digital radiography components and processes.
No
The device is described as a digital radiography system intended for diagnostic imaging, not for treating a disease or condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device acquires X-ray images "for diagnostic purposes". The 'Device Description' also mentions that the system obtains "diagnostic images".
No
The device description explicitly states the system is comprised of hardware components including an acquisition workstation, a gantry with an electrical cabinet, detectors, and X-ray tubes, in addition to the acquisition software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body. They perform tests in vitro (in glass or outside the body).
- This device is a digital radiography system that takes X-ray images of the body. It is used for diagnostic imaging in vivo (in the living body).
The description clearly states it's for "general radiographic exams and applications" and involves "scanning the patient over the area of interest" to obtain "diagnostic images." This is the function of an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient, in the upright or seated position.
The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
The EOSedge system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in follow-up exams. The diagnostic images are stored in a local database and are displayed on a highresolution medical-quality non-diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole body or a reduced area of investigation
Indicated Patient Age Range
pediatric (for Micro Dose feature)
Intended User / Care Setting
Trained medical personnel
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)
EOSedge is designed and has been certified to conform to IEC 60601-1 and collateral standards. Software verification and validation testing was also conducted. Additional performance and functional testing have confirmed the equivalent performance of EOSedge compared to the cleared predicate EOS System. This included bench testing to confirm appropriate dosing and image quality. Bench performance testing were conducted based on FDA's Guidance for the Submission of 510/k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as 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.
EOS imaging's EOS System (K152788)
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.
Not Found
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
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Image /page/0/Picture/0 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 27, 2019
EOS Imaging c/o Bernard Ismael Quality and Regulatory Affairs Director 10 rue Mercoeur Paris, 75011 FRANCE
Re: K192079
Trade/Device Name: EOSedge Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: July 31, 2019 Received: August 2, 2019
Dear Bernard Ismael:
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
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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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
EOSedge™
Indications for Use (Describe)
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single body or a reduced area of investigation of a patient, in the upright or seated position.
The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
EOS imaging's EOSedge System
EOS imaging 10 Rue Mercoeur F-75011, Paris FRANCE
Phone: Facsimile: + 33 1 55 25 60 61
Contact Person: Bernard ISMAEL, Quality and Requlatory Affairs Director
Date Prepared: July 31, 2019
| Name of Device: | EOSedge™ |
|---|---|
| Common or Usual Name: | Digital Radiography System |
| Classification Name: | 21 C.F.R §892.1680; Stationary X-ray System |
| Regulatory Class: | Class II |
| Product Code: | KPR - System, X-ray, Stationary |
| Predicate Device: | EOS imaging's EOS System (K152788) |
Device Description
The EOSedge system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in follow-up exams. The diagnostic images are stored in a local database and are displayed on a highresolution medical-quality non-diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
Intended Use / Indications for Use
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient, in the upright or seated position.
The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
Performance Data
EOSedge is designed and has been certified to conform to IEC 60601-1 and collateral standards. Software verification and validation testing was also conducted. Additional performance and functional
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testing have confirmed the equivalent performance of EOSedge compared to the cleared predicate EOS System. This included bench testing to confirm appropriate dosing and image quality. Bench performance testing were conducted based on FDA's Guidance for the Submission of 510/k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device.
Substantial Equivalence
EOSedge has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared predicate device. EOSedge is an updated version of the cleared EOS System (K152788) with the main modification being a change in the type of detector used, namely, solid state photon counting detectors rather than gaseous detectors. Although the design of the equipment is being updated to accommodate the new detector, there are no major changes to the tube assembly and beam-limiting features. Both systems have two sets of detectors and X-ray tubes positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The two orthogonal acquisition chains consist of HV generators, X-ray tubes, collimators and detectors, positioned on C-shaped arms translating along a vertical axis. The software for the two systems are also fundamentally the same.
A substantial equivalence table summarizing the similarities and differences between EQSedge and its predicate device is provided below.
| | EOS imaging's EOSedge | EOS imaging's cleared EOS System
(K152788) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Indications for Use | General X-ray imaging system
EOSedge is intended for use in general
radiographic exams and applications,
excluding the evaluation of lung nodules and
exams involving fluoroscopy, angiography,
and mammography. EOSedge allows the
radiographic acquisition of either one or two
orthogonal X-ray images, for diagnostic
purposes, in one single scan, of the whole
body or a reduced area of investigation of a
patient, in the upright or seated position.
The Micro Dose feature is indicated for
assessing global skeletal deformities in
follow-up pediatric examinations. | General X-ray imaging system
EOS is intended for use in general
radiographic examinations and applications,
excluding the evaluation of lung nodules and
examinations involving fluoroscopy,
angiography, and mammography. EOS
allows the radiographic acquisition of either
one or two orthogonal X-ray images for
diagnostic purposes, in one single scan, of
the whole body or a reduced area of
investigation of a patient in the upright or
seated position.
The Micro Dose feature is indicated for
imaging with a patient entrance dose of 10
to 90 µGy for assessing global skeletal
deformities in follow-up pediatric
examinations. Micro Dose is not indicated
for focal skeletal abnormalities and/or other
pediatric abnormalities. Micro Dose is not
indicated for use in patients with a Body
Mass Index over 30. |
| Contraindications | EOSedge is not designed to perform
fluoroscopy, angiography or mammography
exams.
The Micro Dose feature is not designed for
morphological analysis of bone structures and
lesions.
The Micro Dose feature is not indicated:
• for analysis of spine static in the | This system was not designed to perform
mammograms, angiograms or fluoroscopy
examinations.
The Micro Dose functionality is not designed
for morphological analysis of bone
structures and lesions. It is not indicated for
analysis of spine static in the presence of
fusion material or for analysis of the bone- |
| | EOS imaging's EOSedge | EOS imaging's cleared EOS System
(K152788) |
| | presence of fusion material or for
analysis of the bone-implant interface
in the case of focal skeletal anomalies
•
and/or other pediatric abnormalities
•
for use in patients with a Body Mass
Index over 30 | implant interface. |
| User Population | Trained medical personnel | Trained medical personnel |
| Technological
Characteristics | Digital radiography system in which two sets
of detectors and X-ray tubes are positioned
orthogonally to generate frontal and lateral
images simultaneously by scanning the
patient over the area of interest. The 2
orthogonal acquisition chains consist of HV
generators, X-ray tubes, collimators and
detectors, positioned on C-shaped arms
translating along a vertical axis. | Digital radiography system in which two sets
of detectors and X-ray tubes are positioned
orthogonally to generate frontal and lateral
images simultaneously by scanning the
patient over the area of interest. The 2
orthogonal acquisition chains consist of HV
generators, X-ray tubes, collimators and
detectors, positioned on C-shaped arms
translating along a vertical axis. |
| Dimensions (I x w x
h) | 2.58 m x 2.58 m x 2.706 m
(8.5 ft x 8.5 ft x 8.9 ft) | 2 m x 2 m x 2.7 m
(7.9 ft x 7.9 ft x 10.44 ft) |
| Weight | 2 005 kg (4 420 lb) | 1 623 kg (3579 lb) |
| Accessories | Laser safety barriers
Motorized lifting platform
Gantry console
Laser positioning system
Access and stabilization bars
Bar code reader | Mechanical platform
Laser positioning system
Access and stabilization bars |
| Principles of
Operation | Tube preheating
Selection of the patient, the acquisition
planes, and the anatomical area, as well as
patient positioning
Selection of either automatic mode or manual
mode
Selection of patient morphotype
Image preview
Display of the exposure area, configuration of
the reference planes, and verification and
validation of the acquisition parameters
Image analysis and export of the exam | Tube preheating
Daily detector calibration
Selection of the patient, the acquisition
planes, and the anatomical area, as well as
patient positioning
Selection of patient morphotype
Image preview
Display of the exposure area, configuration
of the reference planes, and verification and
validation of the acquisition parameters
Display of unprocessed images and
reprocessing with various options
Image analysis and export of the exam
Printing |
| Permanent
minimum total | 1.7 mm Al at 75 kV | 1.5 mm Al at 75 kV |
| filtration
(Al equivalent) | Additional filtrations:
• 0.1 mm copper thickness (used for
images with or without Micro-Dose) | Additional filtrations:
• 0.1 mm Cu copper thickness (used for
images with or without Micro-Dose) |
| | EOS imaging's EOSedge | EOS imaging's cleared EOS System
(K152788) |
| | ◦ 0.5 mm copper thickness (used for the
Scout View) | ◦ 1 mm aluminum thickness (used for
large patient with LF and power > 28
kW) |
| Detectors | Direct conversion device - solid state
detector | Direct conversion device - gaseous detector |
| Pixel Depth | 17 bits (> 131 000 grey levels) | 16 bits (> 65 000 grey levels) |
| Pixel Size | 100 μm | 254 μm |
| Resolution | 3.7 lp/mm | 1.6 - 1.7 lp/mm |
| Typical Dynamic
Range | > 100 dB | > 90 dB |
| Software
Specifications | Patient information management
Image acquisition
Display images
Send exam to the PACS
Maintenance management
Access management to the system
System acquisition configuration. | Patient information management
Image acquisition
Display images
Send exam to the PACS
Maintenance management
Access management to the system
System acquisition configuration. |
| Focal Spot | Large focal spot:
0.6 x 1.3 at 120 kV - 100 mA | Large focal spot:
0.6 x 1.3 at 120 kV - 100 mA
Small focal spot:
0.4 x 0.7 at 120 kV - 50 mA
Use of the two focal spot sizes enabled |
| Linear Scanning
Speed (cm/s) | From 4.1 to 32.5 | From 3.8 to 30.5 |
| Average
Acquisition Time | 8 seconds for a spine and 15 seconds for an
entire body | 5 to 10 seconds for a spine and 20 seconds
for an entire body |
Table 1: EOS IMAGING'S EOSEDGE - SUBSTANTIAL EQUIVALENCE CHART
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Conclusion
EOSedge has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device, the EOS System (K152788). The minor differences in indications for use and technology between EOSedge and its predicate device raise no new questions of safety or effectiveness. Performance data further demonstrates that EOSedge is as safe and effective as the cleared EOS System (K152788). Thus, EOSedge is substantially equivalent.