(26 days)
No
The summary describes a digital radiography system with standard image acquisition and processing features. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for diagnostic imaging (radiographic acquisition) and assessment of skeletal deformities, and does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device allows the "radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes."
No
The device description explicitly states it 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". This indicates significant hardware components beyond just software.
Based on the provided information, the EOSedge device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the EOSedge clearly states it is a digital radiography system that acquires X-ray images of the patient's body directly. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for general radiographic exams and applications. This involves imaging the internal structures of the body using X-rays, which is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass or outside the living body).
- The device description focuses on hardware and software for image acquisition and processing. This aligns with the characteristics of a medical imaging device, not an IVD.
Therefore, the EOSedge is a medical imaging device, specifically a digital radiography system, and not an In Vitro Diagnostic.
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, 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
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 identical 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 pediatric exams. The two sets of detectors and X-ray tubes are identical between the predicate device and the subject device. The image acquisition can be performed with a MANUAL mode or an AUTO mode of patient examination. To select the area of interest (acquisition area), a vertical collimation is set using green lasers and to correctly position the patient in the EOSedge, a centering system is used based on red lasers. The diagnostic images are stored in a local database and are displayed on a high-resolution medical-quality non-diagnostic monitor. The diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
Mentions image processing
Yes
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 exams (specifically for the 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)
Software verification and validation testing was conducted. Additional performance and functional testing 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, 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.
EOS imaging % Mr. Bernard Ismael Quality and Regulatory Affairs Director 10 rue Mercoeur Paris, F-75011 FRANCE
Re: K202394
Trade/Device Name: EOSedge™ Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: August 19, 2020 Received: August 21, 2020
Dear Mr. 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 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
September 16, 2020
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.
For
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 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.
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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K202394 510(k) SUMMARY
EOS imaging's EOSedge System
EOS imaging 10 Rue Mercoeur F-75011, Paris FRANCE
Phone: + 33 1 55 25 60 60 Facsimile: + 33 1 55 25 60 61
Contact Person: Bernard ISMAEL, Quality and Regulatory Affairs Director
Date Prepared: August 19, 2020
| 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 EOSedge System (K192079) |
| 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 |
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 identical 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 pediatric exams. The two sets of detectors and X-ray tubes are identical between the predicate device and the subject device. The image acquisition can be performed with a MANUAL mode or an AUTO mode of patient examination. To select the area of interest (acquisition area), a vertical collimation is set using green lasers and to correctly position the patient in the EOSedge, a centering system is used based on red lasers. The diagnostic images are stored in a local database and are displayed on a high-resolution medical-quality non-diagnostic monitor. The diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
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The frontal and lateral detectors are identical. The technical specifications of the detectors are presented in the Table 1 below:
| Attribute | Technical Specifications |
|---|---|
| Quantity | 2 |
| Type | Hybrid CdTe-CMOS dual energy photons counting X-ray detector |
| Dimensions | Width 585 mm x 98 mm |
| Thickness 131 mm | |
| Weight | 131 000 gray levels) |
| Nominal input voltage | 12 VDC – 20 A |
| Temperature control | Internal check, Peltier + PWM |
| Ventilator system checked | |
| DQE type | RQA5 spectrum ~ 80% |
| MTF type | ~70% @ 2lp / mm |
| ~25% @ 5lp / mm |
| Table 1: DETECTORS SPECIFICATIONS | |
|---|---|
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, 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 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.
All the testing standards used for bench testing of the EOSedge system are listed in Table 2 below:
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| Standards N°. | Standards Title | Date |
|---|---|---|
| AAMI/ANSI | ||
| ES60601-1 | ||
| :2005/(R)2012 and A1:2012 | Medical electrical equipment. Part 1: general requirements for basic | |
| safety and essential performance | 2012 | |
| IEC 60601-1-2 | Medical electrical equipment. Part 1-2: general requirements for | |
| safety; electromagnetic compatibility-requirements and tests. | 2014 | |
| IEC 60601-1-3 | Medical electrical equipment. Part 1-3: general requirements for | |
| safety; general requirements for radiation protection in diagnostic X- | ||
| ray equipment. | 2013 | |
| IEC 60601-1-6 | Medical electrical equipment. Part 1-6: General requirements for basic | |
| safety and essential performance -Collateral standard: Usability | 2013 | |
| IEC 60601-2-54 | Medical electrical equipment. Part 2-54: Particular requirements for | |
| the basic safety and essential performance of X-ray equipment for | ||
| radiography and radioscopy | 2015 | |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and | |
| requirements | 2007 | |
| IEC 62220-1 | Medical Electrical Equipment-Characteristics Of Digital X-Ray | |
| Imaging Devices, Part 1-1: Determination Of The Detective Quantum | ||
| Efficiency, Detectors Used In Radiographic Imaging | 2015 |
Table 2: Bench Testing Standards Used for the EOSedge system
Substantial Equivalence
EOSedge has the same intended use, indications, principles of operation, and technological characteristics as the cleared predicate device. EOSedge is an updated version of the cleared EOSedge System (K192079) with the main modifications being optimization of some acquisition protocol parameters, improvement of image processing and change in system data processing.
A substantial equivalence table summarizing the similarities and differences between EOSedge and its predicate device is provided in Table 3 below.
| | EOS imaging's EOSedge | EOS imaging's cleared EOSedge
System (K192079) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General X-ray imaging system | General X-ray imaging system |
| 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 examinations. | 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. |
| 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. | 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. |
| | EOS imaging's EOSedge | EOS imaging's cleared EOSedge
System (K192079) |
| | | |
| | The Micro Dose feature is not indicated: | The Micro Dose feature is not indicated: |
| | for analysis of spine static in the 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 | for analysis of spine static in the 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 |
| 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 | 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. | along a vertical axis. |
| Dimensions (I x w | 2.58 m x 2.58 m x 2.706 m | 2.58 m x 2.58 m x 2.706 m |
| x h) | (8.5 ft x 8.5 ft x 8.9 ft) | (8.5 ft x 8.5 ft x 8.9 ft) |
| Weight | 2 005 kg (4 420 lb) | 2 005 kg (4 420 lb) |
| Accessories | Laser safety barriers
Motorized lifting platform | Laser safety barriers
Motorized lifting platform |
| | Platform console | Platform console |
| | Laser positioning system | Laser positioning system |
| | Access and stabilization bars | Access and stabilization bars |
| | Bar code reader | Bar code reader |
| 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
Scout View
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
Dose Report
Printing | 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
Scout View
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 |
| Permanent
minimum total
filtration | 1.7 mm Al at 75 kV | 1.7 mm Al at 75 kV |
| (Al equivalent) | Additional filtrations:
0.1 mm copper thickness (used for images with or without Micro-Dose) 0.5 mm copper thickness (used for the Scout View) | Additional filtrations:
0.1 mm copper thickness (used for images with or without Micro-Dose) 0.5 mm copper thickness (used for the Scout View) |
| Detectors | Direct conversion device - solid state
detector | Direct conversion device - solid state
detector |
| | 17 bits (> 131 000 grey levels) | 17 bits (> 131 000 grey levels) |
| Pixel Depth | | |
| Pixel Size | 100 μm | 100 μm |
| Resolution | 3.7 lp/mm | 3.7 lp/mm |
| Typical Dynamic | > 100 dB | > 100 dB |
| Range | | |
| | EOS imaging's EOSedge | EOS imaging's cleared EOSedge
System (K192079) |
| Values of the kV
parameters | 40 to 140 kV, bi-polar | 40 to 140 kV, bi-polar |
| Values of the mA
parameters | 10 to 500 mA | 10 to 500 mA |
| Software
Specifications | Patient information management
Image acquisition
Display images
Generation of dose report
Send exam to the PACS or USB
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 | 0.6 x 1.3 at 120 kV - 100 mA | 0.6 x 1.3 at 120 kV - 100 mA |
| Linear Scanning
Speed (cm/s) | From 4.1 to 32.5 | From 4.1 to 32.5 |
| Average
Acquisition Time | 7 seconds for a spine and 13 seconds for
an entire body | 8 seconds for a spine and 15 seconds for
an entire body |
| Laser Positioning
System | | |
| Maximum average
radiant power/
wavelength | 0.136 mW / 520 nm (green)
0.130 mW / 635 nm (red) | 0.136 mW / 520 nm (green)
0.130 mW / 635 nm (red) |
| Class according to
IEC 60825-1 | Class1 | Class1 |
Table 3: EOS IMAGING'S EOSEDGE - SUBSTANTIAL EQUIVALENCE CHART
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Conclusion
Modified EOSedge has the same intended use, indications for use, technological characteristics, and similar principles of operation as its predicate device, the cleared EOSedge System (K192079). The minor differences in principles of operation and software specifications between EOSedge and its predicate device raise no new questions of safety or effectiveness. Performance data further demonstrates that modified EOSedge is as safe and effective as the cleared EOSedge System (K192079). Thus, modified EOSedge is substantially equivalent.