EOSedge
Device Facts
| Record ID | K202394 |
|---|---|
| Device Name | EOSedge |
| Applicant | Eos Imaging |
| Product Code | KPR · Radiology |
| Decision Date | Sep 16, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Digital radiography system; acquires orthogonal frontal/lateral X-ray images simultaneously via scanning patient over area of interest. Components: acquisition workstation, gantry with electrical cabinet, two sets of X-ray tubes/detectors on C-shaped arms. Operation: manual or auto mode; patient positioned via red laser centering system; vertical collimation via green lasers. Input: X-ray radiation; Output: diagnostic images stored locally, displayed on high-resolution monitor, transmitted via DICOM. Used in clinical settings by trained medical personnel. Micro Dose feature provides low-dose imaging for pediatric skeletal deformity follow-up. System includes dose reporting and image export capabilities. Benefits: simultaneous orthogonal imaging, reduced acquisition time, and pediatric-specific low-dose options.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via bench testing per FDA's 'Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices' (Sept 2016) to confirm dosing and image quality. Conformance to IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 60825-1, and 62220-1 standards.
Technological Characteristics
Digital radiography system; two orthogonal acquisition chains (HV generators, X-ray tubes, collimators, detectors) on translating C-shaped arms. Detectors: Hybrid CdTe-CMOS dual energy photon counting, 100x100 μm pixel size, 17-bit depth, 5,139 pixels/line. X-ray voltage: <160 kVp. Connectivity: DICOM compatible network. Laser positioning: Class 1 (IEC 60825-1). Cooling: Peltier + PWM ventilator. Standards: IEC 60601-1, 60601-2-54, 62220-1.
Indications for Use
Indicated for general radiographic exams (excluding lung nodules, fluoroscopy, mammography) in patients requiring whole-body or regional orthogonal X-ray imaging in upright/seated positions. Micro Dose feature indicated for follow-up pediatric exams assessing global skeletal deformities.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- EOS imaging's EOSedge System (K192079)
Submission Summary (Full Text)
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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
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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)
K202394
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<br>Thickness 131 mm |
| Weight | <10 kg |
| X-ray conversion material | CdTe |
| X-ray voltage range | < 160 kVp |
| Active area | 514 mm x 6 mm |
| Pixel size | 100 x 100 $\mu m^2$ , elementary |
| Tile gap | <=100 $\mu m$ |
| Overall fill factor | 99.63% |
| Number of pixels/lines | 5,139 pixels |
| Imaging speed | Up to 5,000 lines/s, in TDS mode |
| Counting output range (Pixel depth) | 17 bits (TDS mode) (> 131 000 gray levels) |
| Nominal input voltage | 12 VDC – 20 A |
| Temperature control | Internal check, Peltier + PWM<br>Ventilator system checked |
| DQE type | RQA5 spectrum ~ 80% |
| MTF type | ~70% @ 2lp / mm<br>~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<br>ES60601-1<br>:2005/(R)2012 and A1:2012 | Medical electrical equipment. Part 1: general requirements for basic<br>safety and essential performance | 2012 |
| IEC 60601-1-2 | Medical electrical equipment. Part 1-2: general requirements for<br>safety; electromagnetic compatibility-requirements and tests. | 2014 |
| IEC 60601-1-3 | Medical electrical equipment. Part 1-3: general requirements for<br>safety; general requirements for radiation protection in diagnostic X-<br>ray equipment. | 2013 |
| IEC 60601-1-6 | Medical electrical equipment. Part 1-6: General requirements for basic<br>safety and essential performance -Collateral standard: Usability | 2013 |
| IEC 60601-2-54 | Medical electrical equipment. Part 2-54: Particular requirements for<br>the basic safety and essential performance of X-ray equipment for<br>radiography and radioscopy | 2015 |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and<br>requirements | 2007 |
| IEC 62220-1 | Medical Electrical Equipment-Characteristics Of Digital X-Ray<br>Imaging Devices, Part 1-1: Determination Of The Detective Quantum<br>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<br>System (K192079) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General X-ray imaging system | General X-ray imaging system |
| Indications for<br>Use | EOSedge is intended for use in general<br>radiographic exams and applications,<br>excluding the evaluation of lung nodules<br>and exams involving fluoroscopy,<br>angiography, and mammography.<br>EOSedge allows the radiographic<br>acquisition of either one or two orthogonal<br>X-ray images, for diagnostic purposes, in<br>one single scan, of the whole body or a<br>reduced area of investigation of a patient,<br>in the upright or seated position.<br>The Micro Dose feature is indicated for<br>assessing global skeletal deformities in<br>follow-up pediatric examinations. | EOSedge is intended for use in general<br>radiographic exams and applications,<br>excluding the evaluation of lung nodules<br>and exams involving fluoroscopy,<br>angiography, and mammography.<br>EOSedge allows the radiographic<br>acquisition of either one or two orthogonal<br>X-ray images, for diagnostic purposes, in<br>one single scan, of the whole body or a<br>reduced area of investigation of a patient,<br>in the upright or seated position.<br>The Micro Dose feature is indicated for<br>assessing global skeletal deformities in<br>follow-up pediatric examinations. |
| Contraindications | EOSedge is not designed to perform<br>fluoroscopy, angiography or<br>mammography exams.<br>The Micro Dose feature is not designed for<br>morphological analysis of bone structures<br>and lesions. | EOSedge is not designed to perform<br>fluoroscopy, angiography or<br>mammography exams.<br>The Micro Dose feature is not designed for<br>morphological analysis of bone structures<br>and lesions. |
| | EOS imaging's EOSedge | EOS imaging's cleared EOSedge<br>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<br>Characteristics | Digital radiography system in which two<br>sets of detectors and X-ray tubes are<br>positioned orthogonally to generate frontal<br>and lateral images simultaneously by<br>scanning the patient over the area of<br>interest. The 2 orthogonal acquisition<br>chains consist of HV generators, X-ray<br>tubes, collimators and detectors,<br>positioned on C-shaped arms translating | Digital radiography system in which two<br>sets of detectors and X-ray tubes are<br>positioned orthogonally to generate frontal<br>and lateral images simultaneously by<br>scanning the patient over the area of<br>interest. The 2 orthogonal acquisition<br>chains consist of HV generators, X-ray<br>tubes, collimators and detectors,<br>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<br>Motorized lifting platform | Laser safety barriers<br>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<br>Operation | Tube preheating<br>Selection of the patient, the acquisition<br>planes, and the anatomical area, as well<br>as patient positioning<br>Selection of either automatic mode or<br>manual mode<br>Selection of patient morphotype<br>Scout View<br>Display of the exposure area,<br>configuration of the reference planes, and<br>verification and validation of the<br>acquisition parameters<br>Image analysis and export of the exam<br>Dose Report<br>Printing | Tube preheating<br>Selection of the patient, the acquisition<br>planes, and the anatomical area, as well<br>as patient positioning<br>Selection of either automatic mode or<br>manual mode<br>Selection of patient morphotype<br>Scout View<br>Display of the exposure area,<br>configuration of the reference planes, and<br>verification and validation of the<br>acquisition parameters<br>Image analysis and export of the exam |
| Permanent<br>minimum total<br>filtration | 1.7 mm Al at 75 kV | 1.7 mm Al at 75 kV |
| (Al equivalent) | Additional filtrations:<br>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:<br>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<br>detector | Direct conversion device - solid state<br>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<br>System (K192079) |
| Values of the kV<br>parameters | 40 to 140 kV, bi-polar | 40 to 140 kV, bi-polar |
| Values of the mA<br>parameters | 10 to 500 mA | 10 to 500 mA |
| Software<br>Specifications | Patient information management<br>Image acquisition<br>Display images<br>Generation of dose report<br>Send exam to the PACS or USB<br>Maintenance management<br>Access management to the system<br>System acquisition configuration | Patient information management<br>Image acquisition<br>Display images<br>Send exam to the PACS<br>Maintenance management<br>Access management to the system<br>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<br>Speed (cm/s) | From 4.1 to 32.5 | From 4.1 to 32.5 |
| Average<br>Acquisition Time | 7 seconds for a spine and 13 seconds for<br>an entire body | 8 seconds for a spine and 15 seconds for<br>an entire body |
| Laser Positioning<br>System | | |
| Maximum average<br>radiant power/<br>wavelength | 0.136 mW / 520 nm (green)<br>0.130 mW / 635 nm (red) | 0.136 mW / 520 nm (green)<br>0.130 mW / 635 nm (red) |
| Class according to<br>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.
