(119 days)
Not Found
No
The summary describes a digital radiography system and its features, focusing on image acquisition and dose reduction. There is no mention of AI, ML, or any related image processing techniques that would suggest the use of such technologies for analysis or interpretation.
No
The device is described as a digital radiography system intended for diagnostic purposes and imaging of skeletal deformities and other follow-up examinations. It is not used for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that EOS allows for "radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes." Additionally, the "Device Description" mentions that "The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed."
No
The device description clearly states that EOS is a "digital radiography system" with "two sets of xenon gas filled digital detectors and Xray tubes," which are hardware components. It also mentions a "high-resolution, medical-quality monitor" for display. This indicates it is a hardware system that likely includes software for image acquisition, processing, and display, but it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the EOS system, is a digital radiography system that directly images the patient's body using X-rays. It does not involve the analysis of blood, urine, tissue, or any other biological sample.
- The intended use and device description clearly describe an imaging system. The purpose is to acquire radiographic images for diagnostic purposes by scanning the patient.
- The performance studies focus on image quality and the ability to assess skeletal deformities. This is consistent with an imaging device, not an IVD.
Therefore, based on the provided information, the EOS system is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MOB
Device Description
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and Xray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. A new acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric exams. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 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; spine or lower limb (for Micro Dose feature specifically for global skeletal deformities)
Indicated Patient Age Range
Pediatric (for Micro Dose feature)
Intended User / Care Setting
Not Found
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)
Performance testing was designed to confirm performance of the EOS System at a dose level used by the Micro Dose feature. Performance testing included safety testing according to IEC, image quality bench testing, and clinical testing. The objective of these performance tests was to confirm the ability of the EOS System's Micro Dose acquisition feature to generate very low X-ray dose images allowing for the follow-up assessment of global skeletal deformities in pediatric patients. The Micro Dose image quality was assessed by: (1) rating the visibility of the anatomical landmarks used for the measurement of the clinical parameters for spine scoliosis follow up; and (2) assessing the reproducibility and the accuracy of the measurements of clinically relevant scoliosis angles. Based on the results of these performance tests it was concluded that the Micro Dose feature enables the analysis of global skeletal deformity in the context of radiographic examinations which do not require fine bone structure analysis, such as follow-up exams of the spine or lower limb.
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.
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2015
EOS Imaging % Mr. John J. Smith Regulatory Counsel Hogan Lovells US L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K142773
Trade/Device Name: EOS System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: December 12, 2014 Received: December 12, 2014
Dear Mr. Smith:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A. Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142773
Device Name EOS System
Indications for Use (Describe)
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.
| 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
EOS imaging's EOS System
| EOS imaging |
|---|
| 10 rue Mercoeur |
| PARIS F-75011 |
| FRANCE |
| Phone: | + 33 1 55 25 60 60 |
|---|---|
| Facsimile: | + 33 1 55 25 60 61 |
| Contact Person: | Karine Chevrie, Quality and Regulatory Affairs Officer |
|---|---|
| Date Prepared: | January 22, 2015 |
Name of Device and Name/Address of Sponsor:
| EOS System |
|---|
| EOS imaging |
| 10 rue Mercoeur |
| PARIS F-75011 |
| FRANCE |
| Common or Usual Name: | Digital Radiography System |
|---|---|
| Classification Regulation: | 21 C.F.R. § 892.1680; Stationary X-Ray System |
| Product Code KPR – System, X-Ray, Stationary |
Predicate Devices: EOS imaging's EOS (K123740)
Intended Use/ indication for use
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.
Technological Characteristics
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and Xray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. A new acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric exams. The diagnostic images are stored in a local
4
database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving.
Performance Data
The company's performance testing was designed to confirm performance of the EOS System at a dose level used by the Micro Dose feature. Performance testing included safety testing according to IEC, image quality bench testing, and clinical testing. The objective of these performance tests was to confirm the ability of the EOS System's Micro Dose acquisition feature to generate very low X-ray dose images allowing for the follow-up assessment of global skeletal deformities in pediatric patients. The Micro Dose image quality was assessed by: (1) rating the visibility of the anatomical landmarks used for the measurement of the clinical parameters for spine scoliosis follow up; and (2) assessing the reproducibility and the accuracy of the measurements of clinically relevant scoliosis angles. Based on the results of these performance tests it was concluded that the Micro Dose feature enables the analysis of global skeletal deformity in the context of radiographic examinations which do not require fine bone structure analysis, such as follow-up exams of the spine or lower limb. In such exams, the patient entrance dose of 10 to 90 µGy associated with the Micro Dose feature is an advantage, especially in pediatric patients who are more susceptible to radiation.
Substantial Equivalence
The EOS is essentially the same device as its predicate device with the exception of the revised indications for use that includes the indication for use of the Micro Dose acquisition protocol, which is more specific compared to the indication for use of higher X-ray dose acquisition settings. 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. This change does not alter the device's diagnostic effect, and performance testing demonstrates safety and performance comparable to the predicate. Thus, the EOS is substantially equivalent to the predicate device.