(30 days)
No
The document describes a digital X-ray detector and associated software for image acquisition and processing, but there is no mention of AI or ML technologies being used. The image processing is described as "digital imaging and processing techniques," which is a general term and does not specifically indicate AI/ML.
No.
Explanation: The device is intended for taking diagnostic radiographic exposures, which means it is used for diagnosis, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states the device is "for taking diagnostic radiographic exposures". While it doesn't directly perform diagnosis, it captures images that are used by a qualified/trained doctor or technologist for diagnostic purposes.
No
The device description explicitly states that the device includes digital flat panels (solid state digital X-Ray detectors) and integrates them with software and a workstation. This indicates the presence of significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for taking diagnostic radiographic exposures of various body parts. This involves imaging the internal structures of the body using X-rays.
- Device Description: The device is described as a digital flat panel X-ray detector that captures and digitalizes X-ray images. This is a component of an X-ray imaging system.
- Input Imaging Modality: The input modality is X-Ray.
- Anatomical Site: The device is used to image various anatomical sites within the body.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device directly images the body itself, not specimens taken from it.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Aquarius 8600 1717TC are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.
The Aquarius 8600 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector.
The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TC and 1417TC medical devices.
The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document
Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document.
Mentions image processing
IDC Magellan 3 is a software program that uses the latest digital imaging and processing techniques to acquire, store, retrieve, transmit, and print medical images for immediate review and disposition. DICOM 3.0 compliant.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
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
Laboratory images using phantoms were acquired with the proposed 1717TC and 1417TC flat panels and compared to images acquired with the IDC X3C predicate device. A Radiological Technologist certified in the United States of America and Canada has reviewed the images (included in this submission) and determined the proposed 1717TC and 1417TC devices produce images that are diagnostically similar, and slightly superior, to the predicate device. A copy of the images was submitted as part of this special 510(k) submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary:
The results of the non-clinical studies demonstrate the 1717TC and 1417TC are substantially equivalent to the predicate device, X3C Digital Radiographic Detector. The tests and corresponding results are summarized below:
A. Comparison of the Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF) and Noise Power Spectrum (NPS).
B. Environmental, electrical, mechanical safety, and performance testing was completed for the 1717TC and 1417TC, and all testing passed, based on IEC 60601-1 Medical Electrical Equipment - Part I General Requirements for Basic Safety and Essential Performance, 300 edition + CORR. 1:2006 + CORR. 2:2007 + A1:2012. EMC testing was completed based on IEC 60601-1-2:2007.
C. "Guidance For The Submission of 510(K)s For Solid State X-Ray Imaging Devices" was utilized for clinical and non-clinical considerations. Results indicate the 1717TC and 1417TC are substantially equivalent to the IDC X3C predicate device.
D. IDC software has a documented lifecycle based on IEC 62304 Edition1.1:2015 "Medical Device Software - Software Lifecycle Processes". IDC software design and requirements specifications, classification of hazards, and full verification, validation, and regression testing is based on the FDA documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".
E. Laboratory images using phantoms were acquired with the proposed 1717TC and 1417TC flat panels and compared to images acquired with the IDC X3C predicate device. A Radiological Technologist certified in the United States of America and Canada has reviewed the images (included in this submission) and determined the proposed 1717TC and 1417TC devices produce images that are diagnostically similar, and slightly superior, to the predicate device. A copy of the images was submitted as part of this special 510(k) submission.
Clinical Test Summary:
No clinical testing was performed for this special 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detective Quantum Efficiency Comparison:
DQE (0): 1717TC and 1417TC (0.684), X3C Detector (0.641)
Modulation Transfer Function:
Spatial Frequency 1 lp/mm: 1717TC and 1417TC (0.517), X3C Detector (0.385)
Spatial Frequency 2 lp/mm: 1717TC and 1417TC (0.230), X3C Detector (0.134)
Spatial Frequency 3 lp/mm: 1717TC and 1417TC (0.123), X3C Detector (0.075)
Spatial Frequency 3.5 lp/mm: 1717TC and 1417TC (0.063), X3C Detector (0.063)
Noise Power Spectrum:
Spatial Frequency 0 lp/mm: 1717TC and 1417TC (8.01), X3C Detector (2.21)
Spatial Frequency 1 lp/mm: 1717TC and 1417TC (3.30), X3C Detector (0.98)
Spatial Frequency 2 lp/mm: 1717TC and 1417TC (1.27), X3C Detector (0.82)
Spatial Frequency 3 lp/mm: 1717TC and 1417TC (0.64), X3C Detector (0.82)
Spatial Frequency 3.5 lp/mm: 1717TC and 1417TC (0.58), X3C Detector (0.81)
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
§ 892.1680 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Imaging Dynamics Company Ltd. % Ms. Nicole Wherry Chief Quality Officer 130, 3510 29th Street NE Calgary, Alberta T1Y 7E5 CANADA
Re: K170202
Trade/Device Name: Aquarius 8600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 14, 2016 Received: January 23, 2017
Dear Ms. Wherry:
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.
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Aquarius 8600
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
| 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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3
Exhibit # 8: 510(K) Summary
510(K) Summary, Special 510(k) K
Page 1 of 9
Date Prepared: 21 February, 2017
1. Submitter 21 CFR 807.92(a)(1):
Imaging Dynamics Company, Ltd. (IDC) #130, 3510-29th Street N.E. Calgary, Alberta, Canada T1Y 7E5 Tel: 403.251.9939 Fax: 403.251.1771 Contact: Nicole Wherry
Identification of the Device 21 CFR 807.92(a)(2): 2.
| Trade Name: | Aquarius 8600 |
|---|---|
| Model Names: | 1717TC and 1417TC |
| Common Name: | Flat Panel Detector |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
3. Equivalent legally marketed devices 21 CFR 807.92(a)(3):
| Predicate device: | K070079, X3C Digital Radiographic Detector, IDC |
|---|---|
| Trade Name: | X3C Digital Radiographic Detector |
| Model Names: | X3C |
| Common Name: | Digital Imaging X-Ray Detector |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4
Page 2 of 9
Reference legally marketed devices
K111098, InnovaXion FP, IDC (Imaging Dynamics Company)
K122173, Digital Flat Panel X-Ray Detector, 1717SCC
K122919, Digital Flat Panel X-Ray Detector, 1417PCA
The 510(k) for K122173 and K122919 was submitted by the original equipment manufacturer. Imaging Dynamics Company Ltd. maintains adequate information demonstrating our legal right to distribute the device.
4. Description of the Device 21 CFR 807.92(a)(4):
The Aquarius 8600 1717TC are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.
The Aquarius 8600 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector.
The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TC and 1417TC medical devices.
Note: The integration of the 1717TC and 1417TC flat panel detectors and Magellan software with the workstation is exactly the same integration as the IDC marketed flat panel, InnovaXion FP, with Magellan software and workstation cleared under K111098.
The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document
Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document.
5
Page 3 of 9
5. Indications for Use (intended use) 21 CFR 807.92(a)(5):
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
6. Technological Characteristics Summary: Predicate and proposed devices comparison 21 CFR 807.92(a)(6):
The proposed 1717TC and 1417TC devices described in this 510(k) have similar technological characteristics and the same indications for use as the predicate device, X3C Digital Radiographic Detector. A summary table comparing the technological properties of the proposed devices to the predicate device has been provided in Table 1.
| Characteristic | Proposed IDC
Aquarius 8600, model 1717TC | Proposed IDC
Aquarius 8600, model 1417TC | Predicate IDC
X3C |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: Proposed IDC Aquarius 8600, model 1717TC | Image: Proposed IDC Aquarius 8600, model 1417TC | Image: Predicate IDC X3C |
| IDC
510(k) number | K170202 | K170202 | K070079 |
| Reference
Device 510(k) # | K122173 | K122919 | K070079 |
| Intended Use | 1717TC Digital Flat Panel X-Ray
Detector is indicated for digital
imaging solutions designed for
general radiographic systems for
human anatomy. It is intended to
replace film or screen based
radiographic systems in
all
general
purpose
diagnostic
procedures. Not to be used for
mammography. | 1417TC Digital Flat Panel X-Ray
Detector is indicated for digital
imaging solutions designed for
general radiographic systems for
human anatomy. It is intended to
replace film or screen based
radiographic
systems in all
general
purpose
diagnostic
procedures. Not to be used for
mammography. | X3C
X-Ray
Detector
is
indicated for digital imaging
solutions designed for general
radiographic systems for human
anatomy. It is intended to
replace film or screen based
radiographic systems in all
diagnostic
general purpose
procedures. Not to be used for
mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | D50 Dalsa /K70 Kodak Camera |
| Scintillator | CsI:Tl | CsI:Tl | CsI:Tl |
| Imaging Area | 17x17 inches | 14x17 inches | 17x17 inches |
| Pixel Matrix | 3328 x 3328 | 2816 x 3328 | 3000 x 3000 |
| Pixel Pitch | 127 um | 127 um | 144 um |
| Resolution | 3.9 lp/mm | 3.9 lp/mm | 3.4 lp/mm |
| A/D Conversion | 14/16 bit | 14/16 bit | 14 bit |
| Preview Time |