(167 days)
No
The document describes a digital X-ray detector and associated image processing software, but there is no mention of AI, ML, or related concepts in the provided text. The image processing is described using general terms like "latest digital imaging and processing techniques."
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
No
This device, an X-ray detector, is used for taking diagnostic radiographic exposures and capturing digital images. While these images are used for diagnosis, the device itself is an image acquisition device, not a diagnostic device that performs the diagnosis. The diagnosis is performed by a qualified/trained doctor or technologist who reviews the images.
No
The device description explicitly states it is a "digital flat panel (specifically termed solid state digital X-Ray detector)" and mentions hardware components like a scintillator and a-Si TFT sensor. While it includes software for image processing, the core device is a hardware component.
Based on the provided information, 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 derived from the human body, such as blood, urine, or tissue, in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
This device operates in vivo (within the body) by capturing images of internal structures using X-rays. Therefore, it falls under the category of a medical imaging device, not an IVD.
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 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.
Product codes
MOB, MQB
Device Description
The Aquarius 8600 1417WC is a digital flat panel (specifically termed solid state digital X-Ray detector), with the option for users to use the detector in either a tethered or wireless mode. 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 1417WC (tethered/wireless) represents a modification of our own predicate device cleared under K170202 Aquarius 8600 1717TC (tethered only).
The Aquarius 8600 1417WC integrates the 510(k) cleared tethered/wireless flat panel detector (K141566), with IDC Magellan software and workstation (K170202). There were no changes made to the cleared panel, workstation or software. All components were integrated and tested to make the Aquarius 8600 1417WC medical device.
Note: The integration of the Aquarius 8600 1417WC flat panel detector and Magellan software with the workstation is exactly the same integration as the IDC marketed flat panel, Aquarius 8600 1717TC, with Magellan software and workstation cleared under K170202.
Mentions image processing
Yes
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
Not Found
Summary of Performance Studies
Non-Clinical Test Summary:
- Comparison of the Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF) and Noise Power Spectrum (NPS).
- DQE: The proposed Aquarius 8600 1417WC detector has similar DQE performance at all spatial frequencies to the predicate Aquarius 8600 1717TC detector.
- MTF: The Aquarius 8600 1417WC detector has the same or better resolution performance than the predicate Aquarius 8600 1717TC detector at all spatial frequencies.
- NPS: The Aquarius 8600 1417WC detector has a similar noise performance profile at spatial frequencies as the predicate Aquarius 8600 1717TC detector.
- Environmental, electrical, mechanical safety, and performance testing was completed for the Aquarius 8600 1417WC, and all testing passed, based on IEC 60601-1 Medical Electrical Equipment - Part I General Requirements for Basic Safety and Essential Performance, 3rd edition + CORR. 1:2006 + CORR. 2:2007 + A1:2012. EMC testing was completed based on IFC 60601-1-2:2007.
- "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 Aquarius 8600 1417WC is substantially equivalent to the Aquarius 8600 1717TC predicate device.
- 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".
- Laboratory images using phantoms were acquired with the proposed Aquarius 8600 1417WC detector and compared to images acquired with the Aquarius 1717TC 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 Aquarius 8600 1417WC device produces images that are diagnostically similar to the predicate device.
Clinical Test Summary: No clinical testing was performed for this special 510(k) submission.
Key Metrics
DQE (0):
- Aquarius 8600 1417WC: 0.817
- Aquarius 8600 1717TC: 0.684
MTF Value:
- Spatial Frequency 1 lp/mm: Aquarius 8600 1417WC: 0.557, Aquarius 8600 1717TC: 0.517
- Spatial Frequency 2 lp/mm: Aquarius 8600 1417WC: 0.280, Aquarius 8600 1717TC: 0.230
- Spatial Frequency 3 lp/mm: Aquarius 8600 1417WC: 0.157, Aquarius 8600 1717TC: 0.123
- Spatial Frequency 3.5 lp/mm: Aquarius 8600 1417WC: 0.118, Aquarius 8600 1717TC: 0.088
NPS Value:
- Spatial Frequency 0 lp/mm: Aquarius 8600 1417WC: 19.15, Aquarius 8600 1717TC: 8.01
- Spatial Frequency 1 lp/mm: Aquarius 8600 1417WC: 7.39, Aquarius 8600 1717TC: 3.30
- Spatial Frequency 2 lp/mm: Aquarius 8600 1417WC: 2.29, Aquarius 8600 1717TC: 1.27
- Spatial Frequency 3 lp/mm: Aquarius 8600 1417WC: 1.01, Aquarius 8600 1717TC: 0.64
- Spatial Frequency 3.5 lp/mm: Aquarius 8600 1417WC: 0.78, Aquarius 8600 1717TC: 0.58
Predicate Device(s)
Reference Device(s)
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.
0
October 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
Imaging Dynamics Company Ltd. % Ms. Nicole Wherry Chief Quality Officer #130, 5310-29th Street NE Calgary, AB T1Y 7E5 CANADA
Re: K171175
Trade/Device Name: Aquarius 8600 1417WC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 20, 2017 Received: September 25, 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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Michael D. O'Hara 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) K171175
Device Name Aquarius 8600 1417WC
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technologist on both and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts on both adult and pediatic 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Exhibit # 8: 510(K) Summary
510(K) Summary, Special 510(k)
Page 1 of 9
Date Prepared: 20 Sep, 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
2. Identification of the Device 21 CFR 807.92(a)(2):
| Trade Name: | Aquarius 8600 1417WC |
|---|---|
| Model Names: | 1417WC |
| Common Name: | Flat Panel Detector (tethered/wireless) |
| 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: | K170202 Aquarius 8600 1717TC Digital Radiographic Detector, IDC |
|---|---|
| Trade Name: | Aquarius 8600 Digital Radiographic Detector |
| Model Names: | 1717TC |
| Common Name: | Flat Panel Detector (tethered only) |
| 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
K141566, Digital Flat Panel X-Ray Detector, 1417WCC (tethered/wireless)
The 510(k) for K141566 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 1417WC is a digital flat panel (specifically termed solid state digital X-Ray detector), with the option for users to use the detector in either a tethered or wireless mode. 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 1417WC (tethered/wireless) represents a modification of our own predicate device cleared under K170202 Aquarius 8600 1717TC (tethered only).
The Aquarius 8600 1417WC integrates the 510(k) cleared tethered/wireless flat panel detector (K141566), with IDC Magellan software and workstation (K170202). There were no changes made to the cleared panel, workstation or software. All components were integrated and tested to make the Aquarius 8600 1417WC medical device.
Note: The integration of the Aquarius 8600 1417WC flat panel detector and Magellan software with the workstation is exactly the same integration as the IDC marketed flat panel, Aquarius 8600 1717TC, with Magellan software and workstation cleared under K170202.
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.
Note: Indications for Use are identical between the subject and predicate devices.
Technological Characteristics Summary: Predicate and proposed devices comparison 6. 21 CFR 807.92(a)(6):
The proposed Aquarius 8600 1417WC device described in this 510(k) has similar technological characteristics and the same indication for use as the predicate device, Aquarius 8600 1717TC. A summary table comparing the technological properties of the proposed device to the predicate device is provided in Table 1.
| Characteristic | Proposed IDC
Aquarius 8600 1417WC | Predicate IDC
Aquarius 8600 1717TC |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: Proposed IDC Aquarius 8600 1417WC | Image: Predicate IDC Aquarius 8600 1717TC |
| IDC
510(k) number | K171175 | K170202 |
| Reference Device
510(k) # | K141566 | K141566 |
| Intended Us
(No change
between subject
and predicate
devices) | Aquarius 8600 1417WC 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. | Aquarius 8600 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. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | CsI:Tl | CsI:Tl |
| Imaging Area | 14 x 17 inches | 17x17 inches |
| Pixel Matrix | 2816 x 3328 | 3328 x 3328 |
| Pixel Pitch | 127 um | 127 um |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D Conversion | 14/16 bit | 14/16 bit |
| Preview Time |