(28 days)
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
This device is a medical x-ray image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a pc where the companion software has been installed. This software was cleared in our previous submission, K170202. A monitor displays this image. Images can then be transferred via the DICOM protocol. This device is nearly identical to the predicate but now the digital panels have Wi-Fi in addition to Ethernet interfaces. The Aquarius 8600 will be marketed in two possible configurations: Aquarius 8600 1717WCl (tethered or wireless), 17 x 17 inch flat panel as a retrofit package with Magellan software). Aquarius 8600 1417WCl (tethered or wireless), 14 x 17 inch flat panel as a retrofit package with Magellan software).
The provided text is a 510(k) premarket notification for a stationary x-ray system (Aquarius 8600 1417WCI; Aquarius 8600 1717WCI). It describes the device, its similarity to a predicate device, and the non-clinical tests conducted to establish substantial equivalence.
Based on the provided information, no specific acceptance criteria or a dedicated study proving the device meets those criteria are explicitly detailed in a format that would allow for a complete answer to all parts of your request.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Aquarius 8600 1417TC/1717TC, K170202) and references a cleared flat panel detector (K160810). The testing described is primarily non-clinical.
Here's an analysis of what information can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria is provided. The document states "Performance characteristics" are similar to the predicate and provides some technical specifications (MTF, DQE, Panel Resolution, Pixel Size) for both the predicate and the new device. It notes that the new panels have "slightly better MTF" and "slightly lower DQE," implying these performance characteristics were measured against the predicate's performance rather than predefined acceptance criteria.
| Characteristic | Predicate Device Performance (Aquarius 8600 1417TC/1717TC K170202) | New Device Performance (Aquarius 8600 1417WCI; Aquarius 8600 1717WCI) | Acceptance Criteria |
|---|---|---|---|
| Panel Communication | Tethered Gigabit Ethernet | Tethered Gigabit Ethernet or Wireless via previously cleared panel (K160810) | Not explicitly stated, implied to be equivalent or enhanced wireless capability is acceptable. |
| Sensor Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same as predicate, implying acceptance. |
| Scintillator | CsI: TI | CsI: TI | Same as predicate, implying acceptance. |
| Panel Resolution | 2816 x 3328 or 3328 x 3328 | 2304 x 2800 or 3072 x 3072 | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Panel Size | 14x17 inches or 17x17 inches | 14x17 inches or 17x17 inches | Same as predicate, implying acceptance. |
| Pixel Size | 127 μm | 150 μm (14x17) or 139 μm (17x17) | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Resolution (lp/mm) | 3.9 lp/mm | 3.59 lp/mm or 3.33 lp/mm | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Image Depth | 14 bits | 14 bits | Same as predicate, implying acceptance. |
| Preview Image | 2 seconds | Less than 3 seconds | "EQUIVALENT" asserted, implying acceptance for slight increase. |
| MTF @1 lp/mm | 14 x 17: 0.60817 x 17: 0.517 | 14 x 17: 0.66717 x 17: 0.706 | "The new panels have slightly better MTF," implying this improved performance is acceptable. |
| DQE (0) | 14 x 17: 0.7417 x 17: 0.68 | 14 x 17: 0.4017 x 17: 0.53 | "The new panels have slightly lower DQE," implying this reduced performance is deemed acceptable for substantial equivalence. |
| Safety/EMC | EN/IEC 60601-1, SafetyEN/IEC 60601-1-2 EMC | SAME (Tested to IEC 60601-1:2012, IEC 60601-1-2:2007) | Compliance with standards, implying acceptance. |
2. Sample size used for the test set and the data provenance
The document mentions "Clinical images were provided," but explicitly states "these images were not necessary to establish substantial equivalence based on the modifications to the device... but they provide further evidence... that the complete system works as intended."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as the clinical images were not presented as part of a formal study with ground truth established by experts for performance evaluation against a specific clinical claim. They were "further evidence" of system functionality.
4. Adjudication method for the test set
Not applicable, as no formal clinical study with ground truth and expert adjudication is described for the purpose of establishing device performance against acceptance criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an x-ray imagine acquisition device, not an AI-powered diagnostic tool. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an x-ray imagine acquisition device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no formal clinical study with ground truth for performance evaluation is described. For the non-clinical bench testing, the "ground truth" would be the physical properties and measurements of the device components themselves, following established engineering and physics principles.
8. The sample size for the training set
Not applicable. This is a hardware device (x-ray panel and system), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device, not an AI algorithm.
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November 9, 2017
Image /page/0/Picture/1 description: The image shows 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.
Imaging Dynamics Company Ltd. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K173273
Trade/Device Name: Aquarius 8600 1417WCI; Aquarius 8600 1717WCI Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 4, 2017 Received: October 12, 2017
Dear Daniel Kamm:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Oels
Robert Ochs, Ph.D. 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) K173273
Device Name
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
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) |
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- Submitter: Name -Imaging Dynamics Company Suite 130, 3510-29th Street NE Calgary, Alberta, Canada T1Y 7E5 Tel: 403.251.9939 Fax: 403.251.1771 www.imagingdynamics.com Contact - Nicole Wherry Date prepared: September 7, 2017
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- Identification of the Device: Device: Aquarius 8600 1417WCl; Aquarius 8600 1717WCI Classification Name: Stationary x-ray system Product Code: MQB Common/Usual Name: Stationary x-ray system (digital) Device Class/Regulation Number: Class II per 21 CFR 892.1680
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- Predicate Device: Manufacturer: Imaging Dynamics Company Device: Aquarius 8600 1417TC/1717TC Number: K170202 Classification Name: Stationary x-ray system Product Code: MQB Common/Usual Name: Stationary x-ray system (digital) Device Class/Regulation Number: Class II per 21 CFR 892.1680
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- Reference Device: K160810
| Trade name: | ViZion DR + Wireless |
|---|---|
| Regulation name: | Stationary x-ray system. |
| Regulation number: | 21 CFR 892.1680 |
| Product code: | MQB |
| Device class: | Class II. |
The flat panel detector integrated into the Aquarius 8600 1417WCI is identical to the flat panel detector cleared in K160810
- A description of the device: This device is a medical x-ray image acquisition device. X-rays generated by ട. X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a pc where the companion software has been installed. This software was cleared in our previous submission, K170202. A monitor displays this image. Images can then be transferred via the DICOM protocol. This device is nearly identical to the predicate but now the digital panels have Wi-Fi in addition to Ethernet interfaces. The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717WCl (tethered or wireless), 17 x 17 inch flat panel as a retrofit package with Magellan software).
Aquarius 8600 1417WCl (tethered or wireless), 14 x 17 inch flat panel as a retrofit package with Magellan software).
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IDC Recommended Generator Specifications.
Exposure is controlled manually by the user through a hand held trigger. Recommended generator specifications are provided to the user and identified below. If additional generator compatibility information is required customers will be notified to contact the Imaging Dynamics Help Desk.
| Generator | Property | Power Requirement |
|---|---|---|
| 40 kW CMP 200 DRX-ray generator | Line Voltage | 208 VAC – 5% to 230 VAC + 10%, 1 phase208 VAC – 5% to 230 VAC + 10%, 3 phase400 VAC ± 10%, 3 phase480 VAC ± 10%, 3 phase |
| Line Frequency | 50/60 Hz | |
| Momentary Current | 275 Amps at 208 VAC (1 phase)154 Amps/phase at 208 VAC (3 phase)250 Amps at 230 VAC (1 phase)139 Amps/phase at 230 VAC (3 phase)80 Amps/phase at 400 VAC65 Amps/phase at 480 VAC | |
| Nominal Current | ≤ 5 Amps | |
| Momentary Power Consumption | 55 kVA | |
| 50 kW CMP 200 DRX-ray generator | Line Voltage | 208 VAC – 5% to 230 VAC + 10%, 3 phase400 VAC ± 10%, 3 phase480 VAC ± 10%, 3 phase |
| Line Frequency | 50/60 Hz | |
| Momentary Current | 192 Amps/phase at 208 VAC174 Amps/phase at 230 VAC100 Amps/phase at 400 VAC80 Amps/phase at 480 VAC | |
| Nominal Current | ≤ 5 Amps | |
| Momentary Power Consumption | 65 kVA | |
| 65 kW CMP 200 DRX-ray generator | Line Voltage | 400 VAC ± 10%, 3 phase480 VAC ± 10%, 3 phase |
| Line Frequency | 50/60 Hz | |
| Momentary Current | 125 Amps/phase at 400 VAC105 Amps/phase at 480 VAC | |
| Nominal Current | ≤ 5 Amps | |
| Momentary Power Consumption | 85 kVA |
Indications for Use: Intended for use by a qualified/trained doctor or technologist on both adult and 6. 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. (Rx Only)
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- The Magellan 1417WCl/Magellan 1717WCl panels have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. See the comparison table below.
| Characteristic | Aquarius 8600 Aquarius 8600 1417TC/1717TCK170202Imaging Dynamics Company | Aquarius 8600 1417WCI;Aquarius 8600 1717WCIImaging Dynamics Company |
|---|---|---|
| Indications | Intended for use by a qualified/trained doctoror technologist on both adult and pediatricpatients for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body partson both adult and pediatric patients.Applications can be performed with patientsitting, standing or lying in the prone or supinepositions. Not intended for mammography.(Rx Only) | Intended for use by a qualified/trained doctor ortechnologist on both adult and pediatric patientsfor taking diagnostic radiographic exposures ofthe skull, spinal column, chest, abdomen,extremities, and other body parts on both adultand pediatric patients. Applications can beperformed with patient sitting, standing or lyingin the prone or supine positions. Not intendedfor mammography. (Rx Only)(EXACTLY THE SAME) |
| Panel Communi-cation | Tethered Gigabit Ethernet | Tethered Gigabit Ethernet orWireless via previously cleared panel (K160810) |
| Sensor Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Csl: TI | Csl: TI |
| Panel Resolution | 2816 x 3328 or 3328 x 3328 | 2304 x 2800 or 3072 x 3072 |
| Panel Size | 14x17 inches or 17 X 17 inches | 14x17 inches or 17 X 17 inches SAME |
| Pixel Size | 127 μm | 150 μm. (14x17) or 139 μm (17x17)NOT A MEANINGFUL DIFFERENCE |
| Resolution | 3.9 lp/mm | 3.59 lp/mm or 3.33 lp/mmNOT A MEANINGFUL DIFFERENCE |
| Image depth | 14 bits | 14 bits SAME |
| Preview Image | 2 seconds | Less than 3 seconds EQUIVALENT |
| Data Output | RAW *the RAW files are convertible intoDICOM 3.0 by console software | RAW *the RAW files are convertible into DICOM3.0 by console software |
| DICOM | Yes | SAME |
| Safety/EMC | EN/IEC 60601-1, SafetyEN/IEC 60601-1-2 EMC | SAME |
| OperatingEnvironment | Storage and transportationConditions: Temperature -10 to +50°CHumidity 10 to 80% | SAME |
| MTF @1 lp/mm | 14 x 17: 0.60817 x 17: 0.517 | 14 x 17: 0.66717 x 17: 0.706The new panels have slightly better MTF |
| DQE (0) | 14 x 17: 0.7417 x 17: 0.68 | 14 x 17: 0.4017 x 17: 0.53The new panels have slightly lower DQE |
| Trigger | Auto sense or manual | SAME |
| Characteristic | Aquarius 8600 Aquarius 8600 1417TC/1717TCK170202Imaging Dynamics Company | Aquarius 8600 1417WCI;Aquarius 8600 1717WCIImaging Dynamics Company |
| Power Source | 100 -250V ~ 50/60Hz 250V ~ | 100 -250V ~ 50/60Hz 250V OR RechargeableBattery |
| Photo | Image: Aquarius 8600 | Image: Aquarius 8600 |
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Comparison Conclusion:
The proposed new device has the following similarities to the predicate:
- Sensor Type a)
- c) Active Area
- d) Sensor Pixel
- e) Dimensions
- Performance characteristics. f)
- IDENTICAL Indications for Use g)
The main difference is the new proposed panels may operate wirelessly or tethered, whereas the predicate panels could only work tethered.
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- Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as integration validation and risk analysis. Bench testing for imaging characteristics such as MTF and DQE was performed in accordance with the FDA Guidance Document on Solid State Imaging Devices: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." Labeling complies with FDA guidelines.
Testing was performed in accordance with the following standards:
- Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as integration validation and risk analysis. Bench testing for imaging characteristics such as MTF and DQE was performed in accordance with the FDA Guidance Document on Solid State Imaging Devices: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." Labeling complies with FDA guidelines.
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a. IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
b. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
-
NEMA PS 3.1~PS 3.18 Digital Imaging and Communications in Medicine (DICOM)][7/31/2008] ﻥ
-
d. IEC 60601-2-54 Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy
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- IEC 62133 Secondary cells and batteries containing alkaline or other non-acid electrolytes Safety e. requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- f. Our device software and labeling has addressed cybersecurity via reference to the FDA's cybersecurity guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." It was used in the development of the device and precautions were added to the labeling.
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- Description of clinical tests. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note x-ray system that uses previously cleared detectors) but they provide further evidence in addition to bench testing data to show that the complete system works as intended.
-
- Conclusions drawn: The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
§ 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.