Aquarius 8600 1417WC

K171175 · Imaging Dynamics Company , Ltd. · MQB · Oct 5, 2017 · Radiology

Device Facts

• Record ID: K171175
• Device Name: Aquarius 8600 1417WC
• Applicant: Imaging Dynamics Company , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Digital flat panel X-ray detector (tethered/wireless) captures X-ray signals using a scintillator coupled with an a-Si TFT sensor; converts X-rays into digital RAW files. Used in clinical settings (upright stands, tables) by physicians or technologists. Magellan software processes RAW files into DICOM 3.0 images for review, storage, and transmission. Device replaces film/screen-based systems; provides immediate diagnostic images to support clinical decision-making; benefits patients through reduced radiation exposure and faster imaging workflows.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing including DQE, MTF, and NPS comparisons against the predicate, and phantom image review by a certified Radiological Technologist.

Technological Characteristics

Solid-state digital flat panel detector; Amorphous Silicon (a-Si) TFT sensor; CsI:Tl scintillator; 14x17 inch imaging area; 127 um pixel pitch; 14/16-bit A/D conversion; tethered/wireless connectivity; DICOM 3.0 compliant; IEC 60601-1 and IEC 60601-1-2 compliant.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, and extremities. Contraindicated for mammography.

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

• Aquarius 8600 1717TC Digital Radiographic Detector (K170202)

Reference Devices

• Digital Flat Panel X-Ray Detector, 1417WCC (K141566)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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: [phone] Fax: [phone] 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 |

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# 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.

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# 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<br>Aquarius 8600 1417WC | Predicate IDC<br>Aquarius 8600 1717TC |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: Proposed IDC Aquarius 8600 1417WC | Image: Predicate IDC Aquarius 8600 1717TC |
| IDC<br>510(k) number | K171175 | K170202 |
| Reference Device<br>510(k) # | K141566 | K141566 |
| Intended Us<br>(No change<br>between subject<br>and predicate<br>devices) | Aquarius 8600 1417WC Digital Flat<br>Panel X-Ray Detector is indicated for<br>digital imaging solutions designed for<br>general radiographic systems for human<br>anatomy. It is intended to replace film or<br>screen based radiographic systems in all<br>general purpose diagnostic procedures.<br>Not to be used for mammography. | Aquarius 8600 1717TC Digital Flat<br>Panel X-Ray Detector is indicated for<br>digital imaging solutions designed for<br>general radiographic systems for human<br>anatomy. It is intended to replace film or<br>screen based radiographic systems in all<br>general purpose diagnostic procedures.<br>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 | < 2 seconds | < 2 seconds |
| Data Output | RAW<br>*the RAW files are convertible into<br>DICOM 3.0 by console software. | RAW<br>*the RAW files are convertible into<br>DICOM 3.0 by console software. |
| Firmware | The Firmware provided with the flat<br>panel will be utilized in this medical<br>device without modification and has the<br>same functionality as the IDC 8600<br>1717TC | The Firmware provided with the flat<br>panel is utilized in this medical device<br>without modification |
| Software | IDC Magellan 3 is a software program<br>that uses the latest digital imaging and<br>processing techniques to acquire, store,<br>retrieve, transmit, and print medical<br>images for immediate review and<br>disposition.<br>DICOM 3.0 compliant. | IDC Magellan 3 is a software program<br>that uses the latest digital imaging and<br>processing techniques to acquire, store,<br>retrieve, transmit, and print medical<br>images for immediate review and<br>disposition.<br>DICOM 3.0 compliant. |
| Dimensions | 384 x 460 x 15 mm | 460 x 460 x 15.5 mm |

Table 1: Comparison of the Aquarius 8600 1417WC with the Aquarius 8600 1717TC Predicate

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# Page 4 of 9

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| Weight | 3.0 kg (including battery) | 4.0 kg |
|-------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Application | General Radiology system<br>Use with upright stand, table,<br>universal stand. | General Radiology system<br>Use with upright stand, table, universal<br>stand. |
| Storage and<br>Transportation | Storage and transportation<br>Conditions:<br>Temperature -10 to +50°C Humidity<br>10 to 80% | Storage and transportation Conditions:<br>Temperature -10 to +50°C Humidity 10 to<br>80% |

### Page 5 of 9

* Compliance to NEMA PS 3.1-3.20 "Digital Imaging and Communications in Medicine (DICOM) Set

# Key Technology Differences:

- A. Wireless Technology: the predicate IDC Aquarius 8600 1717TC is a tethered digital flat panel imaging detector and the proposed Aquarius 8600 1417WC is a digital flat panel imaging detector that can be used in either a tethered or wireless mode.
Risk management activities are based on ISO 14971:2007 "Medical Devices – Application of Risk Management to Medical Devices". As identified in the IDC FMEA Risk Assessment, the Aquarius 8600 1417WC has similar safety risks when compared to the predicate Aquarius 8600 1717TC device.

The tethered and wireless options for the proposed Aquarius 8600 1417WC device do not affect device performance.

- B. Software: IDC Magellan 3 software was integrated for use on the proposed Aquarius 8600 1417WC digital flat panel imaging detector. The operating system for the proposed Aquarius 8600 1417WC digital flat panel imaging detector is identical to the predicate Aquarius 8600 1717TC device. IDC will supply the workstation and software with the medical device proposed in this 510(k) application.
No changes were made to the previously cleared 1417WCC reference medical device and associated firmware for the proposed Aquarius 8600 1417WC medical device.

No changes were made to the IDC Magellan 3 software for integration with the previously cleared Aquarius 8600 1717TC flat panel for the proposed Aquarius 8600 1417WC medical device. As regular software maintenance was performed, full system level verification, validation and regression testing was performed.

No changes have been made to the IDC Magellan 3 software for integration with potential wireless technology.

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# Page 6 of 9

# IDC Recommended Generator Specifications.

Exposure is controlled manually by the user through a hand held trigger connected to the generator. 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 DR<br>X-ray generator | Line Voltage | 208 VAC - 5% to 230 VAC + 10%, 1 phase<br>208 VAC - 5% to 230 VAC + 10%, 3 phase<br>400 VAC ± 10%, 3 phase<br>480 VAC ± 10%, 3 phase |
| | Line Frequency | 50/60 Hz |
| | Momentary Current | 275 Amps at 208 VAC (1 phase)<br>154 Amps/phase at 208 VAC (3 phase)<br>250 Amps at 230 VAC (1 phase)<br>139 Amps/phase at 230 VAC (3 phase)<br>80 Amps/phase at 400 VAC<br>65 Amps/phase at 480 VAC |
| | Nominal Current | ≤ 5 Amps |
| | Momentary Power Consumption | 55 kVA |
| | 50 kW CMP 200 DR<br>X-ray generator | Line Voltage |
| Line Frequency | | 50/60 Hz |
| Momentary Current | | 192 Amps/phase at 208 VAC<br>174 Amps/phase at 230 VAC<br>100 Amps/phase at 400 VAC<br>80 Amps/phase at 480 VAC |
| Nominal Current | | ≤ 5 Amps |
| Momentary Power Consumption | | 65 kVA |
| 65 kW CMP 200 DR<br>X-ray generator | Line Voltage | 400 VAC ± 10%, 3 phase<br>480 VAC ± 10%, 3 phase |
| | Line Frequency | 50/60 Hz |
| | Momentary Current | 125 Amps/phase at 400 VAC<br>105 Amps/phase at 480 VAC |
| | Nominal Current | ≤ 5 Amps |
| | Momentary Power Consumption | 85 kVA |

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# Page 7 of 9

#### 7. Summary of Safety and Performance Testing 21 CFR 807.92(b)

## Non-Clinical Test Summary:

The results of the non-clinical studies demonstrate the Aquarius 8600 1417WC is substantially equivalent to the predicate device. Aquarius 8600 1717TC. 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).
# Detective Quantum Efficiency Comparison:

A comparison of measured DQE curves show that the proposed Aquarius 8600 1417WC detector has similar DQE performance at all spatial frequencies to the predicate Aquarius 8600 1717TC detector.

| | Aquarius 8600 1417WC | Aquarius 8600 1717TC |
|---------|----------------------|----------------------|
| DQE (0) | 0.817 | 0.684 |

# Modulation Transfer Function:

A comparison of measured MTF curves show that the Aquarius 8600 1417WC detector has the same or better resolution performance than the predicate Aquarius 8600 1717TC detector at all spatial frequencies.

| Spatial Frequency | MTF Value | |
|-------------------|----------------------|----------------------|
| | Aquarius 8600 1417WC | Aquarius 8600 1717TC |
| 1 lp/mm | 0.557 | 0.517 |
| 2 lp/mm | 0.280 | 0.230 |
| 3 lp/mm | 0.157 | 0.123 |
| 3.5 lp/mm | 0.118 | 0.088 |

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# Page 8 of 9

# Noise Power Spectrum:

A comparison of measured NPS curves show that the Aquarius 8600 1417WC detector has a similar noise performance profile at spatial frequencies as the predicate Aquarius 8600 1717TC detector.

| Spatial Frequency | NPS Value | |
|-------------------|----------------------|----------------------|
| | Aquarius 8600 1417WC | Aquarius 8600 1717TC |
| 0 lp/mm | 19.15 | 8.01 |
| 1 lp/mm | 7.39 | 3.30 |
| 2 lp/mm | 2.29 | 1.27 |
| 3 lp/mm | 1.01 | 0.64 |
| 3.5 lp/mm | 0.78 | 0.58 |

- B. 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.
- 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 Aquarius 8600 1417WC is substantially equivalent to the Aquarius 8600 1717TC 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 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. 8-8

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# Page 9 of 9

#### 8. Conclusion:

The Aquarius 8600 1417WC medical device has identical indications for use, and similar technological characteristics as the Aquarius 8600 1717TC predicate device.

The detector components for the Aquarius 8600 1417WC are identical to the detector components listed as the reference device (cleared separately in K141566), and employs the same firmware and software as the Aquarius 8600 1717TC predicate device.

The Aquarius 8600 1417WC device has similar weight and dimensions as the predicate IDC Aquarius 8600 1717TC device.

The proposed Aquarius 8600 1417WC detector conform to US Performance Standards and are UL listed to US Standards for safety for medical devices.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of IDC that the Aquarius 8600 1417WC is substantially equivalent in comparison with the IDC Aquarius 8600 1717TC predicate device as described herein.