INNOLUX RIC

K162344 · Innolux Corporation · MQB · Dec 20, 2016 · Radiology

Device Facts

• Record ID: K162344
• Device Name: INNOLUX RIC
• Applicant: Innolux Corporation
• Product Code: MQB · Radiology
• Decision Date: Dec 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Device Story

Portable digital flat panel detector; captures X-ray exposures for diagnostic radiography. Integrates with external X-ray generator and operating PC. Supports wired/wireless data communication. Used in clinical environments (upright/recumbent exams, free cassette). Detector converts X-rays to digital signals via scintillator (Gd2O2S:Tb or CsI:Tl) and amorphous silicon (a-Si) array. Output is digital radiographic image displayed on workstation. Assists clinicians in visualizing anatomy for diagnostic decision-making. Benefits include portability and compatibility with standard radiographic workflows.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including image quality evaluation (MTF, DQE) and verification/validation of software and hardware performance per FDA guidance.

Technological Characteristics

Portable digital flat panel detector; a-Si indirect conversion; Scintillators: Gd2O2S:Tb or CsI:Tl; Pixel size: 150 μm; 16-bit acquisition; Wired/Wireless connectivity; Standards: AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366.

Indications for Use

Indicated for general projection radiographic imaging of human anatomy, including pediatric and neonatal patients. Contraindicated for mammography, fluoroscopy, tomography, and angiography.

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

• FDR D-EVO II Flat Panel Detector System (K142003)
• VIVIX-S WIRELESS (K122865)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2016

INNOLUX Corporation % Mr. Andy Kuo Director No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Park, 74147 TAIWAN (R.O.C.)

Re: K162344 Trade/Device Name: INNOLUX RIC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 23, 2016 Received: November 29, 2016

Dear Mr. Kuo:

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Ochs

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)

K162344

Device Name

INNOLUX RIC

Indications for Use (Describe)

The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

### 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 [e-mail]

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Innolux. The logo has the company name in blue and green letters on the top line, with the last letter in red. Below the company name are four Chinese characters in black.

## 510(k) Summary

## INNOLUX RIC

#### Date: November 23, 2016

### Submitter's Information:

INNOLUX Corporation No.3, Sec. 1, Huansi Rd., Tainan City, Southern Taiwan Science Park, 74147, Taiwan (R.O.C.)

### Contact Person:

| Name: | Andy Kuo |
|------------|-----------------------|
| Title: | Director |
| Telephone: | [phone] #64330 |
| Facsimile: | [phone] #65992 |

### Identification of the Device:

Proprietary/Trade Name: INNOLUX RIC Classification Name: Stationary x-ray system 21 CFR 892.1680 Regulations Number: Product Codes: MQB Device Class: Class II Review Panel: Radiology Common Name: Flat Panel Digital Detector System

### Identification of the Legally Marketed Device:

FDR D-EVO II Flat Panel Detector System. K142003 cleared 10/21/2014 VIVIX-S WIRELESS, K122865 cleared 02/01/2013

#### l. DEVICE DESCRIPTION

The INNOLUX RIC Flat Panel Detector is a portable digital detector that integrated with an operating PC and an X-ray generator to acquire and digitize x-ray exposures from, standard radiographic systems and transfer for radiography diagnostic. The INNOLUX RIC is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired data communication. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.

#### II. INDICATIONS FOR USE

The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for Innolux. The word "Innolux" is written in large, bold, sans-serif font, with each letter in a different color. Below the word "Innolux" is the company's name in Chinese characters.

#### SUBSTANTIAL EQUIVALENCE lll.

INNOLUX RIC is substantially equivalent to the following legally marketed device.

| Legally Marketed Device | 510(k) # | Clearance Date |
|-----------------------------------------|----------|----------------|
| VIVIX-S WIRELESS | K122865 | 02/01/2013 |
| FDR D-EVO II Flat Panel Detector System | K142003 | 10/21/2014 |

INNOLUX RIC and FDR D-EVOII / VIVIX-S WIRELESS are portable digital detector systems that are used to acquire x-ray exposures. The INNOLUX RIC has the same Indications for Use, and very similar functional and technical requirements as the currently-cleared predicate device, K122865 / K142003. The most detector characteristics remain unchanged for INNOLUX RIC, and the image quality is substantially equivalent to the predicate device. The design made for the INNOLUX RIC have been successfully tested and validated as summarized below.

Predicate Comparison Table:

| | Subject/Proposed Device | Predicate Device K142003,<br>DR-ID1201SE, DR-ID1202SE<br>DR-ID1211SE, DR-ID1212SE |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | RIC 35G,RIC 43G<br>RIC 35C,RIC 43C<br>The Wireless/Wired INNOLUX RIC flat panel<br>detector is intended to capture for display<br>radiographic images of human anatomy. It is<br>intended for use in general projection radiographic<br>applications including pediatric and neonatal<br>exams wherever conventional film/screen or CR<br>systems may be used. The INNOLUX RIC is not<br>intended for mammography, fluoroscopy,<br>tomography, and angiography applications. | The Wireless/Wired FDR D-EVO II flat panel<br>detector system is intended to capture for display<br>radiographic images of human anatomy. It is<br>intended for use in general projection radiographic<br>applications including pediatric and neonatal<br>exams wherever conventional film/screen or CR<br>systems may be used. The FDR D-EVO II is not<br>intended for mammography, fluoroscopy,<br>tomography, and angiography applications. |
| Scintillator | Same as K142003<br>RIC 35G, RIC 43G Gd2O2S:Tb<br>RIC 35C, RIC 43C CsI:Tl | DR-ID1201SE, DR-ID1202SE Gd2O2S:Tb<br>DR-ID1211SE, DR-ID1212SE CsI:Tl |
| X-ray<br>Conversion | Same as K142003 | Indirect conversion (a-Si) |
| Detector Cord | Same as K142003 | Wired / Wireless |
| Detector Weight | RIC 35G, RIC 35C:Approx. 6.5 lbs<br>RIC 43G, RIC 43C:Approx. 8.0 lbs | DR-ID1201SE,DR-ID1211SE : Approx.5.8 lbs<br>DR-ID1202SE,DR-ID1212SE : Approx.7.1 lbs |
| Exposure<br>size/Active Area<br>(inch) | Same as K142003<br>RIC 35G, RIC 35C:13.8x16.8<br>RIC 43G ,RIC 43C:16.8x16.7 | DR-ID1201SE, DR-ID1211SE :13.8x16.8<br>DR-ID1202SE, DR-ID1212SE :16.8x16.7 |
| Dimensions<br>(inch)<br>(Detector<br>exterior) | Same as K142003<br>RIC 35G, RIC 35C:<br>18.1(W) x 15.1(D) x 0.6 (H)<br>RIC 43G, RIC 43C:<br>18.1(W) x 18.1(D) x 0.6 (H) | DR-ID1201SE, DR-ID1211SE:<br>18.1(W) x 15.1(D) x 0.6 (H)<br>DR-ID1202SE, DR-ID1212SE:<br>18.1(W) x 18.1(D) x 0.6 (H) |
| Pixel Size | Same as K142003 | 150 μm |
| Acquisition Bit<br>Depth | Same as K142003 | 16 bit |
| DQE (RQA5, 1<br>Ip/mm, 1mR) –<br>detector alone,<br>without<br>tabletop | RIC 35G,RIC 43G<br>31%<br>Measurement tolerance (±10%)<br>RIC 35C,RIC 43C<br>54% (Csl)<br>Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE<br>30%<br>Measurement tolerance (±10%)<br>DR-ID1211SE,DR-ID1212SE<br>54% (Csl)<br>Measurement tolerance (±10%) |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Innolux. The logo is in blue, red, and green. Below the English name is the Chinese name for the company in black.

| | Subject/Proposed Device | Predicate Device K142003, |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | RIC 35G,RIC 43G | DR-ID1201SE,DR-ID1202SE |
| | RIC 35C,RIC 43C | DR-ID1211SE,DR-ID1212SE |
| MTF (RQA5, 2<br>lp/mm) | RIC 35G,RIC 43G<br>42%<br>Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE<br>42%(High mode)<br>Measurement tolerance (±10%) |
| | RIC 35C,RIC 43C<br>54%<br>Measurement tolerance (±10%) | DR-ID1211SE,DR-ID1212SE<br>54%(High mode)<br>Measurement tolerance (±10%) |
| *Standard<br>Configuration<br>Components | System requires<br>one or more RIC detectors, one or two power<br>supply unit(s), and one control unit*. | System requires<br>one FDX Console, one or more D-EVO detectors,<br>one or two power supply unit(s),<br>and one control unit*. |
| | * In order to display an image, it requires the<br>image processing unit to meet the interface<br>specification of RICMC. | *Depending on configuration, the control unit<br>software can be installed in the FDX Console<br>PC. |
| *Workstation | N/A<br>Workstation is not included in the system.<br>Same as K122865 | FDX Console Version 8.0 and above |

*The Subject device and another predicate. K122865 are not including image processing unit (console).

#### IV. SUMMARY OF STUDIES

Non-clinical Performance Data: INNOLUX RIC conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the INNOLUX RIC detectors is substantially equivalent to that of the predicate device.

Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.

#### V. CONCLUSION

Based upon the supporting data summarized above, we concluded the INNOLUX RIC is as safe and effective as the legally marketed device FDR D-EVO II (K142003) and VIVI-S WIRELESS (K122865), and do not raise different questions of safety and effectiveness than K132509 and K122865.