SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW

K013897 · Bio-Scan S.A · MQB · May 21, 2002 · Radiology

Device Facts

• Record ID: K013897
• Device Name: SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
• Applicant: Bio-Scan S.A
• Product Code: MQB · Radiology
• Decision Date: May 21, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

Models IRIS 20 or IRIS 41 SSXI detector combined with IRIS-View Image Acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.

Device Story

IRIS 20/41 are solid-state X-ray imagers (SSXI) for radiotherapy portal imaging. System consists of a flat-panel detector (amorphous silicon thin-film transistor photodiode array with Gd2O2S(Tb) luminescent screen) and IRIS-View PC-based console. Detector captures X-ray beam (up to 30 MeV) during treatment; converts to digital signal; transmits to console. Console software processes data for display on standard PC monitor; enables image archiving in DICOM format. Used in radiation oncology clinics; operated by radiation therapists/physicists. Provides real-time visualization of treatment field; replaces conventional film; allows windowing/leveling for improved assessment of target organ lesions; enhances clinical decision-making regarding patient positioning and treatment accuracy.

Clinical Evidence

Clinical study conducted at University of Pennsylvania with 30 patients undergoing radiation therapy. Comparison of IRIS SSXI images vs. conventional X-ray film. 7 specialists in radiation oncology evaluated images. Results: 90% of IRIS images rated better than film; 10% rated equivalent; 0% rated poorer. Study supports clinical effectiveness for portal imaging.

Technological Characteristics

Flat panel X-ray detector; Gd2O2S(Tb) luminescent screen; Amorphous Silicon Thin Film Transistor Photodiode Integrating Storage Matrix Array. Dimensions: IRIS 20 (26x53x7cm), IRIS 41 (69.2x59.9x5cm). Connectivity: PC card interface, DICOM III standard. Power: 110/230VAC. Software: Windows-based image processing. Regulatory: Class II, Product Code 90 MQB.

Indications for Use

Indicated for patients undergoing radiation therapy requiring portal imaging. Used in conjunction with medical accelerator radiotherapy devices as an alternative to conventional portal film.

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

• Generic X-Ray film/screen (preamendment device)

Submission Summary (Full Text)

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K01389/s/

January 15, 2002

MAY 2 1 2002

**Bio-Scan**

— See life in real-time

# SUMMARY of SAFETY and EFFECTIVENESS

#### I. GENERAL INFORMATION PER 21 CFR 807.87

| Device Classification Name: | Solid State X-Ray Imager (flat panel/digital imager) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submission Type: | New Device |
| Regulation Number: | 892.1650 |
| 510(k) Number: | K013897 filed on November 26, 2001 |
| Device Names: | <i>IRIS 20</i> , <i>IRIS 41</i> , <i>IRIS-View</i> |
| Device Product Code | 90 MQB |
| Device Classification: | Class II, per FDA guidance for the submission of<br>510(k) 's for Solid State Imaging Devices, FDA, CDRH,<br>ODE issue date August 6, 1999 |
| Predicate Device: | Generic X-Ray film/screen (a preamendment device) |
| Registration Action: | Device Listing Document Number 103059 for <i>IRIS</i><br>Device Models submitted to FDA, CDRH, Information<br>Processing and Office Automation Branch (HFZ-308)<br>was filed on 07/24/2001 |
| Applicant: | Bio-Scan SA |
| Manufacturer's Address: | Bio-scan SA,<br>Pre Bouview 27,<br>CH-1217 Meyrin/Geneva, Switzerland |
| United States Contact: | Richard M. Sano<br>Consultant to Bio-Scan SA<br>153 Sanford Lane,<br>Stamford, Connecticut 06905<br>Phone: [phone]<br>Page Number: 917-424-0330<br>FAX: [phone]<br>E-mail: [e-mail] |
| Proposed Labeling: | Operators Manual, Preliminary Product Data Sheets,<br>CE, ISO, and EN Labels are included in the abbreviated<br>510(k) submission |

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#### II. DEVICE DESCRIPTION

### IRIS SOLID STATE X-RAY IMAGER RECTANGULAR SSXI FLAT PANEL X-RAY TRANSDUCER

Applicable elements contained in FDA guidance for the submission of 5100x) 's for Solid State Imaging Devices, FDA, CDRH, ODE issue date August 6, 1999

Indications for Use.

Models IRIS 20 or IRIS 41 SSXI detector combined with IRIS-View Image Acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.

### Detectors

The IRIS flat panel X-ray detector is available in two sizes, 20 x 20 cm (IRIS 20) and 41 x 41 cm (IRIS 41), with an Element Matrix of 256 x 256 and 1024 x 1024 respectively. X-rays are converted to light using a Gd202S(Tb) opto-mechanical luminescent screen coupled to an Amorphous Silicon Thin Transistor Photodiode Integrating Storage Matrix Array.

### Viewing Console

The IRIS-View console accepts the digital signals from the detectors through a PC card interface into a standard PC with a Microsoft Windows operating system. Software processing of the data is applied to enhance the visibility of the viewed image seen on a standard PC Color Monitor.

#### REGULATORY REQUIREMENTS III.

Under MDA, the IRIS Device in this abbreviated 510(k) submission is being shown to be substantially equivalent to a legally marketed predicate device, Generic X-ray film/screen (a preamendment device). Even though the preamendment device is exempt from 510(k) requirements, FDA guidance for the submission of 510(k) 's for Solid State Imaging Devices, FDA, CDRH, ODE issue date August 6, 1999, assigns a classification of Class II and a Product Code "90 MQB" for these SSXI devices.

#### IV. NONCLINICAL CONSIDERATIONS

A. Physical Characteristics:

- 1. Overall Dimension: IRIS 20, 26 x 53 x 7 cm. IRIS 41, 69.2 x 59.9 x 5 cm
- 2 Active Area: IRIS 20, 192 x 192 mm. IRIS 41 409.6 x 409.6mm
- 3 Matrix : IRIS 20, 256 x 256 (750 x 750um), IRIS 41, 1024 x 1024 (400 x 400μm)
- 4 Fill Factor: 80%
- 5 Drawings: Cutaway of the SSXI panel, System Components and Connections
- 6 Power: 110vac ±10% 60 cycle or 230vac ±10% 50 cycle

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- B. Operational Functions:
- 1. Exposure Characteristics: There is no physical or electrical control of the Medical Accelerator possible through any manual or automatic IRIS or IRIS-View control interactions. The Medical Accelerator which is used with IRIS is not manufactured or marketed by Bio-Scan SA. When used in conjunction with a Medical Accelerator, the IRIS device is as passive as X-ray film, and does not control output of Energy from the Medical Accelerator Device.

Frame rate: Typically single static images, IRIS is not intended for fluoroscopic applications

Dynamic Mode: dependent on field of view, from 10 fps for 10 x 10cm partial area to 4 fps for 41 x 41cm

Integration time: 285mecs to 10,000msec (user selected)

- 2. X-ray Absorber: 25mm thick aluminum absorber
Detection properties: Up to 30 MeV accelerator beam source Measured linear from 50kV to 117kV

- Energy Conversion: Gd2O2S(Tb) opto-mechanical luminescent screen 3.
- 4. Readout Mechanism: Amorphous Silicon Thin Film Transistor Photodiode Integrating Storage Matrix Array, 35us signal charge transfer time, minimum integration time 285msec
- Output Signal: Internal between SSXI Detector and IRIS-View PC Computer ర్ is 16 bit intensity data and serial matrix addressing output signal for images into a network or onto CD-R or CD-RW are DICOM III standard format. (Bitmap format is also available for standard PC graphic presentation archiving)
- C. Functional Characteristics:
- No video Signal output, Output to Monitor is SVGA PC display standard 1.
- DQE: over 65% at 0.3 mm 1 frequency for 10μGy exposure 2.
- 3. SNR: proportional to square root of exposure, SNR vs. Entrance Kerma is measured and graph submitted from 0 to 25 µGy for 50kV to 117kV showing SNR from 25 to 275
- MTF: measured and graph submitted from 0.1 to 1.275mm1 frequency 4. showing MTF from 0.98 to 0.01
- ડ. Aliasing: Matrix doubling algorithm is utilized to eliminate aliasing
- Dynamic Range: Slice Profile of a 45° wedge filter image shows input energy 6. from 18MeV vs. 16 bit digital intensity output. Dose Response is plotted from 0 uGy to 40 uGy for 50 to 117 kV, showing linear response from 0 to 65,535 intensity units.
- 7. Lag Time: Lag time includes 35usec signal charge transfer and reset to zero
- Underscanning: Field of View is user selected from the IRIS-View Console 8.

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- 9. X-ray Beam Alignment: Equipment installation function, Detector is mounted in alignment directly behind X-ray film cassette housing on the Medical Linear Accelerator Arm.
- 10. Pixel Defects: up to 5% may be noisy or inefficient and are ignored by a calibration protocol. These defects are corrected by adjacent pixel averaging algorithm
- 11. Device Ready: After one hour after power turn-on, IRIS Device is "Ready" and after an exposure in 280 msec the IRIS Device can acquire another image.
- 12. Latent image: Part of the readout cycle is the reset to zero. After 35 usec, the integrator is reset to zero with in a few milliseconds. A time of 280 msec total is set before a new integration
- D. Exposure Characteristics:
- 1. Dose Requirement: Acceptable SNR or 100 can be achieved at Entrance Air Kerma of 2uGy from 50 to 117kV
- Stability: After one hour of power on, the IRIS system is stable. 2
- 3. Uniformity: Weekly Quality assurance protocol produces a calibration matrix, which corrects for any non uniformity of the gain of individual pixels and also corrects for X-Ray beam non uniformities.
- 4. Frame Rate: This device is not indicated for Fluoroscopic applications.
- 5. Reuse Rate: Serial static images can be acquired from 4 fps to 10 fps depending on field of view selected. The limitation is related to readout rate from the photosensors.
- V. SAFETY
- A. Ready Indicator: An indicator with the word "READY" is seen on the monitor when the system is prepared to accept and process an X-ray input
- B. Passive System: The IRIS detector is passive as is x-ray film, and does not control the x-ray beam or movements of the Therapy accelerator. Bio-Scan does not manufacturer or distribute the Medical Accelerator Therapy devices.
- C. Leakage Currents: The detector is mounted under the treatment table and not in contact with the patient. However, as with UL testing. conformity with all provisions of the directive 93/42/EEC certifies through testing by an authorized body that the system passes ISO 13485/EN46001 Quality system for medical devices.
- D. RF Emissions: The FCC Class A Verification testing by an authorized body was performed to assure that EMC emissions are within levels that do not interfere with other devices.

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## VI. CLINICAL CONSIDERATIONS - EFFECTIVENESS

- A. Concurrence Effectiveness Study: A clinical trial under Local IRB approval was sponsored and conducted by University of Pennsylvania Radiation Oncology Department, Division of Medical Physics with 30 patients scheduled to undergo radiation therapy. A table of reader responses was developed comparing the results from x-ray film with simultaneously acquired IRIS SSXI Images. Reading was done by specialists in the radiation treatment of the specific target organ lesions to be irradiated.
- B. Effectiveness Results:
- 1. In no situation was any quality of the Bio-Scan Image rated of poorer quality than the X-ray film image
- 2. In 27 out of 30 comparison images, the Bio-Scan Images were rated better than the X-ray images
- 3. In three out of the total of 30 image comparisons by 7 physicians, the rating was considered equivalent
- C. Effectiveness Conclusion: Physicians with expertise in the Speciality of Radiation Oncology for the target organ, rated the Bio-Scan IRIS results better in 90% of the comparison images or equivalent in 10% of the studies to the practice standard used, X-ray film/screen cassette acquired images.
- D. Sample Images: Copies of all 60 comparative images are printed in the submission and samples of films are provided in the submission. Copies of the IRIS images are provided in CD for review as bitmap images.
- E. Other findings: Written comments by Oncology readers of the comparative images
- 1. "Windowing (on IRIS-View) allows much more dynamic range so that each aspect of the assessment can be individually optimized."
- 2. "Increased dynamic range (of IRIS) helps assessment"
- 3. "Table edge interferes with assessment of both modalities (IRIS and film)."
- "Film assessment is very difficult. Very simple with IRIS." র্ব
- "Study is good, but technique not as good as other films (study # 9010)." న్న

## VII. LABELING

Indication for use, promotional PowerPoint presentation, promotional product data sheets, user manual, installation instructions, and scientific papers (bibliography) are provided in this submission.

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## VIII. QUALITY ASSURANCE PROGRAM

The ISO 9001 "Quality Documentation including the CE 0120 "Quality Manual Master File" is available on-site for inspection. Upon request, a copy can be made and submitted for review by FDA ODE.

The declaration of Conformity is included in the submission per directive 93/42 CE:

| 0 | ISO 9001 | Quality system |
|--------------------------|--------------------|----------------------------------------------------------------------------------|
| 0 | ISO 13585/EN 46001 | Quality system, medical devices |
| ロ | EN 1441 | Risk Analysis |
| 0 | EN1041 | Information supplied by the manufacturer with<br>medical devices |
| 0 | CEI 61223-3-1 | Evaluation & routine testing in |
| ם | CEI 61 223-3-3 | medical imaging departments |
| D | EN 980 | Graphical Symbol for use in the labeling of medical<br>devices |
| D | EN 540 | Clinical investigation of medical devices for human<br>subjects |
| 0 | EN 60601 | Electromagnetic Compatibility (FCC Class A) |
| 0 | EN 60950-A4 | Safety on information technology equipment |
| The Testing was done by: | | SGS Yarsley International Certification Services Ltd<br>as Notified Body CE 0120 |
| | | INTERTest Systems, GMBH, international<br>Zulassungen und Testsysteme |

Copies of the Certificates of Compliance are included in the submission.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Bio-Scan, SA % Mr. Richard M. Sano, Consultant Columbia University The Neurological Institute Mail Box #48 710 West 168th Street NEW YORK NY 10032

AUG 23 2013

Re: K013897

Trade/Device Name: Solid State X-Ray Imaging Systems (IRIS) Model 20 & 41 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and LHN Dated: February 16, 2002 Received: February 20, 2002

Dear Mr. Sano:

This letter corrects our substantially equivalent letter of May 21, 2002.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (it known): Kll13897

Devica Namo:_IRIS 20 and 41 with IRIS-View

Models IRIS 20 or IRIS 41 SSX1 detector combined with IRIS-View Indications For Use: image acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.

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