PerkinElmer, XRpad 4343 F MED Flat Panel Detector

K142698 · Perkinelmer, Inc. · MQB · Oct 23, 2014 · Radiology

Device Facts

• Record ID: K142698
• Device Name: PerkinElmer, XRpad 4343 F MED Flat Panel Detector
• Applicant: Perkinelmer, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 23, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The XRpad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

Device Story

XRpad 4343 F MED is a cassette-sized, flat panel X-ray detector for digital radiography. It captures X-ray radiation using an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator. The device integrates into fixed room X-ray systems, receiving X-ray exposure and converting it into digital image data. It is operated by radiology technicians or clinicians within a clinical setting. The detector connects to an X-ray system via cable (GigE interface) and uses dedicated electronics to process and transmit images to the X-ray unit's imaging software. Healthcare providers view these digital images to make diagnostic decisions. The device benefits patients by enabling high-quality digital radiography, replacing traditional film-based systems, and facilitating faster diagnostic workflows.

Clinical Evidence

No new clinical study was required. Substantial equivalence is supported by non-clinical performance testing (DQE, MTF) and the applicability of clinical data previously submitted for the predicate device (K140551) and its predecessor (K122495).

Technological Characteristics

Amorphous silicon flat panel with directly deposited CsI:T1 scintillator. Pixel pitch 100 µm. Active area 430 mm x 430 mm. Enclosure: carbon-fiber and aluminum. Connectivity: Gb Ethernet. X-ray synchronization via trigger lines or Automatic Exposure Detection. Complies with UL and IEC standards.

Indications for Use

Indicated for generating radiographic images of human anatomy for diagnostic X-ray procedures in patients where conventional screen-film, digital radiography, or computed radiography systems are used. Not intended for mammographic use.

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

• PerkinElmer XRpad 4336 MED Flat Panel Detector (K140551)

Reference Devices

• XRD 1622 AP3 MED (K122495)

Submission Summary (Full Text)

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

October 23, 2014

Perkin-Elmer, Inc. % Ms. Dawn Spooner Associate Director, Regulatory Affairs 940 Winter Street WALTHAM MA 02451

Re: K142698

Trade/Device Name: XRpad 4343F MED Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 22, 2014 Received: September 23, 2014

Dear Ms. Spooner:

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.

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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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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.

Smh

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K142698

Device Name

XRpad 4343 F MED

Indications for Use (Describe)

The XRoad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary XRpad 4343 F MED Flat Panel Detector

This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K142698

October 15, 2014

| Submitted By: | PerkinElmer Medical Imaging<br>2175 Mission College Blvd.<br>Santa Clara, CA 95054<br>U.S.A. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dawn Spooner<br>Associate Director, Regulatory Affairs<br>Tel. [phone]<br>Fax. [phone] |
| Device Name: | PerkinElmer XRpad 4343 F MED Flat Panel Detector |
| Classification: | Product Code: MQB<br>Classification Name: Stationary X-ray System<br>Classification Regulation: 21 CFR 892.1680 |
| Predicate Device: | PerkinElmer XRpad 4336 MED Flat Panel Detector |
| | 510(k) Clearance: K140551; August 1, 2014<br>Product Code: MQB<br>Classification Name: Stationary X-ray System<br>Classification Regulation: 21 CFR 892.1680 |

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# Device Description:

The XRpad 4343 F MED is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure.

The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um.

The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad 4343 F MED:

- XRpad IPU (Interface Power Unit) ●
- XRpad LPT Detector Cable 3 m / 10 ft. ●
- AC Cable IEC 60320 C13 DE ●
- AC Cable IEC 60320 C13 US ●
- Trigger Cable 5 m / 16.5 ft. ●
- Trigger Cable 20 m / 65.5 ft.
- XRD GigE Interface Cable 7.6 m / 25 ft. ●
- XRD GigE Interface Cable 15.25 m / 50 ft. ●
- XRD GigE Interface Cable 30.5 m / 100 ft.

The XRpad 4343 F MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures.

# Indications For Use:

The XRpad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-rav procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

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# Comparison Chart

| Characteristics | Model<br>PerkinElmer<br>XRpad 4336 MED (K140551) | Proposed Model<br>PerkinElmer<br>XRpad<br>4343 F MED |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The XRpad 4336 MED when used with a<br>radiographic imaging system, is indicated<br>for use in generating radiographic images<br>of human anatomy for diagnostic X-ray<br>procedures, wherever conventional screen-<br>film (SF), digital radiography (DR), or<br>computed radiography (CR) systems may<br>be used. It is not intended for<br>mammographic use. | Same |
| Customer<br>Applications | Single energy, single shot RAD in 100 µm | Same |
| Panel | Single substrate amorphous silicon active<br>TFT/diode array | Same |
| Scintillator | Direct deposition CsI:T1 | Same |
| Pixel matrix | 3556 × 4320 pixels | 4318 × 4320 pixels |
| Pixel pitch | 100 µm | Same |
| Limiting<br>resolution | 5 lp/mm | Same |
| Binning<br>capable | 2 × 2 binning for 200 µm | Same |
| Active area | 355 mm × 430 mm | 430 mm × 430 mm |
| External<br>dimensions<br>(w×l×h) | 384 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15 mm |
| Weight | Approximately 4 kg | Approximately 5 kg |
| Housing<br>material | Aluminum with carbon-fiber | Same |
| Communication<br>interface | Gb Ethernet or 802.11n WiFi | Gb Ethernet<br>No wireless capability |
| WiFi band | 5.1-5.3 GHz | None |
| X-ray<br>synchronization<br>interface | Dedicated trigger in/out signal lines or<br>Automatic Exposure Detection | Same |
| Power | External power supply or battery | External power supply |
| Battery<br>capacity | 53Wh | No battery option |
| Connector | For fixed installation | Same |
| Software | Windows OS | Same |

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### Summary of Studies:

The proposed new device and the XRpad predicate device utilize similar technology and materials, are similar in design and construction, and have the same intended use. The construction and physical characteristics of the PerkinElmer XRpad 4343 F MED compared to the predicate PerkinElmer XRpad 4336 MED are similar. The difference is related to the increase in dimensions and does not impact image quality.

The PerkinElmer XRpad 4343 F MED flat panel detector has successfully completed internal non-clinical testing, complies with standards and regulations such as UL and IEC. A new clinical study was not required for the XRpad 4343 MED device. The predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED) and applicable to the predicate device. The XRpad 4343 MED device differences do not invalidate the applicability of the clinical study data submitted in K122495. Through non-clinical testing, we have demonstrated the clinical data collected with the (XRD 1622 AP3 MED) in K122495 is also applicable to the XRpad 4343 MED device as it was applicable for the XRpad 4336 MED device.

### Summary of Design Control and Risk Management:

The XRpad 4343 F MED flat panel X-ray detector is a modification of the XRpad 4336 MED (K140551). The 43 cm × 43 cm XRpad 4343 F MED, as compared to the 43 cm × 36 cm XRpad 4336 MED, is larger in one dimension, is heavier, and does not have a battery, or wireless capability.

The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.

### Summary of Non-Clinical Data:

To demonstrate the equivalence of the PerkinElmer XRpad 4343 F MED to the predicate device, PerkinElmer has performed internal non-clinical testing and demonstrated compliance with accepted standards and regulations such as UL and IEC following the non-clinical considerations outlined in the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, August, 1999. The non-clinical testing was conducted and demonstrated the main physical values of the XRpad 4343 F MED such as DQE and MTF are comparable to the predicate device. The non-clinical performance testing conducted and resulting data demonstrate substantial equivalence.

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## Substantial Equivalency:

The proposed device and predicate device (XRpad 4336 MED flat panel detector) both utilize similar technology and materials, are similar in design and construction, and have been shown to produce images of equivalent diagnostic quality. Both devices are intended for use in generating radiographic images of human anatomy for diagnostic Xray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. The devices are not intended for mammographic use. Both devices produce digital images which can be transmitted to imaging software of the X-ray unit.

### Conclusion:

Similar to the predicate device, the XRpad 4343 F MED has comparable performance and operational standards. Potential hazards have been studied and controlled by a Risk Management Plan. The non-clinical software verification and validation test results demonstrate that the PerkinElmer XRpad 4343 F MED complies with international and FDA recognized consensus standards and meets the acceptance criteria and is adequate for its intended use.

Based on the information supplied in this 510(k) PerkinElmer concludes, the XRpad 4343 F MED is substantially equivalent to the currently marketed device. XRpad 4336 MED (K140551) in terms of safety and effectiveness.