PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

K161966 · Perkinelmer, Inc. · MQB · Sep 8, 2016 · Radiology

Device Facts

• Record ID: K161966
• Device Name: PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
• Applicant: Perkinelmer, Inc.
• Product Code: MQB · Radiology
• Decision Date: Sep 8, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The XRpad2 4336 HWC-M, 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

The XRpad2 4336 HWC-M is a cassette-sized, flat-panel X-ray detector for digital radiography. It captures X-ray signals using an amorphous silicon active TFT/diode array with a directly deposited CsI:Tl scintillator. The device is housed in a carbon-fiber and aluminum enclosure and integrates into fixed room X-ray systems. It supports wired (GigE) or wireless (802.11n WiFi) data transmission to imaging software. The detector uses automatic exposure detection or dedicated trigger signals for synchronization. It is operated by healthcare professionals in clinical settings. The output is a digital radiographic image used by clinicians for diagnostic decision-making. The device benefits patients by enabling high-quality digital imaging in various diagnostic procedures.

Clinical Evidence

No new clinical study was performed. Substantial equivalence is supported by non-clinical bench testing, including DQE and MTF measurements, and compliance with UL and IEC standards. Clinical data from K122495 (XRD 1622 AP3 MED) was leveraged as applicable to the predicate and subject device.

Technological Characteristics

Amorphous silicon active TFT/diode array; CsI:Tl scintillator; carbon-fiber and aluminum housing; 100 μm pixel pitch; 3524 × 4288 pixel matrix; Gb Ethernet and 802.11n WiFi (5.1-5.9 GHz) connectivity; external power or battery; dimensions 460.0 mm × 383.6 mm × 15.5 mm; weight 3.1 kg. Complies with UL and IEC standards.

Indications for Use

Indicated for generating radiographic images of human anatomy for diagnostic X-ray procedures in patients requiring conventional screen-film, digital radiography, or computed radiography. Not 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

September 8, 2016

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

Re: K161966

Trade/Device Name: PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 15, 2016 Received: August 17, 2016

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/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.

Michael 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)

K161966

Device Name PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

#### Indications for Use (Describe)

The XRpad2 4336 HWC-M, 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary XRpad2 4336 HWC-M 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: K161966

August 15, 2016

| <b>Submitted By:</b> | PerkinElmer Medical Imaging 2175 Mission College Blvd. Santa Clara, CA 95054 U.S.A. | | | | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------|----------------------|-------------------------|----------------------------|-------------------------|----------------------------|-----------------|
| <b>Contact Person:</b> | Dawn Spooner Associate Director, Regulatory Affairs Tel. [phone] Fax. [phone] | | | | | | | | |
| <b>Device Name:</b> | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | | | | | | | | |
| <b>Classification:</b> | <table><tr><td>Product Code:</td><td>MQB</td></tr><tr><td>Classification Name:</td><td>Stationary X-ray System</td></tr><tr><td>Classification Regulation:</td><td>21 CFR 892.1680</td></tr></table> | Product Code: | MQB | Classification Name: | Stationary X-ray System | Classification Regulation: | 21 CFR 892.1680 | | |
| Product Code: | MQB | | | | | | | | |
| Classification Name: | Stationary X-ray System | | | | | | | | |
| Classification Regulation: | 21 CFR 892.1680 | | | | | | | | |
| <b>Predicate Device:</b> | PerkinElmer XRpad 4336 MED Flat Panel Detector | | | | | | | | |
| | <table><tr><td>510(k) Clearance:</td><td>K140551; August 1, 2014</td></tr><tr><td>Product Code:</td><td>MQB</td></tr><tr><td>Classification Name:</td><td>Stationary X-ray System</td></tr><tr><td>Classification Regulation:</td><td>21 CFR 892.1680</td></tr></table> | 510(k) Clearance: | K140551; August 1, 2014 | Product Code: | MQB | Classification Name: | Stationary X-ray System | Classification Regulation: | 21 CFR 892.1680 |
| 510(k) Clearance: | K140551; August 1, 2014 | | | | | | | | |
| Product Code: | MQB | | | | | | | | |
| Classification Name: | Stationary X-ray System | | | | | | | | |
| Classification Regulation: | 21 CFR 892.1680 | | | | | | | | |

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### Device Description:

The XRpad2 4336 HWC-M 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 460.0 mm × 383.6 mm × 15.5 mm, which fits into a standard X-ray cassette Bucky.

The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad2 4336 HWC-M:

- XRpad LBC-2 (Lithium Battery Charger) ●
- XRpad IPU-2 (Interface and Power Unit) .
- XRpad LPT2 Detector Cable ●
- XRpad Protective Insert 4336 ●
- 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. ●
- GigE Interface Cable 7.6 m/25 ft. ●
- GigE Interface Cable 15.25 m/50 ft. ●
- GigE Interface Cable 30.5 m/100 ft. .

#### Indications For Use:

The XRpad2 4336 HWC-M, 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.

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# Comparison Chart

| Characteristics | Model<br>PerkinElmer<br>XRpad 4336 MED<br>(K140551) | Proposed Model<br>PerkinElmer<br>XRpad2 4336 HWC-M |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The XRpad 4336 MED when used<br>with a radiographic imaging system,<br>is indicated for use in generating<br>radiographic images of human<br>anatomy for diagnostic X-ray<br>procedures, wherever conventional<br>screen-film (SF), digital radiography<br>(DR), or computed radiography<br>(CR) systems may be used. It is not<br>intended for mammographic use. | Same |
| Panel | Single substrate amorphous silicon<br>active TFT/diode array | Same |
| Scintillator | Direct deposition CsI:Tl | Same |
| Pixel pitch | 100 μm | Same |
| Pixel matrix | 3556 × 4320 pixels | 3524 × 4288 |
| Limiting<br>resolution | 5 lp/mm | Same |
| Binning capable | 2 × 2 binning for 200 μm | Same |
| Data transmit<br>area | 355 mm × 432 mm | 352 mm × 429 mm |
| External<br>dimensions<br>(w×l×h) | 384 mm × 460 mm × 15 mm | 384 mm × 460 mm × 15.5 mm |
| Weight | 3.8 kg | 3.1 kg |
| Housing<br>material | Aluminum with carbon-fiber | Same |
| Finish | Matte carbon-fiber front with white<br>silk-screen active area markers | Same |
| Communication<br>interface | Gb Ethernet or 802.11n WiFi | Same |
| WiFi band | 5.1-5.3 GHz | 5.1-5.9 GHz |
| X-ray<br>synchronization<br>interface | Dedicated trigger in/out signal lines<br>or Automatic Exposure Detection | Same |
| Power | External power supply or battery | Same |
| Software<br>library | Windows OS | Windows and Linux OS |

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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 XRpad2 4336 HWC-M compared to the predicate PerkinElmer XRpad 4336 MED are similar. The difference is related to updates to the housing design which results in a lighter detector and does not impact image quality.

The PerkinElmer XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M device as it was applicable for the XRpad 4336 MED device.

#### Summary of Design Control and Risk Management:

The XRpad2 4336 HWC-M flat panel X-ray detector is a modification of the XRpad 4336 MED (K140551). The modifications are related to the decrease in dimensions and do not impact image quality.

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 XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M such as DOE 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 XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M 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 XRpad2 4336 HWC-M is substantially equivalent to the currently marketed device, XRpad 4336 MED (K140551) in terms of safety and effectiveness.