(52 days)
XRD 1622 AP3 MED K122495
No
The summary describes a standard digital X-ray detector and does not mention any AI/ML capabilities, image processing features, or performance metrics typically associated with AI/ML algorithms.
No
The device is indicated for generating diagnostic images, not for treating any condition or disease.
Yes
The device is indicated for use in "generating radiographic images of human anatomy for diagnostic X-ray procedures." The phrase "diagnostic X-ray procedures" directly implies the images are used for diagnosis.
No
The device description explicitly states it is a "flat panel X-ray detector" consisting of physical components like an amorphous silicon flat panel, scintillator, electronics, and an enclosure. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy for diagnostic X-ray procedures." This involves imaging the body directly, not testing samples taken from the body (which is the core of in vitro diagnostics).
- Device Description: The description details an X-ray detector, which is a component of an imaging system used to capture images of internal structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device is a component of a medical imaging system used for diagnostic purposes, but it operates in vivo (within the living body) by capturing X-rays that pass through the patient. IVD devices operate in vitro (outside the living body) by analyzing samples like blood, urine, or tissue.
N/A
Intended Use / 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.
Product codes
MOB, MQB
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
PerkinElmer XRpad 4336 MED Flat Panel Detector K140551
Reference Device(s)
XRD 1622 AP3 MED K122495
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
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.
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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
| Submitted By: | PerkinElmer Medical Imaging 2175 Mission College Blvd. Santa Clara, CA 95054 U.S.A. | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Contact Person: | Dawn Spooner Associate Director, Regulatory Affairs Tel. 781-663-6071 Fax. 781-663-5969 | ||||||||
| Device Name: | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | ||||||||
| Classification: | Product Code:MQBClassification Name:Stationary X-ray SystemClassification Regulation:21 CFR 892.1680 | 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 | ||||||||
| Predicate Device: | PerkinElmer XRpad 4336 MED Flat Panel Detector | ||||||||
| 510(k) Clearance:K140551; August 1, 2014Product Code:MQBClassification Name:Stationary X-ray SystemClassification 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 | |
| 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.
5
Comparison Chart
| Characteristics | Model
PerkinElmer
XRpad 4336 MED
(K140551) | Proposed Model
PerkinElmer
XRpad2 4336 HWC-M |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Intended Use /
Indications for
Use | The XRpad 4336 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. | Same |
| Panel | Single substrate amorphous silicon
active TFT/diode array | Same |
| Scintillator | Direct deposition CsI:Tl | Same |
| Pixel pitch | 100 μm | Same |
| Pixel matrix | 3556 × 4320 pixels | 3524 × 4288 |
| Limiting
resolution | 5 lp/mm | Same |
| Binning capable | 2 × 2 binning for 200 μm | Same |
| Data transmit
area | 355 mm × 432 mm | 352 mm × 429 mm |
| External
dimensions
(w×l×h) | 384 mm × 460 mm × 15 mm | 384 mm × 460 mm × 15.5 mm |
| Weight | 3.8 kg | 3.1 kg |
| Housing
material | Aluminum with carbon-fiber | Same |
| Finish | Matte carbon-fiber front with white
silk-screen active area markers | Same |
| Communication
interface | Gb Ethernet or 802.11n WiFi | Same |
| WiFi band | 5.1-5.3 GHz | 5.1-5.9 GHz |
| X-ray
synchronization
interface | Dedicated trigger in/out signal lines
or Automatic Exposure Detection | Same |
| Power | External power supply or battery | Same |
| Software
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.
7
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.