(31 days)
No
The summary describes a standard digital radiography detector and does not mention any AI or ML capabilities, image processing algorithms, or performance studies related to AI/ML.
No.
The device is indicated for generating radiographic images for diagnostic procedures, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures." This explicitly indicates its role in diagnostic processes.
No
The device description explicitly states it is a "flat panel X-ray detector" and details its physical components (amorphous silicon flat panel, scintillator, electronics, 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 describes an imaging device used to visualize internal structures, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details an X-ray detector, which is a component of an imaging system. This aligns with the intended use of capturing X-ray images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to capture images of the body itself using X-rays.
N/A
Intended Use / Indications for Use
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.
Product codes
MOB
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures facing to the right. The figures are connected and appear to be in motion.
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.
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/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 (800) 638-2041 or (301) 796-7100 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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
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 XRpad 4343 F MED Flat Panel Detector |
| Classification: | 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, 2014
Product Code: MQB
Classification Name: Stationary X-ray System
Classification Regulation: 21 CFR 892.1680 |
4
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.
5
Comparison Chart
| Characteristics | Model
PerkinElmer
XRpad 4336 MED (K140551) | Proposed Model
PerkinElmer
XRpad
4343 F MED |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 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 |
| Customer
Applications | Single energy, single shot RAD in 100 µm | Same |
| Panel | Single substrate amorphous silicon active
TFT/diode array | Same |
| Scintillator | Direct deposition CsI:T1 | Same |
| Pixel matrix | 3556 × 4320 pixels | 4318 × 4320 pixels |
| Pixel pitch | 100 µm | Same |
| Limiting
resolution | 5 lp/mm | Same |
| Binning
capable | 2 × 2 binning for 200 µm | Same |
| Active area | 355 mm × 430 mm | 430 mm × 430 mm |
| External
dimensions
(w×l×h) | 384 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15 mm |
| Weight | Approximately 4 kg | Approximately 5 kg |
| Housing
material | Aluminum with carbon-fiber | Same |
| Communication
interface | Gb Ethernet or 802.11n WiFi | Gb Ethernet
No wireless capability |
| WiFi band | 5.1-5.3 GHz | None |
| X-ray
synchronization
interface | Dedicated trigger in/out signal lines or
Automatic Exposure Detection | Same |
| Power | External power supply or battery | External power supply |
| Battery
capacity | 53Wh | No battery option |
| Connector | For fixed installation | Same |
| Software | Windows OS | Same |
6
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.
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 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.