(150 days)
No
The summary describes a flat panel X-ray detector and its technical specifications. There is no mention of AI, ML, or any related image processing or analysis capabilities that would typically involve such technologies. The focus is on the hardware and its integration into existing X-ray systems.
No
This device is used for generating radiographic images for diagnostic X-ray procedures. It is not treating a condition.
Yes.
The device is used to generate radiographic images for "diagnostic X-ray procedures."
No
The device description explicitly details hardware components like an amorphous silicon panel, scintillator, and physical dimensions, indicating it is a hardware device.
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 internal structure of the body using X-rays.
- Device Description: The description details a flat panel X-ray detector that captures X-ray images.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not interact with or analyze such specimens.
The device is a component of a medical imaging system used for in-vivo (within the living body) diagnostic procedures, not in-vitro (outside the living body) diagnostic procedures.
N/A
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.
Product codes
MOB
Device Description
The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator.
The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.
The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad 4336 MED
- XRpad™ LBP (Lithium Battery Pack)
- XRpadTM LBC (Lithium Battery Charger)
- XRpad™ IPU (Interface Power Unit)
- XRpad™ LPT Detector Cable, 3m/100ft
- . XRpad™ Protective Insert
- . XRpad™ 4336 Connector Cover Set
- Trigger cable (in lengths of 5 m or 20 m)
- GigE interface cable (in lengths of 7.6 m. 15.25 m. or 30.5 m) .
The XRpad 4336 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. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.
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 XRpad 4336 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during PreSubmission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
PerkinElmer, Inc. % Ms. Dawn Spooner Associate Director, Regulatory Affairs 940 Winter Street WALTHAM MA 02451
Re: K140551
Trade/Device Name: Perkinelmer. XRpad 4336 MED Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 05, 2014 Received: May 06, 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 (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.7)
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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Indications for Use
510(k) Number (if known)
Device Name
XRpad 4336 MED
Indications for Use (Describe)
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.
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)
FDA
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510k Summary
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 K140551
August 1, 2014
| Submitted by: | PerkinElmer Medical Imaging
2175 Mission College Blvd.
Santa Clara, CA 95054 |
|-----------------------------|------------------------------------------------------------------------------------|
| Contact Person:
Primary: | Dawn Spooner
Tel. 781-663-6071
Fax. 781-663-5969 |
| Trade Name: | PerkinElmer XRpad 4336 MED Flat Panel Detector |
| Common Name:
Regulation: | Stationary X-ray system (21 CFR 892.1680) |
| Classification Name: | Stationary X-ray system |
| Classification: | 90 Radiology |
| Product Code: | (MQB) |
| Predicate device: | XRD 1622 AP3 MED X-ray system (Flat Panel Detector in
system) [K122495] |
Device Description:
The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator.
The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.
4
The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad 4336 MED
- XRpad™ LBP (Lithium Battery Pack) ●
- XRpadTM LBC (Lithium Battery Charger) ●
- XRpad™ IPU (Interface Power Unit) ●
- XRpad™ LPT Detector Cable, 3m/100ft ●
- . XRpad™ Protective Insert
- . XRpad™ 4336 Connector Cover Set
- Trigger cable (in lengths of 5 m or 20 m) ●
- GigE interface cable (in lengths of 7.6 m. 15.25 m. or 30.5 m) .
The XRpad 4336 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. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.
Intended 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.
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Comparison Chart:
Comparison of the XRpad 4336 MED device with its predicate.
| Characteristics | Proposed device
PerkinElmer XRpad
4336 MED | Predicate device
(K122495)
PerkinElmer XRD
1622 AP3 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 |
| Panel | Single substrate amorphous silicon active
TFT/diode array | Same |
| Scintillator | Direct deposition CsI:Tl | Same |
| Pixel matrix | 3556 × 4320 pixels | 2048 × 2048 pixels |
| Pixel pitch | 100 μm | 200 μm |
| Active area | 355 mm × 432 mm | 409 mm × 409 mm |
| External dimensions
(w×l×h) | 384 mm × 460 mm × 15 mm | 500 mm × 560 mm ×
22 mm |
| Weight | Approximately 4 kg | Approximately 9 kg |
| Housing material | Aluminum with carbon-fiber | Aluminum |
| Communication interface | Gb Ethernet or 802.11n WiFi | Gb Ethernet |
| Power | External power supply or battery | External power
supply |
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Summary of Studies:
The PerkinElmer XRpad 4336 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during PreSubmission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.
Substantial Equivalency:
The proposed device and predicate device (XRD 1622 AP3 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 X-ray procedures, wherever conventional screenfilm (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:
The PerkinElmer XRpad 4336 MED is substantially equivalent to the PerkinElmer XRD 1622 AP3 MED (K122495) flat panel detector predicate device.