(104 days)
The XRD 1622 AP3 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.
The XRD 1622 AP3 MED is a flat panel x-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRD 1622 AP3 MED detector has an active area of 41cm x 41cm at a pixel pitch of 200μm. Data and control communication is accomplished via a Gigabit Ethernet interface. The detector can be integrated into a fixed room x-ray system to enable digital radiography.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the PerkinElmer XRD 1622 AP3 MED Flat Panel Detector:
Acceptance Criteria and Device Performance Study
The primary study presented aims to demonstrate substantial equivalence to a predicate device, focusing on "equivalent diagnostic quality" of the generated images.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Image Quality / Diagnostic Equivalence | Produce images of equivalent diagnostic quality compared to the predicate device. | "The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed external testing in actual user testing facility and was found to produce images of equivalent diagnostic quality in a study of 30 image pairs of different anatomical regions reviewed by three board certified radiologists." "The proposed device and predicate device (flat panel detector of the predicate) both utilize similar technology and materials, are similar in design and construction, and have been shown to produce images of equivalent diagnostic quality in a clinical setting." |
| Non-Clinical Testing / Specifications | Meet internal specifications, standards, and regulations (UL, IEC). Conform to product safety, radiology, and imaging standards. | "The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. The device has completed verification and validation testing to confirm it meets the specifications and operates as planned. Tests included image quality test with internal experts. The product, manufacturing and development processes have been showen to conform to product safety, radiology and imaging standards." |
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable performance metrics as "acceptance criteria" in the same way a de novo submission might. The key acceptance criterion here is the subjective assessment of "equivalent diagnostic quality."
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 30 image pairs.
- Data Provenance: "external testing in actual user testing facility." This implies prospective data collection, possibly within a clinical environment, specifically for the purpose of this evaluation. The country of origin is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three.
- Qualifications of Experts: "board certified radiologists." The number of years of experience is not specified.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It mentions the images were "reviewed by three board certified radiologists," but it doesn't detail how their opinions were combined or resolved if there were disagreements (e.g., 2+1, 3+1, majority vote, etc.). It simply concludes they "found to produce images of equivalent diagnostic quality."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not explicitly in the sense of comparing human readers with vs. without AI assistance. The study described is a comparison of two different imaging devices (the new device vs. the predicate device), with human readers assessing the image quality from both. It evaluates the diagnostic equivalence of the devices, not the improvement of human readers with AI assistance.
- Effect Size of Human Readers' Improvement with AI vs. without AI assistance: Not applicable, as this type of study was not conducted or reported.
6. Standalone (Algorithm Only) Performance Study
This device is a hardware component (Flat Panel Detector), not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance is intrinsically linked to its ability to capture images that can be interpreted by humans.
7. Type of Ground Truth Used
The ground truth for the comparison was expert consensus / subjective evaluation of diagnostic quality by three board-certified radiologists. They assessed the "equivalent diagnostic quality" of images produced by the new device compared to the predicate device.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware component (a flat panel detector), not an AI-driven software or algorithm that requires a "training set" in the conventional machine learning sense. The device's design and engineering are based on established physics and imaging principles, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable for the same reasons as #8. The "training" for such a device is its engineering, calibration, and adherence to physical principles and manufacturing specifications.
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PerkinElmer Medical Imaging XRD 1622 AP3 MED Flat Panel Detector
NOV 2 8 2012
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 K122495
807.92(a)(1):
Date: November 17, 2012
| Submitted by: | PerkinElmer Medical Imaging2175 Mission College Blvd.Santa Clara, CA 95054 |
|---|---|
| Contact Person:Primary: | Kay A. TaylorTele: 317 418-1735Fax: 317 536-3064 |
| 807.92(a)(2): | |
| Trade Name: | PerkinElmer XRD 1622 AP3 MED Flat Panel Detector |
| Common Name: | Flat Panel Digital Detector (21 CFR 892.1650) |
| Regulation: | |
| Classification Name: | Solid State X-ray Imager |
| Classification: | 90 Radiology |
| Product Code: | (MQB) |
| 807.92(a)(3): | |
| Predicate device: | Definium 5000 X-ray system (Flat Panel Detector in system)[K063283] |
| 807.92(a)(4): |
Device Description:
The XRD 1622 AP3 MED is a flat panel x-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator.
The XRD 1622 AP3 MED detector has an active area of 41cm x 41cm at a pixel pitch of 200μm. Data and control communication is accomplished via a Gigabit Ethernet interface.
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The detector can be integrated into a fixed room x-ray system to enable digital radiography. The following accessories are available for the XRD 1622AP3 MED
- Power supply XRD-LPM (for indoor usage only) .
- Power supply XRD-EPS (for indoor or outdoor usage) .
- DC cable for XRD-EPS (in lengths of 7.6 m, 15.3 m or 30.5 m) .
- AC cable for XRD EPS (country specific AC connector) ●
- Trigger cable (in lengths of 5 m or 20 m) .
- GigE interface cable (in lengths of 7.6 m, 15.3 m, 30.5 m, or 61m) .
807.92(a)(5):
Intended Use:
The XRD 1622 AP3 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.
807.92(a)(6):
Technological Characteristics Comparison:
Comparison of the XRD 1622 AP3 MED device with its predicate.
| PerkinElmer XRD 1622 AP3 MED | ||
|---|---|---|
| Characteristics | Proposed Device | Predicate (K063283) |
| IntendedUse/Indications forUse | The XRD 1622 AP3 MED, whenused with a radiographic imagingsystem, is indicated for use ingenerating radiographic images ofhuman anatomy for diagnostic X-ray procedures, whereverconventional screen-film (SF),digital radiography (DR), orcomputed radiography (CR)systems may be used. It is notintended for mammographic use. | The Definium 5000 x-ray system isintended for use by a qualified /trained doctor or technician on bothadult and pediatric subjects fortaking diagnostic radiographicexposures of the skull, spinal column,chest, abdomen, extremities, andother body parts. Applications canbe performed with the patient sitting,standing, or lying in the prone orsupine position.Note: The predicate submission(K063283) was to combine twopreviously cleared devices; theSedecal X Plus LS Plus UniversalRadiographic System and the GEMedical Systems DigitalRadiographic Detector (K042876) towhich substantial equivalency isclaimed for the XRD 1622 AP3MED. |
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| Panel | Single substrate a-Si TFT/diodearray | Same |
|---|---|---|
| Scintillator | Direct deposit CsI:Tl | Same |
| Active area | 40.96cm x 40.96cm | Same |
| Pixel pitch | 200μm | Same |
| Power | External power supply | Same |
| Communication | Ethernet | Same |
807.92(b)(1):
Summary of Non-Clinical Studies:
The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. The device has completed verification and validation testing to confirm it meets the specifications and operates as planned. Tests included image quality test with internal experts. The product, manufacturing and development processes have been showen to conform to product safety, radiology and imaging standards.
807.92(b)(2):
Summary of Clinical Studies:
The PerkinElmer XRD 1622 AP3 MED flat panel detector has successfully completed external testing in actual user testing facility and was found to produce images of equivalent diagnostic quality in a study of 30 image pairs of different anatomical regions reviewed by three board certified radiologists.
807.92(b)(3):
Substantial Equivalency:
The proposed device and predicate device (flat panel detector of the predicate) both utilize similar technology and materials, are similar in design and construction, and have been shown to produce images of equivalent diagnostic quality in a clinical setting. 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:
The PerkinElmer XRD 1622 AP3 MED is substantially equivalent to the flat panel detector of the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of a human figure embracing or supporting another, suggesting care and assistance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 28, 2012
PerkinElmer C/O Ms. Kay A. Taylor, MT (ASCP) RAC Vice President, Quality and Clinical Affairs 8275 Carloway Road INDIANAPLOIS IN 46236
Re: K122495
Trade/Device Name: PerkinElmer XRD 1622 AP3 MED Flat Panel Detector Regulation Number: 21 CFR 892.1650 Regulation Name: ImageOintensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: November 17, 2012 Received: November 20, 2012
Dear Ms. Taylor:
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Michael D. O'Hara
Janine M. Morris, M.S. 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 2.
510(k) Number (if known): K 122495
Device Name: PerkinElmer XRD 1622 AP3 MED Flat Panel Detector
Indications for Use:
The XRD 1622 AP3 MED, when used with a radiographic imaging system, is indicated for The AKD 1022 AF 5 MED, which ases of him in and only for diagnostic X-ray procedures, use in generating radiographic inlages of thinks and only to: Chegary of Child Stars of the Property wherever conventional served. Inni (82), angel.
(CR) systems may be used. It is not intended for manmographic use.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE OF . NEEDED)
Concurrence of CDRH, Office of Device (ODE)
Michael D. O'Hern
(Division Sign Off)
Division of Radiological Ho Office of In Vitro Diagnostics a
510(k) 5122495
Page 1 of 1
§ 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.