(284 days)
The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.
The Atlas is provided high resolution radiographic images in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
Here's an analysis of the provided text regarding the ATLAS Digital X-Ray Detector, focusing on acceptance criteria and supporting studies:
It is important to note that the provided document is a 510(k) summary for premarket notification, not a full study report. As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing independent clinical or performance studies with specific acceptance criteria and detailed patient-level data. The document does not contain information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details. The "Performance Characteristics" section lists applied standards rather than reporting actual performance against specific acceptance criteria.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, explicit "acceptance criteria" for performance metrics in the context of a prospective study are not detailed. Instead, the document demonstrates substantial equivalence by comparing the device's technical specifications and intended use to legally marketed predicate devices. The implicit "acceptance criterion" is that the ATLAS device's specifications should be comparable to or better than the predicate devices without raising new safety or effectiveness concerns.
| Feature | ATLAS (Reported Performance) | Comparison to Predicate Devices (Implicit Acceptance) |
|---|---|---|
| Intended Use | Matches predicate devices. | Met: The intended use of ATLAS is identical to the main predicate (Xaminer) and broadly aligned with the second predicate (QXR-9), covering head-to-toe diagnostic radiographic exposures for adult and pediatric patients, excluding mammography. |
| Classification | Class II / MQB | Met: Matches predicate devices. |
| Feature (General) | High-resolution digital imaging, 98% fill factor, lower dose, single CCD detector. | Met: Similar general features and benefits (high resolution, digital format, fill factor, lower dose) as described for Xaminer. QXR-9 also emphasizes high-resolution digital imaging. The ATLAS shares the 98% fill factor, while Xaminer claims 100%. This difference is not presented as raising new safety/effectiveness concerns, implying it's either negligible or offset by other factors. |
| Sensor | CCD + scintillator | Met: While the phrasing is slightly different ("CCD+ scintillator" vs. "CCD- scintillator" for predicates), this is understood to be the same underlying technology for indirect digital radiography, utilizing a scintillator to convert X-rays to light, which is then captured by a CCD. |
| Imaging Pixels | 3,103 x 3,085 (9 Megapixel) | Met: Comparable to predicate devices (3,072 x 3,072, 9 Megapixel). |
| Active Image Size | 17" x 17" | Met: Matches predicate devices (43 cm x 43 cm or 17" x 17"). |
| Pixel Size | 144 microns | Met: Matches predicate devices. |
| Nyquist Resolution | 3.5 lp/mm | Met (or exceeded): This is higher than Xaminer (3.2 lp/mm) and matches QXR-9 (3.5 lp/mm). This improvement is considered a positive technological characteristic. |
| Bit Depth | 16Bit capture | Met (or exceeded): This is higher than both predicate devices (14 bit capture). This improvement is considered a positive technological characteristic, allowing for more grayscale information. |
| Fill Factor | 98% | Comparable: Xaminer reports 100%, but 98% is still a very high fill factor, indicated as contributing to maximum efficiency and lower dose. The submission implies this difference does not raise new concerns. |
| Preview Image | Less than 5 seconds | Met: Comparable to Xaminer (Less than 5 seconds), and slightly longer than QXR-9 (Less than 3.5 seconds). This difference is implicitly deemed acceptable and not a new safety/effectiveness concern for the intended use. |
| Imaging Detector Weight | 45kg-50kg | Improved: Significantly lighter than Xaminer (75 kg). This is an improvement in handling and logistics, not raising new safety/effectiveness concerns. |
| Safety Standards | Conforms to EN ISO 14971, EN 60601-1, EN 60601-1-4, EN 60601-1-2. | Met: Conforms to the same or equivalent international and European safety standards as the predicate devices, indicating adherence to established safety requirements. |
The conclusion states that ATLAS "has substantial equivalent intended use... and has substantial equivalent technological and performance characteristics," with "few technological differences" that "do not raise new types of safety or effectiveness issues." This is the core "proof" presented for a 510(k).
Study Details (Based on the Provided Text):
1. Sample sized used for the test set and the data provenance:
* Sample Size (Test Set): Not specified. The document does not describe a specific clinical or technical test set with patient data for the ATLAS device in the way a full performance study would. The comparisons are based on technical specifications and potentially bench testing rather than a separate device performance evaluation on a patient dataset.
* Data Provenance: Not specified. No mention of country of origin or whether data was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not specified. The document does not detail a study involving expert-established ground truth for a test set. This type of information would be relevant for studies assessing diagnostic accuracy, which is not the primary focus of this 510(k) summary for a digital X-ray detector seeking substantial equivalence.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. No adjudication method is mentioned as there is no described test set with human interpretation.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No. An MRMC study was not done. The ATLAS is a digital X-ray detector, which is a component of an X-ray system, not an AI-powered diagnostic tool. Its function is to capture and digitize images.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* No. The ATLAS is a hardware device (digital detector), not an algorithm or AI. Standalone performance as typically understood for AI or image processing algorithms is not applicable here. Its performance is inherent in its image acquisition capabilities.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable/Not specified. The assessment appears to be based on engineering specifications and adherence to standards, rather than direct comparison to a clinical ground truth for diagnostic accuracy. For a digital X-ray detector, ground truth often involves phantoms and objective image quality metrics (e.g., Modulation Transfer Function, Detective Quantum Efficiency) rather than clinical diagnostic outcomes. However, such detailed performance data is not provided here. The implicit "ground truth" for showing equivalence is the established performance of the predicate devices.
7. The sample size for the training set:
* Not applicable/Not specified. This device is not an AI or machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established:
* Not applicable/Not specified. As above, there is no training set for this type of device.
Summary of "Proof" in the 510(k):
The "proof" in this 510(k) summary for the ATLAS Digital X-Ray Detector is primarily based on:
- Comparison to Predicate Devices: Demonstrating that its intended use, technological characteristics, and performance specifications are substantially equivalent to those of two already-cleared predicate devices (Xaminer and QXR-9). Where differences exist (e.g., higher Nyquist resolution, greater bit depth, lighter weight, slightly different fill factor), they are presented as either improvements or not raising new safety or effectiveness concerns.
- Adherence to Standards: Compliance with relevant international safety and quality management standards (e.g., EN ISO 14971, EN/IEC 60601 series, ISO 13485).
- Bench and Laboratory Testing: The conclusion mentions "analyzing both bench as well as laboratory testing to applicable standards." While details of these tests are not provided in the summary, this indicates that the device underwent engineering and performance verification against technical benchmarks to ensure it met its specifications and safety requirements.
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510(K) SUMMARY
[as required by 807.92(c)]
DEC 2 1 2010
A. 510k Number:
B. Applicant:
Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: 714-523-1592 Fax: 714-523-1592
C. Proprietary and Established Names: COMED CO LTD Address: #58, Hakdong-Ri, Chowol-Eup, Gwangju-City, Gyeonggi-Do, Korea
D. Requlatory Information
Classification : Class II CFRcord : 892 . 1680 , Regular Name : Stationary X-ray system Product cord : MQB
E. Intended Use
The ATLAS is integrated into the user`s stationary radiography system. This typical configuration permits a qualified/trained doctor or technicolgosist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient. Applications can be performed with patient sitting, standing of lying in the prone or supine positions in an integrated system. The ATLAS is not intended for mammography.
F. Device Description
The Atlas is provided high resolution radiographic images in a digital format without use of film , chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
For the technological characteristics the Company is relying on the above mentioned
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ATLAS. COMED Co., Ltd. believes that ATLAS is substantially equivalent in intended use, principles of operation, and technological characteristics to the predicate devices presented above and any differences with Xaminer (K061595), QXR-9 (K073056) do not raise new types of safety or effectiveness issues, as further discussed below.
| Model Name | ATLAS | Xaminer | QXR-9 |
|---|---|---|---|
| 510K Number | Not yet | K061595 | K073056 |
| Classification | Class II Device /MQB (21 CFR 892.1650) | Class II Device /MQB (21 CFR 892.1650) | Class II Device /MQB (21 CFR 892.1650) |
| INTENDED USE | The ATLAS is integrated into the user'sstationary radiography system.This typical configuration permits aqualified/trained doctor or technologistto take a range of head-to-toe diagnosticradiographic exposures of the skull,spinal column, chest abdomen, extremities,and other body parts on bothadult and pediatric patients. Applications canbe performed with patient. Applications can beperformed with patient sitting standing oflying in the prone or supine positions in anintergrated systemThe ATLAS is not intended for mammography | The Xaminer (510k submission device) isintegrated into the user's stationary radiographysystem This typical configuration permits aqualified/trained doctor or technologist to take arange of head-to-toe diagnostic radiographicexposures of the skull spinal column, chestabdomen, extremities, and other body parts onboth adult and pediatric patients. Applicationscan be performed with patient sitting, standing orlying in the prone or supine positions in anintegrated systemThe Xaminer (510k submission device) is notintended for mammography | QXR-9 Digital Radiography system isindicated for digital imaging solutiondesigned for general radiographic system forhuman anatomy. It is intended to replace filmor screen based radiographic systems in allgeneral purpose diagnostic procedures. Notto be used for mammography. |
| Feature | The Atlas is provided high resolutionradiographic images in a digital format withoutuse of film, chemistry, cassettes or expensiveimaging plates. With 98% of fill factor in eachpixel there is a maximum efficiency and lowerdose required for image capture. It has singleCCD detector | The Xaminer is the latest version of Xplorerdigital radiographic detectors. It includesfeatures and functions that have been developedsince the introduction of the original Xplorer1000 (predicate device). Xaminer provides highresolution radiographic images at 3.2 lp/mmin a digital format without use of film, chemistry,cassettes or expensive imaging plates. With 98 %of fill factor in each pixel there is a maximumefficiency and lower dose required for imagecapture. It has single CCD detector with 9 megapixel digitized at 14 bits per pixels | The QXR-9 Digital Radiography Systems is ahigh-resolution digital imaging systemdesigned for digital radiography. It isdesigned to replace conventional filmradiography techniques. This system consistsof Detector Power Supply Unit, Accessories,and S/W. The S/W is operated at aworkstation that is using Windows XP basedOS as its operating system. The system allowsthe operator to acquire and displayimages(Image size 3072x3072 pixels) or1600 x 1200 high resolution monitor.Various features of S/W such as imageinversion, image processing, zooming,panning, window level adjustment, contrastadjustment etc enable the operator to viewdiagnostic details difficult to see usingconventional non-digital techniques. |
| STANDARD | EN ISO 14971EN 60601-1EN 60601-1-4EN 60601-1-2 | EN ISO 14971EN 60601-1EN 60601-1-4EN 60601-1-2 | EN ISO 14971EN 60601-1EN 60601-1-2 |
| Sensor | CCD+ scintillator | CCD- scintillator | CCD- scintillator |
| Imaging Pixels | 3,103 x 3,085(9 Megapixel) | 3,072 x 3,072 (9 Megapixel) | 3,072 x 3,072 (9 Megapixel) |
Comparison with predicate 2.
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| Active Image Size | 17" x 17" | 43 cm x 43 cm (17" x 17") | 43 cm x 43 cm (17" x 17") |
|---|---|---|---|
| Pixel Size | 144 microns | 144 microns | 144 microns |
| Nyquist Resolution | 3.5 lp/mm | 3.2 lp/mm | 3.5 lp/mm |
| Bit Depth | 16Bit capture | 14 bit capture | 14 bit capture |
| Fill Factor | 98% | 100% | << |
| Preview Image | Less than 5 seconds | Less than 5 seconds | Less than 3 5 seconds |
| Imaging DetectorWeight | 45kg-50kg | 75 kg (165 lb) | << |
3. Conclusion
Based on the above, we conclude that the Digital X-ray Detector ATLAS has substantial equivalent intended use as the-market-cleared Xaminer (K061595), QXR-9 (K073056) and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of ATLAS is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns.
Consequently, it is clear that it substantially equivalent to the predicate devices.
H. Performance Characteristics (If/when applicable)
Applied by standard of
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- IEC 980:2003, Graphical symbols for use in the labeling of medical devices
- IEC1041:1998, Information supplied by the manufacturer with medical devices
- · ISO 13485:2003. Medical devices Quality management systems -Requirements for requlatory purposes
- ISO 14155-1:2003, Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO 14971:2007, Medical devices Application of risk management to medical devices
- · IEC 60601-1 Medical electrical equipment Part 1:General requirements for safety (IEC 60601-1:1988/A1:91/A2:95)
- IEC 60601-1-2:2001/A1:2006, Medical electrical equipment Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -
- Requirements and tests
- IEC 60601-1-4:1996+A1:1999:1999, Medical electrical equipment. Part 1-4: General requirements for safety- Collateral standard: Programmable electrical medical systems
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an emblem of a stylized eagle with its wings spread. The eagle is facing to the left and has three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
COMED Co., Ltd. c/o Mr. Brandon Choi Representative PATS Corporation 49 Candlewood Way BUENA PARK CA 90621
DEC 2 1 2010
K100703 Trade Name: ATLAS (Digital X-Ray Detector) Regulation Number: 21 CFR § 892,1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MBQ Dated: November 5, 2010 Received: November 10, 2010
Dear Mr. Choi:
Re:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: ATLAS (Digital X-Ray Detector)
Indications For Use: The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system.
The Atlas is not intended for mammography.
Prescription Use x (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 IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of Radiological Devices
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100703
§ 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.