(119 days)
The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment. The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
Here's a summary of the acceptance criteria and the study that proves the FLAATZ 560 device meets those criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FLAATZ 560 are based on demonstrating substantial equivalence to its predicate device, the KRYSTALRAD 560 (FLAATZ 560) SYSTEM. The performance metrics are compared directly to the predicate device.
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (FLAATZ 560) |
|---|---|
| DQE: 48.5% @ 0.5 lp/mm | DQE: 49.3% @ 0.5 lp/mm |
| MTF: 78% @ 3 lp/mm | MTF: 78% @ 3 lp/mm |
| Resolution: 3.6 lp/mm | Resolution: 3.6 lp/mm |
| Ghosting: <1% @ RQA5 Condition | Ghosting: <1% @ RQA5 Condition |
| Non-clinical performance test | Concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 |
| Clinical test report | Concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 |
| EMC compatibility | Suitable for EMI and EMS test |
| Electrical safety | Acceptable electrical safety level |
| Thermal safety | Acceptable thermal safety level |
| Standards Compliance (IEC 60601-1, IEC 60601-1-2) | Met |
Study Details
The provided document describes both non-clinical and clinical studies to demonstrate the substantial equivalence of the FLAATZ 560 to its predicate device.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either non-clinical or clinical tests. For the clinical study, it mentions "Various parts of FLAATZ 560 images were shown to 5 experts," implying multiple images, but the exact number isn't quantified.
- Data Provenance: Not explicitly stated, but the submitter is DRTECH Corporation from Gyeonggi-do, Korea, which suggests the studies were conducted by or for them, likely using data generated in Korea or a similar setting. The studies are prospective in the sense that they are specifically conducted to evaluate the FLAATZ 560 for regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 5 experts were used for the clinical study.
- Qualifications of Experts: Not specified. It only states "5 experts."
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Adjudication method for the test set:
- Not explicitly described. It states that "clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560)" based on images shown to 5 experts. This implies a consensus or comparative evaluation by the experts, but the specific adjudication rules (e.g., majority vote, independent review with arbitration) are not detailed.
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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. This is not an AI-powered device. It is a radiographic image acquisition device intended to replace film/screen systems. The clinical study was a comparative effectiveness study between two imaging devices (FLAATZ 560 vs. KRYSTALRAD 560), not a study evaluating human reader improvement with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As explained above, this is an image acquisition device, not an AI algorithm. The performance tests (DQE, MTF, Resolution, Ghosting) are intrinsic technical performance measures of the device itself and can be considered "standalone" in the sense that they measure the device's physical output quality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (DQE, MTF, Resolution, Ghosting), the "ground truth" is established by direct measurement of physical properties of the imaging system against established industry or regulatory standards for image quality.
- For the clinical test, the "ground truth" for equivalence was based on expert consensus regarding the diagnostic quality of images produced by the FLAATZ 560 compared to the predicate device.
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The sample size for the training set:
- This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense. The device's performance is driven by its physical design and manufacturing, not by algorithms trained on data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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| 1. Submitter | DRTECH Corporation333-1 Sangdaewon1-Dong, Seongnam CityGyeonggi-do, Korea [462-807]www.drtech.co.kr |
|---|---|
| 2. Contact Person | Choul-Woo ShinVice Presidentcwshin@drtech.co.kr+ 82-31-788-7653 |
| 3. Date Prepared | March 25, 2011 |
| 4. Device Name | FLAATZ 560 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | MQB |
| 8. Predicate Device | KRYSTALRAD 560 (FLAATZ 560) SYSTEMMedicatech USA,510(k) No.: K102284 |
9. Device Description
The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment.
The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
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- K 111 583
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- Intended Use
The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy.
It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
11. Substantial Equivalence
The FLAATZ 560 is substantially equivalent to the KRYSTALRAD 560 (FLAATZ 560) cleared on Jan 3, 2011 via 510k K102284.
Those two systems include same detector, FLAATZ 560, so technological characteristics are equivalent.
| FLAATZ 560 | KRYSTALRAD 560(FLAATZ 560) SYSTEM | ||
|---|---|---|---|
| 510(k) Number | Pending | K102284 | |
| Indication for Use | The FLAATZ 560 is indicatedfor use in general radiographicimages of human anatomy too.It is the upgraded model ofprevious FLAATZ500(K091747), also intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures | Same as predicate | |
| Panel Shape | Rectangular Panel | Rectangular Panel | |
| Detector Size | 353 x 424 (mm) | 353 x 424 (mm) | |
| Design | Dimensions(W x L x H) | 383 x 460 x 15 (mm) | 383 x 460 x 15 (mm) |
| Pixel Pitch | 139 x 139 (μm) | 139 x 139 (μm) | |
| Image Size | 2,560 x 3,072 (pixels) | 2,560 x 3,072 (pixels) | |
| Se Thickness | 500 (μm) | 500 (μm) | |
| Weight (Detector) | 3.0(kg) | 3.0 (kg) | |
| Materials | Amorphous Selenium(a-Se) Detector | Amorphous Selenium(a-Se) Detector | |
| DQE | 49.3% @ 0.5lp/mm | 48.5% @ 0.5 lp/mm | |
| Performance | MTF | 78% @3lp/mm | 78% @3lp/mm |
| Resolution | 3.6 lp/mm | 3.6 lp/mm | |
| Ghosting | <1% @ RQA5 Condition | <1% @ RQA5 Condition | |
| Anatomical Sites | General Radiography | General Radiography | |
| Energy Used and/or Delivered | The Control Box has thefollowing Power Requirement:100 | The Control Box has thefollowing Power Requirement:100 |
Comparison between FLAATZ 560 and KRYSTALRAD 560 (FLAATZ 560) SYSTEM
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| FLAATZ-560 | KRYSTALRAD 560(FLAATZ 560) SYSTEM | ||
|---|---|---|---|
| CompatibilitywithEnvironmentand otherDevices | EMCOperatingTemperature | Suitable for EMI and EMS test. | Suitable for EMI and EMS test. |
| StorageTemperature | +0 to +40 °C | +0 to +40 °C | |
| Electrical Safety | Acceptable electrical safetylevel. | Acceptable electrical safetylevel. | |
| Thermal Safety | Acceptable thermal safetylevel. | Acceptable thermal safetylevel. | |
| Standards Met | - IEC 60601-1Medical electrical equipment - Part 1:General Requirements for safety.- IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for safetyCollateral standard:Electromagnetic compatibility- Requirements and tests | - IEC 60601-1Medical electrical equipment - Part 1: General Requirements for safety.- IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for safetyCollateral standard:Electromagnetic compatibility- Requirements and tests | |
| Non-clinical test report | Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 560 and the result concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 (FLAATZ 560). | Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 560 and the result concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 (FLAATZ 560). | |
| Clinical test report | Various parts of FLAATZ 560 images were shown to 5 experts and clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560) | Various parts of FLAATZ 560 images were shown to 5 experts and clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560) |
12. General Safety and Effectiveness Concerns
The FLAATZ 560 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The FLAATZ 560 has also met applicable Electro Magnetic Compatibility (EMC) requirements.
13. Conclusion
The FLAATZ 560 is substantially equivalent to the Predicate Device in design and Performance.
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Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract image of an eagle. The eagle is facing to the right and has its wings spread.
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
DRTECH Corporation % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826
4 2311
Re: K111583
Trade/Device Name: FLAATZ 560 Regulation Number: 21 CFR 892.1650 Regulation Name: Intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: September 9, 2011 Received: September 15, 2011
Dear Mr. Mack:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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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,
Mary Pastel
Mary S. Pastel, Sc.D. 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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KIII583
Indications for Use Statement
510(k) Number (if known): ponding K (1) 583
Device Name: FLAATZ 560
Indications for Use:
The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generaldiagnostic procedures purpose (excluding fluoroscopic, angiographic. and mammographic applications).
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Spatill
Division Sign Off
Division of Radiologica Office of In Vitro Diagnostic De
510K. K111583
DRTECH
" "
CONFIDENTIAL
Premarket Notification: FLAATZ 560
§ 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.