(37 days)
ViZion DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
The ViZion DR system represents the straightforward integration of two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.
This is a 510(k) premarket notification for a new version of the Viztek ViZion DR, a Digital Radiography (DR) system. The submission focuses on replacing the digital flat panel detector (FPD) with a new model while maintaining the existing software and overall functionality. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device, rather than proving a specific diagnostic accuracy against a clinical ground truth.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, specifically regarding safety and effectiveness, and the absence of new indications for use or technological differences that would raise new questions of safety or effectiveness. The reported performance is a comparison to the predicate.
| Characteristic | Acceptance Criteria (Implicitly, as per Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Same as Viztek ViZion DR K102123: Digital image capture in general radiographic examinations (excluding fluoroscopy, angiography, mammography), imaging skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | SAME (Matches predicate exactly) |
| Digital Panel | Samsung LTX240AA01-A (K090742) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. | Samsung LLX240AB01 (K102587) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. |
| Software | Employs OPAL-RAD PACS image viewing and acquire interface software technology, K063337. | SAME (Matches predicate exactly) |
| Electrical Safety | Electrical Safety per IEC-60601. UL listed. | SAME (Matches predicate exactly) |
| Safety and Effectiveness | As safe and effective as predicate devices. | "The results of clinical image inspection, bench, and test laboratory indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates." |
| Technological Differences | No new technological differences that raise new questions of safety or effectiveness. | "have few technological differences" (only change is the FPD) and "no new indications for use, thus rendering it substantially equivalent". |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical images collected demonstrate equal or better image quality as compared to our predicates." However, it does not specify the sample size for this clinical image inspection, nor does it provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for a component change (the FPD), this might have been a limited comparative study rather than a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "clinical image inspection" but does not provide any information on the number of experts involved in this inspection or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. It only mentions "clinical image inspection."
5. 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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool. The comparison is between the new detector and a previous detector system, with the focus on image quality and equivalence, not reader performance improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human intervention. Since the device is a digital X-ray detector system (hardware), not a diagnostic algorithm, this concept does not apply. The "standalone performance" for this device would relate to its hardware specifications and image acquisition capabilities, which are covered by bench and laboratory testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The available information suggests that the "ground truth" for the comparison was based on "clinical image inspection" and possibly "bench, and test laboratory" results, comparing the image quality of the new device to that of the predicate device. This implies a subjective assessment of image quality by potentially experts, but the specifics are not detailed. It is unlikely to involve pathology or outcomes data for this type of 510(k) submission.
8. The Sample Size for the Training Set
This submission is for a digital X-ray detector system, not an AI algorithm that requires a training set. Therefore, there is no training set in the context of this device.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this hardware device, this question is not applicable.
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112661 Page I of 2 510(k) Summarv 510(k) Number K11
Viztek, LLC. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: August 9, 2011 Contact: Bruce Ashby, Sales and Marketing Manager
- l. Identification of the Device: Proprietary-Trade Name: ViZion DR Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital X-Ray Receptor Panel
-
- Indications for Use (intended use) ViZion DR is intended for digital image capture use in gencral radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and manınography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
- Description of the Device: The ViZion DR system represents the straightforward integration of 4. two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel.
ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed. Our main predicate is ViZion DR, K102123, wherein we combined our OPAL-RAD software with the Samsung panel cleared in K090742. Only the panel has changed.
-
- Safety and Effectiveness, comparison to predicate device. The results of clinical inage inspection, bench, and test laboratory indicates that the new device is as of e and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
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K112661 Page 2 of 2
6. Substantial Equivalence Chart
| Characteristic | Viztek ViZion DR K102123 | Viztek ViZion DR |
|---|---|---|
| Intended Use: | ViZion DR is intended for digital imagecapture use in general radiographicexaminations, wherever conventionalscreen-film systems may be used,excluding fluoroscopy, angiography andmammography. ViZion allows imagingof the skull, chest, shoulders, spine,abdomen, pelvis, and extremitics. | ViZion DR is intended for digitalimage capture use in generalradiographic examinations, whereverconventional screen-film systems maybe used, excluding fluoroscopy,angiography and mammography.ViZion allows imaging of the skull,chest, shoulders, spine, abdomen,pelvis, and extremities. |
| Configuration | This submission is for the Digital Paneland Software only, no generator or standprovided. | This submission is for the Digital Paneland Software only, no generator orstand provided. |
| Digital Panel | Samsung LTX240AA01-A (K090742)Pixel size 143 µm3072 x 3072 pixels9 million pixels. | Samsung LLX240AB01 (K102587)Pixel size 143 um3072 x 3072 pixels9 million pixels. |
| Software | Employs OPAL-RAD PACS imageviewing and acquire interface softwaretechnology, K063337 | SAME |
| Electrical safety | Electrical Safety per IEC-60601. ULlisted | SAME |
7. Conclusion
After analyzing bench, inage, and external laboratory testing to applicable standards, it is the conclusion of Viztek Inc that the Viztek ViZion DR is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalein to the predicate device. ı
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by a serpent.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Viztek LLC % Mr. Daniel Kamm Principal Engineer 8870 Ravello Ct NAPLES FL 34114
Re: K112661
Trade/Device Name: ViZion DR. Digital Flat Panel X=Ray Detector System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: September 9, 2011 Received: September 19, 2011
Dear Mr. Kamm:
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. Patel
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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KI12661
Indications for Use
510(k) Number (if known): K11266
Device Name: ViZion DR, Digital Flat Panel X-Ray Detector System
Indications For Use:
ViZion DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Postel
Page 1 of I
(Division Sian-Of Division of Radiological De Office of In Vitro Diagnostic Device Eva 510K
§ 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.