(115 days)
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
This device is simply the combination of two cleared devices, the same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to existing film x-ray systems. It should be installed by a qualifics trained by a qualifics trained
The KrystalRad 660 Digital Radiographic Portable Retrofit System's acceptance criteria and study details are provided below based on the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in quantitative terms (e.g., minimum sensitivity, fidelity metrics). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The primary performance metric is the qualitative comparison of clinical images and integration testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical images are not significantly different from predicate. | Clinical images acquired were compared to predicate images; no significant differences. |
| Integration testing successfully completed. | Integration testing was performed. |
| Device is as safe and effective as predicate devices. | The new device is as safe and effective as the predicate device. |
| Conforms to US Performance Standards. | The modified device conforms to US Performance Standards. |
| Hardware is UL Listed to US Standards for medical device safety. | The hardware is UL Listed to US Standards for safety for medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Clinical images were acquired and compared to our predicate images." However, it does not specify the sample size for the test set (number of images or patients).
The data provenance is not explicitly stated regarding its country of origin or whether it was retrospective or prospective. It only mentions "clinical images were acquired," which could imply prospective acquisition, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical images. The comparison is described simply as "compared to our predicate images," suggesting an internal comparison rather than a formal expert review process for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method for the test set. The statement "no significant differences between them" suggests a qualitative assessment without detailing a specific process like 2+1 or 3+1 consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this submission. The study focuses on demonstrating equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a hardware combination (digital X-ray panel and image processing software). The "performance" being evaluated is the image quality and functionality of this combined system itself. Therefore, the "standalone" performance in this context refers to the system acquiring images, which was done by collecting and comparing clinical images. It's not an "algorithm-only" performance in the sense of an AI diagnostic aid.
7. The Type of Ground Truth Used
The ground truth for the comparison was based on "our predicate images." This implies comparing images from the KrystalRad 660 system to images produced by the previously cleared predicate devices (Philips Wireless Portable Detector FD-W17 K090625 and the image processing software from K080582 DDR MAK Series or K100403 OmniVision). The "ground truth" is therefore the established image quality and clinical utility of the predicate devices.
8. The Sample Size for the Training Set
The device is a combination of two already cleared predicate devices. The "study" described is a comparison and integration test of this combination, not the development or training of a new algorithm. Therefore, there is no specific "training set" mentioned for the KrystalRad 660 as it's not a de novo AI algorithm requiring training. The image processing software itself (cleared under K080582 or K110040) would have had its own validation/training, but details are not provided here for KrystalRad 660.
9. How the Ground Truth for the Training Set was Established
As stated in point 8, there isn't a "training set" for the KrystalRad 660 as a new device. The ground truth for the predicate image processing software or detector would have been established during their original clearance, likely involving various methods (e.g., expert review, physical phantoms for image quality metrics), but these details are not provided in this submission for K112132. The KrystalRad 660 leverages the already established "ground truth" (i.e., safety and effectiveness) of its predicate components.
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K1.12132
NOV 1 8 2011
510(K) Summary, 510(k) K11 Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Frce : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: July 10, 2011
1. I dentification of the Device:
i
Proprietary-Trade Devel.
Proprietary-Trade Name: KrystalRad 660 Digital Radiographic Portable Retrofit System Classification Name: Solid state x-ray imager (flat panel/digital imager), MQB
Common/Usual Name: Solid state x-ray imager (flat panel/digital imager), MQB Common/Usual Name: Digital X-Ray Panel
Equivalent legally marketed devices: 2.
- The image processing software is the same as provided in our 510(k) K080582 DDR MAK . Series. Allemately the image processing sollware is the same as in OmniVision, K. I 100403
made by Modely Module Inc made by Modern Module Inc. - The Detector is identical to the Wireless Portable Detector FD-W17 (K090625) marketed by
Philips Mcdical Systems . Philips Medical Systems - Description of the Device: This device is simply the conbination of two cleared devices, the 3. same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station
if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size:
3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to cxisting film x-ray systems. It should be installed by a qualifics trained by a qualifics trained -
- Indications for Use (intended use): Intended for use by a qualifical/trained doctor or technologist. As part of a radiographic system, the KryslalRad 660 intended to acquire digital radiographic images. It is suite for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, candidating fluoroscopy, angiography and manimography,
- Safety and Effectiveness, comparison to predicate device. This combination device has the પંચ same indications for use and technological characteristics as the prodication devices, in fact employing the predicate devices in the end product.
-
- Description of Testing: Clinical images were acquired and compared to our predicate images. There no significant differences between them. We also performed integration testing. The results of a review of clinical, between them. We also performed integration testing. The that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is U. Listed to US Standards for safety for medical devices.
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7. Substantial Equivalence Chart
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| Characteristic | Philips Wireless Portable DetectorFD-W17 K090625 | KrystalRad 660 |
|---|---|---|
| Intended Use: | As a part of a radiographic system,the Wireless Portable Detector FD-W17 is intended to acquiredigital radiographic images. TheWireless Portable DetectorFD-W1 7 is suitable for all routineradiography exams, includingspecialist areas like intensive care,trauma, or pediatric work,excluding fluoroscopy,angiography and mammography. | Intended for use by a qualified/traineddoctor or technologist. As part of aradiographic system, the KrystalRad660 is intended to acquire digitalradiographic images. It is suitable forall routine radiography exams,including specialist areas like intensivecare, trauma, or pediatric work,excluding fluoroscopy, angiographyand mammography. |
| Configuration | Battery operated wireless | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Image acquisition panel | PIXIUM PORTABLE 3543 | SAME |
| Image acquisitionsoftware | Philips XD-S workstation(K063781) | Same as: K080582 DDR MAK SeriesMedicatech USA (E-Com) - OR-K110040 OmniVision, ModernModule Inc. |
| Communication | WiFi or hardwire | SAME |
| Electrical safety | Electrical Safety per IEC-60601.UL listed | SAMESAME |
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Mcdicatech USA that the KrystalRad 660 is as safe and clinical
the predicate devices, have almost no technological liff the predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices,
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Medica Tech USA % Mr. Daniel Kamm, P.E. AUG 2 3 2013 Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K112132
Trade/Device Name: KrystalRad 660 Digital Radiographic Portable Retrofit System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 17, 2011 Received: October 20, 2011
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 18, 2011.
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 modious 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 witification. The FDA finding of substantial equivalence of your device to a legally marketed nodicate 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 If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-000), 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 under the MDA regulation (21 °CF (1 at 009), processor of 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 Tou inay 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,
Janine M. Morris
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): K112| 32
Device Name: KrystalRad 660 Digital Radiographic Portable Retrofit System
Indications For Use:
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Prescription Usc _ 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)
(Division Sign-Off)
Division of Radiological Dou
Office of in Vitro O
Office of In Vitro Radiological Devices
Diagnostic Device Evaluation and
510K B112132
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§ 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.