(92 days)
No
The summary describes a digital radiography system that replaces film and offers image processing capabilities, but it does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The 'Intended Use' section states that the device is "intended to acquire digital radiographic images," which is a diagnostic function, not a therapeutic one.
No
The device is described as acquiring digital radiographic images and serving as a functional replacement for radiographic film, which are tools used in diagnostic imaging, but the device itself does not perform the diagnosis. Its output (images) is used by a qualified/trained doctor or technologist for diagnostic purposes.
No
The device description explicitly states it is a "combination of already cleared software and already cleared digital receptor panels," and mentions the hardware is UL Listed, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring digital radiographic images as part of a radiographic system. This is an imaging function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description focuses on the device's function as a replacement for radiographic film and its role in capturing and processing X-ray images. It describes the technology used for image acquisition and enhancement, which is characteristic of medical imaging devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to capture images of the internal structures of the body using X-rays.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system. the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; climination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image.
The Thin Film Transistor (TFT) Panel accumulates the visible ray (rendered visible by the scintillator, which is transformed from X-ray by the scintillator, at the photodiodes. The accumulated photic signal in the photodiode is output by readout Integrated Circuit (ROIC) and displayed after an Analog to Digital Convertor (ADC) transforms photic signal to digital signal. When the detector receives a signal from X-ray high voltage generator, it converts cumulated signal to 14-bit digital images at detector circuit and transmits those images to the workstation using the Gigabit Ethernet. The workstation receives images them with software to display on the monitor and to save data in the hard disk.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing: Integration testing was performed. The results of a review of bench, safety test, and software validation documentation indicates 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 UL Listed to US Standards for safety for medical devices. Standards testing performed included:
- IEC 60601-1 (1988) +IEC 60601-1 Amendment 1 (1991); +IEC 60601-1 Amendment 2 (1995) Safety of Medical Electrical Equipment, Part 1. General Requirements for Safety
- IEC 60601-1-2 Collateral standard: Electromagnetic compatibility -Requirements and tests
- NEMA PS 3.1 3.18 (2009), Digital Imaging and Communications in Medicine (DICOM) Set.
Summary of Clinical Testing: Clinical images were acquired and compared to our predicate images by a board certified radiologist. There were no significant differences between them. Images were found to be of excellent diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K103554, K110040, K080582, K122866, K122865
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 1 7 2013
510(K) Summary, 510(k) K130377 Submitter: MedicaTech USA 50 Maxwell Irvine . CA . 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 . FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: March 27, 2013
-
- Identification of the Device:
Proprietary-Trade Name: KrystalRad "New Series" Radiographic Portable Retrofit System Classification Name: Solid state x-ray imager (flat panel/digital imager). MQB Common/Usual Name: Digital X-Ray Panel
- Identification of the Device:
-
Equivalent legally marketed devices: K112132. KrystalRad 660. MedicaTech USA. The 2. modified device represents the combination of already cleared devices.
-
- Description of the Device: This device represents the combination of already cleared software and already cleared digitan receptor panels.
a) How the device functions. This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; climination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image. b) Scientific concept forming the basis of the device.
Image /page/0/Figure/7 description: The image shows a schematic of an X-ray detector. The detector consists of a layer of Cesium Iodide (CsI) or Gadolinium oxysulfide (Gadox) that converts X-ray radiation into light. The light is then detected by an array of pixels, each containing a photodiode and a thin-film transistor (TFT). The signal from each pixel is read out by a detector circuit, which includes a readout integrated circuit (IC) and an analog-to-digital converter (ADC), and then transmitted via Gigabit Ethernet to a computer.
The Thin Film Transistor (TFT) Panel accumulates the visible ray (rendered visible by the scintillator, which is transformed from X-ray by the scintillator, at the photodiodes. The accumulated photic signal in the photodiode is output by readout Integrated Circuit (ROIC) anddisplayed after an Analog to Digital Convertor (ADC) transforms photic signal to digital signal. When the detector receives a signal from X-ray high voltage generator, it converts cumulated
1
signal to 14-bit digital images at detector circuit and transmits those images to the workstation using the Gigabit Ethernet. The workstation receives images them with software to display on the monitor and to save data in the hard disk.
c) Significant physical and performance characteristics: This device is functionally identical to our recent submission K112132, a wireless digital upgrade to existing film systems. A wired panel is also available. We have changed the wireless panel to another model of a nearly identical size and resolution (already cleared). We have changed the software to the 510(k) cleared package from K 103554, now sold under the trade name Voyance-M. The upgrade should be installed by a qualified trained field engineer. Alternately we still offer the original software package, the Modern Module Omnivision.
-
- Indications for Use (intended for use by a qualified/trained doctor or technologist. As part of a radiographic system. the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography..
-
- Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and technological characteristics as the predicate devices, in fact employing already cleared devices in the end product.
| Comparison Chart, KrystalRad "New Series," MedicaTech USA | ||
|---|---|---|
| Characteristic | K112132, KrystalRad 660, | |
| MedicaTech USA | KrystalRad "New Series," | |
| MedicaTech USA | ||
| Explanation | This is the device we have MODIFIED | |
| with new panels and software | This device represents the | |
| combination of already cleared | ||
| devices, PACS software and | ||
| digital x-ray panels. | ||
| Intended Use: | Intended to acquire digital | |
| radiographic images. It is suitable for | ||
| all routine radiography exams, | ||
| including specialist areas like intensive | ||
| care or trauma work, excluding | ||
| fluoroscopy, angiography and | ||
| mammography | SAME as KrystalRad 660, | |
| unchanged. | ||
| Configuration | Battery operated wireless or Wired | |
| Ethernet | Battery operated wireless or | |
| Wired Ethernet | ||
| Image acquisition panel | ||
| specifications | Wireless panel | |
| 2400 by 3000 pixels | ||
| Pitch: 144 $\mu$m | ||
| Bit depth 14 bit | Wired panels: | |
| 2,560 x 3.072 pixels | ||
| 3,072 x 3.072 pixels | ||
| or Wireless panel | ||
| 2560 x 3072 pixels | ||
| Pitch: 140 $\mu$m | ||
| Bit depth 14 bit. | ||
| Identification of the Panels | PIXIUM 3543 pR | Vieworks Vivix-S K122866 or |
| Vivix-S Wireless K122865 | ||
| Communication Standard | IEEE 802.11n (2.4 GHz) or hardwire | |
| Ethernet | IEEE 802.11n (2.4 GHz) or | |
| hardwire Ethernet | ||
| DICOM | DICOM 3 | DICOM 3 |
| Image acquisition software | Same as: K080582 DDR MAK Series | |
| Medicatech USA (E-Com) - OR- | ||
| K110040 OmniVision. Modern | ||
| Module Inc | Same as: K103554 Metron MD, | |
| EponaTech LLC, rebranded | ||
| Voyance-M OR OmniVision. | ||
| K110040 made by Modern | ||
| Module Inc |
6. Substantial Equivalence Chart
2
| Characteristic | K112132, KrystalRad 660,
MedicaTech USA | KrystalRad "New Series,"
MedicaTech USA |
|-------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication | WiFi or hardwire | SAME |
| Image Dimensions | 14 x 17 in. (35 x 43 cm) / 17 x 17 in.
(43 x 43 cm) | 14 x 17 in. (35 x 43 cm) / 17 x 17
in. (43 x 43 cm) |
| Weight | 4.7 kg | 6.3 lbs (2.9 kg / GOS) & 6.8
lbs.(3.1 kg / Csl)
Wireless: 6.8 lbs (3.1 kg / GOS)
& 7.2 lbs.(3.3 kg / Csl)
17 x 17 in. Fixed: 24.2 lbs (11 kg /
GOS) & 24.2 lbs.(11 kg / Csl) |
| Electrical safety | Electrical Safety per IEC-60601. UL
listed | Electrical Safety per IEC-60601.
UL listed |
-
- Summary of non-clinical testing: We performed integration testing. The results of a review of bench. safety test, and software validation documentation indicates 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 UL Listed to US Standards for safety for medical devices. Standards testing performed included:
- a. IEC 60601-1 (1988) +IEC 60601-1 Amendment 1 (1991); +IEC 60601-1 Amendment 2 (1995) Safety of Medical Electrical Equipment, Part 1. General Requirements for Safety
- b. IEC 60601-1-2 Collateral standard: Electromagnetic compatibility -Requirements and tests
- c. NEMA PS 3.1 3.18 (2009), Digital Imaging and Communications in Medicine (DICOM) Set.
-
- Summary of clinical testing: Clinical images were acquired and compared to our predicate images by a board certified radiologist. There were no significant differences between them. Images were found to be of excellent diagnostic quality.
-
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Medicatech USA that the KrystalRad "New Series" is as safe and effective as the predicate devices. have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2013
Medicatech USA C/O Daniel Kamm. P.E. Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K130377
Trade/Device Name: KrystalRad "New Series" Digital Radiographic Portable Retrofit
System Regulation Number: 21 CFR 892,1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Dated: April 1, 2013 Received: April 5, 2013
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. 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 (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.
4
Page 2-Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130377
Device Name: KrystalRad "New Series" 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 "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
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)
Sm.h.7)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k): K130377