(48 days)
No
The summary describes a standard digital x-ray system with updated components and software. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The software validation focuses on standard software development and cybersecurity practices, not AI/ML model training or evaluation.
No.
The device is specifically described for "taking diagnostic radiographic exposures," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "taking diagnostic radiographic exposures." Additionally, the "Device Description" mentions "diagnostic x-ray components," and the "Summary of Performance Studies" indicates that clinical images acquired from the new panel were found to be "of excellent diagnostic quality."
No
The device description explicitly states it is a "new combination of already cleared solid state digital x-ray acquisition panels... and software with the diagnostic x-ray components required to make a complete system." It lists various hardware components like digital panels, tube stand, collimator, x-ray tube, and high voltage generator. While software is a component, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for taking "diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details components like digital x-ray acquisition panels, software, tube stand, collimator, x-ray tube, and high voltage generator. These are all components of an X-ray imaging system.
- Input Imaging Modality: The input modality is explicitly stated as "X-ray."
- Anatomical Site: The anatomical sites listed are parts of the human body that are imaged using X-rays.
- Performance Studies: The performance studies described involve software validation, risk management, integration testing, and review of clinical images by a radiologist. These are typical evaluations for medical imaging devices.
- Predicate Device: The predicate devices are also described as "KrystalRad" systems, which are known to be X-ray imaging systems.
In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on bodily samples. It is an imaging device that produces images of the inside of the body.
N/A
Intended Use / Indications for Use
The MasteRad MX30 is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray components required to make a complete system. The purchaser may select their digital panel from this list: Varex PaxScan 2530Wv4 (Master X CW25), Varex PaxScan 4336Wv4 (Master X CW36), Varex PaxScan 4343R (Master X FC43), Varex PaxScan 4343RC (Master X PT43), Varex XRpad 4343F (Master X HDF43), Varex XRpad 3025 (Master X WPH25), Varex XRpad 4336 (Master X WHD36), Toshiba FDXA4343R (Master X FA43). As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, extremities, and other body parts; chest, abdomen
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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
A new digital x-ray receptor panel (Toshiba Model FDXA4343R) not previously cleared by FDA is offered. Clinical images were acquired from the new Toshiba panel and reviewed by a board certified radiologist, as recommended in the FDA document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: Software validation and risk management were performed for the updated software version. The device conforms to US Performance Standards and the hardware is UL Listed to US Standards for safety for medical devices (UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety standard by Underwriters Laboratories, 04/25/2003.). Integration testing showed that each panel performed correctly in the full system. Test information for the new digital receptor panel was provided per Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016.
Clinical testing: Clinical images were acquired from the new Toshiba panel (FDXA4343R) and reviewed by a board certified radiologist. The 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.
K161459, K172951, K142698, K161942, K161966, K130377, K130883
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
April 25, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle-like figure, representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
MedicaTech USA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K190601
Trade/Device Name: MasteRad MX30 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MOB Dated: March 29, 2019 Received: April 2, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190601
Device Name MasteRad MX30
Indications for Use (Describe)
The MasteRad MX30 is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) Summary, 510(k) K190601
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: January 23, 2019
1. Identification of the Device:
Trade/Device Names: MasteRad MX30 Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray System
- Equivalent legally marketed device: K143257 Trade/Device Name: KrystalRad 1100 and KrystalRad 3000 Manufacturer: MedicaTech USA Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray System
-
- Indications for Use The MasteRad MX30 is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
- Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:.
| Manufacturer Model Number | MedicaTech Model Number | 510(k) Number |
|---|---|---|
| Varex PaxScan 2530Wv4 | Master X CW25 | K161459 |
| Varex PaxScan 4336Wv4 | Master X CW36 | K161459 |
| Varex PaxScan 4343R | Master X FC43 | K172951 |
| Varex PaxScan 4343RC | Master X PT43 | K172951 |
| Varex XRpad 4343F | Master X HDF43 | K142698 |
| Varex XRpad 3025 | Master X WPH25 | K161942 |
| Varex XRpad 4336 | Master X WHD36 | K161966 |
| Toshiba* FDXA4343R | Master X FA43 | New |
4
As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377
The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. *Toshiba panel division has recently been purchased by Canon.
-
- Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels (except for the Toshiba unit) and software.
| Characteristi
C | K143257 KrystalRad 1100 and
KrystalRad 3000 Digital Stationary
Radiographic Systems | MastRad MX30 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use: | The KrystalRad Systems are intended for
use by a qualified/trained doctor or
technician on both adult and pediatric
subjects for taking diagnostic
radiographic exposures of the skull,
spinal column, chest. abdomen,
extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the
prone or supine position. Not for
mammography. | MasteRad MX30 is intended for use by a
qualified/trained doctor or technician on
both adult and pediatric subjects for taking
diagnostic radiographic exposures of the
skull, spinal column, chest. abdomen,
extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the prone
or supine position. Not for mammography.
SAME |
| Configuration
of Digital
Panels | Battery or AC operated wireless IEEE
802.11n or Wired Ethernet | Battery or AC operated wireless IEEE 802.11n
or Wired Ethernet (depending on the model
chosen) SAME |
| Digital Panel
Models | Vieworks FXRD-1717SA/SB, or
Vieworks FXRD-1417SA/SB or
Vieworks FXRD-1417WA/WB or
Toshiba: FDX4343R/RPW or
Toshiba FDX3543RP/RPW or
Varex XRpad 4336 | Varex PaxScan 2530Wv4 or
Varex PaxScan 4336Wv4 or
Varex PaxScan 4343R or
Varex PaxScan 4343RC or
Varex XRpad 4343F or
Varex XRpad 3025 or
Varex XRpad 4336 or
Toshiba (Now Canon) FDXA4343R |
| DICOM | DICOM 3 | SAME |
Substantial Equivalence Chart: 6.
5
| Characteristi
c | K143257 KrystalRad 1100 and
KrystalRad 3000 Digital Stationary
Radiographic Systems | MastRad MX30 |
|----------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Image
acquisition
software | Voyance | Voyance. Updated. |
| Power Source | AC Line, various voltages available | SAME |
| Photo | Image: Krystalrad 3000 | Image: MasteRad MX30
Difference: Floor Mount instead of Ceiling
Mount. |
| Generator | CPI CMP 200DR | SAME |
| X-Ray Tube | Toshiba | SAME |
| Collimator | Ralco R301A | Collimare LLC, one of the following FDA
certified models: CML-150-0001-C,
CTL-150-0001-C, CML-125-0001-C |
A new digital x-ray receptor panel not previously cleared by FDA is offered. The predecessor to this panel was cleared in K130883. The characteristics are compared in the table below. The images were evaluated by a Board Certified Radiologist, and found to be of diagnostic quality.
| Characteristic | Sedecal Digital Radiogniphic Upgrade
Model SDRU-T K130883 (Toshiba Model
FDX4343R) | Toshiba Model FDXA4343R (One of the
available models for MasteRad.) |
|------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Image Format | | |
| X-ray
Conversion
Layer | Cesium lodide (Csl) with Amorphous
Silicon (a-Si) Photodiode | SAME |
| Active Area | 430(H)×439(V)mm (16.9×17.3 inch) | 426 (H)×425 (V) mm (16.8×16.7 inch)
(Not a meaningful difference) |
| Pixel Matrix | 3008(H)×3072(V) | 3040 (H)×3036 (V) (Not a meaningful
difference) |
| Pixel Pitch | 143 $ \mu $ m | 140 $ \mu $ m (Not a meaningful difference) |
6
| Characteristic | Sedecal Digital Radiogniphic Upgrade
Model SDRU-T K130883 (Toshiba Model
FDX4343R) | Toshiba Model FDXA4343R (One of the
available models for MasteRad. |
|------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Cycle Time | Shot to Shot 6sec | Shot to Shot 6sec No difference |
| Performance | | |
| Limiting
Resolution | 3.5 Lp/mm typ | 3.7 Lp/mm Max. Slightly better |
| MTF (2.0
Lp/mm, 70
kVp, 1x1) | 36 % Typ | 50 % typ Slightly better |
| DQE (0),
Quantum -
Limited | > 70 % | > 56 % (Typ.) (Not a meaningful
difference. Images found to be of
diagnostic quality, however) |
| A/D
Conversion | 14 bit | 16 bit Slightly better |
-
- Summary of non-clinical testing: We performed software validation and risk management for the updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine We revised our labeling in light of the FDA guidance: Pediatric Information for X-ray (DICOM) Set. Imaqinq Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The device conforms to US Performance Standards and the hardware is UL Listed to US Standards for safety for medical devices (UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety standard by Underwriters Laboratories, 04/25/2003.) There is one new digital receptor panel, and we were provided test information per Guidance for the Submission of 510(k)s for Solid State X-ray Imaginq Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016 The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device
-
- Summary of clinical testing: Clinical images are not required for the previously cleared panels, but the new Toshiba panel has not previously received FDA clearance. Clinical images were acquired from the new Toshiba panel and reviewed by a board certified radiologist, as recommended in the FDA document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices The 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 "MedRad" system is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.