(47 days)
No
The summary describes a standard digital X-ray detector and does not mention any AI/ML capabilities or image processing features that would typically involve such technology.
No
The device is indicated for generating diagnostic images, not for treating a condition or disease.
Yes
The device is indicated for use in "generating radiographic images of human anatomy for diagnostic X-ray procedures." The term "diagnostic" explicitly states its purpose for diagnosis.
No
The device description explicitly states it is a "flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator," which is a hardware component.
Based on the provided information, the DIGIVIEW 395 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for generating radiographic images of human anatomy for diagnostic X-ray procedures. This involves imaging the internal structures of the body, which is an in vivo (within a living organism) process, not an in vitro (in glass or outside the body) process.
- Device Description: The description details a flat panel X-ray detector, which is a component of an X-ray imaging system. X-ray imaging is a diagnostic modality that works by passing X-rays through the body and capturing the resulting image.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.
Therefore, the DIGIVIEW 395 is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator.
The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.
The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the DIGIVIEW 395
- DV395 LBP (Lithium Battery Pack)
- DV395 LBC (Lithium Battery Charger)
- DV395 IPU (Interface Power Unit)
- DV395 LPT Detector Cable, 3m/100ft
- DV395 Protective Insert
- DV395 Connector Cover Set
- Trigger cable (5m or 20m)
- GigE interface cable (7.6m, 15.25m, or 30.5m)
The DIGIVIEW 395 is designed to work with X-ray systems (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures that the following parameters may fulfil. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc. are designed to support the necessary compatibility.
Energy range for compatibility is 20-150kVp.
The DIGIVIEW 395's auto exposure detection (AED) mode allows integration with OEM systems that there is no access to intercept the Prep/Expose signal.
Any modifications for hard wire integration to a previously installed OEM x-ray system that was utilized for analog or Computed Radiography are limited to integration between the hand-switch and it's connector to the x-ray console.
All integration work must be conducted by qualified service personnel and proper operation verified before releasing system for use on patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below. No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.
Recognized Consensus Standards
IEC 62220-1 Edition 1.0 (2003-10) Medical electrical equipment -. Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
IEC 62220-1-3 Edition 1.0 (2008-06) Medical electrical equipment -● Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment -. Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
IEC PAS 61910-1 First Edition 2007-07 Medical electrical equipment -. Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set
IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2 43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
NEMA XR 24-2008 (R2014) Primary user controls for interventional . angiography x-ray equipment
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
KUB Technologies, Inc. % Vikram Butani President 270 Rowe Avenue, Unit E MILFORD CT 06461
Re: K151221
Trade/Device Name: Kubtec DIGIVIEW 395 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 5, 2015 Received: May 7, 2015
Dear Vikram Butani:
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
For
Robert Ochs. Ph.D. Acting 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)
K151221
Device Name Kubtec DIGIVIEW 395
Indications for Use (Describe)
The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
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
Image /page/3/Picture/0 description: The image is a logo for Kubtec. The logo features a stack of three squares in different shades of gray and blue on the left side. To the right of the squares is the word "kubtec" in red, with the tagline "GOING BEYOND THE SURFACE" in gray underneath.
DIGIVIEW 395 510(K) Summary
Identification of Device:
| Proprietary/Trade Name: | DIGIVIEW 395 (DV395) |
|---|---|
| Classification name: | SYSTEM, STATIONARY X-RAY |
| Classification: | Class II |
| CFR Section: | 21 CFR 892.1680 |
| Product Codes: | MQB |
| Common Name: | Stationary X-ray system |
Predicate Device:
| Device Name: | Perkinelmer, XRpad 4336 MED Flat Panel Detector |
|---|---|
| 510(k) Number: | K140551 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MQB |
| Regulation Name: | Stationary x-ray system |
I. INDICATIONS FOR USE
The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic Xray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
II. DEVICE DESCRIPTION
The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator.
The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.
The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the DIGIVIEW 395
- DV395 LBP (Lithium Battery Pack) ●
- DV395 LBC (Lithium Battery Charger) ●
- DV395 IPU (Interface Power Unit) ●
- DV395 LPT Detector Cable, 3m/100ft ●
- DV395 Protective Insert ●
4
Image /page/4/Picture/0 description: The image contains the logo for Kubtec. To the left of the logo are three overlapping squares in different shades of gray and blue. To the right of the squares is the word "kubtec" in red font, with the words "GOING BEYOND THE SURFACE" in gray font underneath.
- . DV395 Connector Cover Set
- Trigger cable (5m or 20m) ●
- . GigE interface cable (7.6m, 15.25m, or 30.5m)
The DIGIVIEW 395 is designed to work with X-ray systems (consisting of an Xray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures that the following parameters may fulfil. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc. are designed to support the necessary compatibility.
Energy range for compatibility is 20-150kVp.
The DIGIVIEW 395's auto exposure detection (AED) mode allows integration with OEM systems that there is no access to intercept the Prep/Expose signal.
Any modifications for hard wire integration to a previously installed OEM x-ray system that was utilized for analog or Computed Radiography are limited to integration between the hand-switch and it's connector to the x-ray console.
All integration work must be conducted by qualified service personnel and proper operation verified before releasing system for use on patients.
SUMMARY OF STUDIES AND SAFETY III.
Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below. No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.
Recognized Consensus Standards
IEC 62220-1 Edition 1.0 (2003-10) Medical electrical equipment -. Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
IEC 62220-1-3 Edition 1.0 (2008-06) Medical electrical equipment -● Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment -. Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
IEC PAS 61910-1 First Edition 2007-07 Medical electrical equipment -. Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
. NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set
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Image /page/5/Picture/0 description: The image contains the logo for Kubtec. The logo features a series of overlapping squares in shades of gray and blue on the left. To the right of the squares is the word "kubtec" in red, with the tagline "GOING BEYOND THE SURFACE" in smaller, dark blue letters underneath.
. IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2 43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
NEMA XR 24-2008 (R2014) Primary user controls for interventional . angiography x-ray equipment
IV. BASIS FOR THE SUBMISSION
This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 to show Substantial Equivalence of the proposed device and the predicate device.
- PerkinElmer XRpad 4336 MED (K140551)
There is no change for the indication for use from the predicate 510(k) approved device.
| Design and Use of the Device | |||
|---|---|---|---|
| Question | YES | NO | |
| Is the device intended for prescription use (21 CFR 801 Subpart D) ? | X | ||
| Is the device intended for over-the-counter use (21 CFR807 Subpart C)? | X | ||
| Is the device provided sterile? | X | ||
| Is the device intended for single use? | X | ||
| Is the device a reprocessed single use device? | X | ||
| If yes, does this device type require reprocessed validation data? | |||
| Does the device contain a drug? | X | ||
| Does the device contain a biologic? | X | ||
| Does the device use software? | X | ||
| Does the submission include clinical information? | X | ||
| Is the device implanted? | X |
V. COMPARISON CHART
| Characteristics | Proposed device Kubtec
DIGIVIEW 395 | Predicate device
(K140551)
PerkinElmer XRpad
4336 MED |
| ----------------- | ------------------------------------------ | ---------------------------------------------------------------- |
|---|
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Image /page/6/Picture/0 description: The image shows the Kubtec logo. On the left side of the logo are three overlapping squares that are different shades of gray and blue. To the right of the squares is the word "kubtec" in red font. Below the word "kubtec" is the phrase "GOING BEYOND THE SURFACE" in a smaller, gray font.
| Intended Use/ Indications
for Use | The DIGIVIEW 395, when used with a
radiographic imaging system, is indicated
for use in generating radiographic images
of human anatomy for diagnostic X-ray
procedures, wherever conventional
screen-film (SF), digital radiography (DR),
or computed radiography (CR) systems
may be used. It is not intended for
mammographic use. | The XRPad 4336 MED,
when used with a
radiographic imaging
system, is indicated for
use in generating
radiographic images of
human anatomy for
diagnostic X-ray
procedures, wherever
conventional screen-
film (SF), digital
radiography (DR), or
computed radiography
(CR) systems may be
used. It is not intended
for mammographic
use. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Panel | Single substrate amorphous silicon active
TFT/diode array | Same |
| Scintillator | Direct deposition Csi:TI | Same |
| Pixel matrix | 3556 x 4320 pixels | Same |
| Pixel Pitch | 100 μm | Same |
| Active area | 355 mm x 432 mm | Same |
| External dimensions
(w x l x h) | 384 mm x 460 mm x 15 mm | Same |
| Weight | Approximately 4 kg | Same |
| Housing material | Aluminum with carbon-fiber | Same |
| Communication interface | Gb Ethernet or 802.11n WiFi | Same |
| Power | External power supply or battery | Same |
SUBSTANTIAL EQUIVALENCE VI.
The proposed device and predicate device DIGIVIEW 395 is substantially equivalent to the following currently cleared predicate device:
- PerkinElmer XRpad 4336 MED (K140551) a.
The proposed and predicate devices utilize the same technology and materials, comparable safety and effectiveness features, and is similar in design and construction. The Indications for Use and labeling are the same and our labeling contain the required Cautions, Warnings and Contraindications consistent to those required for similar cleared devices. Both systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive. The only difference is utilization of Kubtec's DIGICOM
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Image /page/7/Picture/0 description: The image contains the logo for Kubtec. The logo consists of a series of overlapping squares in shades of gray and blue, followed by the word "kubtec" in red, and the tagline "GOING BEYOND THE SURFACE" in a smaller, sans-serif font. The logo is clean and modern, with a focus on the company name and tagline.
software to manage operation of detector which had previously received 510(K with the Kubtec KUB250 (K141539) and the Kubtec Digiview 250 (K103348)
VII. CONCLUSION
The DIGIVIEW 395 is as safe and effective as the predicate device, has no technological differences in the hardware, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices and conforms to applicable medical device safety standards. The only difference is utilization of Kubtec's DIGICOM software to manage operation of detector which had previously received 510(K) with the Kubtec KUB250 (K141539) and the Kubtec Digiview 250 (K103348)