(413 days)
Not Found
No
The document explicitly states that the algorithm behind the core image calculation is the same as the predicate device (K190993) and does not mention any AI or ML components. The changes described are related to post-processing functions, DICOM handling, and automatic features, none of which indicate the use of AI/ML.
No
This device is described as medical diagnostic software intended to visualize blood vessel structures and assist physicians in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. It provides image-guided solutions, but its primary function is diagnostic imaging and analysis, not direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "stand-alone diagnostic assessment, post-processing, reporting." The "Device Description" also explicitly refers to it as "medical diagnostic software" and mentions "diagnostic review."
Yes
The device description explicitly states that KMIT v4.0 is "medical diagnostic software" and can be deployed on "independent workstation hardware" or "several kinds of angiography systems," indicating it is a software component that runs on existing hardware, not a hardware device itself. The comparison to the predicate device also focuses on software features and algorithms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- KMIT v4.0 Function: The description clearly states that KMIT v4.0 is medical diagnostic software intended to visualize blood vessel structures by detecting the movement of contrast during angiography examinations. It processes medical images obtained from imaging modalities like digital radiographic, fluoroscopic, interventional, and angiographic systems.
- No Sample Analysis: There is no mention of KMIT v4.0 analyzing any biological samples from the patient. Its function is solely based on processing and visualizing medical images.
Therefore, KMIT v4.0 falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is intended to visualize blood vessel structures by detecting the movement of the contrast bolus during angiography examination and to give the medical experts the option to reduce x-ray dose. The effectively achievable radiation reduction depends on the characteristics of the different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally appled acquisition protocols. The software is intended to be used in addition to, or as a replacement for current DSA imaging. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting. It can be configured within a network to send and receive DICOM data. Furthermore, KMIT v4.0 can be deployed on several kinds of angiography systems. It provides solutions in the operating room for imageguided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be also combined with fluoroscopic or radiographic systems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, optimization, communication, reporting, and storage of medical images and data on exchange media. It provides imageguided solutions in the operating room, for image-guided surgery, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. KMIT v4.0 is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems. The algorithm behind the Digital Variance Angiography (DVA) image calculation is the same in KMIT v2.2 (Kinepict Health Ltd. under K190993) and v4.0 (see Device Description / Calculation of DVA section). The postprocessing functions like contrast and brightness settings, choosing mask image, pixel shift applications, and anonymizing options are the same in the two software. Image storing and image sending functions are using the same DICOM technic and ports as Kinepict Medical Imaging Tool v2.2. In v4.0 automatic upload to PACS and automatic opening of screen size view is implemented. These differences do not have any effect on safety and efficiency. In summary, the KMIT v4.0 software does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiography, digital radiographic, fluoroscopic, interventional
Anatomical Site
blood vessel structures, lower limb X-ray angiography (abdominal, femoral, crural regions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical experts, physician / operating room, cath labs
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
Our prospective study enrolled 30 PAD patients (Fontaine IIb-IV, mean age 70 years, range 52-85 years; 10 females, mean age 73 years, range 55-85 years; and 20 males, mean age 69 years, range 52-85) undergoing diagnostic lower limb X-ray angiography between April and July 2019. In all enrolled patients, both normal and low-dose protocols were used for the acquisition of images in three anatomical regions (abdominal, femoral, crural). The contrastto-noise ratio (CNR) of DSA and retrospectively generated DVA images were calculated, and the quality was evaluated by seven specialists using a 5-grade Likert scale. For investigating non-inferiority, the difference of low-dose DVA (ldDVA) and normal dose DSA (ndDSA) scores was analyzed by the one-sample Wilcoxon test. The diagnostic value of low-dose DVA images was compared to that of normal dose DSA images in a task-based survey, where six readers were asked to identify the different artery segments, and evaluate the degree of stenosis on a 5-grade scale.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data: Digital Variance Angiography allows reduction of radiation exposure in X-ray angiography. This was tested in a prospective interventional clinical study on Peripheral Artery Disease (PAD) patients (n=30). The aim was to investigate whether the previously observed quality reserve of DVA can be used for the reduction of DSA-related radiation exposure during lower X-ray angiography using ICM.
Key Results: DVA produced consistently higher (two to threefold) CNR than DSA. The highest ratios (3.0-3.1) were observed in the crural region. IdDVA received significantly higher visual evaluation scores in the crural region than ndDSA (difference 0.25±0.07, p=0.001). No significant difference in the femoral region (-0.08±0.06, p=0.435). ndDSA received significantly higher score in the abdominal region (-0.26±0.12, p=0.036), but after exclusion of patients with excessive intestinal gases (3/30, 10% of patients), the difference in the abdominal region decreased to (-0.10 ± 0.09, p=0.350) and was no longer significant. In the task-based diagnostic test there was no significant difference in the overall number of recognized arteries (ndDSA: 5.56 ± 0.01, ldDVA: 5.46 ± 0.01) and in the proportion of arteries suitable for diagnosis (ndDSA: 92.3 ± 0.1 %, ldDVA: 93.5 ± 0.1 %). The accuracy of ndDSA and ldDVA was identical in the abdominal and femoral regions, but ldDVA had a highest accuracy in the crural region (91% vs 80%) when discordant decisions were supervised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ldDVA reproduced the ndDSA diagnostic categories with 0.84 sensitivity and 0.84 specificity.
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.
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
September 10, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Kinepict Health Ltd % Lilla Strobel Quality and Regulatory Manager Kelta köz 5 Budakeszi 2092 HUNGARY
Re: K202056
Trade/Device Name: Kinepict Medical Imaging Tool 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 9, 2021 Received: August 9, 2021
Dear Lilla Strobel:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202056
Device Name Kinepict Medical Imaging Tool 4.0
Indications for Use (Describe)
Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is intended to visualize blood vessel structures by detecting the movement of the contrast bolus during angiography examination and to give the medical experts the option to reduce x-ray dose. The effectively achievable radiation reduction depends on the characteristics of the different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally appled acquisition protocols. The software is intended to be used in addition to, or as a replacement for current DSA imaging. KMT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting. It can be configured within a network to send and receive DICOM data. Furthermore, KMIT v4.0 can be deployed on several kinds of angiography systems. It provides solutions in the operating room for imageguided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be also combined with fluoroscopic or radiographic systems.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Kinepict Medical Imaging Tool Traditional 510(k). The logo consists of the word "Kinepict" in a stylized font, with three orange squares and one black square above it. The text "Kinepict Medical Imaging Tool Traditional 510(k)" is below the logo.
1.510(k) Summary
510(K) Summary: Kinepict Health Imaging Tool Kinepict Health Ltd Company:
2092 Kelta köz 5. Budakeszi, Hungary
Date Prepared:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
General Information:
Importer/Distribution
Kinepict Health Ltd
2092 Kelta köz 5.
Budakeszi, Hungary
Manufacturing Site:
Kinepict Health Ltd
1026 Budapest Júlia utca 11
Budapest, Hungary
Contact Person
Ms. Lilla Strobel
Quality Assurance Manager
Kinepict Health Ltd Hungary
1025 Budapest Júlia utca 11
Budapest. Hungary
Phone: +36317852260
Email: lilla.strobel@kinepict.com
Device Name and Classification:
Trade Name:
Kinepict Medical Imaging Tool
4
Image /page/4/Picture/0 description: The image shows the logo for Kinepict Medical Imaging Tool Traditional 510(k). The logo features the word "Kinepict" in a stylized font, with the letters in orange. Above the word, there are four squares, three of which are orange and one of which is black. Below the logo, the text "Kinepict Medical Imaging Tool Traditional 510(k)" is written in a smaller font.
| Classification Name: | Medical image management and processing system |
|---|---|
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892. 2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Legally Marketed Predicate Device | |
| Trade Name: | Kinepict Medical Imaging Tool 2.2 |
| 510(k) Clearance | K190993 |
| Clearance Date | March 5, 2020 |
| Classification Name: | Medical image management and processing system |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892. 2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
Recall Information: This predicate device has not been the subject of any design related recalls.
a. Device Description:
The Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, optimization, communication, reporting, and storage of medical images and data on exchange media. It provides imageguided solutions in the operating room, for image-guided surgery, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. KMIT v4.0 is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems. The algorithm behind the Digital Variance Angiography (DVA) image calculation is the same in KMIT v2.2 (Kinepict Health Ltd. under
5
Image /page/5/Picture/0 description: The image shows the logo for Kinepict Medical Imaging Tool Traditional 510(k). The logo features the word "Kinepict" in a stylized font, with three orange squares and one black square above the word. Below the logo, the text "Kinepict Medical Imaging Tool Traditional 510(k)" is written in a smaller font.
K190993) and v4.0 (see Device Description / Calculation of DVA section). The postprocessing functions like contrast and brightness settings, choosing mask image, pixel shift applications, and anonymizing options are the same in the two software. Image storing and image sending functions are using the same DICOM technic and ports as Kinepict Medical Imaging Tool v2.2. In v4.0 automatic upload to PACS and automatic opening of screen size view is implemented. These differences do not have any effect on safety and efficiency. In summary, the KMIT v4.0 software does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
b. Intended use
Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is intended to visualize blood vessel structures by detecting the movement of the contrast bolus during angiography examination and to give the medical experts the option to reduce x-ray dose. The effectively achievable radiation reduction depends on the characteristics of the different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally appled acquisition protocols. The software is intended to be used in addition to, or as a replacement for current DSA imaging. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting. It can be configured within a network to send and receive DICOM data. Furthermore, KMIT v4.0 can be deployed on several kinds of angiography systems. It provides solutions in the operating room for image-guided surgery, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be also combined with fluoroscopic or radiographic systems.
c. Substantial Equivalence
The Kinepict software has the same intended use as the Kinepict Medical Imaging Tool v2.2 (Kinepict Health Ltd. under K190993) software, but the performance with lower x-ray dose is clinically proven. Between the postprocessing functions: contrast and brightness settings, choosing mask image, pixel shift applications and anonimising options are the same in two
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Image /page/6/Picture/0 description: The image shows the logo for Kinepict Medical Imaging Tool Traditional 510(k). The logo consists of the word "Kinepict" in orange letters, with a graphic of orange and black squares above it. Below the logo is the text "Kinepict Medical Imaging Tool Traditional 510(k)".
software. Image storing and image sending functions are used the same DICOM technic and ports as Kinepict Medical Imaging Tool v2.2 (Kinepict Health Ltd. under K190993).
These differences do not have an effect on safety and efficiency compared with the predicate software. In summary, the Kinepict software does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
In conclusion, the Kinepict is substantially equivalent to Kinepict Medical Imaging Tool v2.2 (Kinepict Health Ltd. under K190993).
d. Performance Data
a. Clinical data
Digital Variance Angiography allows reduction of radiation exposure in X-ray angiography
The dose management capability of the Kinepict Medical Imaging Tool and the Digital Variance Angiography (DVA) technology was tested in a prospective interventional clinical study on Peripheral Artery Disease (PAD) patients. The aim was to investigate whether the previously observed quality reserve of DVA can be used for the reduction of DSA-related radiation exposure during lower X-ray angiography using ICM.
Our prospective study enrolled 30 PAD patients (Fontaine IIb-IV, mean age 70 years, range 52-85 years; 10 females, mean age 73 years, range 55-85 years; and 20 males, mean age 69 years, range 52-85) undergoing diagnostic lower limb X-ray angiography between April and July 2019. In all enrolled patients, both normal and low-dose protocols were used for the acquisition of images in three anatomical regions (abdominal, femoral, crural). The contrastto-noise ratio (CNR) of DSA and retrospectively generated DVA images were calculated, and the quality was evaluated by seven specialists using a 5-grade Likert scale. For investigating non-inferiority, the difference of low-dose DVA (ldDVA) and normal dose DSA (ndDSA) scores was analyzed by the one-sample Wilcoxon test. The diagnostic value of low-dose DVA images was compared to that of normal dose DSA images in a task-based survey, where six readers were asked to identify the different artery segments, and evaluate the degree of stenosis
7
Image /page/7/Picture/0 description: The image shows the logo for Kinepict Medical Imaging Tool Traditional 510(k). The logo consists of the word "Kinepict" in orange letters, with three orange squares and one black square above the word. Below the logo, the words "Kinepict Medical Imaging Tool Traditional 510(k)" are written in black.
on a 5-grade scale. The endpoints were the number of recognized arteries, the proportion of arteries suitable for diagnostic evaluation, and the sensitivity and specificity of low dose DVA images to obtain the same diagnostic category as the normal dose DSA images.
DVA produced consistently higher (two to threefold) CNR than DSA. The highest ratios (3.0-3.1) were observed in the crural region. In line with this, IdDVA received significantly higher visual evaluation scores in the crural region than ndDSA (difference 0.25±0.07, p=0.001). There was no significant difference in the femoral region (-0.08±0.06, p=0.435), but ndDSA received significantly higher score in the abdominal region (-0.26±0.12, p=0.036). However, after exclusion of patients with excessive intestinal gases (3/30, 10% of patients), the difference in the abdominal region decreased to (-0.10 ± 0.09, p=0.350) and was no longer significant. In the task-based diagnostic test there was no significant difference in the overall number of recognized arteries (ndDSA: 5.56 ± 0.01, ldDVA: 5.46 ± 0.01) and in the proportion of arteries suitable for diagnosis (ndDSA: 92.3 ± 0.1 %, ldDVA: 93.5 ± 0.1 %). IdDVA reproduced the ndDSA diagnostic categories with 0.84 sensitivity and 0.84 specificity. When the discordant decisions were supervised and the valid diagnostic category was determined by an expert, the accuracy of ndDSA and ldDVA was identical in the abdominal and femoral regions, but ldDVA had a highest accuracy in the crural region (91% vs 80%).
The described clinical investigation is a proof-of-concept study, which demonstrates that the previously verified quality reserve of DVA can be effectively converted into radiation dose reduction without compromising the image quality and diagnostic value of angiograms. The study was performed using a Siemens Artis Zee angiography system and Ultravist 370 iodinated contrast medium, and provided evidence for a substantial dose reduction during lower limb X-ray angiography. The effectively achievable radiation reduction depends on the characteristics of different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally applied acquisition protocols. Nevertheless, this dose management capacity is based on the better image quality of DVA technology (a claim previously approved by FDA, see K190993), therefore a certain amount of radiation dose reduction will be achievable on other angiography systems as well.