(56 days)
Not Found
No
The summary describes standard image processing and analysis techniques for DWI and PWI data, without mentioning any AI or ML methodologies. The performance studies compare the device to a predicate device using traditional metrics, not AI/ML-specific validation.
No
This device is image processing software that provides analysis results to medical professionals, but it does not directly treat or diagnose a disease.
No
This device is image processing software, which performs analysis of medical images (DWI and PWI) to calculate parameters related to tissue flow and blood volume. While it provides analysis results that medical professionals can review, it does not directly diagnose conditions. The software supports professionals in their diagnostic process by providing quantitative data, but it is not itself a diagnostic device.
Yes
The device is explicitly described as "image processing software package" and "image processing software designed to analyze" images. It runs on standard off-the-shelf computers or virtual platforms and receives data from DICOM-compliant devices. There is no mention of proprietary hardware components included with the device.
Based on the provided information, JLK-PWI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze specimens from the human body. The core function of an IVD is to examine biological samples like blood, urine, tissue, etc., to provide information about a person's health.
- JLK-PWI analyzes medical images. The software processes and analyzes images acquired directly from a patient's brain using an MRI scanner. It does not interact with or analyze biological specimens.
- The intended use and device description clearly state image processing and analysis. The documentation focuses on the software's ability to view, process, and analyze DWI and PWI images from MRI systems.
Therefore, JLK-PWI falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
JLK-PWI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of Diffusion-weighted imaging (DWI) and Perfusion-weighted imaging (PWI) images for the brain from Magnetic Resonance Imaging (MRI) systems. Data and images are acquired through DICOM-compliant imaging devices. JLK-PWI provides both viewing and analysis capabilities for dynamic imaging datasets obtained through MRI protocols.
The DWI analysis capabilities are used to analyze local water diffusion properties from diffusionweighted MRI data.
The PWI analysis capabilities are for analyzing dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculating parameters related to tissue flow (perfusion) and tissue blood volume.
Product codes
LLZ
Device Description
JLK-PWI is image processing software designed to analyze Diffusion-weighted imaging (DWI) and Perfusionweighted imaging (PWI) images from Magnetic Resonance Imaging (MRI) scanners. The software calculates local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images.
JLK-PWI can be used to communicate with a DICOM-compliant device or a PACS server to receive DWI and PWI images. The software is designed to automatically receive and analyze DWI and PWI images with DICOM image data. The analyzed diffusion and perfusion parameters, which are related to the tissue blood flow and volume, are written to the source DICOM and stored in the data storage. Medical professionals can review the analysis results through the implemented user interface (UI) or a connected PACS server.
Mentions image processing
JLK-PWI is an image processing software package
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians and medical technicians.
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)
JLK, Inc. conducted extensive performance validation testing and software verification of the JLK-PWI system. This performance validation testing demonstrated that the JLK-PWI system accurately represents key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. The documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Content of Premarket Submissions for Device Software Functions," June 14, 2023.
JLK-PWI demonstrated reliable and accurate performance in calculating local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images. The software's results were substantially equivalent to those obtained using RAPID. These results indicate that JLK-PWI meets the predetermined performance criteria, validating its reliability and accuracy in analyzing DWI and PWI images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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November 4, 2024
JLK. Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K242709
Trade/Device Name: JLK-PWI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 28, 2024 Received: October 29, 2024
Dear Dave Yungvirt:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical
2
devices/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,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K242709
Device Name
JLK-PWI
Indications for Use (Describe)
JLK-PWI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of Diffusion-weighted imaging (DWI) and Perfusion-weighted imaging (PWI) images for the brain from Magnetic Resonance Imaging (MRI) systems. Data and images are acquired through DICOM-compliant imaging devices. JLK-PWI provides both viewing and analysis capabilities for dynamic imaging datasets obtained through MRI protocols.
The DWI analysis capabilities are used to analyze local water diffusion properties from diffusionweighted MRI data.
The PWI analysis capabilities are for analyzing dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculating parameters related to tissue flow (perfusion) and tissue blood volume.
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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Image /page/4/Picture/0 description: The image shows a logo with the letters JLK in blue, with a unicorn graphic above them. The unicorn is white with a red horn and blue wings. Above the unicorn is a blue vertical rectangle.
October 21, 2024
K242709 510(k) Summary
1. Contact Details (21 CFR 807.92(a)(1))
- Applicant Name: JLK, Inc.
- Applicant Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
- Applicant Contact Telephone: (+82)1038507933
- Applicant Contact: Dr. Dongmin Kim
- Applicant Contact Email: dmkim@jlkgroup.com
- Correspondent Name: JLK, Inc.
- Correspondent Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
- Correspondent Contact Telephone: (+82)1087641328
- Correspondent Contact: Dr. Jeeah Shin
- Correspondent Contact Email: jashin@jlkgroup.com
| 2. Device Name [21 CFR 807.92(a)(2)] | |
|---|---|
| Device Trade Name | JLK-PWI |
| Common Name | Medical image management and processing system |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 892.2050 |
| Product Code(s) | LLZ |
2. Device Name (21 CFR 807.92(a)(2))
3. Legally Marketed Predicate Devices (21 CFR 807.92(a)(3))
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K121447 | iSchemaView RAPID | LLZ |
4. Device Description Summary (21 CFR 807.92(a)(4))
JLK-PWI is image processing software designed to analyze Diffusion-weighted imaging (DWI) and Perfusionweighted imaging (PWI) images from Magnetic Resonance Imaging (MRI) scanners. The software calculates local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images.
JLK-PWI can be used to communicate with a DICOM-compliant device or a PACS server to receive DWI and PWI images. The software is designed to automatically receive and analyze DWI and PWI images with DICOM image data. The analyzed diffusion and perfusion parameters, which are related to the tissue blood flow and volume, are written to the source DICOM and stored in the data storage. Medical professionals can review the analysis results through the implemented user interface (UI) or a connected PACS server.
5. Intended Use/Indications for Use (21 CFR 807.92(a)(5))
JLK-PWI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of Diffusion-weighted imaging (DWI) and Perfusion-weighted
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Image /page/5/Picture/0 description: The image shows a logo with the letters JLK in blue. Above the letters is a stylized image of a unicorn with wings. The unicorn is mostly blue, but the horn is red. Above the unicorn is a blue vertical bar.
imaging (PWI) images for the brain from Magnetic Resonance Imaging (MRI) systems. Data and images are acquired through DICOM-compliant imaging devices.
JLK-PWI provides both viewing and analysis capabilities for dynamic imaging datasets obtained through MRI protocols.
The DWI analysis capabilities are used to analyze local water diffusion properties from diffusion-weighted MRI data.
The PWI analysis capabilities are for analyzing dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculating parameters related to tissue flow (perfusion) and tissue blood volume.
6. Indications for Use Comparison (21 CFR 807.92(a)(5))
JLK-PWI is an image processing software package that is substantially equivalent to iSchemaView Inc.'s RAPID (K121447), which is a previously cleared predicate devices share the same intended use, similar indications, technological characteristics, and principles of operation.
7. Technological Comparison (21 CFR 807.92(a)(6))
The proposed and predicate devices are brain DWI and PWI analysis tools designed to support trained professionals including but not limited to physicians and medical technicians. JLK-PW1 integrates seamlessly with the hospital's MR equipment or PACS server, receiving DWI and PWI DICOM images and analyzing diffusion and perfusion parameters such as Apparent Diffusion Coefficient (ADC), Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Mean Transit Time (MTT), and Residue function time-to-peak (Tmax).
The proposed and predicate devices are equally intended for use as analysis tools in image processing for a MR perfusion study. Both devices run on standard physical and/or virtual servers installed within the hospital's network and protected by the firewall.
8. Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))
JLK, Inc. conducted extensive performance validation testing and software verification of the JLK-PWI system. This performance validation testing demonstrated that the JLK-PWI system accurately represents key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. The documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Content of Premarket Submissions for Device Software Functions," June 14, 2023.
JLK-PWI demonstrated reliable and accurate performance in calculating local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images. The software's results were substantially equivalent to those obtained using RAPID. These results indicate that JLK-PWI meets the predetermined performance criteria, validating its reliability and accuracy in analyzing DWI and PWI images.
In conclusion, JLK-PWI, which has the same intended use and exhibits substantially equivalent technological, safety, and performance characteristics, is substantially equivalent to the legally marketed predicate device, iSchemaView RAPID (K121447).