(203 days)
Unknown
The description mentions "auto segmentation for specific target" and "advanced image quality improvement," which could potentially utilize AI/ML, but the summary does not explicitly state the use of AI, ML, or related terms like DNN. The lack of information on training/test sets further suggests that if AI/ML is used, it's not a primary focus of the summary provided.
No
The device is described as software for image processing and treatment planning, creating non-diagnostic 3D printed models, not a device used to treat a disease or condition.
No.
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The 3D printed models generated from the output file are meant for non-diagnostic use." It also mentions that the product "should be used in conjunction with other diagnostic tools."
Yes
The device description explicitly states "MEDIP PRO is medial image processing software" and the intended use describes it as a "software interface and image segmentation system". The performance studies focus on software validation and comparative performance tests of software functionalities. While it processes images from hardware (CT/MRI) and outputs files for hardware (3D printing), the device itself, as described, is the software.
Based on the provided information, MEDIP PRO is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the 3D printed models generated are for non-diagnostic use. It also emphasizes that MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement, implying it's a supporting tool, not a standalone diagnostic device.
- Device Description: While it processes medical images, its primary functions described are 3D reconstruction, visualization, segmentation, and exporting data for 3D printing. These are pre-operative planning and visualization tools, not diagnostic tests performed on biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. MEDIP PRO operates on medical images, not biological samples.
In summary, MEDIP PRO is a medical image processing software intended for pre-operative planning and visualization, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning.
The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MEDIP PRO is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis and etc. through loading DICOM file imaged from CT or MRI by user(doctors). Also, it supports exporting STL data for 3D printing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM imaging information from CT, MRI
Anatomical Site
Not Found
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)
Non-Clinical Test Summary:
-
Software Validation: The MEDIP PRO contains MODERATE level of concern software and was designed, developed, verified, and validated according to a software development process.
-
Performance Test: The MEDIP PRO application has been validated for its intended use to determine substantial equivalence to the predicate device. The device functionalities were performed, verified and validated to be within specification.
Comparative Performance Test: The MEDIP PRO engineers conducted a Comparative Performance Test for segmentation and measurement functionalities in the software with predicate device. This included:
- Measurement of Distance Phantom study
- Segmentation Performance
- Usability test System measurements & segmentation
Clinical Test Summary: No clinical studies were considered necessary and performed.
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
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
November 7, 2019
MEDICALIP Co., Ltd % GeumHyeon Kim Lead Consultant DT&S Co., Ltd. #202, Mario Tower, 28, Digital-ro 30-gil Guro-gu, 08389 SEOUL KR
Re: K191026
Trade/Device Name: Medip Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 5, 2019 Received: September 16, 2019
Dear GeumHyeon Kim:
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.
1
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 and Part 809); 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191026
Device Name MEDIP PRO
Indications for Use (Describe)
MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning.
The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.
| 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/3/Picture/0 description: The image is a logo for a company called MEDICAL IP. The logo features a blue semicircle above a blue line graph, which is likely meant to represent a heartbeat. Below the semicircle and line graph, the words "MEDICAL IP" are written in a sans-serif font. Underneath the company name is the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller font.
K191026
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
November 7, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | MEDICAL IP Co., Ltd. |
|---|---|
| - Address: | 7F, Changkyung Building,174, Yulgok-ro, Jongno-gu, Seoul, Republic of |
| Korea, 03127 | |
| - Telephone No.: | +82-2-2135-9148 |
3. Submission Correspondent
| - Name of company: | DT&S Co., Ltd. |
|---|---|
| - Address: | #202, Mario Tower, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, |
| Republic of Korea | |
| - Contact Name: | GeumHyeon Kim |
| - Contact Title | Lead Consultant |
| - E-mail Address | ghkim@dtncro.co.kr |
| - Telephone No.: | +82-2-357-8401 |
| - Fax No.: | +82-2-357-8027 |
4. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name | MEDIP PRO |
|---|---|
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communications system |
| Regulation Class | II |
| Product Code | LLZ |
| Product Code Name | System, Image Processing, Radiological |
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Image /page/4/Picture/0 description: The image shows the logo for Medical IP. The logo is blue and features a stylized heart rate line with a curved line above it. Below the graphic, the text "MEDICAL IP" is written in a sans-serif font, with the tagline "Empowering Medicine through Lifesaving Technologies" written in a smaller font below it.
5. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow:
| Predicate device | |
|---|---|
| - 510(k) Number: | K173619 |
| - Applicant: | Materialise N.V. |
| - Classification Name: | System, Image processing, Radiological |
| - Trade Name: | Mimics inPrint |
| Reference device | |
| - 510(k) Number: | K161841 |
| - Applicant: | 3D Systems, Inc. |
| - Classification Name: | System, Image processing, Radiological |
| - Trade Name: | D2P |
6. Description of the Device [21 CFR 807.92(a)(4)]
MEDIP PRO is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis and etc. through loading DICOM file imaged from CT or MRI by user(doctors). Also, it supports exporting STL data for 3D printing.
7. Indications for Use [21 CFR 807.92(a)(5)]
MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning.
The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.
8. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences in the technological characteristics of this device compared to the predicate devices which adversely affect safety or effectiveness. The below table is summarized and compared with the technological characteristics between the MEDIP PRO and the predicate device:
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Image /page/5/Picture/0 description: The image shows the logo for Medical IP. The logo features a blue semicircle above a blue line that resembles a heart rate monitor. Below the graphic is the text "MEDICAL IP" in a sans-serif font, with the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller font underneath.
| Table 1. Technological Characteristics Comparison | ||
|---|---|---|
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| K Number | K191026 | K173619 | K161841 |
| Manufacturer | MEDICALIP.CO.,LTD | Materialise N.V. | 3D Systems, Inc. |
| Model | MEDIP PRO | Mimics inPrint | D2P |
| Product Code | LLZ | LLZ | LLZ |
| Indications | |||
| for Use | MEDIP PRO is intended for | ||
| use as a software interface | |||
| and image segmentation | |||
| system for the transfer of | |||
| DICOM imaging | |||
| information from a medical | |||
| scanner to an output file. It | |||
| is also used as pre-operative | |||
| software for treatment | |||
| planning. | |||
| The 3D printed models | |||
| generated from the output | |||
| file are meant for non- | |||
| diagnostic use. MEDIP PRO | |||
| should be used in | |||
| conjunction with other | |||
| diagnostic tools and expert | |||
| clinical judgement. | Mimics inPrint is intended | ||
| for use as a software | |||
| interface and image | |||
| segmentation system for the | |||
| transfer of DICOM imaging | |||
| information from a medical | |||
| scanner to an output file. It | |||
| is also used as pre-operative | |||
| software for treatment | |||
| planning. For this purpose, | |||
| the Mimics inPrint output | |||
| file can be used for the | |||
| fabrication of physical | |||
| replicas of the output file | |||
| using traditional or additive | |||
| manufacturing methods. | |||
| The physical replica can be | |||
| used for diagnostic purposes | |||
| in the field of orthopedic, | |||
| maxillofacial and | |||
| cardiovascular applications. | |||
| Mimics inPrint should be | |||
| used in conjunction with | |||
| other diagnostic tools and | |||
| expert clinical judgement. | The D2P software is | ||
| intended for use as a | |||
| software interface and | |||
| image segmentation system | |||
| for the transfer of imaging | |||
| information from a medical | |||
| scanner such as a CT | |||
| scanner to an output file. It | |||
| is also intended as pre- | |||
| operative software for | |||
| surgical planning. | |||
| 3D printed models | |||
| generated from the output | |||
| file are meant for visual, | |||
| non-diagnostic use. | |||
| Type of Use | Prescription Use | Prescription Use | Prescription Use |
| Component | Stand-alone software | Stand-alone software | Stand-alone software |
| Image | |||
| Support Type | DICOM imaging | ||
| information from CT, MRI | DICOM imaging | ||
| information from CT, MRI | DICOM imaging | ||
| information from CT, MRI | |||
| Feature/ | |||
| Functionality | Analysis & Measurement | ||
| Image Enhancement | |||
| 2D/3D visualization | |||
| Segmentation | |||
| 3D Rendering | |||
| Exporting STL data for 3D | |||
| Printing | Analysis & Measurement | ||
| Image Enhancement | |||
| 2D/3D visualization | |||
| Segmentation | |||
| 3D Rendering | |||
| Exporting STL data for 3D | |||
| Printing | Analysis & Measurement | ||
| Image Enhancement | |||
| 2D/3D visualization | |||
| Segmentation | |||
| 3D Rendering | |||
| Exporting STL data for 3D | |||
| Printing |
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Image /page/6/Picture/0 description: The image shows a logo for a company called "MEDICAL IP". The logo features a blue graphic of a heartbeat line underneath a curved line. Below the graphic, the words "MEDICAL IP" are written in a bold, sans-serif font. Underneath the company name is the tagline "Empowering Medicine through Lifesaving Technologies" in a smaller, lighter font.
A detailed comparison shows the subject device is substantially equivalent in intended use, software type, modality support operating system, image communication standard and functionality to the predicate device. The subject device only intends to be a software for treatment planning and does not include the simulation of treatment options. The 3D printed models generated from the output file are meant for nondiagnostic use.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
-
- Software Validation
The MEDIP PRO contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
- Software Validation
The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
- · Verification of each independent software subsystem against defined requirements
- · Verification of interfaces between software subsystems against defined interface requirements
- · Validation of fully integrated system including all subsystems against overall system requirements.
-
- Performance Test
The MEDIP PRO application has been validated for its intended use to determine substantial equivalence to the predicate device. The device functionalities were performed, verified and validated to be within specification.
Comparative Performance Test
The MEDIP PRO engineers conducted a Comparative Performance Test for segmentation and measurement functionalities in the software with predicate device.
- · Measurement of Distance Phantom study
- · Segmentation Performance
- · Usability test System measurements & segmentation
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
9. Conclusion [21 CFR 807.92(b)(3)]
Based on a comparison of the intended use and technological characteristics, the MEDIP PRO software is substantially equivalent to the identified predicate device and reference device. Minor differences in technological and performance characteristics did not raise new or different questions of safety and effectiveness. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device and reference device.