(279 days)
No
The device description explicitly states, "XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes," which is a common application of AI/ML in medical imaging. The summary also lacks any mention of AI, ML, or related terms, and there is no description of training or test sets typically associated with AI/ML development.
No
The device is a software for viewing and manipulating medical images, intended for diagnostic purposes, not for providing therapy.
No.
The device is purely for viewing and manipulating existing medical images, and does not include any automated or semi-automated process for the detection of nodules or other shapes, which would be characteristic of a diagnostic device. It explicitly states that "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation."
Yes
The device description explicitly states "XELIS 3D is a software package" and details its functions as software-based image viewing and manipulation, without mentioning any accompanying hardware components provided by the manufacturer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "viewing of images acquired from various imaging modalities" and for "capturing, storing, communicating, processing, and displaying" these images. This describes a medical image viewing and processing software, not a device that performs tests on biological specimens (which is the core function of an IVD).
- Device Description: The description reinforces this by stating it's a "software package intended for viewing and manipulating DICOM-compliant medical images." It mentions functions like 3D volume rendering, segmentation, and registration, all related to image processing and visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests. The focus is entirely on medical imaging data.
Therefore, Xelis 3D™ is a medical image processing and viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Product codes
LLZ
Device Description
XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.
XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.
XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.
XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DR, US, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Clinicians and referring Physicians.
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)
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS 3D software in each operational mode and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client. results are provided in the 510(k)
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).
0
JUL 28 2011
103130
1
This 510(k) summary of safety information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: June 1, 2011
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Tristan Choi, Program Manager INFINITT Co., Ltd. 12F Daerung Post Tower III, 182-4 Guro-dong, Guro-gu, Seoul, 152-050, Korea Tel: +82-2-2194-6673 Fax: +82-2-2194-1698
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | XELIS 3D |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Device Classification: | 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K082990 | K070831 |
|---|---|---|
| Device Classification Name | System, image | |
| processing, radiological | System, image | |
| processing, radiological | ||
| Device Name | INFINITT XELIS | Voxar 3D Enterprise with |
| ColonMetrix and PET/CT | ||
| Perfusion | ||
| Applicant | INFINITT CO., LTD | BARCOVIEW MIS |
| EDINBURGH | ||
| Regulation Number | 892.2050 | 892.2050 |
| Classification Product Code | LLZ | LLZ |
| Decision Date | 11/20/2008 | 05/22/2007 |
| Classification Advisory | ||
| Committee | Radiology | Radiology |
| Type | Traditional | Traditional |
Device Description: 21 CFR 807 92(a)(4)
XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.
1
510(k) Summary of Safety
XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.
XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.
XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.
Indications for Use: 21 CFR 807 92(a)(5)
Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US, PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Technological Characteristics: 21 CFR 807 92(a)(6)
XELIS 3D is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians.
A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS 3D software in each operational mode and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
2
510(k) Summary of Safety
If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client. results are provided in the 510(k)
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for XELIS 3D contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate devices.
Therefore, XELIS 3D is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Infinitt Co., Ltd. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories 1285 Walt Whitman Rd. MELVILLE NY 11747
JUL 2 8 2011
Re: K103130
Trade/Device Name: Xelis 3DTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 29, 2011 Received: July 1, 2011
Dear Mr. Conry:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K / / 3 / 30
Device Name: Xelis 3D™
Indications for Use:
Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mohd. O'Khas
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K103130
Page 1 of