(84 days)
Not Found
No
The summary describes standard medical image viewing and manipulation software features (DICOM viewing, 3D rendering, virtual endoscopy) and explicitly states "Mentions AI, DNN, or ML: Not Found". There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as a software package for viewing and manipulating medical images, which is diagnostic in nature, not therapeutic. It does not exert any direct treatment or therapy on a patient.
No.
The device is described for "viewing and manipulating DICOM-compliant medical images" and "real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports," but it does not claim to provide a diagnosis or aid in making a diagnosis.
Yes
The device description explicitly states "REX™ 1.0 is a software package" and "The proposed software provides..." without mentioning any accompanying hardware components that are part of the regulated device. The performance studies focus on software validation and DICOM conformance.
Based on the provided information, REX™ 1.0 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description of REX™ 1.0 clearly state that it is for viewing and manipulating medical images acquired from CT scanners. This is an in-vivo (within the living body) imaging modality, not an in-vitro (outside the living body) diagnostic test.
- The functions described are image processing and visualization. REX™ 1.0 performs tasks like real-time image viewing, manipulation, 3D rendering, and virtual endoscopy. These are all related to processing and presenting medical images, not analyzing biological samples.
Therefore, REX™ 1.0 falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
REX™ 1.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained 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)
The proposed REX™ 1.0 software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3.0. Validation testing was provided that confirms that REX™ 1.0 performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification.
To ensure performance to specifications, Federal Regulations and User Requirements:
- Software Development Practices and .
- The Validation and Verification Process .
have been followed. Procedures specify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation and maintenance.
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.
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
JUN 2 7 2002
Section II - Section 510(k) Premarket Notification Summary (as required by 807.92 (j))
Submitter:
PointDx, Inc. 635 West Fourth Street, Suite 200 Winston-Salem. NC 27101 Phone: 336.723.1450 Fax: 336.723.1458
Date Prepared:
April 2, 2002
Contact Person(s):
Francis Bonk, Director of Quality Assurance and Regulatory Affairs 336-723-1450 (v) 336-723-1458 (f)
r
Device Trade Name:
REXTM
Device Common Name:
PACS / Image Processing Software
Classification Name:
Class II - System, Image Processing, RA (90) LLZ
Substantially Equivalent To:
Rapidia® V 2.0 (K012290) 3D Med Co. Ltd. 940-319 Research Park SNU. San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 Republic of Korea
Device Description:
REX™ 1.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Indications for Use:
REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing. image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Technological Comparison to Predicate Device:
The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant CT images. The proposed and predicate software can be operated from a personal computer. REX™ 1.0 is a subset of the Rapidia® V 2.0 features with an added monitor to allow a Radiologist the convenience of using two monitors, one for image viewing, and the other for report viewing. The REX ™1.0 software has substantially equivalent features and
1
specifications versus the existing Rapidia® V 2.0, for those features and specifications the two devices have in common.
Non-Clinical Performance Data:
The proposed REX™ 1.0 software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3.0. Validation testing was provided that confirms that REX™ 1.0 performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification.
To ensure performance to specifications, Federal Regulations and User Requirements:
- Software Development Practices and .
- The Validation and Verification Process .
have been followed. Procedures specify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation and maintenance.
Adverse Effects on Health:
The potential hazards are identified in the Hazard Analysis and are controlled by:
-
. Designing controls directed at the cause and/or
il -
Introducing protective measures and/or ●
-
. Warning the Users.
Conclusions:
The REX™ 1.0 does not result in any new potential safety risks and performs in accordance with its intended use as well as the Rapidia® V 2.0 device currently on the market. PointDx considers features of the REX™ 1.0 to be substantially equivalent to the subset of features in common with Rapidia® V 2.0 (K012290) device.
2
Substantial Equivalence Chart
រួ
| System | REX™ | Rapidia® |
|---|---|---|
| Version | 1.0 | 2.0 |
| Manufacturer | PointDx, Inc. | 3D Med Co., Ltd. |
| 510(k) Number | K012290 | |
| Classification | Class II | |
| 892.2050 | ||
| 90 LLZ | Class II | |
| 892.2050 | ||
| 90 LLZ | ||
| Intended Use | REX™ 1.0 is a software package intended for | |
| viewing and manipulating DICOM- | ||
| compliant medical images acquired from CT | ||
| scanners. REX™ 1.0 can be used for real- | ||
| time image viewing, image manipulation, 3D | ||
| volume rendering, virtual endoscopy, and | ||
| issuance of reports. | Rapidia® is a software package | |
| intended for viewing and | ||
| manipulating DICOM-compliant | ||
| medical images from CT and MR | ||
| scanners. Rapidia® can be used for | ||
| real-time viewing, image | ||
| manipulation, segmentation, 3D | ||
| volume and surface rendering, virtual | ||
| endoscopy, and issuing reports. | ||
| Graphical User Interface | Yes | Yes |
| Platform | ||
| PC | Yes | Yes |
| Operating System | ||
| Windows 2000 | Yes | Yes |
| Windows XP | No | Yes |
| Windows NT | No | Yes |
| Image Display Monitor | 1 | 1 |
| Report Display Monitor | 1 | Unspecified |
| Patient Demographics | Yes | Yes |
| Networking | ||
| TCP/IP | Yes | Yes |
| Image Communication | ||
| DICOM 3.0 compliant | Yes | Yes |
| Image Compression | ||
| PNG (Lossless) | Yes | Unspecified |
| Image Processing | ||
| Annotations - marker | Yes | Yes |
| 3D Image Processing | ||
| Volume rendering | Yes | Yes |
| Image Review | ||
| Still | Yes | Yes |
| Window | Yes | Yes |
| Level | Yes | Yes |
| Zoom | Yes | Yes |
| Pan | Yes | Yes |
| Flip | Yes | Yes |
| 2D Measurements | ||
| Length | Yes | Yes |
| Area | Yes | Yes |
| System | REX™ | Rapidia® |
| Image Source | ||
| CT | Yes | Yes |
| MR | No | Yes |
| Image Input | ||
| DICOM 3.0 | Yes | Yes |
| Image Output | PNG (lossless snapshots) | JPEG, BMP, DICOM |
| Use Standard Monitor | Yes | Yes |
| Patient and Study Browser | Yes | Yes |
| Multi Planer Reformatting | No | Yes |
| Measure CT Numbers | ||
| ROI | Yes | Yes |
| Type of Software | ||
| Standalone | Yes | Yes |
| Virtual Endoscopy | ||
| Instant access to lesions by single | ||
| click | Yes | Yes |
| Real time display of endoscopic view | Yes | Yes |
| Internal and external viewing of any | ||
| hollow structures | Yes | Yes |
| Fly-through | No | Yes |
| Real time interactive correlation | ||
| among 3D image, endoscopic image | ||
| and MPR images with respect to the | ||
| point of view, viewing area and lesion | ||
| localization | No | Yes |
| Display multiple objects in different | ||
| color and opacity | No | Yes |
| Local Image Storage | Yes | Yes |
| True Color | Yes | Yes |
| User Login | Yes | Unspecified |
| Preset Window and Level | Yes | Yes |
| Image Conversion | Yes (for viewing in browser) | Yes |
| Device Users | ||
| Trained Physicians | Yes | Yes |
| Compliance Standards | ||
| DICOM 3.0 | Yes | Yes |
| Algorithms | ||
| Volume Rendering | Yes | Yes |
| Reporting | Yes | Yes |
| Physical Characteristics | Software Package | |
| ● Operates on off-the-shelf hardware | ||
| ● (multiple vendors) | ||
| ● Windows 2000 operating system | ||
| ● DICOM compatible | Software Package | |
| Operates on off-the-shelf | ||
| hardware (multiple vendors) | ||
| Windows 2000, XP, or NT | ||
| operating system | ||
| DICOM compatible | ||
| Safety | ● Clinician interactive review/editing of | |
| data integral to use of tool | Unspecified |
Tabular Comparison of Features and Specifications of the REX™ 1.0 and the Rapidia® V2.0
3
Table 1. Substantial Equivalence
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Re: K021099
Mr. Robert Anderson Chief Operating Officer PointDX, Inc. 635 West Fourth Street, Suite 200 WINSTON-SALEM NC 27101
Trade/Device Name: REX™ 1.0 PACS / Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: April 3, 2002 Received: April 4, 2002
Dear Mr. Anderson:
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 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); 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.
5
This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K_KO2/099
Device Name: REX™ 1.0 PACS / Image Processing Software
INDICATIONS FOR USE:
Intended Use:
Indications for Use:
REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X Per 21 CFR 801.109
OR
Over-The-Counter Use)
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021099