(56 days)
REX™ 3.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT and MR scanners. REX™ 3.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
REX™ 3.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT and MR images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
The provided text is a 510(k) Premarket Notification Summary for the REX™ 3.0 PACS / Image Processing Software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets them in the way modern AI/medical device submissions typically do.
Based on the provided text, here's a breakdown of the information requested, with "N/A" where the information is not available in the document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the device's performance through a comparison to predicate devices rather than against pre-defined, quantitative acceptance criteria. The "acceptance criteria" here are implicitly that the REX™ 3.0 software performs all specified functions in line with software requirements and safety standards, and is substantially equivalent to predicate devices.
| Feature/Criterion | REX™ 3.0 Reported Performance (Implicit Acceptance) |
|---|---|
| DICOM Conformance | Conforms to DICOM Version 3.0. |
| Functional Requirements | Performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification. Validation testing confirmed this. |
| Non-Clinical Performance (Safety/Hazards) | Potential hazards identified in Hazard Analysis are controlled by design controls, protective measures, and user warnings. No new potential safety risks identified. |
| Intended Use | Performs in accordance with its intended use (viewing and manipulating DICOM-compliant medical images from CT and MR scanners, real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports). |
| Equivalence to REX™ 1.0 | Substantially equivalent to REX™ 1.0 with the addition of MR image analysis functions and a dual-monitor setup (one for image viewing, one for report viewing). |
| Equivalence to Rapidia® V 2.0 | Substantially equivalent in common features and specifications. |
| Image Sources | Supports CT and MR images (enhancement over REX™ 1.0 which only supported CT). |
| Operating System | Operates on Windows 2000. (Note: Not on Windows XP or NT, unlike Rapidia® V 2.0). |
| Multi Planar Reformatting | Yes (enhancement over REX™ 1.0 which did not have this). |
| Other Features (GUI, Patient Demographics, | Yes (comparable to predicate devices for these listed features: GUI, Platform, PC, Patient Demographics, Networking (TCP/IP), DICOM 3.0 compliant, PNG (Lossless) image compression, Annotations, 3D Volume rendering, Still/Window/Level/Zoom/Pan/Flip for image review, 2D measurements (length, area), DICOM 3.0 image input, PNG (lossless snapshots) image output, Standard monitor use, Patient and Study Browser, Measure Image Intensity Values (ROI), Standalone software, Virtual Endoscopy (instant access to lesions, real-time display, internal/external viewing of hollow structures), Local Image Storage, True Color, User Login, Preset Window and Level, Image Conversion (for browser viewing), Trained Physician users, Volume Rendering algorithms, Reporting, Off-the-shelf hardware, Windows 2000 OS, DICOM compatible). |
| Image Communication, Image Processing etc.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Validation testing" but does not specify a separate "test set" with a defined sample size for clinical or image-based performance evaluation. The "test set" is implicitly the DICOM-compliant images used during software validation, but no details are provided about their origin, number, or whether they were retrospective or prospective.
- Sample Size: N/A (Not specified as a distinct clinical test set with a quantifiable size)
- Data Provenance: N/A (Not specified)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. The submission does not describe a process for establishing ground truth by expert consensus for a test set, as it is a PACS/image processing software focused on viewing and manipulation, not diagnostic interpretation or algorithm-based detection needing labeled ground truth in the context of an AI device. The validation is focused on software functionality and compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Since no specific test set with expert-established ground truth is described, no adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI-assisted diagnostic device. It is a PACS/image processing software. Therefore, an MRMC study concerning AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is described as "Standalone" software (meaning it's not embedded within a larger system). However, a "standalone algorithm performance" study related to an AI diagnostic function is not applicable here as it is not an AI diagnostic algorithm. The safety statement explicitly mentions: "Clinician interactive review/editing of data integral to use," indicating human-in-the-loop is part of its intended operational model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. Ground truth in the context of diagnostic accuracy is not discussed because this is an image viewing and manipulation software, not a diagnostic algorithm. The "truth" for its proper functioning is adherence to DICOM standards and its own software requirements specification.
8. The sample size for the training set
N/A. This is not an AI/machine learning device that relies on a "training set" in the context of deep learning models. The software performs deterministic image processing and viewing functions.
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set mentioned or implied for an AI/ML model.
Summary of the Study and Device Performance:
The "study" described in K030457 is primarily a software validation and verification process to ensure the REX™ 3.0 software conforms to its design specifications, DICOM standards (Version 3.0), and relevant regulations. It is a non-clinical performance data assessment rather than a clinical trial or performance study involving patient data in a diagnostic context.
The primary method to "prove" the device meets acceptance criteria (which are largely functional and safety-based for this type of software) is through:
- Conformance to DICOM 3.0: Stated directly in the "Non-Clinical Performance Data" section.
- Validation and Verification Process: PointDx followed established procedures for software development, validation, and verification which confirm that REX™ 3.0 "performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification."
- Hazard Analysis: Potential hazards were identified and controlled through design, protective measures, and user warnings, concluding that REX™ 3.0 "does not result in any new potential safety risks."
- Substantial Equivalence Comparison: A detailed tabular comparison against predicate devices (REX™ 1.0 and Rapidia® V 2.0) highlights that REX™ 3.0 has similar features and functionalities, with improvements such as MR image support and multi-planar reformatting compared to REX™ 1.0, and overall equivalence in common features to Rapidia® V 2.0. This comparison implicitly serves as evidence that the device meets the "acceptance criteria" of being similar in performance and safety to already cleared devices.
In essence, the submission relies on software engineering best practices and regulatory compliance to demonstrate that the REX™ 3.0 software functions as intended and is safe, rather than a clinical study measuring diagnostic performance or accuracy against ground truth.
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Section II - Section 510(k) Premarket Notification Summary (as required by 807.92 (j))
APR 0 8 2003
Submitter:
PointDx, Inc. 635 West Fourth Street, Suite 200 Winston-Salem, NC 27101 Phone: 336.723.1450 Fax: 336.723.1458
Date Prepared:
February 7, 2003
Contact Person(s):
Robert Anderson, Chief Operating Officer Francis Bonk, Director of Quality Assurance and Regulatory Affairs 336-723-1450 (v) 336-723-1458 (f)
Device Trade Name:
REXTM
Device Common Name:
PACS / Image Processing Software
Classification Name:
Class II - System, Image Processing, RA (90) LLZ
Substantially Equivalent To:
| REX TM 1.0 | Rapidia® V 2.0 |
|---|---|
| (K021099) | (K012290) |
| PointDx, Inc. | 3D Med Co, Ltd. |
| 635 West Fourth Street | 940-319 Research Park |
| Suite 200 | SNU, San 4-8 |
| Winston-Salem, NC 27101 | Bongcheon-dong, Gwanak-gu |
| USA | Seoul 151-818 |
| Republic of Korea |
Device Description:
REX™ 3.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT and MR images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Indications for Use:
REX™ 3.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT and MR scanners. REX™ 3.0 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 and MR images. The proposed and predicate software can be operated from a personal computer. REX™ 3.0 adds the capability to display MR images to REX™ 1.0 and
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convenience of using two monitors, one for image viewing, and the other for report viewing. The REX™ 3.0 software has substantially equivalent features and specifications versus the existing REX™ 1.0 and Rapidia® V 2.0, for those features and specifications the two devices have in common.
Non-Clinical Performance Data:
The proposed REX™ 3.0 software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3.0. Validation testing confirms that REX™ 3.0 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 ●
- Introducing protective measures and/or ●
- Warning the Users. .
Conclusions:
REX™ 3.0 does not result in any new potential safety risks and performs in accordance with its intended use as well as REX™ 1.0 and Rapidia® V 2.0 devices currently on the market. PointDx considers features of REX™ 3.0 to be substantially equivalent to REX™ 1.0 (K021099) with the addition of MR image analysis functions and a subset of features in common with the Rapidia® V 2.0 (K012290) device.
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Substantial Equivalence Chart
| System | REX™ | REX™ | Rapidia® |
|---|---|---|---|
| Version | 3.0 | 1.0 | 2.0 |
| Manufacturer | PointDx, Inc. | PointDx, Inc. | 3D Med Co., Ltd. |
| 510(k) Number | - | (K021099) | K012290 |
| Classification | Class II892.205090 LLZ | Class II892.205090 LLZ | Class II892.205090 LLZ |
| Intended Use | REX™ 3.0 is a softwarepackage intended forviewing and manipulatingDICOM-compliantmedical images acquiredfrom CT and MRscanners. REX™ 3.0 canbe used for real-timeimage viewing, imagemanipulation. 3D volumerendering, virtualendoscopy, and issuanceof reports. | REX™ 1.0 is a softwarepackage intended forviewing and manipulatingDICOM-compliantmedical images acquiredfrom CT scanners. REXTM1.0 can be used for real-time image viewingimage manipulation. 3Dvolume rendering, virtualendoscopy, and issuanceof reports. | Rapidia® is a softwarepackage intended forviewing and manipulatingDICOM-compliantmedical images from CTand MR scanners.Rapidia® can be used forreal-time viewing, imagemanipulation.segmentation, 3D volumeand surface rendering.virtual endoscopy, andissuing reports. |
| Graphical User Interface | Yes | Yes | Yes |
| Platform | PC | PC | PC |
| PC | Yes | Yes | Yes |
| Operating System | |||
| Windows 2000 | Yes | Yes | Yes |
| Windows XP | No | No | Yes |
| Windows NT | No | No | Yes |
| Image Display Monitor | 1 | 1 | 1 |
| Report Display Monitor | 1 | 1 | Unspecified |
| Patient Demographics | Yes | Yes | Yes |
| Networking | |||
| TCP/IP | Yes | Yes | Yes |
| Image Communication | |||
| DICOM 3.0compliant | Yes | Yes | Yes |
| Image Compression | |||
| PNG (Lossless) | Yes | Yes | Unspecified |
| Image Processing | |||
| Annotations - | Yes | Yes | Yes |
| System | REX™ | REX™ | Rapidia® |
| 3D Image ProcessingVolume rendering | Yes | Yes | Yes |
| Image ReviewStill | Yes | Yes | Yes |
| Window | Yes | Yes | Yes |
| Level | Yes | Yes | Yes |
| Zoom | Yes | Yes | Yes |
| Pan | Yes | Yes | Yes |
| Flip | Yes | Yes | Yes |
| 2D MeasurementsLength | Yes | Yes | Yes |
| Area | Yes | Yes | Yes |
| Image SourceCT | Yes | Yes | Yes |
| MR | Yes | No | Yes |
| Image InputDICOM 3.0 | Yes | Yes | Yes |
| Image Output | PNG (lossless snapshots) | PNG (lossless snapshots) | JPEG, BMP, DICOM |
| Use Standard Monitor | Yes | Yes | Yes |
| Patient and Study Browser | Yes | Yes | Yes |
| Multi Planer Reformatting | Yes | No | Yes |
| Measure Image Intensity ValuesROI | Yes | Yes | Yes |
| Type of SoftwareStandalone | Yes | Yes | Yes |
| Virtual EndoscopyInstant access to lesions by single click | Yes | Yes | Yes |
| Real time display of endoscopic view | Yes | Yes | Yes |
| Internal and external viewing of any hollow structures | Yes | Yes | Yes |
| Fly-through | No | 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 | No | Yes |
| System | REX™ | REX™ | Rapidia® |
| Display multiple objects in different color and opacity | No | No | Yes |
| Local Image Storage | Yes | Yes | Yes |
| True Color | Yes | Yes | Yes |
| User Login | Yes | Yes | Unspecified |
| Preset Window and Level | Yes | Yes | Yes |
| Image Conversion | Yes (for viewing in browser) | Yes (for viewing in browser) | Yes |
| Device UsersTrained Physicians | Yes | Yes | Yes |
| Compliance StandardsDICOM 3.0 | Yes | Yes | Yes |
| AlgorithmsVolume Rendering | Yes | Yes | Yes |
| Reporting | Yes | 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 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 | Clinician interactive review/editing of data integral to use | Unspecified |
Tabular Comparison of Features and Specifications of REX™ 3.0, REX ™ 1.0 and Rapidia® V2.0
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Table 1. Substantial Equivalence
:
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Mr. Francis Bonk Director of Quality Assurance and Regulatory Affairs PointDx. Inc. 635 West Fourth St., Suite 200 WINSTON-SALEM NC 27101 Re: K030457 Trade/Device Name: REX™ 3.0 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: February 7, 2003 Received: February 11, 2003
Dear Mr. Bonk:
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. Iisting 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 r 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.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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 yours,
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
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510(k) Number (if known): K 8 3 045 7
Device Name: REX™ 3.0 PACS / Image Processing Software
INDICATIONS FOR USE:
Intended Use:
Indications for Use:
REX™ 3.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT and MR scanners. REX™ 3.0 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)
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
§ 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).