REX, VERSION 1.0

K021099 · Pointdx, Inc. · LLZ · Jun 27, 2002 · Radiology

Device Facts

• Record ID: K021099
• Device Name: REX, VERSION 1.0
• Applicant: Pointdx, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

REX™ 1.0 is a software package for viewing/manipulating DICOM-compliant CT images. Input: DICOM CT images. Processing: 3D volume rendering, virtual endoscopy, image manipulation (zoom, pan, flip, window/level), and measurement (length, area, ROI). Output: Visualized images, 3D renderings, and clinical reports. Used in clinical settings by trained physicians on off-the-shelf PCs running Windows 2000. Supports dual-monitor configuration for simultaneous image and report viewing. Facilitates lesion localization and internal/external viewing of hollow structures. Clinician performs interactive review/editing; output assists in diagnostic decision-making.

Clinical Evidence

No clinical data. Bench testing only. Validation confirmed software performs all input/output functions and actions according to Software Requirements Specification. Conformance to DICOM 3.0 verified.

Technological Characteristics

Software-only device; operates on off-the-shelf PC hardware. OS: Windows 2000. Connectivity: TCP/IP, DICOM 3.0 compliant. Features: 3D volume rendering, virtual endoscopy, 2D measurements (length, area, ROI), and report generation. Image output: PNG (lossless).

Indications for Use

Indicated for use by trained physicians for viewing and manipulating DICOM-compliant CT images, including real-time viewing, 3D volume rendering, virtual endoscopy, and report generation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Rapidia® V 2.0 (K012290)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

#### 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)

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# 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

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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.

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# Substantial Equivalence Chart

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| System | REX™ | Rapidia® |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Version | 1.0 | 2.0 |
| Manufacturer | PointDx, Inc. | 3D Med Co., Ltd. |
| 510(k) Number | | K012290 |
| Classification | Class II<br>892.2050<br>90 LLZ | Class II<br>892.2050<br>90 LLZ |
| Intended Use | REX™ 1.0 is a software package intended for<br>viewing and manipulating DICOM-<br>compliant medical images acquired from CT<br>scanners. REX™ 1.0 can be used for real-<br>time image viewing, image manipulation, 3D<br>volume rendering, virtual endoscopy, and<br>issuance of reports. | Rapidia® is a software package<br>intended for viewing and<br>manipulating DICOM-compliant<br>medical images from CT and MR<br>scanners. Rapidia® can be used for<br>real-time viewing, image<br>manipulation, segmentation, 3D<br>volume and surface rendering, virtual<br>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<br>click | Yes | Yes |
| Real time display of endoscopic view | Yes | Yes |
| Internal and external viewing of any<br>hollow structures | Yes | Yes |
| Fly-through | No | Yes |
| Real time interactive correlation<br>among 3D image, endoscopic image<br>and MPR images with respect to the<br>point of view, viewing area and lesion<br>localization | No | Yes |
| Display multiple objects in different<br>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<br>● Operates on off-the-shelf hardware<br>● (multiple vendors)<br>● Windows 2000 operating system<br>● DICOM compatible | Software Package<br>Operates on off-the-shelf<br>hardware (multiple vendors)<br>Windows 2000, XP, or NT<br>operating system<br>DICOM compatible |
| Safety | ● Clinician interactive review/editing of<br>data integral to use of tool | Unspecified |

Tabular Comparison of Features and Specifications of the REX™ 1.0 and the Rapidia® V2.0

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Table 1. Substantial Equivalence

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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