(14 days)
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No
The document describes a software application for interactive measurements and comparisons, with no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device is described as a software application that assists clinicians in analyzing anatomy and pathology for diagnosis by providing measurement schemes and comparisons, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is intended "to aid in the diagnosis of disorders and deformities."
Yes
The device is described as a "plug-in software application for PACS workstations" and its function is solely based on processing existing 2D X-ray images and providing measurement and comparison tools. There is no mention of any accompanying hardware or hardware components included with the device itself.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that OrthoGon is "indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities." This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic purposes. While the input is imaging data (X-ray), the purpose is to provide information for diagnosis.
- Diagnostic Aid: The device is designed to "aid in the diagnosis of disorders and deformities." This is a key characteristic of an IVD.
- Analysis of Anatomy and Pathology: The device assists in the analysis of anatomy and pathology, which are fundamental aspects of diagnosis.
- Comparison to Normative References: Comparing measurements to normative references is a common practice in diagnostic procedures.
While the device processes imaging data rather than biological specimens in the traditional sense of an IVD, the regulatory definition of an IVD is broad and includes devices used to provide information for diagnostic purposes. In this case, the software is processing data derived from the human body (X-ray images) to provide information that aids in diagnosis.
Therefore, OrthoGon fits the definition of an IVD.
N/A
Intended Use / Indications for Use
OrthoGon is a plug-in software application for PACS workstations. The package is indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities.
OrthoGon is intended for use in the fields of musculoskeletal radiology. orthopedics, traumatology and pediatrics using 2D X-ray images based on DICOM standards.
The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.
Product codes
LLZ
Device Description
OrthoGon, the new device, is similar in principals of operation and technology to the predicates. All are software devices that run on commercially available computer systems.
OrthoGon assists physicians in their analysis of anatomy and pathology by providing easy to use, interactive measurement schemes.
OrthoGon allows the user to easily perform standard measurements and to compare results to prior measurements and to normal values from the medical literature.
OrthoGon uses X-ray images based on the DICOM standards. The device is compatible with multiple PACS workstations and software versions.
OrthoGon allows the user export results into Excel formatted reports.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
2D X-ray images based on DICOM standards.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Intended User: radiologists, radiographers, technologists, referring physicians and orthopedic surgeons
Care Setting: operating theaters, mobile and military environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
OrthoGon has been tested for compatibility with Agfa's Impax® PACS Systems.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510(k) Summary Aqfa OrthoGon
Agfa OrthoGon
Common/Classification Name: Picture Archiving and Communications DEC ¿ § 2007 System (PACS), 21 CFR 892.2050 Proprietary Name: OrthoGon
Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Tom Holbrook, Prepared: November 2, 2007 Telephone: (519) 746-6210 ext. 3297 Facsimile: (519) 746-3745
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's OrthoGon software. The predicate devices are Agfa's previous orthopedic application; Orthopedic Software for Impax® Workstations (K071972) and OrthoCrat Limited's TraumaCAD (K042816). The new device is similar in indications and has the same intended use as the predicate devices.
DEVICE DESCRIPTION B.
OrthoGon, the new device, is similar in principals of operation and technology to the predicates. All are software devices that run on commercially available computer systems.
OrthoGon assists physicians in their analysis of anatomy and pathology by providing easy to use, interactive measurement schemes.
OrthoGon allows the user to easily perform standard measurements and to compare results to prior measurements and to normal values from the medical literature.
OrthoGon uses X-ray images based on the DICOM standards. The device is compatible with multiple PACS workstations and software versions.
OrthoGon allows the user export results into Excel formatted reports.
INTENDED USE C.
OrthoGon is a plug-in application for PACS workstations. The package is intended to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against
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prior measurements and against normative references to aid in the diagnosis of disorders and deformities.
OrthoGon is intended for use primarily in the field of musculoskeletal radiology, orthopedics, trauma and pediatrics using 2D X-ray images based on DICOM standards.
The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's OrthoGon Software has similar indications and the same intended use as the legally marketed predicate devices.
The differences do not modify the intended diagnostic or therapeutic effect. It is intended to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid diagnosis of disorders and deformities.
OrthoGon is used primarily in the fields of musculoskeletal radiology, orthopedics, trauma and pediatrics.
Descriptive characteristics and data provided in this submission are sufficiently precise to assure substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics are the same in the proposed and predicate devices. All devices use similar, commercially available, computers with Windows® operating systems. All operate on DICOM images. All use interactive measurement "wizards" to guide the user in selecting anatomical landmarks. All allow comparison to normative data from the medical literature
F. TESTING
OrthoGon has been tested for compatibility with Agfa's Impax® PACS Systems.
G. CONCLUSIONS
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various quidance documents issued by the Center for Devices and Radiological Health.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 resembling an eagle or bird with three stylized wing-like shapes.
DEC 0 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 250 Street NW BUFFALO MN 55313
Re: K073271
Trade/Device Name: Agfa OrthoGon Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 9, 2007 Received: November 21, 2007
Dear Mr. Job:
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 such 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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter,
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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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Indications for Use
510(k) Number (if known):
Device Name: Agfa OrthoGon Indications for Use:
OrthoGon is a pluq-in software application for PACS workstations. The package is indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities.
OrthoGon is intended for use in the fields of musculoskeletal radiology. orthopedics, traumatology and pediatrics using 2D X-ray images based on DICOM standards.
The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number