(30 days)
No
The summary describes a device that performs 2D to 3D image conversion, which is a standard image processing technique and does not explicitly mention or imply the use of AI or ML algorithms. The lack of information regarding training/test sets and performance metrics typically associated with AI/ML devices further supports this conclusion.
No
The device is described as an image processor that converts 2D images to 3D images for viewing and diagnosis, surgical planning, interventional procedures and treatment follow-up. It does not exert any direct therapeutic effect on the patient.
Yes
The device's intended use states that it facilitates diagnosis.
No
The device is described as a "PC based system" and an "image processor," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an image processor that takes 2D rotational images (acquired from an X-ray system) and converts them into 3D images for viewing. It works with imaging data, not biological samples.
- Intended Use: The intended use is for imaging internal body structures to facilitate diagnosis, surgical planning, interventional procedures, and treatment follow-up. This is a function of medical imaging, not in vitro testing.
The device is clearly described as an image processing system used in conjunction with an angiography X-ray system and a 3D workstation. Its purpose is to manipulate and present imaging data, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
This device is designed to be used with Toshiba Infinix Angiography X-ray Systems and a 3D Workstation. The image processor receives 2D images and converts the data to 3D images sets that are transmitted to the 3D Workstation for viewing. The device is indicated for imaging both hard and soft tissue, as well as other internal body structures to facilitate diagnosis, surgical planning, interventional procedures and treatment follow-up.
Product codes
90LLZ
Device Description
The XIDF-100A/B1 is an image processor that, when used in conjunction with the Toshiba Infinix Angiography System and a 3D Workstation, can acquire 2D images and convert them to 3D images. The system then transmits the 3D images to the 3D Workstation for display and viewing. This device employs similar materials and processes as found in the predicate devices. The device is a PC based system that has software which is used for image acquisition and transmission.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (2D rotational images)
Anatomical Site
hard and soft tissue, as well as other internal body structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Toshiba XIDF-100A (K002424), Siemens DynaCT (K042646)
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).
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K073259
pg. 1 of 2
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; XIDF-100A/B1 Image Process
510(k) Summary
| Date: | November 1, 2007 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs |
| (714)730-5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | XIDF-100A/B1, Image Processor |
| Common Name: | System, Image Processor, Radiology |
| [Fed. Reg. No. 892.2050, Pro. Code: 90LLZ] | |
| Regulatory Class: | II (per 21 CFR 892.2050) |
| Performance Standard: | None |
| Predicate Device(s): | Toshiba XIDF-100A (K002424) |
| Siemens DynaCT (K042646) | |
| Reason For Submission | Modification of existing device |
Description of this Device:
The XIDF-100A/B1 is an image processor that, when used in conjunction with the Toshiba Infinix Angiography System and a 3D Workstation, can acquire 2D images and convert them to 3D images. The system then transmits the 3D images to the 3D Workstation for display and viewing.
Summary of Intended Uses:
This device is intended to acquire 2D rotational images and convert them to 3D images.
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K07959
pg. 2 of 2
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; XIDF-100A/B1 Image Processor
Technological Characteristics:
This device employs similar materials and processes as found in the predicate devices. The device is a PC based system that has software which is used for image acquisition and transmission.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. This device is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60950-1.
Substantial Equivalence:
The XIDF-100A/B1 has similar functions and indications as those of the predicate devices:
Toshiba XIDF-100A; K002424 Siemens DynaCT; K042646
Therefore this device is substantially equivalent to devices that are already commercialized.
2
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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical System, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K073259
Trade/Device Name: XIDF-100A/B1, Image Processor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: II Product Code: LLZ Dated: December 12, 2007 Received: December 13 7, 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.
3
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.
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/cdrh/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
4
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for XIDF-100A/B1 Image Processor
Indications for Use
510(k) Number (if known):
Device Name: XIDF-100A/B1, Image Processor
Indications for Use:
This device is designed to be used with Toshiba Infinix Angiography X-ray Systems and a 3D Workstation. The image processor receives 2D images and converts the data to 3D images sets that are transmitted to the 3D Workstation for viewing. The device is indicated for imaging both hard and soft tissue, as well as other internal body structures to facilitate diagnosis, surgical planning, interventional procedures and treatment follow-up.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Lonu N. Whay
(Division Sign-Off)
eproductive. Abdominal and 510(k) Nun