(23 days)
This device is a digital radiography system used in diagnostic X-ray angiography system configuration.
This X-ray anglography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
The provided 510(k) summary for the Toshiba Solid State X-Ray Imager (DFP-8000D / FPD) does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.
Here's an analysis based on the provided text, highlighting the absence of some requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, resolution, contrast-to-noise ratio) for the new device. It primarily relies on the concept of "substantial equivalence" to the predicate device. Therefore, a table for acceptance criteria and reported performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific test set or any associated sample sizes. The concept of "substantial equivalence" as presented here implies that the new device's performance is expected to be similar to the predicate device, but no independent testing with a defined test set is detailed. Consequently, data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no specific test set is described, there is no mention of experts or their qualifications used to establish ground truth.
4. Adjudication Method for the Test Set:
With no described test set or expert evaluation, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device itself and its equivalence, not on the impact of the device on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is a "Digital Radiography System," which by its nature is an imaging system, not an independent algorithm. Therefore, the concept of a "standalone" algorithmic performance study as typically understood for AI algorithms does not apply directly in this context. The document describes the system's ability to process, display, and record digital images, implying its standalone function as an imaging device.
7. The Type of Ground Truth Used:
Since no specific test or evaluation is described to establish performance against an independent ground truth, no type of ground truth is mentioned.
8. The Sample Size for the Training Set:
The document does not mention any training set or sample sizes related to it. This suggests that the device, being an imaging system, was likely developed and validated through engineering specifications and conformity to standards, rather than through a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Device Acceptance and "Study" (as implied):
The acceptance of the Toshiba Solid State X-Ray Imager (DFP-8000D / FPD) is based on a demonstration of substantial equivalence to an existing legally marketed predicate device:
- Predicate Device: DFP-8000D (K013608) with Image Intensifier (model RTP9211J-G11) (K993038).
- Key Change: The new device replaces the Image Intensifier technology with a Flat Panel Detector (FPD).
- Implied "Study": The "study" that proves the device meets the acceptance criteria is the 510(k) premarket notification process itself, which involves providing sufficient information to the FDA to demonstrate that the new device is as safe and effective as the predicate device. This typically involves:
- Technical Benchmarking: Comparing technical specifications of the FPD with the Image Intensifier, ensuring comparable image quality metrics (though not explicitly detailed in this summary).
- Clinical Intended Use Equivalence: Demonstrating that the new device performs the same diagnostic and interventional cardiac examinations as the predicate.
- Safety Considerations: Ensuring that the FPD technology does not introduce new or different questions of safety or effectiveness.
The letter from the FDA (AUG 23 2013) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" and the outcome of the "study" in this context.
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KO41027
R 1 72
MAY 1 4 2004
510(k) SUMMARY
| 1. DEVICE NAME: | Solid State X-Ray Imager |
|---|---|
| Model Name: | DFP-8000D / FPD |
| Trade/Proprietary Name: | Digital Radiography System with Flat Panel Detector (FPD) |
-
- ESTABLISHMENT REGISTRATION: 2020563
- U.S. Agent Name and Address: 3. TOSHIBA AMERICA MEDICAL SYSTEMS,INC. 2441 MICHELLE DRIVE TUSTIN, CA 92780
Contact Person:
Senior Regulatory Affairs Specialist (714) 730 - 5000 Manufacturing Site:
Michaela Mahl
TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- Date of Submission: April 08, 2004
7. DEVICE DESCRIPTION This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiography system configuration. This equipment processes, displays, and records digital images obtained from the Flat Panel Detector, and it replays the recorded images.
8. SUMMARY of INTENDED USE
This device is a digital radiography used in diagnostic X-ray angiography system configuration.
This X-ray angiography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
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p. 242
9. EQUIVAALENCY INFORMATION
TOSHIBA Medical Systems Corporation believes that the new Digital Radiography System, model DFP-8000D/FDP is substantially equivalent to the current Digital Radiography System, model DFP-8000D (K013608) with Image Intensifier (model RTP9211J-G11) (K993038) except for the new Flat Panel Detector (FPD).
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with snakes, representing health and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
AUG 23 2013
Re: K041027
Trade/Device Name: Digital Radiography Systems with Flat Panel Detector, Model DFP-8000D/FDP Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI and MOB Dated: April 15, 2004 Received: April 21, 2004
Dear Mr. Job:
This letter corrects our substantially equivalent letter of May 14, 2004.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K041027 510(k) Number (if known):
Device Name: Digital Radiography System with Flat Panel Detector, Model DFP-8000D/FDP
Indications for Use:
This device is a digital radiography system used in diagnostic X-ray angiography system configuration.
This X-ray anglography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
...
David R. Lagmm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number RO41027
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.