(27 days)
The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.
The J-Advanced I.I., Model RTP9211J-G11 is a modification to a previously cleared device, 6' I.I. system [K771298].
This 510(k) submission describes the Toshiba J-Advanced I.I., Model RTP9211J-G11, which is a modification to a previously cleared X-ray image intensifier system. The submission does not contain a detailed study with acceptance criteria and device performance as typically seen for novel AI/software devices. Instead, it relies on substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications. There are no new claims of effectiveness and no new intended uses offered with this new intensifier."
Since this is an image intensifier, common performance specifications would revolve around image quality. However, specific numerical acceptance criteria and reported values are not explicitly stated in this summary. Instead, a qualitative "nominally improved" is provided.
| Acceptance Criterion (Inferred from "nominally improved") | Reported Device Performance |
|---|---|
| Improved Resolution | Nominally improved resolution compared to predicate. |
| Improved Contrast | Nominally improved contrast compared to predicate. |
| Compliance with Federal Diagnostic X-ray Equipment Standard (21 CFR Subchapter J) | Met (as per Safety and Effectiveness Concerns section). |
| Compliance with IEC-60601 Medical Device Safety Standards | In conformance with applicable parts (as per Safety and Effectiveness Concerns section). |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical study in the form typically seen for new AI/software devices with a specific "test set" in the context of diagnostic accuracy. The device is a hardware component (an image intensifier), and its performance assessment is likely based on engineering specifications, bench testing, and potentially laboratory comparisons rather than a clinical trial with patient data. Therefore, this information is not applicable/not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.
4. Adjudication Method for the Test Set
As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The device described is an X-ray image intensifier, a hardware component for image acquisition, not an Artificial Intelligence (AI) or software-based diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is an X-ray image intensifier, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of Ground Truth Used
Given the nature of the device as an image intensifier, "ground truth" would likely refer to objective physical performance characteristics measured through engineering and quality control tests (e.g., MTF for resolution, contrast-to-noise ratio). The specific methods for establishing ground truth for resolution and contrast are not detailed in this summary but would be based on instrument-based measurements.
8. The Sample Size for the Training Set
This device is not an AI/machine learning model, so there is no training set in the typical sense. Performance is based on the physical characteristics and design of the intensifier.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this information is not applicable.
Summary of the Study (as described in the 510(k) submission):
The submission for the Toshiba J-Advanced I.I., Model RTP9211J-G11, is based on demonstrating substantial equivalence to a previously cleared predicate device (Toshiba 6" I.I. System [K771298]). The "study" here is not a typical clinical trial but rather a comparison of technological characteristics and compliance with regulatory standards.
- Rationale for Equivalence: The document states, "This device employs the same technological characteristics as the predicate device. The changes to the device are a result of continuing technological development towards the goals of increasing efficiency and reducing cost."
- Performance Comparison: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications." This suggests direct comparison of technical specifications and possibly bench testing rather than clinical trials.
- Safety and Effectiveness Concerns: The device's safety and effectiveness are supported by its design and manufacture under Quality System Regulations (21 CFR § 820) and compliance with the Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33) and applicable parts of IEC-60601 Medical Device Safety standards.
In essence, the submission relies on the fundamental similarity of the technology, documented nominal improvements in key image quality metrics (resolution and contrast), and adherence to established regulatory and quality standards, rather than a specific clinical study with patient data and statistical endpoints.
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7 1999 OCT
510(k) Summary
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. Specifically, the string reads 'K993038'.
| Date: | 9 September 1999 |
|---|---|
| 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: | Diana Thorson, Regulatory Affairs Specialist, (714)730-5000 |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.) |
| Common Name: | System, X-Ray, Fluoroscopic, Image Intensified[Fed. Reg. No. 892.1650, Pro. Code: 90JAA] |
| Regulatory Class: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | Toshiba 6' I.I. System [K771298] |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The J-Advanced I.I., Model RTP9211J-G11 is a modification to a previously cleared device, 6' I.I. system [K771298].
Summary of Intended Uses:
The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.
Technological Characteristics:
This device employs the same technological characteristics as the predicate device. The changes to the device are a result of continuing technological development towards the goals of increasing efficiency and reducing cost. A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications. There are no new claims of effectiveness and no new intended uses offered with this new intensifier.
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Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this device, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this device, J-Advanced I.I., Model RTP9211J-G11, is substantially equivalent to the predicate, Toshiba 6" I.I. System.
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Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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.
OCT 7 1999
Ms. Diana Thorson Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive, P.O. Box 2068 Tustin, CA 92781-2068
Dear Ms. Thorson:
h
Re:
K993038 J-Advanced Image Intensifier Model RTP9211J-G11 Dated: September 9, 1999 Received: September 10, 1999 Product Code: 90 JAA Requiatory Class: II (TWO) 21 CFR 892.1650
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _________________________________________________________________________________________________________________________________________________
Device Name: J-Advanced I.I., RTP9211J-G11
Indications for Use:
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993038 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.