FV-RF by PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.

Device Description

The FV-RF is a Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

AI/ML Overview

The provided text describes a 510(k) notice for the "FV-RF," a Stationary X-ray System. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CAD device. This document is a regulatory submission for a conventional X-ray system, focusing on substantial equivalence to legally marketed devices and compliance with safety standards, rather than performance metrics of an AI algorithm.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to extract what is available and indicate what is missing:

Acceptance Criteria and Device Performance Study for FV-RF (Stationary X-ray System)

Acceptance Criteria	Reported Device Performance
No explicit quantitative acceptance criteria are provided in the document for the device's diagnostic performance. The document focuses on regulatory compliance and substantial equivalence to existing devices.	"The product will perform in accordance with the development specifications." "The FV-RF represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices." "Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development."

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "Shimadzu's evaluation throughout all phases of the FV-RF development" but does not detail specific test sets, sample sizes, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. This is a conventional X-ray system, not an AI or CAD system requiring expert-established ground truth for its performance assessment in the context of this 510(k). The "ground truth" for a conventional X-ray system's performance would typically relate to image quality parameters, radiation dose, and functional accuracy, which are assessed against technical specifications and regulatory standards rather than clinical expert consensus on specific diagnoses from a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a conventional X-ray system, and such a study is not relevant to its regulatory submission as described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a conventional X-ray system, not an algorithm. Its performance is inherent in its physical operation and image acquisition capabilities.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. The "effectiveness" mentioned in the document for the FV-RF is based on meeting development specifications and adherence to safety and performance standards (e.g., UL 187, IEC 601-1, FDA 21 CFR 820, 1020.30 through 32), not on diagnostic outcomes or expert consensus on a disease state from a dataset.
The sample size for the training set:
- Not applicable. This is a physical X-ray system, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of what the document does state regarding effectiveness and testing:

Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development. This implies internal testing and validation against design specifications.
The product will perform in accordance with the development specifications. This is a general statement of intent regarding performance.
The FV-RF represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices. Substantial equivalence is a key aspect of this 510(k).
Compliance with Federal Diagnostic X-Ray Performance Standards and other safety standards (UL 187, IEC 601-1, FDA 21 CFR 820, 1020.30 through 32) are explicitly mentioned as part of the safety and effectiveness considerations. These standards often dictate specific tests and performance limits for components (e.g., radiation output, image quality parameters like resolution, contrast, noise). However, the specific acceptance criteria and numerical results from such tests are not provided in this summary document.

This document is a high-level summary for a conventional medical device's 510(k) submission, confirming its regulatory compliance and functional intent, rather than a detailed performance study for an AI component.

Summary

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K9841111

Picker 510(k) Notice

FV-RF

Summary of Safety and Effectiveness

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (ODE), specifically DRAERD of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3).

Preliminary functional specifications and operator's instructions are included in the Attachments "B" and "C" respectively. Final documentation will be provided with production units.

The FV-RF is substantially equivalent to legally marketed devices and is under control of health care professionals who are trained and responsible for radiographic and fluoroscopic examinations. The FV-RF will be certified to comply with Federal Diagnostic X-Ray Performance Standards. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.

Shimadzu adheres to FDA 21 CFR 820, 1020.30 through 32, and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1.

Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development. The product will perform in accordance with the development specifications. The FV-RF represents the current state-of- the-art technology, therefore, is equivalent to legally marketed devices.

Shimadzu has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the FV-RF. In addition, all information contained in this 510(k) Notice is accurate and complete.

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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Michael J. Hayes Senior Product Review Engineer Picker International, Inc. 595 Milner Road Cleveland, Ohio 44143

Re: K984111

FV-RF (Radiographic/Fluoroscopic System) Dated: November 16, 1998 Received: November 17, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Hayes:

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 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). 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 (Premarket Approvial), 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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/dsmardsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

FV-RF Number (if known): K_

Device Name: FV-RF

Indications for Use: Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.