(52 days)
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
The provided text is a 510(k) summary for the Omega Medical Imaging, Inc. CS-Series radiographic/fluoroscopy system. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as an acceptance criteria table and performance data are not typically included in a 510(k) summary for devices of this nature (angiographic X-ray systems).
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a new, high-risk device might. The document confirms that the device complies with relevant safety and performance standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, and various IEC and UL standards).
Therefore, I cannot provide the requested information from the given text.
Here's why each specific point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document states compliance with general safety and performance standards, but no specific acceptance criteria (e.g., for image quality, diagnostic accuracy) are listed, nor is performance data against such criteria.
- Sample size used for the test set and the data provenance: Not applicable. No clinical or performance test set data (e.g., patient cases) is mentioned for proving diagnostic or clinical performance. The "testing" primarily refers to compliance with safety regulations and electrical standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As there is no mention of a test set requiring ground truth, no experts for this purpose are stated.
- Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are typically for evaluating diagnostic accuracy using human readers, often comparing AI-assisted vs. unassisted performance. This 510(k) summary is for an X-ray system, not an AI diagnostic algorithm, and therefore such a study is not part of this document.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an X-ray system, not a standalone algorithm. Its function is to acquire images, not to interpret them autonomously.
- The type of ground truth used: Not applicable. Given the nature of the device and the content of the 510(k) summary, no ground truth (e.g., pathology, outcomes data) for diagnostic performance is discussed.
- The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set. The software/firmware mentioned is for controlling mechanical subsystems and is obtained from certified suppliers, not developed by Omega Medical Imaging, Inc. for diagnostic purposes.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.
{0}------------------------------------------------
OMEGA MEDICAL IMAGING, INC.
510(k) SUMMARY
MAY 1 8 2007
| Company Name: | Omega Medical Imaging, Inc |
|---|---|
| Address: | 675 Hickman CircleSanford, FL 32771 |
| Telephone No: | 407-323-9400 |
| Registration No.: | 1052701 |
| Contact person: | James A. Princehorn |
| Date Prepared: | 1 February 2007 |
| Device (trade) name: | CS-Series radiographic/fluoroscopy system |
| Classification Name: | Angiographic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 892.1650 and 892.1600 |
| Device Class: | Class II |
| Device Code: | JAA, IZI |
| Common/usual name: | System, X-Ray, Fluoroscopic, Image-Intensified |
Predicate device(s):
- Siemens AXIOM ARTIS U Angiography System (K040675) .
- Philips Integris H5000 Angiography System (K984545) .
- Omega Medical Imaging e-VIEW Fluoroscopy System (K062647). .
Device description:
- The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image . receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
Intended use:
- The Omega Medical Imaging, Inc. CS-Series systems are intended for use in . radiographic/fluoroscopic cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
{1}------------------------------------------------
Safety information:
- The Omega CS-Series systems will comply with the applicable requirements of 21 CFR . 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega CS-Series systems will comply with the international safety standards IEC 60601-. 1, IEC 60101-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 .
- The Omega CS-Series systems will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-. M90
Software/Firmware
Omega Medical Imaging, Inc. manufactures the mechanical sub-systems for the CS-series systems. The control of these mechanical sub-systems is achieved without involvement of software or firmware. Omega Medical Imaging, Inc. obtains certified components from FDA registered suppliers that contain software/firmware. Omega Medical Imaging does not modify any of the software/firmware obtained by the suppliers. Omega Medical Imaging, Inc. conducts Vendor Audits of these suppliers to assure that these vendored components are suitable for this application.
Conclusion:
The Omega CS-Series systems do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the CS-Series systems to be substantially equivalent with the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a logo with three stylized, overlapping figures that resemble birds in flight or abstract human figures. The figures are depicted in black and are arranged diagonally, creating a sense of movement or progression. To the left of the figures, there is text arranged vertically along a curved path, but the text is too small to read.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771
MAY 1 8 2007
Re: K070834
Trade/Device Name: CS-Series Fluoroscopy System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: March 22, 2007 Received: March 27, 2007
Dear Mr. Princehorn:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.
Protecting and Promoting Public Health
{3}------------------------------------------------
Page 2 -
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Omega Medical Imaging, Inc.
Omega Medical Imaging, Inc. CS-series Radiographic/Fluoroscopic Systems
Indications for Use:
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Prescription Use ✓
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070834
§ 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.