(14 days)
The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
The Expedio 500 A is designed to perform radiographic and fluoroscopic X-ray examinations
The Expedio 500D R&F X-ray System consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; Wall stand; Overhead tube suspension; Operator Console; and Digital Archive system.
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria.
The document is a 510(k) summary and an FDA clearance letter for the "Expedio 500D Radiographic and Fluoroscopic Imaging System." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing performance data against specific acceptance criteria.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used or their qualifications.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the date "JUN - 8 2001" in bold, black font. The month is abbreviated to "JUN", followed by a hyphen, the number 8, and the year 2001. The text is clear and easily readable.
GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE Medical SystemsTel. (414) 544-3894Summary prepared: 19 February, 2001 |
|---|
| Identification of Product: Expedio 500D Radiographic and Fluoroscopic Imaging SystemClassification Name: Stationary X-ray SystemManufacturer: GE Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53118 |
| Device Description: The Expedio 500D R&F X-ray System consists of an X-raygenerator; angulating table with X-ray Tube, collimator and imageintensifier; Wall stand; Overhead tube suspension; OperatorConsole; and Digital Archive system. |
The Expedio 500D is designed to perform radiographic and Indications for Use: fluoroscopic x-ray examinations.
The Expedio 500D R&F X-ray System is substantially equivalent Comparison with: to the Advantx Radiographic System (Originally cleared as the SCX K862120), InfiMed Patriot (K963037) and the Legacy/Legacy D Table (K973039).
The Expedio 500D R&F X-ray System will conform to applicable Conformance: sections of 21CFR 1020.30, 1020.31, and 1020.32. The system will also conform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3.
{1}------------------------------------------------
Conclusions:
In the opinion of GE Medical Systems, the Expedio 500D R&F Xray System is substantially equivalent to the presently marketed Advantx Legacy/Legacy D R&F X-ray System (K862120 and K973039) and the InfiMed Patriot Digital System (K963037). The Expedio 500D does not include any new indications for use, nor does use of this device result in any new potential hazards.
2/2
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems % Mr. Reiner Krumme
TUV Rheinland of North America, Inc.
Re: K011624
JUN - 8 2001
Expedio 500D R&F X-Ray System Dated: May 22, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Krumme:
12 Commerce Road
NEWTON CT 06470
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 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 (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) 594-4639. 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" (21CFR 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.
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
{3}------------------------------------------------
Attachment I b
| Page | of |
|---|---|
| 510(k) Number (if known): | K011624 |
| Device Name: |
Indications For Use:
The Expedio 500 A is designed to
perform radiographic and fluoroscopic
X-ray examinations
(see 510(k) Summary of Safety
and Effectiveness, attachment 1 of
submission)
(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 Formal 1-2-96)
David K. Flynn
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 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.