(51 days)
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
The provided text is a 510(k) premarket notification letter from the FDA to Swissray Medical AG for their ddRCompact device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness studies (MRMC) or standalone performance studies.
The letter is a regulatory approval document and focuses on:
- Confirming the device name (ddRCompact) and regulatory classification (Class II).
- Stating that the device is substantially equivalent to predicate devices.
- Outlining the general controls provisions of the Act that the manufacturer must comply with.
- Providing contact information for regulatory advice.
- Including the "Indications for Use" for the device, which describes its intended purpose and settings.
To provide the detailed information requested in your prompt, a different type of document, such as a clinical study report, a technical performance report, or detailed sections from the 510(k) submission itself (beyond the summary provided here), would be required.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol consists of three curved lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Swissray Medical AG c/o Mr. John Monahan QA Manager Swissray International, Inc. 1180 McLester Street, Unit #2 ELIZABETH NJ 07201-2948
2 2007
Re: K070678
Trade/Device Name: ddRCompact Regulation Number: 21 CFR 8892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code; KPR Dated: March 8, 2007 Received: March 16, 2007
Dear Mr. Monahan:
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 Hoss metic Act (Act) that do not require approval of a premarket approval application (PMA), Your costi. 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 a 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, FFA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "PDA" in large, bold letters. Underneath "PDA" is the word "Centennial" in a smaller font. At the very bottom of the logo are three stars arranged horizontally. The logo appears to be for the centennial celebration of the PDA, spanning from 1906 to 2006.
Protecting and Promoting Public Health
{1}------------------------------------------------
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the word "Swissray" in a simple, sans-serif font. To the right of the word is a small, abstract graphic. The graphic is composed of several small squares arranged in a cluster.
Page 11/42
Section D
510 (K) Number (if known)
Device name : ddRCompact
Indication for Use
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System.
This system can be used in a hospital or doctor practice X-ray room.
The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position.
The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
Prescription Use
Nancy C. Bordon
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070678
(Please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Prescription Use or Over The Counter Use
(Optional Format 1-2-96) (Per 21 CFR 801.109)
§ 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.