(46 days)
the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.
WDS is a wireless digital X-ray sensor for intraoral radiography.
The provided text is a 510(k) summary for the WDS Wireless Digital X-ray Sensor, indicating its intended use and establishing substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot provide the requested table or detailed answers to the specific questions regarding acceptance criteria and study particulars, as this information is not present in the provided document.
The document primarily focuses on:
- Device Description: WDS is a wireless digital X-ray sensor for intraoral radiography.
- Intended Use: To capture intraoral digital X-ray images for diagnostic purposes and transmit them wirelessly to a PC.
- Substantial Equivalence Comparison: Claiming substantial equivalence to predicate devices (K031448 RSV VISIODENT, K050693 ACCENT, K990002 QUICKRAY DSX730) based on similar components, design, technical characteristics, and mode of operation.
To answer your request, information regarding performance studies and acceptance criteria would need to be in a different section of a full 510(k) submission, typically in a "Performance Data" or "Clinical Data" section, which is not included here.
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KO61114
510(K) SUMMARY
JUN - 6 2006
This summary of Safety and Effectiveness is in accordance with the requirements of:
- Device Description: .
WDS is a wireless digital X-ray sensor for intraoral radiography.
Intended Use: .
The wireless digital X-ray sensor is intended to capture an intraoral digital X-ray image when exposed to X-Rays for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via a wireless Bluetooth connection. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially
- . Summary of Substantial Equivalence Comparison:
K031448, RSV, VISIODENT
K050693 ACCENT, AIR TECHNIQUES, INC
K990002 QUICKRAY DSX730, JULIE ALLIANCE
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the The proposed and the predicated devices are substantially equivalent; file.
-
ACCENT is a wireless sensor very similar to WDS, the existing minor differences regarding use ergonomics only.
-
QuickRay DSX730 is connected to the personal computer through a USB connector, and powered off the same connection.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 6 2006
CEFLA s.c.r.l. c/o Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110 E. Granada Blvd., Suite 207 ORMOND BEACH FL 32176
Re: K061114
Trade/Device Name: WDS Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatorv Class: II Product Code: MUH Dated: April 20, 2006 Received: April 21, 2006
Dear Mr. Berthoin:
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/1/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top and the letters "FDA" in a large, bold font in the center. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The text "Centennial" is surrounded by a circular border with additional text.
Protecting and Promoting Public Health
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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/cdrh/industry/support/index.html.
Sincerely vours,
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
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INDICATION FOR USE
Applicant: CEFLA s.c.r.l.
510(k) Number (if known): K061114
Device Name: WDS
Indication For Use: the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes.
The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
preserí
Daniel R. Leggett
(Division Sign-Off)
Division of Reproductiv and Radiological Devic 510(k) Number
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.