(43 days)
The KRYSTAL-X WiFi digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.
Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography.
This 510(k) submission primarily focuses on establishing substantial equivalence for the Krystal-X WiFi, a wireless digital X-ray sensor, by comparing it to previously cleared devices. It does not present a study with specific acceptance criteria and reported device performance in a robust fashion that would allow for a detailed answer to all your points.
The document states: "The proposed and the predicated devices are substantially equivalent." and "The only difference is the method of communication between the sensor and the computer from a wired to a wireless interface." This approach means that a new comprehensive study with acceptance criteria is typically not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness of the device.
However, I can extract information related to what would be the context if such a study were present, based on the provided text.
Here's a breakdown of the requested information, indicating where the document lacks specific details:
1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT PRESENT in the provided document. The 510(k) focuses on substantial equivalence based on similarity to predicate devices, not on a new, explicit study with defined acceptance criteria and performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is NOT PRESENT in the provided document, as no specific performance study with a test set is detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is NOT PRESENT in the provided document, as no specific performance study with ground truth established by experts is detailed.
4. Adjudication Method for the Test Set
This information is NOT PRESENT in the provided document, as no specific performance study with an adjudication method is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
This information is NOT PRESENT in the provided document. The submission does not describe an MRMC study comparing human readers with and without AI assistance. The device itself (Krystal-X WiFi) is an imaging sensor, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
This information is NOT PRESENT in the provided document. The device is an image capture sensor, and the document clarifies that "The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing." Therefore, a standalone algorithm performance study for this specific device would not be applicable or described here.
7. Type of Ground Truth Used
This information is NOT PRESENT in the provided document, as no specific performance study requiring ground truth is detailed. For intraoral imaging, ground truth for diagnostic accuracy would typically involve clinical diagnosis or potentially pathology if biopsies were taken, but this is not discussed here.
8. Sample Size for the Training Set
This information is NOT PRESENT in the provided document. The 510(k) submission does not describe any machine learning or AI component that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is NOT PRESENT in the provided document, as there is no mention of a training set or AI/machine learning.
Summary of the 510(k) Approach in the Provided Document:
The 510(k) for Krystal-X WiFi relies on establishing "substantial equivalence" to previously cleared devices. This means that instead of conducting a new, full-scale performance study against specific acceptance criteria, the manufacturer argues that their device is safe and effective because it is fundamentally similar to devices already on the market.
Key aspects contributing to this argument are:
- Similar components and design: "The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation."
- Minor modification: The "only difference is the method of communication between the sensor and the computer from a wired to a wireless interface."
- Predicate devices: Comparison to (WDS X-RAY, ACCENT, CDR Wireless, KRYSTAL-X - an earlier wired version from the same company).
- No alteration to intended use: "The WiFi device modification...in no way alters the indications for use of this device beyond what was originally approved in K053172."
Therefore, the acceptance criteria and study details you requested for a new performance study are not applicable to how this particular 510(k) approval was likely achieved.
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APR 5 - 2007
510(k) Summary
This summary of Safety and Effectiveness is in accordance with the requirements of:
-
Device Description .
Krystal-X WiFi 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 for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via WiFi. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially. -
Summary of Substantial Equivalence Comparison .
K061114 - WDS X-RAY, CEFLA
K050693 - ACCENT, AIR TECHNIQUES, INC.
K022953 - CDR Wireless, SCHICK TECHNOLOGIES
K053172 - KRYSTAL-X,
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 a method of wireless transmission to transmit the digital image to a personal computer for viewing and further management of the file. The proposed and the predicated devices are substantially equivalent;
- WDS X-RAY is a wireless digital X-Ray sensor that captures an intraoral . X-Ray, when exposed to X-Rays and transmits images via Bluetooth wireless technology, for diagnostic purposes ..
- . ACCENT is a wireless sensor very similar to WDS, which also transmits images via Bluetooth wireless technology.
- . KRYSTAL-X is a conventional system, non-wireless, but identical in all other regards to KRYSTAL-X WiFi.
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- CDR Wireless is a wireless sensor that captures and transmits images via . RF (Radio Frequency).
KRYSTAL-X WiFi is most similar in components to the original KRYSTAL-X, from our company, which was cleared by your agency on June 9, 2006.
The only difference is the method of communication between the sensor and the computer from a wired to a wireless interface. This modification is similar to the one Schick Technologies did when they introduced the CDR Wireless which modified their original CDR.
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
APR 5 = 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OWANDY, Inc. % Mr. Claude Berthoin President/Owner Video Dental Concepts, Inc. 110 East Granada Boulevard. Suite 207 ORMOND BEACH FL 32176
Re: K070505
Trade/Device Name: Krystal-X WiFi Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MQB Dated: March 29, 2007 Received: April 2, 2007
Dear Mr. Berthion:
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 indivet 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 in microad in microade of the 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 masil 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 shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. The word "Centennial" is written in a cursive font below the acronym. There are three stars at the bottom of the logo.
Protecting and Promoting Public Lands
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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/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
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INDICATION FOR USE
Applicant: Owandy
510(k) Number (if known): K053172 (Krystal-X Standard)
Device Name: Krystal-X WiFi
Indication for use: The KRYSTAL-X WiFi digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Syzmon
Division of Renmountive, Abdomin
escription Use ✓
§ 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.