(17 days)
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. Accessories to be used with the intraoral sensors include holders and hygienic covers. Use of the SIDEXIS differs from conventional X-ray imaging only due to the use of the PC and the X-ray sensors. The X-rays are produced using the customary method of the intraoral or extraoral X-ray system, however, an electronic, radiation sensitive sensor element is used in place of the conventional film carrier. The radiation is then converted into electronic signals that are relayed through cables connecting the sensor to the PC directly or through a network.
The SIDEXIS can be used with:
- Intraoral sensors and an intraoral dental X-ray device (e.g., Heliodent DS); and .
- Panoramic or cephalometric sensors and an extraoral source X-ray device (e.g., . Orthophos 3DS, DS, or DS Ceph).
The provided document is a 510(k) Special Summary for the SIDEXIS Digital Radiography Imaging System. This type of submission is for modifications to a device that has already received 510(k) clearance and relies on the substantial equivalence to a predicate device. It does not contain a study demonstrating that the device meets acceptance criteria in the way a de novo or a new 510(k) for a novel device would.
Instead, the submission focuses on validating that the modifications to the already cleared SIDEXIS system do not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to its predicate.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study methodologies for proving performance against those criteria are not present in this document, as they would have been part of the original K972168 submission or are covered by the general principles of substantial equivalence for a modified device.
However, I can extract information related to the basis for substantial equivalence for this modified device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for modifications, specific numerical "acceptance criteria" and "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are not provided in this document. The acceptance for this submission is based on maintaining substantial equivalence to the predicate device after modifications.
The document states:
- "A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified to the original SIDEXIS Digital Radiography Imaging System."
This indicates that validation testing was performed, and the acceptance criterion appears to be that the modified device performs adequately and safely according to the design controls, and does not negatively impact the performance established for the prior cleared device (K972168). While the specific results of this validation testing are not detailed, the FDA's clearance implies these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in this Special 510(k) document. The submission focuses on hardware and software modifications and their validation rather than a new clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in this Special 510(k) document.
4. Adjudication Method for the Test Set
Not applicable/Not provided in this Special 510(k) document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not provided in this Special 510(k) document. The submission focuses on device modifications and substantial equivalence, not a comparative effectiveness study with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable/Not provided in this Special 510(k) document. This is an imaging acquisition system, not an AI algorithm for standalone diagnostic performance.
7. Type of Ground Truth Used
For the modifications described (additional sensors, acquisition boards, operating systems, computer platform), the "ground truth" would likely relate to objective physical measurements (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio, signal-to-noise ratio) and functional verification (e.g., successful interface, software compatibility, system stability). This isn't a "ground truth" in the diagnostic sense (e.g., pathology report). The document implicitly states that these were validated through "validation testing" and compliance with "Design Controls."
8. Sample Size for the Training Set
Not applicable/Not provided in this Special 510(k) document. This is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in this Special 510(k) document.
{0}------------------------------------------------
K 992644
Special 510(k) Summary for SIDEXIS Digital Radiography Imaging System
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 3294 Telephone:
August 5, 1999 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SIDEXIS Digital Radiography Imaging System |
|---|---|
| Common/Usual Name: | Digital X-ray Imaging System |
| Classification Name: | Accessory to Extraoral Source X-ray System |
3. PREDICATE DEVICE
SIDEXIS Digital Radiography System - K972168
INTENDED USE 4.
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
ડ. DEVICE DESCRIPTION
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. Accessories to be used with the intraoral sensors include holders and hygienic
{1}------------------------------------------------
covers. Use of the SIDEXIS differs from conventional X-ray imaging only due to the use of the PC and the X-ray sensors. The X-rays are produced using the customary method of the intraoral or extraoral X-ray system, however, an electronic, radiation sensitive sensor element is used in place of the conventional film carrier. The radiation is then converted into electronic signals that are relayed through cables connecting the sensor to the PC directly or through a network.
The SIDEXIS can be used with:
- Intraoral sensors and an intraoral dental X-ray device (e.g., Heliodent DS); and .
- Panoramic or cephalometric sensors and an extraoral source X-ray device (e.g., . Orthophos 3DS, DS, or DS Ceph).
-
- BASIS FOR SUBSTANTIAL EQUIVALENCE
The SIDEXIS that is the subject of this 510(k) premarket notification is a modification of the SIDEXIS previously cleared for marketing under K972168. The modified SIDEXIS has the same intended use and principles of operation as the original SIDEXIS. Modifications are summarized as follows:
- Additional sensors are available .
- Additional image acquisition boards are available to interface between the . sensors and the computer.
- The system is offered in a variety of kit configurations to allow for installation . in a personal computer system or in an adapter box for wall mounting, which can be used in a network system
- The SIDEXIS can now be used under the Windows® 98 and Windows® NT . operating systems.
- . The recommended computer platform has been upgraded to a Pentium-based system.
A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified to the original SIDEXIS Digital Radiography Imaging System.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight. The profiles are connected and appear to be a single, continuous line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 1999
Sirona Dental Systems GMBH C/o Sheila Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
RE: K992644
SIDEXIS Digital Radiography Imaging Dental System Dated: August 5, 1999 Received: August 6, 1999 Regulatory Class: II 21 CFR 872.1800/Procode: 90 MUH
· Dear Ms. Hemeon-Heyer:
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). 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 vour device is classified (see above) into either 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 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) 594-4613. 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"(21 CFR 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known):
Device Name: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
Indications For Use:
The SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Strait L. Bejron
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System 8/2/99
CONFIDENTIAL Page vi
§ 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.