(123 days)
The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.
The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with the STRATO Panoramic X-ray System (K002432), manufactured by VILLA SISTEMI MEDICALI S.P.A (registration number 8021091) and a computer work station for Dental Panoramic Radiographic Imaging.
The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.
The provided text is a 510(k) Premarket Notification Summary for the Owandy SA EVApan Digital (K1VSM2000) Dental Panoramic Sensor. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the format requested.
Therefore, much of the requested information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission for market clearance based on equivalence, not a research paper detailing performance against a defined metric.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Stated (No explicit numerical performance criteria are mentioned in the summary) | The device is stated to capture images in the form of a charge pattern on its surface, which are then digitized and sent to a computer screen for image presentation. |
| "capture, evaluation, and storage of high quality digital dental X-rays" (This is a qualitative statement of capability, not a measurable performance metric against an acceptance criterion). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not provided. The document does not describe a performance study with a specific test set.
- Data Provenance: Not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI assistance
- MRMC Study: Not indicated. The device is a digital imaging sensor, not an AI-powered diagnostic tool. The document focuses on the sensor's ability to produce digital images, not on an AI's impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not indicated. As above, this document describes an imaging sensor, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for this type of submission. The device is a digital replacement for traditional X-ray film; its "ground truth" would be the fidelity of the captured radiographic image, which is implicitly assessed against predicate devices rather than a ground truth for a diagnostic task.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The device is an imaging sensor, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable.
Summary of what the document does provide regarding equivalence, which is the core of a 510(k) submission:
- Intended Use: To be used with standard dental panoramic systems and Dental Image Management Software for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.
- Device Description: Replaces traditional dental X-ray film with a solid-state sensor that captures images as a charge pattern, digitizes electronic signals, and sends them to a computer for presentation.
- Predicate Devices: Signet Radiology DXIS (K983283) and Trophy DigiPan (K961826, K991912, K012514).
- Substantial Equivalence Argument: The EVApan Digital / K1VSM2000 System is substantially equivalent to the predicate devices because they share the same intended use (capture, evaluation, and storage of high-quality digital dental X-rays with existing X-ray equipment), and similar technological characteristics (X-ray sensitive solid-state imaging array, connected via cable to digitizing and control electronics, interfacing with a computer).
- Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
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AUG 3 0 2004
Koyllzo
510(k) Premarket Notification Summary For Owandy SA EVApan Digital (also known as model K1VSM2000) Dental Panoramic Sensor
1. SPONSOR
AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523
| Contact Person: | James Johnson |
|---|---|
| Telephone: | (914) 592-6100 |
Date Prepared: April 27, 2004
2. Device Name
| Proprietary Name: | EVApan Digital / K1VSM2000 panoramic sensor |
|---|---|
| Common/Usual Name: | Accessory to Extra oral X-Ray System |
| Classification Name: | Extra oral Source X-Ray System Accessory |
3. PREDICATE DEVICES
Signet Radiology DXIS
Trophy DigiPan
4. Intended Use
The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals.
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5. Device Description
The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.
6. Substantial Equivalence and Technological Characteristics
The EV Apan Digital / K 1 VSM2000 System is substantially equivalent to the several other Digital Panoramic systems currently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K I VSM2000 System and the predicate devices listed, the Trophy DigiPan and the Signet DXIS, have the same intended use. All are intended to be used with a Dental Panoramic X-ray Source, Dental Image Management Application Software and standard computer hardware for the capture, evaluation, and storage of high quality digital dental X-rays using existing X-Ray equipment. The system and its predicates all consist of an X-ray sensitive solid state imaging array installed in the Dental Panoramic X-ray system in place of the traditional photographic film, connected via cable to digitizing and control electronics which in turn interface to a computer via a standard interface. The proposed and predicate devices are intended for patients receiving routine dental radiography, in a clinical environment by dental professionals.
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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 symbol that resembles three human profiles facing to the right, with wavy lines underneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2004
Mr. James Johnson Director of Sustaining Engineering AFP Imaging Corporation 250 Clearbrook Road ELMSFORD NY 10523
Re: K041120
Trade/Device Name: EVApan Digital / K1VSM2000 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: 90 MUH Dated: July 7, 2004 Received: July 9, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beenemed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrobard, 10 stgm 3
commerce prior to May 28; 1976, the enactment date of the Medical Device Amendments, or to conner oc pror to may 20, 20, 20, 11, 11, 10, 20, 2017, 11, 1998, 1999, 1999, 1999, 1999, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Flor (110) that the device, subject to the general controls provisions of the Act. The I ou may, ate. en ovisions 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 (PMA), it If your device is olassinod (500 as 010) as . Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 that I Dri has made a occertires and regulations administered by other Federal agencies. You must comply or any I Gaeral statues and resaincluding, 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 quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgain nameding your and premarket notification. The FDA miding of basification 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 If you desire specific advice for your development on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, for questions on the prosses note the regulation entitled, "Misbranding Other of Comphanoo at (2017 97) 700 (21CFR Part 807.97) you may obtain. Other general by reletence to premarket notification - (r the Act may be obtained from the Division of Small mormation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 141111443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boyden
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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510(k) Premarket Notification for EVApan Digital / K1VSM2000 Dental Panoramic Sensor System
Page of
510(k) Number (if known): Ko 4 | 20_
EVApan Digital / K1VSM2000 Device Name:
Indications for Use:
The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with The EVApan Digital / K V SW2000 Demail 1 4302439), manufactured by VILLA SISTEMI
the STRATO Panoramic X-ray System (K002432), manufactured by Mation Station station station s the STRATO Panoramic X-Iay System (R002452), Manatoval 2017
MEDICALI S.P.A (registration number 8021091) and a computer work station station for Dental Panoramic Radiographic Imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.