(33 days)
No
The summary describes a standard extraoral X-ray system and does not mention any AI or ML capabilities, image processing, or data sets typically associated with such technologies. The performance studies focus on compliance with electrical and radiation safety standards and equivalence to predicate devices, not AI/ML performance metrics.
No
The device is described as an X-ray source system for diagnostic purposes, specifically for examination and diagnosis of diseases, not for treatment.
Yes
This device is an extraoral X-ray source system intended for "dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures," which directly indicates a diagnostic purpose.
No
The device description explicitly details hardware components including a mobile and articulate double support arm, a central unit with a wall plate, extension, radio control device, and a tube head with an X-Ray Tube. While it mentions software standards (IEC 62304, IEC 60601-1-4), the core device is a physical X-ray system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Ergon-X-HF is an "extraoral X-ray source system" used for "dental radiographic examination and diagnosis." This involves generating X-rays that pass through the patient's body to create an image, not analyzing samples taken from the body.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures," which is a form of medical imaging, not in vitro testing.
- Device Description: The components described (mobile and articulate double support arm, central unit, tube head with X-Ray Tube) are consistent with an X-ray machine, not an IVD device.
The device is a medical imaging device used for diagnosis, but it does not perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.
Product codes
EHD, MUH
Device Description
VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively:
- a central unit equipped with wall plate, extension and radio control device. This unit is the interface on which the control panel is placed;
- the tube head with X-Ray Tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaws, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative test was performed with the predicate device Endos DC (K030634) and this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1412-0318
ERGON-X HF
VIVI S.R.L. 510(K) NOTIFICATION
MAR = 6 2012
510(k) Summary for the VIVI Ergon-X HF
This 510(k) Summary is submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
Contact Person:
VIVI S.r.l. is located at: Via dei Lavoratori, 3/K 20090 - Buccinasco (Milano) ITALY
Guido Bonapace (consultant) ISEMED sri Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-0542-683803 Fax: +39-0542-698456 Email: gbonapace@isemed.eu
Summary Preparation Date:
11,04,2011
- Names 2.
VIVI Ergon-X HF Device Name: Common Name: Unit, x-ray, extraoral with timer Product Code: EHD Classification: ll
3. Predicate Devices
The VIVI Ergon-X HF is substantially equivalent to the following devices:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| Sirona Dental Systems GmbH | HELIODENT Plus | K083344 |
| Villa Sistemi | ENDOS DC | K030634 |
| Progeny Inc | PREVA | K043092 |
Page 21
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VIVI S.R.L. 510(K) NOTIFICATION
VIVI Ergon-X HF and its predicate devices are indicated for the same intended use and have equivalent design solutions .
They have the same operating principle (X-ray tube) and equivalent technical characteristics. Moreover, a comparative test was performed with the predicate device Endos DC (K030634) and this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634).
4. Device Description
VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively:
- a central unit equipped with wall plate, extension and radio control device. This unit is the . interface on which the control panel is placed;
- . the tube head with X-Ray Tube.
5. Indications for Use
Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.
6. Performance Data
VIVI Ergon-X HF device has been developed and tested according to the following international standards:
- . IEC 60601-1 - Medical Electrical Equipment Part.1: General requirements for safety. 1: Collateral standard: safety requirements for Medical Electrical Systems. FDA Recognition number 5-4
- IEC 60601-1-2 Medical Electrical Equipment Part.1: General requirements for safety. 2-. Collateral standard: electromagnetic compatibility - requirements and tests. FDA Recognition number 5-28
- . IEC 60601-1-3 Medical Electrical Equipment - Part.1: General requirements for safety, 3: Collateral standard: general requirements for radiation protection in diagnostic X-ray equipment. FDA Recognition number 12-199
- IEC 60601-2-7 Medical Electrical Equipment Part.2-7: particular requirements for high . voltage generators safety in diagnostic X-ray equipment. FDA Recognition number 12-34
- IEC 60601-2-28 Medical Electrical Equipment Part.2: particular requirements for safety of . X-ray generators assembled in diagnostic X-ray equipment. FDA Recognition number 12-126
- IEC 62304 , Medical device software Software life cycle processes. FDA Recognition . number 13-8
- IEC 60601-1-4, Medical electrical equipment Part 1-4: General requirements for safety --● Collateral standard: Programmable electrical medical systems, edition 1.1. FDA Recognition number 5-41
- ISO 14971 Medical Devices Application of risk management to medical devices. FDA ● Recognition number 5-40
Page 22
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
VIVI S.r.l. % Mr. Guido Bonapace Consultant ISEMED S.r.1. Via Borgo Santa Cristina 12 40026 Imola (BO) ' ITALY
Re: K120318
Trade/Device Name: Ergon-X HF Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD Dated: January 4, 2012 Received: February 1, 2012
MAR - 6 2012
Dear Mr. Bonapace:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional corral Regulations (CFR), Parts 800 to 895. 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I odotal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
VIVI S.R.L. 510(K) NOTIFICATION
Indications for Use
| 510(k) Number (if known): | K120318 |
|---|---|
| Device Name: | Ergon-X HF |
Indications for Use:
Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.
. Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Scott
(Division Sign-Off) Division of Radiological Devices Division of Hadlologiour So Rose.
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120318
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