ENDOS AC/ACP

K030185 · Villa Sistemi Medicali S.P.A. · EHD · Mar 11, 2003 · Dental

Device Facts

• Record ID: K030185
• Device Name: ENDOS AC/ACP
• Applicant: Villa Sistemi Medicali S.P.A.
• Product Code: EHD · Dental
• Decision Date: Mar 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth

Device Story

ENDOS AC/ACP is an extraoral dental X-ray system. It generates X-rays using a CEI OCX 70-G tube insert (70 kV, 8 mA). The system is operated by dental professionals in a clinical setting. It features microprocessor-controlled exposure timing (0.020 to 3.2 seconds) and automatic compensation for line voltage fluctuations via a software algorithm. The ACP model includes pre-programmed exposure settings, while the AC model uses manual settings. Safety features include a dead-man switch and acoustic/visual signaling. The device provides radiographic images to assist clinicians in diagnosing dental diseases, potentially improving diagnostic accuracy and patient care.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technical specifications to the predicate device.

Technological Characteristics

Extraoral dental X-ray system; 70 kV, 8 mA; CEI OCX 70-G tube; 0.8 mm focal spot (IEC 336); single-phase, self-rectifying; >2.0 mm Al filtration; >1.5 mm Al HVL; microprocessor-controlled exposure timing; automatic line voltage fluctuation compensation via software algorithm; dead-man switch safety feature.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth in patients requiring extraoral dental X-ray imaging.

Regulatory Classification

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.

Predicate Devices

• AZTECH 70 (K984524)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 1 1 2003

## Appendix 1 - 510 (k) SUMMARY

## 510(k) summary

## Identification

| Applicant | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan- Italy<br>Registration Number: 8021091 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | [phone] |
| Designated Agent<br>in the US | Andrew Hryndza<br>Del Medical<br>11550 West King Street<br>Franklin Park<br>Illinois 60131<br>Tel. [phone] |
| Manufacturing site | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan - Italy |

Trade name: ENDOS AC – ENDOS ACP

Common name: ENDOS AC – ENDOS ACP intraoral system

Classification name: according to 21 CFR 872-1800, ENDOS AC/ACP is in Class II.

Substantial equivalent device: the ENDOS AC - Endos ACP is defined as Substantially Equivalent (SE) to the AZTECH 70 model manufactured by Villa Sistemi Medicali SpA. The predicate device has been approved by FDA and has 510(k) approval number K984524

{1}------------------------------------------------

| | ENDOS AC-ACP | Aztech 70 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended use | extra oral source X-ray<br>system for dental<br>radiographic examination<br>of the teeth | extra oral source X-ray<br>system for dental<br>radiographic examination<br>of the teeth |
| High Voltage value | 70 kV | 70 kV |
| Tube current | 8 mA | 8 mA |
| X-ray Tube insert | CEI OCX 70-G | CEI OCX 70-G |
| Focal spot size | 0.8 mm (IEC 336) | 0.8 mm (IEC 336) |
| H.V. type: | Single phase, self<br>rectifying | Single phase, self<br>rectifying |
| X-Ray exposure<br>time control | Microprocessor<br>Controlled | Microprocessor<br>Controlled |
| Compensation of<br>Line Voltage<br>Fluctuations | Yes, automatically by<br>software algorithm | Yes, automatically by<br>software algorithm |
| Total filtration | > 2.0 mm Al | > 2.0 mm Al |
| HVL | > 1.5 mm Al | > 1.5 mm Al |
| X-Ray exposure<br>time control | Automatic - pre-<br>programmed in the ACP<br>model; manual in the AC<br>model<br>Microprocessor<br>Controlled | Automatic - pre-<br>programmed<br>Microprocessor<br>Controlled |
| X-Ray exposure<br>timing | 0.020 sec to 3.2 sec | 0.040 sec to 3.2 sec |
| Electrical<br>characteristics | 120 V +/- 10%<br>7.6 impulsive A max | 120 V +/- 10%<br>7.6 impulsive A max |
| Focus film distance | > 20 cm | > 20 cm |
| Leakage radiation | < 25 mR/h at 1 meter from<br>focus | < 25 mR/h at 1 meter from<br>focus |
| X-ray beam<br>dimension at 20cm | < 6cm | < 6cm |
| Safety features | Dead man command | Dead man command |
| Signaling devices | Acustic and visual signal | Acustic and visual signal |

The following table compares the ENDOS AC- ENDOS ACP with the predicate device

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

Villa Sistemi Medicali, S.p.A. % Mr. Andrew Hryndza Del Medical 11550 West King Street FRANKLIN PARK IL 60131

Re: K030185

Trade/Device Name: Endos AC/ACP Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 76 EHD Dated: January 10, 2003

Received: January 21, 2003

Dear Mr. Hryndza:

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 (PMA), it may be subject to 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.

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.

{3}------------------------------------------------

Page 2

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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

KU3 0185

## Indication for use.

The indication for use of the ENDOS AC – ENDOS ACP is: : extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

Vaind b. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

*Prescription Use*