(49 days)
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
ENDOS AC – ENDOS ACP intraoral system
This document is a 510(k) summary for the ENDOS AC – ENDOS ACP intraoral system, seeking substantial equivalence to the AZTECH 70 model. The submission focuses on comparing technical specifications rather than clinical performance based on specific acceptance criteria and detailed study results. Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, the AZTECH 70. This largely involves matching or exceeding its technical specifications and intended use. The table below outlines the key comparative elements provided in the document.
| Acceptance Criteria Focus (Implicit) | Predicate Device (Aztech 70) Performance | Subject Device (ENDOS AC-ACP) Performance | Device Meets Acceptance Criteria? (Based on Substantial Equivalence Claim) |
|---|---|---|---|
| Intended Use | extra oral source X-ray system for dental radiographic examination of the teeth | extra oral source X-ray system for dental radiographic examination of the teeth | Met: Identical intended use. |
| High Voltage Value | 70 kV | 70 kV | Met: Identical. |
| Tube Current | 8 mA | 8 mA | Met: Identical. |
| X-ray Tube Insert | CEI OCX 70-G | CEI OCX 70-G | Met: Identical. |
| Focal Spot Size | 0.8 mm (IEC 336) | 0.8 mm (IEC 336) | Met: Identical. |
| H.V. Type | Single phase, self rectifying | Single phase, self rectifying | Met: Identical. |
| X-Ray Exposure Time Control | Microprocessor Controlled | Microprocessor Controlled | Met: Identical. |
| Compensation of Line Voltage Fluctuations | Yes, automatically by software algorithm | Yes, automatically by software algorithm | Met: Identical. |
| Total Filtration | > 2.0 mm Al | > 2.0 mm Al | Met: Identical. |
| HVL | > 1.5 mm Al | > 1.5 mm Al | Met: Identical. |
| X-Ray Exposure Timing | 0.040 sec to 3.2 sec | 0.020 sec to 3.2 sec | Met: Subject device has a wider range which encompasses and expands upon the predicate. |
| Electrical Characteristics | 120 V +/- 10%, 7.6 impulsive A max | 120 V +/- 10%, 7.6 impulsive A max | Met: Identical. |
| Focus-Film Distance | > 20 cm | > 20 cm | Met: Identical. |
| Leakage Radiation | < 25 mR/h at 1 meter from focus | < 25 mR/h at 1 meter from focus | Met: Identical. |
| X-ray Beam Dimension at 20cm | < 6cm | < 6cm | Met: Identical. |
| Safety Features | Dead man command | Dead man command | Met: Identical. |
| Signaling Devices | Acoustic and visual signal | Acoustic and visual signal | Met: Identical. |
| X-Ray Exposure Time Control (specifics) | Automatic - pre-programmed | Automatic - pre-programmed in the ACP model; manual in the AC model | Met: Subject device offers both automatic (like predicate) and manual options. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy. The comparison provided is based on technical specifications and functional attributes of the device itself against a predicate device. Therefore, no information on sample size or data provenance (country, retrospective/prospective) for a clinical test set is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Given that no clinical "test set" or diagnostic accuracy study is described, there is no information on the number or qualifications of experts used to establish ground truth. The technical specifications listed are likely verified through engineering testing and quality assurance checks by the manufacturer.
4. Adjudication Method for the Test Set
As there is no described clinical test set, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the document. The submission focuses on substantial equivalence based on technical specifications and intended use, not on a comparative effectiveness study involving human readers with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Since the device described is an X-ray system (hardware) and not an AI algorithm for image analysis, the concept of "standalone performance" for an algorithm is not applicable here and no such study is mentioned. The "standalone" performance here refers to the system's ability to produce X-rays according to its specifications.
7. Type of Ground Truth Used
For the technical specifications, the "ground truth" would be established through:
- Engineering measurements and calibration data: For parameters like kV, mA, focal spot size, filtration, HVL, leakage radiation, beam dimension, and exposure timing.
- Design specifications and regulatory standards: Ensuring the device adheres to established safety features and electrical characteristics.
- Comparison against the predicate device's documented specifications.
8. Sample Size for the Training Set
This document does not describe an AI algorithm or a "training set." The device is an X-ray system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI algorithm or training set is mentioned.
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MAR 1 1 2003
Appendix 1 - 510 (k) SUMMARY
510(k) summary
Identification
| Applicant | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 BUCCINASCO - Milan- ItalyRegistration Number: 8021091 |
|---|---|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | +39 02 48859233 |
| Designated Agentin the US | Andrew HryndzaDel Medical11550 West King StreetFranklin ParkIllinois 60131Tel. 847-288-7000 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 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
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| ENDOS AC-ACP | Aztech 70 | |
|---|---|---|
| Intended use | extra oral source X-raysystem for dentalradiographic examinationof the teeth | extra oral source X-raysystem for dentalradiographic examinationof 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, selfrectifying | Single phase, selfrectifying |
| X-Ray exposuretime control | MicroprocessorControlled | MicroprocessorControlled |
| Compensation ofLine VoltageFluctuations | Yes, automatically bysoftware algorithm | Yes, automatically bysoftware algorithm |
| Total filtration | > 2.0 mm Al | > 2.0 mm Al |
| HVL | > 1.5 mm Al | > 1.5 mm Al |
| X-Ray exposuretime control | Automatic - pre-programmed in the ACPmodel; manual in the ACmodelMicroprocessorControlled | Automatic - pre-programmedMicroprocessorControlled |
| X-Ray exposuretiming | 0.020 sec to 3.2 sec | 0.040 sec to 3.2 sec |
| Electricalcharacteristics | 120 V +/- 10%7.6 impulsive A max | 120 V +/- 10%7.6 impulsive A max |
| Focus film distance | > 20 cm | > 20 cm |
| Leakage radiation | < 25 mR/h at 1 meter fromfocus | < 25 mR/h at 1 meter fromfocus |
| X-ray beamdimension 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
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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.
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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 | (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 Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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
§ 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.