(14 days)
The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.
The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:
- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .
Optional components: - . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone
The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds
In response to your request, here's an analysis of the provided text regarding the de Gotzen "synchro" Intraoral Dental X-Ray System, focusing on acceptance criteria and the study proving its compliance:
The provided text is a 510(k) summary statement for a dental X-ray system. Such submissions generally focus on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a novel clinical study with explicit acceptance criteria for performance derived from a completely new device.
Therefore, the "acceptance criteria" here are implicitly based on meeting or demonstrating comparable performance to the predicate devices in key technical specifications and safety parameters, as mandated by regulatory guidelines for substantial equivalence. The "study" proving this is the comparison of technological characteristics outlined in the document.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary focused on substantial equivalence, the "acceptance criteria" are the specifications of the predicate devices. The device "meets" these by demonstrating similar or equivalent specifications, indicating it is as safe and effective.
| Specification | Predicate Device Performance (Acceptance Criteria) | de Gotzen synchro Performance (Reported) |
|---|---|---|
| Line Requirements | Varied (e.g., 110V-120V 50Hz-60Hz to 220V/230V/240V, 6A)across different predicates | 220V/230V/240V, 8A110V - 120V 5.5A50hZ - 60hZ |
| Generator Type | AC (consistent across all predicates) | AC |
| Tube Voltage | 65 kV or 70 kV (across various predicates) | 70 kV |
| Tube Current | 7 mA, 8 mA, or 10 mA (across various predicates) | 8 mA |
| Exposure Time Selection | Varied (e.g., 0.03 - 3.0 Sec to 0.08 - 3.2 Sec, various step counts) | 0.08 - 3.2 Sec. 17 Steps |
| Focal Spot | Varied (e.g., 0.6mm, 0.7mm, 0.8mm, 0.7 X 0.7 mm, 0.8 X 0.8mm) | 0.7 X 0.7 mm |
| Focal Length | 8in/12in (consistent across all predicates) | 8in/12in |
| Total Filtration in X-ray tube unit | >2 mm Al, >2.5 mm Al, >2.1 mm Al (across various predicates) | >2.0 mm Al |
| Leakage Radiation | 28 mR/hr at 1m from focal spot (for Dent-x Image x-70 Plus). Other predicates state "Compatible with Film and Digital" or "Unknown" | Less than 2.5 mGy/h (which is significantly lower than 28 mR/hr reported by a predicate, demonstrating superior safety). Compatible with Film and Digital. |
| Compatibility with Film and Digital | Yes (consistent across all predicates) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not describe a test set in the traditional sense of a clinical or image-based study. The "test set" is conceptualized as the technical specifications of the de Gotzen synchro device itself, which are compared against the specifications of five predicate devices. There is no mention of a patient or image sample size.
- Data Provenance: The data provenance is from the manufacturer's specifications and testing of the de Gotzen synchro device and the published or known specifications of the predicate devices. The document does not specify a country of origin for the data (beyond Italy for the manufacturer). It is retrospective in the sense that it relies on existing specifications of marketed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This substantial equivalence submission does not involve a direct assessment of image ground truth by experts in a clinical study. The "ground truth" for this type of submission is the engineering and performance specifications of the devices themselves, as measured and reported by their respective manufacturers and reviewed by regulatory bodies (FDA). No external experts (e.g., radiologists) are mentioned in establishing this "ground truth."
4. Adjudication Method for the Test Set
Since there is no clinical test set requiring expert interpretation or labeling, there is no adjudication method described. The comparison is based on direct specification matching and assessment of equivalence by the submitter and FDA reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document is a 510(k) submission for substantial equivalence based on technical specifications, not a clinical trial evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply to this submission.
7. The Type of Ground Truth Used
The "ground truth" used is the technical and performance specifications of the de Gotzen synchro Intraoral Dental X-Ray System, as measured by the manufacturer, and compared against the established technical and performance specifications of the predicate devices, as accepted by the FDA when those devices were cleared. This is essentially an engineering and regulatory "ground truth."
8. The Sample Size for the Training Set
This document does not describe a training set because it is not an AI/machine learning device. The "training" for such a device would be the engineering design, development, and testing processes conducted by the manufacturer to meet specific design requirements, which are then summarized in the technical specifications.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of AI/machine learning, this question does not apply. The "ground truth" in the design and manufacturing process would be established through engineering standards, regulatory requirements, and internal quality control measurements to ensure the device performs according to its intended specifications.
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MAY 0-3 2002
<021245
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510K Summary Statement for the de Gotzen "synchro" Intraoral Dental X-Ray System.
General Information
| Manufacturer: | de Gotzen S.r.lVia Roma 4521057 OLIGIATE OLONA (Varese) Italy |
|---|---|
| Establishment Registration: | |
| Telephone: | (011) 39 0331 376760 |
| Fax Line: | (011) 39 0331 376763 |
| Contact Person: | Antonella GASPARRI, International Compliance Office |
| Submitter: | The Gotzen Group, Inc., (dba) TG Group, Inc. Canada3505 Laird Road, Unit #7Mississauga, Ontario L5L 5Y7 |
| Establishment Registration: | #9615032 & Health Canada Establishment: # 692 |
| Telephone: | (877) 557-4888 (Watts Line) |
| Fax Line: | (905) 820-3215 |
| Contact Person: | Wayne Lebeau, President |
| USA Office: | TG Group USA, LLC30 Alden TerraceFlanders, NJ 07836 |
| Telephone: | (973) 927-3730 |
| Fax Line: | (973) 927-4006 |
| Contact Person: | Donald R. Hill, VP Sales & MarketingUSA FDA Liaison |
| Summary Preparation Date: | January 24, 2002 |
Name and Classification
Device Name:
de Gotzen synchro Intraoral Dental X-Ray System 90EHD - Unit, X-Ray, Extraoral with Timer Dental
Primary Classification Name: Classification Panel:
Predicate Devices
The de Gotzen synchro Intraoral Dental x-ray System is substantially equivalent to the following previously cleared and currently marketed devices.
Aztech 70 Gendex Gx770 Sirona Heliodent Vario Dent-x image X-70 Plus Belmont Belray 096
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Product Description
Page 2 of 4
The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:
- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .
Optional components:
- . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone
The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds
Intended Use:
The de Gotzen synchro Intraoral Dental X-Ray System is an Extraoral source of x-rays for Intraoral images in dental radiography.
Comparison of Technological Characteristics:
Rationale for Substantial Equivalence.
The de Gotzen synchro Intraoral Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features and therefore is Substantially Equivalent to the predicate devices listed in this summary.
Table comparing performance of de Gotzen synchro with predicate devices:
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| Specifications | Aztech 70 | Gendex Gx770 | Sirona Heliodent Vario | Dent-x Image x-70 Plus | Belmont Belray 096 | de Gotzen synchro |
|---|---|---|---|---|---|---|
| Registration Number | K984524 | K935046 | K000672 | K000551 | K963699 | |
| Line Requirements | 110V-120V 50Hz-60Hz | 110V - 130V 60Hz | 100V/110V/120V, 11A220V/230V/240V, 6A50Hz/60Hz | 110V/220V, 50Hz/60Hz | 108V - 132V 50Hz.60Hz | 220V/230V/240V, 8A110V - 120V 5.5A50hZ - 60hZ |
| Generator Type | AC | AC | AC Single Pulse | AC | AC | AC |
| Tube Voltage | 65 kV | 70 kV | 70 kV | 70 kV | 70 kV | 70 kV |
| Tube Current | 8 mA | 7 mA | 7mA | 8 mA | 10 mA | 8 mA |
| Exposure Time Selection | 0.03 -3.0 Sec | 3-99 impulses (28 Steps) | 0.03 - 3.2 Sec | 0.08- 3.2 Sec | 0.02 -3.0 Sec | 0.08- 3.2 Sec. 17 Steps |
| Focal Spot | 0.7 | 0.6mm | 0.8mm | 0.7 X 0.7 mm | 0.8 X 0.8mm | 0.7 X 0.7mm |
| Focal Length | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in |
| Total Filtration in X-ray tube unit | Unknown | Unknown | >2 mm Al | >2.5 mm Al | >2.1 mm Al | >2.0 mm Al |
| 28 mR/hr at 1m from focal spot | Less than 2.5 mGy/h | |||||
| Leakage Radiation Compatiabel with Film and Digital | Yes | Yes | Yes | Yes | Yes | Yes |
:
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Conclusion
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The deGotzen synchro Intraoral Dental X-Ray System was found to be /is substantially Equivalent to the predicate devices; the Aztech 70, Gendex Gx770, Siron Heliodent Vario, Dent-x image x-70, and Belmont Belray 096. The de Gotzen synchro shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of an eagle.
Public Health Service
MAY 03 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Gotzen Group, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K021245 Trade/Device Name: deGotzen synchro Intraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 18, 2002 Received: April 19, 2002
Dear Mr. Mosenkis:
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 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 this 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" (21 CFR Part 807.97). 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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XI. INDICATIONS FOR USE STATEMENT
Applicant: de Gotzen S.r.L.
510(k) Number (if known): k_02/245
Device Name: de Gotzen "synchro" Intraoral Dental X-Ray System
Indications for Use: The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.
(Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | _____ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K021245 |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT |
| And Radiological Devices |
510K Number___________________________________________________________________________________________________________________________________________________________________
§ 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.