(34 days)
The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.
The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The system consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components include a 12 inch cone and an 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6, or 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.
The provided 510(k) summary for the Progeny, Inc. PREVA Intraoral Dental X-Ray System describes a device for generating X-rays for dental imaging. However, it does not include acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) or detailed study results demonstrating such performance.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Gendex Gx-770 and Gendex 765DC) based on shared indications for use, materials, design, and operational/functional features. The safety and effectiveness are supported by:
- Performance testing and verification to meet product specifications (general statement, no specifics provided).
- Software testing to validate software design and performance (general statement, no specifics provided).
- Hazard analysis and risk level assessment (general statement, no specifics provided).
- The fact that it shares the same indications for use as predicate devices.
Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their achievement cannot be extracted from this document, as the submission relies on substantial equivalence for a device generating X-rays, rather than presenting a comparative diagnostic performance study against a ground truth.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
Based on the provided document, specific quantitative acceptance criteria for diagnostic imaging performance (e.g., image quality, diagnostic accuracy measures like sensitivity, specificity, or AUC) are not defined or reported. The "acceptance criteria" presented are implicit in the comparison to predicate devices, focusing on key physical and operational characteristics to demonstrate substantial equivalence, rather than a quantifiable measure of diagnostic utility.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (PREVA) |
|---|---|---|
| Kv (Kilovoltage Peak) | Comparable to predicate devices (fixed 70 kVp, fixed 65 kVp) | 60, 65, 70 kVp, selected |
| mA (Milliampere) | Comparable to predicate devices (7.0 mA, 7.5 mA) | 4, 6, 8mA, selected |
| Operator Technique Selection | Exposure Duration Only (as in predicate devices) | kV, mA, Exposure Duration |
| Suspension | Articulated Arm (as in predicate devices) | Articulated Arm |
| X-Ray Field Size | Within range of predicate devices (6.5 cm diameter, 6.0 cm diameter) | 6.5 cm diameter |
| Focal Distance | Comparable to predicate devices (8 in. cone, 12 in. cone) | 8 in. cone, 12 in. cone |
| Operator Exposure Control | Deadman Switch (as in predicate devices) | Deadman Switch |
| Safety and Effectiveness | Demonstrated by performance testing, software testing, hazard analysis, and similar indications for use as predicate devices. | Meets the above criteria (no specific performance metrics given). |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a test set or data from a diagnostic performance study to establish clinical effectiveness or accuracy. The evaluation is based on technical specifications and substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No expert ground truth establishment for a diagnostic test set is detailed in this document.
4. Adjudication method for the test set
Not applicable. No test set or related adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to an X-ray hardware system (the generator of the X-rays), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray generator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The document describes a medical device (X-ray system), not an interpretative algorithm, thus, no "ground truth" for diagnostic performance is discussed. The ground truth for the technical performance data would be the physical measurements of the device's output (e.g., kVp, mA, exposure time).
8. The sample size for the training set
Not applicable. This is an X-ray hardware system, not a software algorithm that requires a training set in the AI/machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is an X-ray hardware system.
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510(k) Summary
DEC 1 3 2004
as required by CFR section 807.92(c)
Koy 3092
I. General Information
- November 6, 2004 Date:
- Progeny, Inc. Applicant: 1807 Barclay Blvd. Buffalo Grove, Ill. 60089
- Alan Krema Contact Person:
- 847-850-3800 x785 Telephone:
- 847-850-3800 Fax:
II. Names
Device Name:
| Trade Name: | PREVA |
|---|---|
| Common Name: | Intra Oral X-Ray System |
| Classification Name: | 76 EHD – Unit, X-Ray, Extra oral with Timer |
III. Predicate Devices
Gendex Gx-770 Gendex 765DC
IV. Product Description
The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography.
The Progeny, Inc. PREVA Intraoral Dental X-Ray System consists of the following main components:
page 4-1
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K04301Z
X-ray tubehead Rotating yoke for tubehead mounting Articulation arm Horizontal extension arm Electronic control unit Wall mount 8 inch cone
Optional Components:
12 inch cone 8 ft. coil cord with exposure switch
The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6,0r 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.
V. Indications for Use / Rationale for Substantial Equivalence
The PREVA Intraoral Dental X-Ray System is to be used as an extraoral source of xrays in Dental radiography.
The PREVA shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.
There are several major independent manufacturers of Intra Oral diagnostic Radiographic Systems on the U.S. market. One is the Dentsply Gx770. The 510(k) number is K935046 . The classification of the Dentsply device is listed as product code 76EHD.
The other currently marketed device is the Gendex 765, manufactured by Dentsply, Inc. the 510(k) number is K992610. The classification of the Gendex 765 is listed as product code 76EHD .
Labeling for the currently marketed devices is included as Appendix B.
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Progeny Inc.
| Characteristic | Gx 770 | Gendex 765 | Progeny PREVA |
|---|---|---|---|
| Kv | 70 kVp fixed | 65 kVp fixed | 60, 65, 70 kVp, selected |
| mA | 7.0 mA | 7.5 mA | 4, 6, 8mA, selected |
| Operator TechniqueSelection | ExposureDuration Only | ExposureDuration Only | kV, mA, ExposureDuration |
| Suspension | Articulated Arm | Articulated Arm | Articulated Arm |
| X-Ray Field Size | 6.5 cm diameter | 6.0 cm diameter | 6.5 cm diameter |
| Focal Distance | 8 in. cone12 in. cone | 8 in. cone | 8 in. cone12 in. cone |
| Operator ExposureControl | DeadmanSwitch | DeadmanSwitch | DeadmanSwitch |
VI. Safety and Effectiveness Information
Safety and effectiveness is demonstrated by:
Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.
All of the above steps and evaluations combine to demonstrate that the PREVA Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.
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Ku43092
VII. Conclusion
The Progeny, Inc. PREVA Intraoral Dental X-Ray System is determined to be substantially equivalent to the predicate devices, the Gendex Gx-770, and the Gendex 765DC. The PREVA shares the same indications for use, materials, design, operational and functional features to the currently marketed predicate devices listed in section III of this summary. The PREVA Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.
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Image /page/4/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850'
DEC 1 3 2004
Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089
Re: K043092
Trade/Device Name: PREVA Extraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: 90 EHD Dated: November 3, 2004 Received: November 15, 2004
Dear Mr. Krema:
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 (Premarket Approval), it may be subject to such 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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.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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Indications for Use
510(k) Number (if known):_____K043092
PREVA Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.:
Prescription Use
(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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadon
(Division Sign-Off) Division of Reproductive Abdomina and Radiological Devices 510(k) Number _
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.