(23 days)
The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The Progeny, Inc. JB-70 Intraoral Dental X-Ray 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: 12 inch cone, 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
The provided text is a 510(k) summary for the Progeny JB-70 Intraoral X-Ray System. It explicitly states that the device's safety and effectiveness are demonstrated by "Performance testing and verification to meet product specifications." However, the document does not detail specific acceptance criteria or the study that proves the device meets those criteria, nor does it provide the type of outcomes data that would typically be used to assess the clinical effectiveness of a medical device against a ground truth.
Instead, the document 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. It lists a comparison table of technical characteristics between the devices.
Therefore, most of the requested information cannot be extracted from this document. I will provide the information that is present and explicitly state what is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states that performance testing and verification were done to meet product specifications, but it does not specify what those product specifications (acceptance criteria) were, nor does it report the results of such performance testing in a quantifiable manner (e.g., specific metrics for image quality, radiation dose, diagnostic accuracy, etc.). The "Comparison Table" provided focuses on design characteristics (kVp, mA, field size, etc.) rather than performance metrics against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available. There is no mention of a clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on technical comparison and a general statement of performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not available. Since no clinical test set or ground truth establishment is mentioned, there is no information about experts or their qualifications.
4. Adjudication Method
Not applicable/Not available. No clinical study or ground truth adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is an X-ray system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not available. The device is an X-ray system, not an algorithm. There is no mention of an algorithm-only performance study.
7. Type of Ground Truth Used
Not available. No clinical study involving ground truth (e.g., expert consensus, pathology, or outcomes data) is described for product performance evaluation. The safety and effectiveness are established via performance testing to product specifications and substantial equivalence to predicate devices.
8. Sample Size for the Training Set
Not available. The document does not describe a training set, as it's not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there is no training set mentioned, there is no information on how its ground truth would have been established.
Summary of available information related to performance:
The document states:
- "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."
The core argument for safety and effectiveness, beyond internal performance testing (details not provided), rests on substantial equivalence to two predicate devices:
The comparison table highlights similarities in key technical characteristics between the JB-70 and its predicates:
| Characteristic | Gx 770 | Gendex 765 | Progeny JB-70 |
|---|---|---|---|
| Fixed Kv | 70 kVp | 65 kVp | 70 kVp |
| Fixed mA | 7.0 mA | 7.5 mA | 8.0 mA |
| Operator TechniqueSelection | ExposureDuration Only | ExposureDuration Only | ExposureDuration Only |
| 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 |
The conclusion states that the JB-70 is "substantially equivalent to the predicate devices" because it "shares the same indications for use, materials, design, operational and functional features." This implies that the performance is expected to be similar because the device is technically comparable to already cleared devices, rather than through a direct demonstration of clinical performance against specific acceptance criteria in a clinical study.
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510(k) Summary FEB 01 2002
as required by CFR section 807.92(c)
I. General Information
| Date: | January 2, 2002 |
|---|---|
| Applicant: | Progeny, Inc.1807 Barclay Blvd.Buffalo Grove, Ill.60089 |
| Contact Person: | Alan Krema |
| Telephone: | 847-850-3800 x785 |
- Fax: 847-850-3800
II. Names
Device Name:
1
| Trade Name: | JB-70 |
|---|---|
| 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. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography.
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components:
page 4-1
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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 fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
V. Indications for Use / Rationale for Substantial Equivalence
The JB-70 Intraoral Dental X-Ray System is to be used as an extraoral source of xrays in Dental radiography.
The JB-70 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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Comparison Table:
| Characteristic | Gx 770 | Gendex 765 | Progeny JB-70 |
|---|---|---|---|
| Fixed Kv | 70 kVp | 65 kVp | 70 kVp |
| Fixed mA | 7.0 mA | 7.5 mA | 8.0 mA |
| Operator TechniqueSelection | ExposureDuration Only | ExposureDuration Only | ExposureDuration Only |
| 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 JB-70 Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.
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VII. Conclusion
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is determined to be substantially equivalent to the predicate devices, the Gendex Gx-770, and the Gendex 765DC. The JB-70 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 JB-70 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 is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089
Re: K020070
Trade/Device Name: JB-70 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: January 2, 2002 Received: January 9, 2002
Dear Mr. Krema:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are 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 nredicate 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. Snogdon
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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| Page | of |
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| - | 1 1 |
510(k) Number (if known): *
Device Name: のお気になる。
Indications For Use:
Statement of Indications for Use:
Intended Use for the Progeny JB-70:
The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Stenson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030010
Prescription Usc (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.