(109 days)
The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.
The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.
The provided text describes the Progeny Inc. Vivid Intraoral Camera System and its 510(k) submission (K090079) but does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Gendex EZ CAM and Schick USB CAM) by comparing characteristics and stating that "Performance testing and verification to meet product specifications" was performed. There's no detailed study report or specific performance metrics mentioned that would constitute "acceptance criteria."
However, I can extract the available information and present it in the requested format, highlighting what is implicitly or explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria are not defined with numerical targets in the provided document, I will infer the implicitly accepted performance based on the comparison to predicate devices, which serves as the basis for substantial equivalence. The "Reported Device Performance" for the Progeny Vivid Camera is its ability to match or be within the range of the predicate devices' characteristics.
| Characteristic | Implicit Acceptance Criteria (based on Predicates) | Reported Vivid Camera Performance |
|---|---|---|
| Image sensor | 1/4 inch CCD or 1/3 inch CCD | 1/4 inch CCD |
| Video output | USB full motion video or NTSC video | NTSC video |
| Pixel Area | 659 x 494 or 768 x 494 NTSC | 768 x 494 NTSC |
| Focus Range | 8 – 40 mm or 10 – 50 mm | 7 – 50 mm |
| PC Interface | USB 1.1 or USB 2 | USB 2 |
| PC Compatibility | MS Direct X video | MS Direct X video |
| Light Source | LED | LED |
| Integrated Frame Capture Button | YES | YES |
| Indications for Use | Ability to view oral cavity prior to and subsequent to dental procedures (same as predicates) | Ability to view oral cavity prior to and subsequent to dental procedures |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample size for a test set used to evaluate the device. The evaluation appears to be based on "Performance testing and verification to meet product specifications" and comparison of technical characteristics, rather than a clinical or user study with a defined test set. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The submission focuses on technical specifications and substantial equivalence, not on expert-adjudicated ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided as no specific test set or associated adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or described in the provided text. The document does not mention any studies involving human readers or AI assistance, nor does it discuss an effect size for human improvement with AI.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study focused on an algorithm's performance without human-in-the-loop was not conducted or described. The device is an intraoral video camera, not an AI algorithm, and its performance is evaluated based on its functional characteristics.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/performance studies (e.g., expert consensus, pathology, outcome data) is not applicable or mentioned in this submission. The evaluation is based on verifying that the camera's technical specifications and functional features are comparable to the predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set. This device is an imaging hardware component, not an AI/machine learning algorithm that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth would have been established.
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Progeny Inc.
Proprietary and Confidential
510(k) Summary
as required by CFR section 807.92(c)
MAY - 1 2009
I. General Information
Date:
December 23, 2008
Progeny, Inc. Applicant: 675 Heathrow Dr. Lincolnshire, III. (೧೧೯೪
Alan Krema Contact Person:
Telephone: 847-415-9800
847-415-9800 Fax:
II. Names
Device Name:
Trade Name: Vivid Intra Oral Camera System Common Name: Classification Name: Intraoral Video Camera
III. Predicate Devices
Gendex EZ CAM Schick USB CAM
IV. Product Description
The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.
The Progeny, Inc. Vivid Intraoral Camera Systern consists of the following main components:
page 4-1
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System Configurations
The Vivid Intraoral Video Camera is intended to be connected to a USB hub that is connected to a computer's USB port or to be directly connected to a computer's USB ports.
Connecting the Vivid camera using a USB hub requires that only one USB port on the computer be used for the Vivid camera.
Image /page/1/Figure/5 description: This image shows a diagram of a Vivid camera system connected to a computer. The system includes a Vivid camera handpiece, a USB-Video converter, a powered USB hub, and a computer. The camera is connected to the converter via a Vivid Camera Cable, and the converter is connected to the USB hub via two USB cables. Finally, the USB hub is connected to the computer via a USB cable.
Components List
| Part Number | Description |
|---|---|
| 40-A0002 | Handpiece, Vivid USB Camera |
| 40-A0003 | USB Video Converter |
| 40-08010 | Vivid Camera Cable and Handpiece Connector |
| 40-08030 | Vivid Camera Cable and Handpiece Connector |
| 40-08003 | USB Cable |
| 40-07001 | USB 4-port Hub |
| 195-059 | Color Chart |
| 00-02-1591 | Installation and User Manual CD ROM |
| 40-S0006 | Sheath package |
| 40-A2005 | Wall Mount Holder |
| 40-A2006 | Monitor/Delivery Unit Holder |
V. Indications for Use / Rationale for Substantial Equivalence
The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. The Vivid 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 Intrainal Video Camera Systems on the U.S. market. One is the Gendex EZ CAM. The 510(k) number is K032904 . The classification of this device is listed as product code ElA.
The other currently marketed device is the SCHICK USB CAM, manufactured by Schick Technologies, Inc. the 510(k) number is K963778. The classification of this device5 is listed as product code EIA .
Labeling for the currently marketed devices is included as Appendix B.
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Progeny Inc.
| Characteristic | Schick USB CAM | Gendex EX CAM | Progeny Vivid |
|---|---|---|---|
| Image sensor | 1/4 in. CCD | 1/3 in. CCD | 1/4 in. CCD |
| Video output | USB full motion video | NTSC video | NTSC video |
| Pixel Area | 659 x 494 | 768 x 494 NTSC | 768 x 494 NTSC |
| Focus Range | 8 – 40 mm | 10 - 50 mm | 7 – 50 mm |
| PC Interface | USB 1.1 | USB 2 | USB 2 |
| PC Compatibility | MS Direct X video | MS Direct X video | MS Direct X video |
| Light Source | LED | LED | LED |
| Integrated Frame Capture Button | YES | YES | YES |
Comparison Table:
Safety and Effectiveness Information VI.
Safety and effectiveness is demonstrated by:
Performance testing and verification to meet product specifications. Same indications for use as predicate devices. Certification to Safety Standards.
All of the above steps and evaluations combine to demonstrate that the Vivid Intraoral Video Camera System is safe and effective when the device is used as labeled.
page 4-3
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VII. Conclusion
.
The Progeny, Inc. Vivid Intraoral Video Camera System is determined to be substantially equivalent to the predicate devices, the Gendex EZ CAM, and the Schick USB CAM. The Vivid 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 Vivid Intraoral Video Camera System is safe and effective when the device is used as labeled.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines. The emblem is positioned in the center of the circle, slightly offset to the right.
Public Health Service
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Krema Director, Products Development Progeny, Incorporated 675 Heathrow Drive Lincolnshire, Illinois 60069
Re: K090079
Trade/Device Name: Vivid Intraoral Video Camera Regulation Number: 872.6640 Regulatory Class: I Product Code: EIA Dated: April 14, 2009 Received: April 17, 2009
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2- Mr. Krema
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Gunner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 0900 791
Progeny
Vivid Intraoral Video Camera
510k number: K090079
Statement of Indications for Use:
Intended Use for the Progeny Vivid Camera:
The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.
Rai Muling San Mse
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: JC090079
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.