(147 days)
The SpectraVu Family of Intracral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference.
These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves,
The SpectraVu Family of Intraoral Camera Systems . consist of a power supply, digital camera processor, circuit boards, a light source, optical and electronic cables, and an ergonomic hand piece with an autoclavable sleeve containing an optical system. The components are capable of capturing images over a wide focal range. The images can be displayed on a television monitor, in a computer or may be printed out.
The provided text is a 510(k) summary for the SpectraVu Family of Intraoral Camera Systems. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria and detailed quantitative metrics.
Here's an analysis based on the provided text, focusing on the requested information where available, and noting what is not explicitly stated in this document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define explicit quantitative acceptance criteria or report specific performance metrics from a dedicated study. Instead, it relies on demonstrating technological similarities and intended use equivalence to a predicate device.
| Feature/Criterion (Implied) | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (from "Summary of technological similarities") |
|---|---|---|
| Intended Use | Aid in patient education, defect detection, image storage, not surgical use. | "Capturing images over a wide focal range... intended to be used to aid in patient education, enhancement of defect detection, and for image storage. These are not intended to aid in dental surgical procedures." |
| Output | Display on monitor, computer, or print. | "Images can be displayed on a television monitor, in a computer or may be printed out." |
| Image Resolution | High resolution image. | "High resolution image" (Qualitative statement) |
| Color Accuracy | Accurate color image. | "Accurate color image" (Qualitative statement) |
| Image Storage | Digital, on-board image storage. | "Digital, on-board image storage" |
| Portability/Design | Ergonomic, portable design; portable and fixed models. | "Ergonomic, portable design"; "Portable and fixed models" |
| Autoclavable Components | Autoclavable window sleeves. | "Autoclavable window sleeves" (A differentiator from predicate with "Yes" vs "No") |
| EMC Approval | EMC approved. | "EMC approved" (A differentiator from predicate with "Yes" vs "UL Approved") |
2. Sample size used for the test set and the data provenance
Not mentioned. The document does not describe a test set or clinical study with a specified sample size. The 510(k) focuses on a comparison of technical features rather than a performance study involving a subject cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned. Since no explicit test set or ground truth establishment is described for a performance study, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned. No adjudication method is described as there is no mention of a performance study requiring ground truth adjudication.
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 device (an intraoral camera) is not an AI-powered device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed. The submission focuses on the camera's ability to capture and display images for patient education and defect identification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware imaging system, not an algorithm. Its function inherently involves a human operator (the dentist) to capture and interpret images. There is no standalone "algorithm only" performance to be evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly described in the context of a performance study. The "ground truth" for this device, based on its intended use, would implicitly be the actual oral cavity conditions that the camera is intended to visualize and aid in identifying. The submission demonstrates that the camera's technical specifications and features (like high-resolution and accurate color imaging) are suitable for this purpose, but it doesn't detail a formal process for establishing a "ground truth" for a study.
8. The sample size for the training set
Not applicable/Not mentioned. This is a hardware device; there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable/Not mentioned. As there's no training set, this information is irrelevant.
In summary:
This 510(k) submission primarily relies on a comparison of technological features and intended use to demonstrate substantial equivalence to a legally marketed predicate device (UltraCam II). It does not describe a clinical performance study with predefined acceptance criteria, test sets, ground truth establishment, or expert evaluations in the manner typically seen for more complex diagnostic or AI-driven devices. The "reported device performance" is mainly a qualitative assertion of its capabilities as they match the predicate, such as "High resolution image" and "Accurate color image".
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4/29/99
129184332
AUSTIN W. BREWIN, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Suite 330, Oakland, CA 94611 USA 510-547-1211 Phone and Fax e-mail abrewin@well.com
25 November 1998
510(k) Summary as required by section 807.92(c)
Submitted by the contact person: Austin Brewin, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Oakland, CA 94611 Phone, Fax: 510-547-1211
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The Device: ●
Trade Name: SpectraVu Family of Intraoral Camera Systems manufactured and marketed by International Technology Concepts (ITC/SpectraVu) of 11501 Dublin Boulevard, Dublin, CA 94568. Phone: 800-549-2727 Fax: 408-395-1490 Common Name: Intraoral video camera Classification Name: Dental Operative Unit and Accessories (76 EIA) -
Equivalent legally marketed device: . Ultracam II, made by Ultrac, Inc, a division of Dental Vision Direct, Inc. The 510(k) number assigned for this equivalent system is K941452.
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Summary of technological similarities between the SpectraVu and UltraCam systems: .
| Feature: | SpectraVu | UltraCam |
|---|---|---|
| Used for dental patient education | Yes | Yes |
| General dental office use | Yes | Yes |
| Ergonomic, portable design | Yes | Yes |
| Portable and fixed models | Yes | Yes |
| Built-in back-up battery | Yes | Yes |
| Accurate optical lens system | Yes | Yes |
| Variable focal lengths | Yes | Yes |
| Integrated camera-light cable | Yes | Yes |
| Digital, on-board image storage | Yes | Yes |
| High resolution image | Yes | Yes |
| Accurate color image | Yes | Yes |
| Display single or multiple images | Yes | Yes |
| Computer or S-Video output | Yes | Yes |
| On the unit control | Yes | Yes |
| Handpiece image capture control | Yes | Yes |
| Autoclavable window sleeves | Yes | No |
| EMC approved | Yes | UL Approved |
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- Summary Description of the Device: The SpectraVu Family of Intraoral Camera Systems . consist of a power supply, digital camera processor, circuit boards, a light source, optical and electronic cables, and an ergonomic hand piece with an autoclavable sleeve containing an optical system. The components are capable of capturing images over a wide focal range. The images can be displayed on a television monitor, in a computer or may be printed out.
- Intended use of the device: Intraoral images captured and displayed by the cameras are . intended to be used to aid in patient education, enhancement of defect detection, and for image storage. These are not intended to aid in dental surgical procedures.
- The Spectra Vu Family of Intraoral Camera Systems provides intraoral images, and are not . substantially different from currently marketed devices such as the UltraCam systems.
Respectfully submitted,
B. leum
Austin Brewin, M.D.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with a bird-like figure above them. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
International Technology Concepts C/O Austin W. Brewin, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Suite 330 Oakland, California 94611
Re: K984332 Spectra Vu 1000 Series Intraoral Camera, Trade Name: Spectra Vu 2000 Series Requlatory Class: I Product Code: EIA Dated: March 15, 1999 Received: March 23, 1999
Dear Dr. Brewin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Brewin
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (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 requlation entitled, "Misbranding by reference to ene regaracron Chercica) Titblanding II Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K 984332
13. Statement of indications for use:
The SpectraVu Family of Intracral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference.
These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves,
Susan Runge
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K184332
Prescription DEVICE
TV
§ 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.