(32 days)
The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners.
The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions.
The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines.
The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution.
Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
The Perfect Shot Intra-Oral Camera is a wireless intra-oral camera that transmits an RF signal to a receiver. It has voice activated instructions to freeze a view or take a picture. It uses a CCD with 640-480 lines resolution. The picture is transmitted to a monitor and can be printed or attached to computers for digital storage or transmission.
The provided text is a 510(k) clearance letter from the FDA for the "Perfect Shot Intra-Oral Camera." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) process is based on demonstrating substantial equivalence to a legally marketed predicate device, not on meeting specific performance acceptance criteria from a new clinical study. The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to pre-amendments devices, thereby allowing it to be marketed.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a detailed predicate comparison or a separate clinical study report, neither of which is part of this 510(k) clearance letter. The document focuses on regulatory approval based on substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Roger C. Claar, PhD. Vice President of Operations & Regulatory Affairs International Imaging Electronics --881 Remington Boulevard Bolingbrook, Illinois 60440-4932
JUL - 3 1997
Re : K972019 Trade Name: Perfect Shot Regulatory Class: I Product Code: EIA Dated: May 29, 1997 Received: June 1, 1997
Dear Dr. Claar:
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 aqainst misbrandinq 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 Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Claar
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 807.97). 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 (if known): K972019
Device Name: Perfect Shot Intra-Oral Camera
Indications For Use:
The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners.
The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions.
The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines.
The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution.
Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972019 |
| Prescription Use(Per 21 CFR 801.109) | / |
|---|---|
| ------------------------------------------ | ---------------------------------------------------------------- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| (Optional Format 1-2-96) |
§ 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.