(61 days)
Not Found
Not Found
No
The summary describes a fiberscope and sheath for direct visualization, with no mention of AI, ML, image processing, or any related performance metrics.
Yes
The "Intended Use / Indications for Use" section explicitly states "direct visualization and therapy of periodontal disease," indicating a therapeutic purpose.
No
The device is used for direct visualization and therapy, indicating it is an interventional or therapeutic device rather than purely diagnostic.
No
The device description explicitly mentions a "Fiberscope and Window Sheath," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity." This describes a device used in vivo (within the living body) for direct observation and treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device's use does not involve the analysis of any biological specimens.
Therefore, the PerioView Model DV-1 Fiberscope and Window Sheath is a medical device used for direct visualization and therapy within the oral cavity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.
Product codes
EIA
Device Description
PerioView Model DV-1 Fiberscope and Window Sheath
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Mr. Wendell Ebling President/CEO DentalView™, Incorporated 15540-D Rockfield Boulevard Irvine, California 92618
K982480 Re: PerioView Model DV-1 Fiberscope and Window Trade Name: Sheath Requlatory Class: I Product Code: EIA Dated: July 14, 1998 Received: July 16, 1998
Dear Mr. Ebling:
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 leqally 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), 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Ebling
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral ' 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/dsma/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
2
| 510(k) Number (if known): | K982480 |
|---|---|
| --------------------------- | --------- |
Device Name:
INDICATIONS FOR USE
The PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suxer Runper
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)