(85 days)
The intraoral camera system, Vipercam, of Integra Medical Corporation is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Vipercam, intraoral camera system, and accessories
The provided text is a 510(k) premarket notification letter from the FDA for a device called "Vipercam." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is primarily a regulatory approval letter based on "substantial equivalence" to a predicate device, meaning it's similar enough to an already approved device that a full new trial is not required. It focuses on the legal and regulatory framework for marketing the device, not the detailed technical and clinical performance data that would typically be found in a study report.
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JUL 2 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. W. Edward Johansen ·Integra Medical Corporation 11661 San Vicente Boulevard Los Angeles, California 90049
Re : K981534 Trade Name: Vipercam Requlatory Class: I Product Code: EIA April 28, 1998 Dated: Received: April 29, 1998
Dear Mr. Johansen:
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 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). 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 Register. 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 - Mr. Johansen
through 542 of the Act for devices under the Electronic chiough 312 or on 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 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 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/dsma/dsmamain.html".
Sincerely yours,
Patricia Cuciniello
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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REMARKET NOTIFICATION
INDICATIONS FOR USE
510 (k) Number: K981534
Device Name:__Vipercam, intraoral camera system, and accessories Indications for Use:
The intraoral camera system, Vipercam, of Integra Medical Corporation is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Singer Rumorer
(Division Sign-Off) Division of Donal. Infection Control. and General Hospital Device 510(k) Number
Prescription Use: (Per 21 CFR 801.109
OR
Over-The-Counter-Use :_
§ 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.