(50 days)
General Usage:
For the absorption/Collection and removal of excessive saliva during dental procedures.
For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.
For the absorption/Collection and removal of saliva in General Pediatric Use.
For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.
For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ...
For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.
SIMPLEX™ SALIVA ABSORBER/COLLECTOR
I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, discussing the substantial equivalence of a device (Simplex Saliva Absorber/Collector) to pre-existing devices. It explicitly states that the device is of regulatory class I.
Therefore, the document does not contain information about:
- Acceptance criteria and reported device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance or adjudication methods.
- Expert qualifications or number of experts used to establish ground truth.
- Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
The letter is a regulatory approval document based on substantial equivalence to a predicate device, not a detailed technical study report.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
APR 2 | 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nicholas G. Levandoski, Ph.D. ·President IRT Management Corporation 470 Ansin Boulevard, Suite G Hallandale, Florida 33009
Re : K980783 Simplex Saliva Absorber/Collector, Model Trade Name: SSA-5 Regulatory Class: I Product Code: KHR Dated: February 27, 1998 Received: March 2, 1998
Dear Dr. Levandoski:
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 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. ਬ 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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Dr. Levandoski
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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" (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): K980783
Device Name: SIMPLEX™ SALIVA ABSORBER/COLLECTOR
Indications For Use:
General Usage:
For the absorption/Collection and removal of excessive saliva during dental procedures.
For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.
For the absorption/Collection and removal of saliva in General Pediatric Use.
For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.
For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ...
For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K980783 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
§ 872.6050 Saliva absorber.
(a)
Identification. A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.