(85 days)
Dressing for use after intraoral palatal surgery.
PS Thermoplastic (Aquaplast) Palatal Stent
The provided text is a 510(k) clearance letter from the FDA for a device called "Aquaplast Palatal Stent." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.
The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination of substantial equivalence is based on the device's indications for use and classification, rather than explicit performance metrics from a controlled study described within this document.
Consequently, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria other than "substantial equivalence."
- Sample size used for the test set and the data provenance: No study data or test set information is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study is detailed.
- Adjudication method: Not applicable.
- 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 is a palatal stent, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is purely administrative, granting marketing clearance based on a regulatory comparison to existing devices, not on the presentation of new performance study data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUM N SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, a symbol of medicine, with a staff entwined by two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. John R. Kirk ·President WFR/Aquaplast Corporation 30 Lawlins Park Wyckoff, New Jersey 07481-1443
K973370 Re : Aquaplast Palatal Stent Trade Name: Requlatory Class: II Product Code: EMA Auqust 25, 1997 Dated: Received: September 8, 1997
Dear Mr. Kirk:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
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Page 2 - Mr. Kirk
not affect any obligation you might have under sections 531 not arrect any obtigation for devices under the Electronic Chrough 542 of the Act 101 acvices or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Info icecci wirer 510(k) premarket notification. The FDA described in your sia equivalence of your device to a legally rinding of babbeanelar squared in a classification for your marketed production of mits 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) 594-4618. Additionally, for questions on Compriance at (301) 331 1010. Indiarodevice, please contact the Office of Compliance at (301) 594-4639. Also, please note ens or on on on itled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from cho mumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
U. Walcott
Timot ny A. 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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Page 1_of 1
510(k) Number (if known):__K973370
Device Name: PS Thermoplastic (Aquaplast) Palatal Stent
Indications For Use:
Dressing for use after intraoral palatal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Bunres
(Division Sign-Om
Division of D and Gen 510(k) Number
Prescription Use (Per 21 CFR 801.109)
ાવ્યું
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.