(22 days)
Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.
Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dry to the touch in < 3 minutes | All samples were dry in less than 3 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Five randomly drawn subgroups, with three samples taken from each subgroup, totaling 15 samples.
- Data Provenance: The document does not explicitly state the country of origin. It is a non-clinical test conducted by the manufacturer, Kay-See Dental, in the USA (Kansas City, MO and Belton, MO are the addresses provided). The study is prospective as it involves direct testing of the device for its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document does not specify that experts were used to establish ground truth for the drying time observation. The assessment of "dry to the touch" appears to be a direct physical observation without a formal expert panel consensus for ground truth.
- Qualifications of Experts: Not applicable, as experts are not mentioned for this particular test.
4. Adjudication Method for the Test Set
- Adjudication Method: None stated. The drying time observation seems to be a singular measurement per sample, without the need for multiple observers or an adjudication process for this specific test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: N/A, as no MRMC study was conducted, and the device is a dental varnish, not an AI-powered diagnostic tool.
6. Standalone Performance Study
- Was a standalone study done? Yes. The non-clinical testing for drying time is a standalone performance study of the "Hydro-Cast Acrylic Varnish" itself.
7. Type of Ground Truth Used
- Ground Truth Type: For the drying time test, the ground truth was based on a direct physical observation (dry to the touch) against a pre-defined performance specification.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical product (acrylic varnish) and not an AI/machine learning model, so there is no concept of a "training set" in the context of this document.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
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4/29/99
Image /page/0/Picture/1 description: The image shows the words "510K SUMMARY" in large, bold letters at the top. Below that, there is a handwritten number "K991161". The text and number are centered on a white background.
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Date Prepared 04/06/99
Submitted by Clark Smith D.M.D.
Kay-See Dental 124 East Missouri Avenue Kansas City, MO 64106
Telephone 800-842-8844 Fax 816-842-3204 :
Contact Clark Smith D.M.D.
Prepared by Barry Hale 7707 E 201 terr Belton, MO 64012 816-322-4641
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Trade name - Hydro-Cast Acrylic Varnish
Common name - Acrylic Varnish
Classification Name - Resin, Denture, Relining, Repairing, Rebasing (872.3760)
Substantial equivalence claimed to - PalaSeal K892452
Description of the device. Acrylic varnish.
Intended use of device Is applied to cured materials such as dentures, partial dentures, dental splints, and temporary crowns/bridges for the purpose of sealing the acrylic surface.
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TECHNOLOGICAL CHARACTERISIC COMPARISON
PalaSeal
Preparation of methyl methacrylate monomer, multifunctional methacrylates, light sensitizer, polymerization initiator.
Hydro-Cast Acrylic Varnish
Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.
Summary: The technological characteristics of the two devices are identical.
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NON-CLINICAL TESTING AND DATA
The testing of Hydro-Cast Acrylic Varnish was conducted using five randomly drawn subgroups, with three samples taken from each subgroup. The samples were applied to acrylic denture surfaces and the drying time observed. The specification for drying time is, dry to the touch in < 3 minutes. All samples were dry in less than 3 minutes.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes intertwined around a central staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294
Re : K991161 Hydro-Cast Acrylic Varnish, Model 78125 Trade Name: Requlatory Class: I Product Code: EIA Dated: April 6, 1999 Received: April 7, 1999
Dear Dr. Smith:
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 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Smith
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results 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) 594-4692. 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 gener 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/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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STATEMENT OF INDICATIONS FOR USE
Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.
crylic surface.
Clark Smith D.M.D
Prescription Use
(Per 21 CFR 801.109)
Susan Runno
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices ુવ 1110 510(k) Number
§ 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.