(177 days)
For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.
The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
This document focuses on the substantial equivalence of the Sci-Pharm DFV Varnish to legally marketed predicate devices, rather than establishing acceptance criteria or performance through a clinical study with numerical metrics like sensitivity, specificity, or accuracy.
The manufacturer, Scientific Pharmaceuticals, Inc., sought 510(k) clearance from the FDA for their Sci-Pharm DFV Varnish. The clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific, pre-defined acceptance criteria through a clinical performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not directly applicable here because the submission is based on substantial equivalence, not a performance study against specific acceptance criteria. Instead, the document compares the chemical composition and device function to predicate devices.
| Feature / Criterion | Predicate Device (Duraphat/Durafluor) | Sci-Pharm DFV Varnish Performance |
|---|---|---|
| Material/Composition | ||
| Ethyl Alcohol | 75% | 71.25% |
| Colophony | 20% | 20% |
| Sodium Fluoride | 5% | 5% |
| Water | <1% | 3.75% |
| Device Function/Use | ||
| Consistency | Viscous liquid | Viscous liquid |
| Evaporation | Within a few minutes | Within a few minutes |
| Film Formation (Colophony) | Yes | Yes |
| Sodium Fluoride Suspension | Yes | Yes |
| Adherence to tooth structure | Well adhering | Well adhering |
| Temporary reduction of sensitivities | Accepted worldwide | Accepted worldwide |
| Reduction of post-operative sensitivities | Accepted worldwide | Accepted worldwide |
| Caries prevention under restoratives & cements | Accepted worldwide | Accepted worldwide |
| Solvent Type | Pure ethyl alcohol | Azeotrope of ethyl alcohol and water (95:5 ratio) |
| Cure Speed | Standard | Faster cure |
| Potential for initial irritation | Standard | Reduced potential |
2. Sample Sizes and Data Provenance
This information is not applicable as there was no formal "test set" in the context of a clinical performance study. The data provenance relates to the analysis of the chemical composition and physical properties of the Sci-Pharm DFV Varnish and its predicate devices.
- Sample Size for Test Set: Not applicable (no clinical test set for performance metrics).
- Data Provenance: The data regarding chemical composition and physical properties were likely generated in-house by Scientific Pharmaceuticals, Inc., through laboratory tests (IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, dry residue determination). The document doesn't specify if these were retrospective or prospective analyses, but they would have been performed specifically for the 510(k) submission.
3. Number and Qualifications of Experts for Ground Truth
This is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, was not required for this type of submission. The "ground truth" here is the established chemical composition and functional behavior of the predicate devices and the Sci-Pharm DFV Varnish, determined through analytical laboratory techniques.
4. Adjudication Method
This is not applicable. There was no adjudication method used as this was not a clinical study involving human assessment of outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a 510(k) submission for substantial equivalence of a dental varnish.
6. Standalone (Algorithm Only) Performance Study
No, a standalone study was not done. This submission is for a physical dental varnish, not an algorithm or software. The closest analogy would be the in-lab testing of the varnish's chemical and physical properties to demonstrate its equivalence.
7. Type of Ground Truth Used
The "ground truth" used for this submission was based on:
- Chemical Analysis: Laboratory results from techniques like IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, and dry residue determination to confirm the identity and concentration of ingredients in both the new device and the predicate devices.
- Established Device Function: The document refers to the "accepted worldwide" uses of varnishes with similar compositions, indicating an reliance on existing clinical understanding and historical data for this class of devices.
8. Sample Size for the Training Set
This is not applicable as this is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows a logo with the text "SCI-PHARM" in bold, black letters. To the left of the text is a black silhouette of two beakers. Above the text is a handwritten date, "2/12/99". To the right of the text is a black mortar and pestle.
SCIENTIFIC PHARMACEUTICALS, INC.
3221 Producer Way • Pomona, California USA 91768 PHONE: (909) 595-9922 • Outside California (800) 634-3047 • FAX: (909) 595-0331 E-MAIL: scipharm@msn.com · WEBSITE: http://www.scipharm.com
.chemistry working for medicine and dentistry
Image /page/0/Picture/4 description: The image shows the text "K982915" at the top, followed by the text "510(k) SUMMARY" in bold and underlined. The text appears to be part of a document or form. The text is black and the background is white.
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Dr. Jan A. Orlowski (1) Submitted by: Scientific Pharmaceuticals, Inc. 3221 Producer Way Pomona, California 91768 phone: 909-595-9922
Date Prepared: August 18, 1998 -
(2) Device Trade Name: Sci-Pham DFV Vamish Dental Varnish Device Common Name: Device Classification Name: Cavity Vamish
-
Sci-Pharm DFV Vamish is substantially equivalent to Duraphat by Colgate-Palmolive and (3) Durafluor by PharmaScience (as shown in the table in Point 4 below).
(4) Chemical Composition
| Ingredient | Sci-Pharm DFV Varnish | Colgate Duraphat |
|---|---|---|
| Ethyl Alcohol | 71.25% | 75% |
| Colophony | 20% | 20% |
| Sodium Fluoride | 5% | 5% |
| Water | 3.75% | <1% |
Device Function
The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
- (5) The use of varnishes similar or virtually identical to Sci-Pharm DFV Varnish is accepted worldwide for three major functions:
- temporary reduction of sensitivity of teeth where dentin or cementum is exposed l
- I reduction of post-operative sensitivity
- 트 caries prevention under restoratives and cements
- The technological characteristics (i.e., chemical composition and device function) of Sci-(6) Pharm DFV Varnish are similar to that of cavity varnishes which have been in widespread use for many decades. It is virtually identical to varnishes currently commercially available (Duraphat by Colgate-Palmolive and Durafluor by PharmaScience), the only difference being that it incorporates an azeotrope of ethyl alcohol and water (95:5 ratio) as solvent instead of pure ethyl alcohol, in order to achieve faster cure and reduced potential of initial irritation of very sensitive teeth.
- In order to determine substantial equivalence of Sci-Pharm DFV Varnish to Duraphat and (7) Durafluor, the identity and concentration of solvents (carriers), resin, and fluoride salt comprising Duraphat and Durafluor versus those comprising Sci-Pharm DFV Varnish were determined and confirmed by tests including: IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, and dry residue determination.
Manufacturers of Medical Devices, Fine Chemicals, and Pharmaceuticals
FLUOROSE.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Dr. Jan A. Orlowski Scientific Pharmaceuticals, Incorporated 3221 Producer Way Pomona, California 91768
Re: K982915 Sci-Pharm DFV Varnish Trade Name: Regulatory Class: II Product Code: IBH November 25, 1998 Dated: Received: December 1, 1998
Dear Dr. Orlowski
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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Paqe 2 - Dr. Orlowski
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" (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
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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K982915 510(k) NUMBER (if KNOWN) :
_SCI-PHARM DFV VARNISH DEVICE NAME:
INDICATIONS FOR USE:
For use as a varnish on sensitive teeth over exposed
ed the formism becamerary restoratives and cements For use as a varnish on sensitive ticen ond cements
dentin and under temporary restoratives and cements dentin and under temporary rebebrating of Concern.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
FOR PROFESSIONAL USE ONLY *None of the above:
Shon Turner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.