(86 days)
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
The provided text is a 510(k) summary for a dental product, 3M™ Clinpro™ Prophy Paste. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with specific acceptance criteria, test sets, and expert evaluations as would be expected for a diagnostic AI device.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it's not relevant to this type of device and regulatory submission.
However, I can extract what is available and explain why other information is absent.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Goal: | Substantially equivalent to predicate devices. |
| Technological Characteristics: | Similar to predicate devices (Hawe Cleanic® Prophylaxis Paste, Nupro® Prophylaxis Paste with Fluoride) in that all contain an abrasive, flavorant, colorant, and fluoride. |
| Bench Test Results: | Demonstrated similarity to predicate devices in: - Stain removal - Surface roughness - Relative dentin and enamel abrasion |
Explanation: The document does not specify quantitative acceptance criteria (e.g., "stain removal must be >X%"). Instead, it states that the device has "similar technological characteristics" and that "comparative results of the bench tests" further validate this similarity. The acceptance criterion is implied to be "demonstrating similar performance" to the predicate devices in these specific bench tests, allowing the FDA to determine substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- The studies mentioned are "bench tests" (laboratory tests), not clinical studies involving human patients or data from a specific origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified.
Explanation: As this involves bench testing of a dental paste (material properties), expert clinical consensus is not the method for establishing "ground truth." The "ground truth" for these tests would be the measured results of the predicate devices for comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified.
Explanation: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data to establish a consensus (ground truth). This is not relevant to laboratory bench testing of a dental paste.
5. 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
- MRMC Comparative Effectiveness Study: No.
- Effect Size: Not applicable.
Explanation: The device is a prophylactic dental paste, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable.
Explanation: This is not an algorithm or AI device; it's a physical dental product. Standalone performance refers to the performance of an AI algorithm without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the bench tests would be the measured performance of the predicate devices in stain removal, surface roughness, and relative dentin and enamel abrasion. The new device's performance is compared directly to these established benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: "Training set" refers to data used to train machine learning models. This is a physical product, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Explanation: As there is no training set, this question is not relevant.
{0}------------------------------------------------
MAY
K99 04852
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Name: | Rebecca L. HannackAdvanced Regulatory Affairs Associate | |
|---|---|---|
| Address: | 3M Dental Products Division3M Center, Bldg. 260-2B-12St. Paul, MN 55144 | |
| Telephone: | (651)737-1105 | |
| Fax: | (651)736-0990 | |
| Trade Name: | 3M™ Clinpro™ Prophy Paste | |
| Common Name: | Prophylaxis Paste | |
| Classification Name: | Oral cavity abrasive polishing agent (21 CFR 872.6030) | |
| Predicate Devices: | Hawe Cleanic® Prophylaxis PasteNupro® Prophylaxis Paste with Fluoride |
3M™ Clinpro™ Prophy Paste is to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
3M™ Clinpro™ Prophy Paste has similar technological characteristics as the predicate devices in that they all contain an abrasive, flavorant, colorant, and fluoride. This is further validated by the comparative results of the bench tests conducted including stain removal, surface roughness, and relative dentin and enamel abrasion.
Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Clinpro™ Prophy Paste is safe and effective for its intended use.
{1}------------------------------------------------
Public Health Service
MAY 1 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca L. Hannack Advanced Regulatory Affairs Associate Minnesota Mining and Manufacturing Company Dental Products Division 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144
Re : K990482 3M™ Clinpro™ Prophy Paste, Model 12611 Trade Name: Requlatory Class: I Product Code: EJR Dated: February 10, 1999 Received: February 16, 1999
Dear Ms. Hannack:
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, labelinq, 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 regulations 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 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.
{2}------------------------------------------------
Paqe 2 - Ms. Hannack
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 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:
Device Name: 3M™ Clinpro™ Prophy Paste
Indications for Use:
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
(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 | K990452 |
|---|---|
| Prescription Use | ✓ |
| OR Over-the-Counter Use ______ |
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(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.