(8 days)
To be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
DO-ALL is a lubricant designed for use with air-powered dental handpieces. The product is intended to be used prior to handpiece sterilization to lubricate the moving parts inside of the air-powered turbine. The lubricant is not intended to come into contact with the patient and has no therapeutic function.
The provided document pertains to a 510(k) premarket notification for a dental handpiece lubricant and does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI/ML-driven diagnostics.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. The performance testing mentioned is for the lubricated dental handpiece to ensure it continues to meet existing performance standards after being lubricated with the new product. This is a different type of evaluation than what is usually described as "acceptance criteria" for a novel device's inherent performance.
However, I can extract information related to the closest equivalent of "acceptance criteria" and "study" based on the context provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device itself is a lubricant. The "performance" being evaluated is the ability of a dental handpiece lubricated with "DO-ALL" to continue performing according to established standards.
| Characteristic Tested (on Handpiece lubricated with DO-ALL) | Acceptance Criteria (ISO 7785-1:1997(E) & FDA Guidance) | Reported Device Performance (Handpiece lubricated with DO-ALL) |
|---|---|---|
| Extraction force | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Resistance to corrosion | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Torque | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Noise level | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Reprocessing | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Speed | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Stall torque | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
Note: The document states "DO-ALL performs as well as the predicate device in head-to-head comparisons" and that lubricated handpieces were "shown to meet or exceed all of the applicable performances standards outlined in ISO 7785-1:1997(E)." The specific quantitative acceptance criteria from ISO 7785-1:1997(E) and the FDA Guidance are not explicitly detailed in the provided text, nor are the specific numerical performance results for the lubricated handpieces. The key finding is the compliance with these standards.
2. Sample size used for the test set and the data provenance
- Test Set Description: The study involved testing "Dental handpieces lubricated with DO-ALL" and comparing their performance to those lubricated with the predicate device.
- Sample Size: The document mentions "Extensive testing illustrated that after 250 use/sterilization cycles the handpiece continued to meet all performance requirements." This implies that at least one or more handpieces were subjected to 250 cycles. The exact number of handpieces or the number of repeat tests for each characteristic is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "performance testing presented in the body of this submission." It is a prospective performance evaluation in a lab setting, not a retrospective analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device and study. The "ground truth" here is objective physical performance measurements of the handpiece against established engineering standards (ISO 7785-1:1997(E) and FDA Guidance), not expert consensus on an interpretation of data.
4. Adjudication method for the test set
This section is not applicable. No expert adjudication was involved as the assessments were objective physical measurements.
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
This section is not applicable. This study does not involve human readers, AI, or diagnostic image interpretation. It is a performance study of a mechanical lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. There is no algorithm or AI involved. The study evaluated the mechanical performance of a dental handpiece with the lubricant.
7. The type of ground truth used
The "ground truth" was established by international standards (ISO 7785-1:1997(E)) and FDA Guidance Document on Dental Handpieces, which outline objective performance requirements for dental handpieces measuring various physical parameters (e.g., extraction force, torque, speed, noise level, resistance to corrosion, reprocessing, stall torque).
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a performance evaluation of a physical product, not a machine learning model.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set.
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Image /page/0/Picture/0 description: The image shows the logo for Prodrive Systems. The logo is in a sans-serif font and is in all caps. The word "Prodrive" is on the top line, and the word "Systems" is on the bottom line. The letter "O" in Prodrive is replaced with a circle with a dot in the center. The logo is in black and white.
510(k) SUMMARY
DO-ALL Dental Handpiece Lubricant ProDrive Systems Inc.
OEC ** 7 2007
Owned by:
ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA
Contact Person:
Clive Hooton, Vice President Quality ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA
Date of Summary:
October 15, 2007
Device Name:
| Proprietary Name: | DO-ALL Dental Handpiece Lubricant |
|---|---|
| Common Name: | dental handpiece lubricant |
| Classification Name: | Handpiece, Air-powered, Dental |
| Product Code: | EFB ("Dental handpiece and accessories", 21CFR 872.4200) |
Predicate Device:
| Proprietary Name: | ClearView Dental Handpiece Lubricatorand Lubricant |
|---|---|
| 510(k) Number: | K070297 |
| Product Code: | EFB |
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Image /page/1/Picture/0 description: The image shows the logo for Prodrive Systems. The logo consists of the word "PRODRIVE" in all caps, with a circle containing a dot in the middle replacing the letter "O". Below the word "PRODRIVE" is the word "SYSTEMS" in smaller letters.
Description of Device:
DO-ALL is a lubricant designed for use with air-powered dental handpieces. The product is intended to be used prior to handpiece sterilization to lubricate the moving parts inside of the air-powered turbine. The lubricant is not intended to come into contact with the patient and has no therapeutic function.
The performance testing presented in the body of this submission illustrates that DO-ALL performs as well as the predicate device in head-to-head comparisons. The product is found to withstand repeated cycles of use/sterilization without degradation of the performance of the dental handpiece.
Dental handpieces lubricated with DO-ALL were shown to meet or exceed all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing illustrated that after 250 use/sterilization cycles the handpiece continued to meet all performance requirements.
DO-ALL has been shown to be suitable for lubrication of dental handpieces. Based on its composition and comparisons to the predicate device, it is considered to be safe under normal usage and has no expected hazards.
Intended Use of Device:
DO-ALL Dental Handpiece Lubricant is intended to be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
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Image /page/2/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is in a large, sans-serif font, with a circle in place of the letter "O". Below "PRODRIVE" is the word "SYSTEMS" in a smaller, sans-serif font.
Comparison of Technological Characteristics to Predicate Device:
The following table compares the features of DO-ALL Dental Handpiece Lubricant to the Predicate Device:
| TECHNOLOGICAL CHARACTERISTIC | COMPARISON TO PREDICATE |
|---|---|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Where used | Identical |
| Energy used and/or delivered | Identical |
| Human factors | Identical |
| Design | Identical |
| Performance | Similar |
| Standards met | Identical |
| Materials | Similar |
| Biocompatibility | Identical |
| Compatibility with environment and other devices | Identical |
| Sterility | Identical |
| Electrical safety | Identical |
| Mechanical safety | Identical |
| Chemical Safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
Table 1: Substantial Equivalence Table
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Image /page/3/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The logo is in a sans-serif font and is all caps. The word "SYSTEMS" is smaller and is located below the word "PRODRIVE".
Conclusions Drawn from Technical Comparison:
DO-ALL. Dental Handpiece Lubricant is essentially the same as the predicate device in terms of its intended use, operating principles and materials.
Use of the DO-ALL Dental Handpiece Lubricant has no deleterious effect on the ability of Dental Handpieces to meet the relevant requirements of the ISO 7785-1:1997(E) standard and the FDA Guidance Document on Dental Handpieces, which include testing and performance limits on the following characteristics:
- . Extraction force
- . Resistance to corrosion
- Torque .
- . Noise level . Reprocessing
- Torque . Speed .
- Stall torque .
The performance testing of Dental Handpieces lubricated with DO-ALL indicates that they function as well as Dental handbieces lubricated with the predicate device in all aspects examined.
Therefore, we conclude that the DO-ALL Dental Handpiece Lubricant is both safe and effective for its intended use.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines emanating from the head. The figure is silhouetted and appears to be reaching upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 2007
ProDrive Systems, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K073353
Trade/Device Name: DO-ALL Dental Handpiece Lubricant Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 28, 2007 Received: November 29, 2007
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suite of Michie and.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: DO-ALL Dental Handpiece Lubricant
Indications For Use: To be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruyner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
353
Page 1 of 1
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.