(22 days)
PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The modification involves changing the powder from sodium bicarbonate to calcium carbonate.
The provided text describes a 510(k) summary for the KaVo PROPHYpearls dental cleaning powder. This submission focuses on demonstrating substantial equivalence to a predicate device by changing the powder component from sodium bicarbonate to calcium carbonate. The study mentioned is for proving this equivalence, not necessarily setting acceptance criteria in a strict sense for a medical device's diagnostic performance. Therefore, my response will interpret "acceptance criteria" and "device performance" in the context of demonstrating substantial equivalence for a cleaning powder.
Acceptance Criteria and Device Performance for KaVo PROPHYpearls
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (KaVo PROPHYpearls) |
|---|---|
| Safety: Biocompatibility of the new powder component. | Calcium carbonate is inherently biocompatible and recognized in the Code of Federal Regulations as generally recognized as safe (GRAS). |
| Effectiveness: Equal or better performance in removing plaque deposits and stains from teeth. | Studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. |
| Indications for Use: Identical intent. | Powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces. |
| Mechanism of Action: Similar mechanism. | Projection of a mixture of water, air, and calcium carbonate onto tooth surfaces (similar to predicate's projection of water, air, and sodium bicarbonate). |
Note: The document does not specify quantitative metrics for "equal or better" performance, which is typical for 510(k) submissions focusing on substantial equivalence rather than a new technology's performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "studies have shown that the calcium carbonate powder does an equal or better job of removing plaque." However, it does not provide details on the sample size for these studies or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the performance studies.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key component. The PROPHYpearls is a cleaning powder, not a diagnostic tool requiring human interpretation comparison.
6. Standalone Performance Study
The studies mentioned ("studies have shown that the calcium carbonate powder does an equal or better job of removing plaque") are essentially standalone performance evaluations of the calcium carbonate powder's efficacy in removing plaque, compared to the sodium bicarbonate powder of the predicate device. However, no specific details of these studies (e.g., methodology, endpoints, quantitative results) are provided beyond the summary statement.
7. Type of Ground Truth Used
The "ground truth" for the performance studies would likely have been direct observation or measurement of plaque and stain removal. This could involve:
- Visual assessment of tooth surfaces before and after cleaning.
- Quantitative measurements using plaque indices or stain scores.
- Potentially, laboratory or in-vitro tests mimicking the cleaning process.
The document does not explicitly state the type of ground truth used.
8. Sample Size for the Training Set
This submission is for a medical device (a powder used with a handpiece) and not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no training set for this device.
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EXHIBIT 2 KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Franz, President June 12, 2003 510(k) Summary of Safety and Effectiveness
- Identification of the Device: 1. Proprietary-Trade Name: KaVo PROPHYpearls Classification Name: HANDPIECE, AIR-POWERED, DENTAL, Product Code EFB Common/Usual Name: Cleaning powder for use with dental handpiece
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- Equivalent legally marketed device: This product is similar in design and identical in function to PROPHYflex 2 (K973876) (powder).
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- Indications for Use (intended use): PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
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- Description of the Device: This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The modification involves changing the powder from sodium bicarbonate to calcium carbonate. Calcium carbonate is a substance which is inherently biocompatible, and studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. Calcium carbonate is recognized in the Code of Federal Regulations as a food substance generally recognized as safe.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
9 2003 JUL
KaVo America Corporation C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K031868
Trade/Device Name: PROPHYpearls Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Codes: EJR, EFB Dated: June 16, 2003 Received: June 26, 2003
Dear Mr. Kamm:
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 - Daniel Kamm, P.E.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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 (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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j) Indications for Use
510(k) Number
Device Name: .
Indications for Use: PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use_ Prescription Use OR (Per 21 CFR 801.109)
Ken Ruby for MSR
hesiology. General Hospital.
510(k) Number: K 031868
§ 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.