(98 days)
The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.
This document is a 510(k) Summary of Safety and Effectiveness for a dental airbrush device called PrepAir. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested sections cannot be directly extracted from the provided text as they relate to a different type of study (e.g., performance testing with acceptance criteria, human reader studies, or detailed ground truth establishment), which is not present in this 510(k) submission.
Here's an analysis based on the information available in the document, noting what cannot be provided:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on intended use, device description, and comparison to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present. No specific test set or data provenance is detailed for performance evaluation, as the submission relies on substantial equivalence to predicate devices.
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)
This information is not present. There is no ground truth establishment described for a test set in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present. No test set or adjudication method is described.
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 information is not present. This device is a physical dental airbrush, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not present. This device is a physical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence for a physical device.
8. The sample size for the training set
This information is not present. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This information is not present. Ground truth for a training set is not applicable here.
Summary of what is available from the document:
- Device Name: PrepAir
- Intended Use: For cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals, and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
- Predicate Devices: PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564), and Rondoflex by Kavo America (K002708).
- Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the requirements for marketing without a full Pre-Market Approval (PMA) application, based on its similarity in intended use and technological characteristics to devices already on the market.
Conclusion:
The provided document is a 510(k) summary, which is a premarket submission to FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness data to a predicate, rather than detailing a specific study with quantitative acceptance criteria and performance metrics unique to the new device in the way requested for an AI/algorithm-based product. Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, and study design is not contained within this specific type of regulatory document.
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JAN - 9 2004
:
510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)
| Applicant: | Danville Materials, Inc.2021 Omega Dr.San Ramon, CA 94583 |
|---|---|
| Contact Person: | Craig R. BrunsPhone 925 838-7940Fax 925 838-0944e-mail: cbruns@daneng.com |
| Date of summary | September 29, 2003 |
| Device name | PrepAir |
| Common name | Airbrush |
| Classification names | Regulation Number21 CFR 872.6080 |
| Product CodeKOJ | |
| Device Description | The PrepAir is a dental airbrush using aluminum oxide to prepare all classes ofcaivty prior to restoration. |
| Predicate Device | The device is substantially equivalent to other legally marketed devices in theUnited States including PrepStart by Danville Engineering (K970589),PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques(K981564) and Rondoflex by Kavo America (K002708). |
| Intended Use | The PrepAir is intended for the cutting and preparation of all classes of cavityrestorations; removal of composite resin fillings; surface roughening ofenamel, dentin, metals and composite surfaces prior to adhesive resin bonding;preparation of pits and fissures prior to sealing; cleaning and removal ofcements and adhesives from bridges and crowns prior to re-cementation; andpreparation of adhesive surfaces of orthodontic bands and brackets to increaseretention. |
ENClosure 3
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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 stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2004
Mr. Craig R. Bruns Danville Materials Incorporated 2021 Omega Road San Ramon, California 94583-1229
Re: K033215
Trade/Device Name: PrepAir Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: KOJ Product Code: II Dated: December 30, 2003 Received: January 2, 2004
Dear Mr. Bruns:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to revea 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 morslate octimers of 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 appear as upportions 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 adultcration.
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 (1 Writ), it may of bund 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. Bruns
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Qre
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): _K033215
PrepAir Device Name __________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The PrupAir is intended for the cutting and preparation of all classes of cavity The FripAll is intended for the out.its in fillings; surface roughering of enamel, dentin, restorations, removel or composite room Mings, preparation of pits and fieldis and composite ournated provide of cements and adhesives from bridges and crowns prior to re-cementation, and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DI) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
McCall for MSR
Page 1 of
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”