(206 days)
The Prep Technology Corp. PrepTech 200TM Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.
The Prep Technology Corp. PrepTech 200 Cavity Preparation System is a device that combines pressurized air and aluminum oxide powder to produce a high velocity stream of kinetic particles to perform dental restorative procedures, including preparation for pit and fissure sealants and composite restorations.
The provided text is a 510(k) summary for the Prep Technology Corp. PrepTech 200TM Cavity Preparation System. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It primarily focuses on comparing the new device to predicate devices and establishing substantial equivalence, rather than detailing a specific study to prove the device meets acceptance criteria in the way a clinical trial report would.
Therefore, the sections of your request related to specific study design, performance metrics, ground truth establishment, expert qualifications, and sample sizes for training and test sets are not directly addressed in this 510(k) summary. The summary focuses on the intended use, technological characteristics, and comparison to predicate devices, not on quantitative performance outcomes from a specific clinical study for acceptance criteria.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not provide a table of acceptance criteria with corresponding performance statistics. The device demonstrates "substantial equivalence" to predicate devices, which is the regulatory acceptance criteria for a 510(k) submission.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices | The comparison results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use. |
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 provided in the 510(k) summary. The submission focuses on comparing the device's technological characteristics and intended use to predicate devices, not on a specific clinical study with a test set.
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 provided. Ground truth establishment for a test set is not detailed in this type of regulatory submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods for a test set are not detailed in this type of regulatory submission.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. This device is not an AI-assisted diagnostic tool; it is a physical dental instrument. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a physical instrument, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The device operates with human involvement (dentist) to perform its intended functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to performance studies for diagnostic algorithms is not relevant here. The substantial equivalence is based on comparing the device's technical specifications and intended use against legally marketed predicate devices, not against an absolute ground truth of physiological or pathological conditions.
8. The sample size for the training set
This information is not provided. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not provided, as it is not applicable to this type of device.
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JUL - 9 1998
Prep Technology Corp.
510(k) Summary of Safety and Effectiveness Prep Technology Corp. PrepTech 200TM Cavity Preparation System
Statement of Intended Use:
The Prep Technology Corp. PrepTech 200TM Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.
Submitted by:
Prep Technology Corp. 43204 Christy Street Fremont, CA 9538 Tel: 510.440.8800 Fax: 510.440.8797
Contact Person:
Joe W. Shaffer President Telephone: 510.440.8800
Date Summary Prepared:
November 15, 1997
Name of the Device:
Proprietary Name:
PrepTech 200TM Cavity Preparation System
Common/ Usual Name: Air Abrasive System for Dental Applications
Classification Name:
Airbrush (per 21 CFR 872.6080)
Proprietary Data: This document and the information contained herein may not be reproduced used or disclosed without prior written consent of Prep Technology Corp.
E.2
,
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Predicate Devices:
Danville Engineering PrepStar Cavity Preparation System Sunrise Technologies MicroPrep Cavity Preparation System
Description:
The Prep Technology Corp. PrepTech 200 Cavity Preparation System is a device that combines pressurized air and aluminum oxide powder to produce a high velocity stream of kinetic particles to perform dental restorative procedures, including preparation for pit and fissure sealants and composite restorations.
Comparison to Predicate Devices:
The PrepTech 200 Cavity Preparation System has been compared to legally marketed devices with respect to intended use and technological characteristics. The comparison results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1998
Mr. Joe W. Shaffer President Prep Technology Corporation 43204 Christy Street 94538 Fremont, California
K974655 Re : PrepTech 200™ Cavity Preparation System Trade Name: Requlatory Class: III KOJ Product Code: Dated: November 15, 1997 Received: December 15, 1997
Dear Mr. Shaffer:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Shaffer
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
Timo hy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): Not Yet Assigned
Device Name: Prep Technology Corp. PrepTech™ 200 Cavity Preparation System
Indications For Use:
The Prep Technology Corp. PrepTech 200 Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
(Division Sign-Off)Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Dental, Infection Con and General Hospita 510(k) Number
OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Prep Technology Corp.
§ 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.”