(120 days)
The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.
The provided text is a 510(k) summary for the Axenic Dental, Inc. DHP™ "Disposable High-Performance" Handpiece. It describes the device, its intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (OralSafe™ Disposable Handpieces, K923469) rather than presenting a performance study with detailed acceptance criteria and results. The key claims made are about the device being sterile, pyrogen-free, and maintenance-free, and operating for 12-14 minutes. These are stated as features rather than the outcome of a performance study with numerical results.
Therefore, I cannot provide the requested table and detailed study information based on the given document.
Here's what I can extract based on the structure of your request and the information not present in the document:
Acceptance Criteria and Device Performance Study (Information Not Provided in Document)
The provided 510(k) summary does not contain a specific performance study with acceptance criteria and reported device performance in the typical format you've requested for AI/diagnostic devices. The submission focuses on demonstrating substantial equivalence to a predicate device ("OralSafe™ Disposable Handpieces, K923469") by highlighting similar materials and additional features like sterility, pyrogen-free status, and being maintenance-free.
No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) are presented, nor are there acceptance criteria for such metrics. The document asserts that the enhancements (sterility, pyrogen-free, maintenance-free) will not negatively affect safety or effectiveness, which is a qualitative statement, not a quantitative performance result against acceptance criteria.
Therefore, the following sections will indicate that the information is "Not provided in the document."
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Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document. The 510(k) summary does not present a table of acceptance criteria or specific quantitative performance metrics for the device. It focuses on functional equivalence and additional features.
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Sample size used for the test set and the data provenance
- Not provided in the document. No specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in the document. As no specific performance study with a test set is detailed, information about experts for ground truth establishment is absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided in the document. No adjudication method is mentioned as there is no described test set or performance evaluation.
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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
- Not applicable/Not provided in the document. This device is a dental handpiece, a physical instrument, not an AI or diagnostic software. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in the document. This device is a physical dental handpiece, not an algorithm. Standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the document. As no specific performance study is detailed, the type of ground truth used is not mentioned.
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The sample size for the training set
- Not applicable/Not provided in the document. As this is a physical device and not an AI/ML algorithm, the concept of a "training set" in the context of data for model development is not relevant.
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How the ground truth for the training set was established
- Not applicable/Not provided in the document. As noted above, the concept of a training set and its ground truth is not relevant for this type of device based on the provided document.
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Axenic Dental, Inc., Premarket Notification - 510(k), DHP™ "Disposable High-Ferformance" Handpiece, Model DHP™
SECTION 5: 510(k) Summary
| Submitter: | Axenic Dental, Inc. |
|---|---|
| 259 East Michigan | |
| Suite 409, 4th Floor | |
| Kalamazoo, MI 49007 | |
| Contact: | Joseph T. Sobota, M.D. |
| 269-349-8870 |
JAN 25 25.0
Axenic Dental DHPTM, Disposable High-Performance Handpiece Name of Device:
Predicate Device: OralSafe™ Disposable Handpieces, K923469
Description of the New Device: The Axenic Dental, Inc. DHP™ "Disposable High-Performance Handpiece" is a sterile, single patient use, disposable instrument that is substantially equivalent to standard, re-usable, metal or plastic handpieces. All Axenic DHP™, high-speed, dental hand pieces are designed to operate at maximum specification outputs for 12 to 14 minutes of use. The single patient use nature of the instrument precludes any necessity for maintenance, cleaning, or sterilization.
INTENDED USE OF THE NEW DEVICE: The Axenic Dental, Inc. DHP™ "Disposable High-Performance" handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
Comparison of the Technological Features of the New [Modified] Device and Predicate Devices: The modified device and the lawfully marketed predicate device contain similar materials of construction. Features of the modified device are comparable to those of the predicate device with the exception that the modified device includes sterility and pyrogen free indications and is maintenance free. These enhancements will not negatively affect the safety or effectiveness of the device.
Signed,
Joseph T. Sobota, M.D. Chief Regulatory Executive Axenic Dental, Inc.
DHP™ is a Registered Trademark of Axenic Dental, Inc.
CONFIDENTIAL
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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 eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps.
Public Health Service
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph Sobota Chief Regulatory Executive Axenic Dental, Incorporated 295 East Michigan Suite 409, 4th Floor Kalamazoo, Michigan 49007
Re: K072754
Trade/Device Name: Axenic DHP™ "Disposable High-Performance" Handpiece, Model DHPTM Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 18, 2008 Received: January 22, 2008
Dear Mr. Sobota:
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. Sobota
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suritz y. Michie. ms.
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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Axenic Dental, Inc., Premarket Notification - 510(k), DHP™ "Disposable High-Performance" Handpiece, Model DHP™
SECTION 4: INSTRUCTIONS FOR USE
510(k) Number:
CTIONS FOR USE
Device Name:
Axenic DHP™ "Disposable High-Performance" Handpiece, Model DHP™
The Axenic Dental, Inc. DHP™ "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-the-Counter Use
For Professional Use Only (Dental Health Provider) X
Susan Runny
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072754
CONFIDENTIAL
100 /
§ 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.