(91 days)
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No
The summary describes a mechanical handpiece and motor, with no mention of AI, ML, image processing, or data analysis.
No.
The device is described as a handpiece intended to hold burs or tools and transmit power, which functions as a mechanical tool for procedures, not a device directly providing therapy.
No
The device description states its purpose is to hold tools and transmit power, which are functional tasks, not diagnostic ones. There is no mention of analysis, measurement, or identification of disease.
No
The device description explicitly states it is a handpiece intended to hold burs or other tools and transmit power via a motor, indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is intended to "hold burs or other tools and to transmit power to these via a motor." This describes a mechanical tool used in a procedure, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reiterates the same function, reinforcing that it's a tool for holding and powering other instruments.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, Ax's Endo® handpieces are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit rotational energy to these via a motor.
Product codes
EGS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Mr. Philippe Garcia Director, Quality and Regulatory Affairs Micro-Mega Societe Anonyme 5-12 Rue du Tunnel -BP 1353 Cedex Besancon 25006 FRANCE
Re: K042171
Trade/Device Names: Ax's Endo® Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: July 30, 2004 Received: September 02, 2004
Dear Mr. Garcia:
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.
1
Page 2 - Mr. Philippe Garcia
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that IDA s Issualled of a sacerian complies with other requirements of the Act or that FDA has made a decemination that your ced by other Federal agencies. You must comply with (1) CEP Beach C any Federal statures and regulations administered of to: registration and listing (21 CFR Part 817); all the Act s requirements, morading, bactice requirements as set forth in the quality labeling (21 CFR Part 001), good manager of any of applicable, the electronic product radiation systems (QB) regarders (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) I mis letter wili anow you to begin mancellig of substantial equivalence of your device to a legally premarket notification: "The PDF mainly of bation 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 If you desire specific advice for your ac no november 10-1. Also, please note the regulation entitled, Contact the Office of Compulation and et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general internation on your responsibilities 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 vours,
Clive S. Lewis, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K042171
Device Name: Ax's Endo® Indications for Use:
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit
ed to the success that the saving a motor AX s Endo® handpost to these via a motor.
Prescription Use _ × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russ
K64217
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Ancolnoontoontal Devices
510(k) Number:_
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