(133 days)
IMPLANTEO dental unit is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics.
ANTHOGYR has developed a dental unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices.
IMPLANTEO kit includes: Control unit, Peristaltic pump, Motor, Motor, Motor holder, Control pedal, Calibration module, Bag carner
Four adjustable parameters are displayed on a large size screen : Speed which adjustment takes into account the reduction value used, Torque, Pump flow rate and Contra angle reduction ratio
In order to cover all the possible uses of the motor, up to 3 different protocols can be programmed. Each protocol allows for implant fitting in 4 sequences: drilling, reaming, tapping and screwing.
The provided text describes a 510(k) summary for the IMPLANTEO dental unit, an implantology motor. It outlines the device's intended use and conformity to various voluntary FDA-recognized Consensus standards. However, it does not contain information about acceptance criteria, specific performance studies (like accuracy or efficacy trials), sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence to predicate devices and adherence to general medical device standards, rather than direct performance studies or comparative effectiveness specific to an AI/ML component.
Here's why the requested information cannot be extracted:
- Acceptance Criteria & Reported Device Performance: While the document lists standards the device conforms to (e.g., IEC 60601-1 for safety, ISO 11498 for dental handpieces), these are general safety and performance standards, not specific acceptance criteria with quantifiable performance metrics (like sensitivity, specificity, or accuracy) for an AI/ML model.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document does not describe any specific performance study designed to evaluate the device's functional performance in terms of clinical outcomes or diagnostic accuracy. It mentions that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but no direct performance study data is presented.
- Ground Truth: Since no performance study is described, there's no mention of how ground truth would have been established.
- Training Set & Ground Truth for Training: This information is not relevant as the document does not describe an AI/ML device.
In summary, the provided text is a regulatory submission for a traditional medical device (dental implantology motor) and does not involve AI/ML. As such, the detailed questions regarding acceptance criteria, study design, and ground truth establishment for AI/ML performance are not applicable to this document.
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Image /page/0/Picture/1 description: The image shows the text "K 041279" in a handwritten style at the top. Below this, the word "anthogvr" is written in a stylized font. Underneath "anthogvr", there are three small, square images with different textures or patterns, each appearing to be a close-up or abstract design.
SEP 2 3 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
| Submitter | ANTHOGYR (Registration number 8020776) |
|---|---|
| 164 rue des trois lacs | |
| 74700 SALLANCHES FRANCE | |
| Phone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60 | |
| Contacts | Eric GENEVE (RD Manager) e.geneve.rd@anthogyr.com |
| Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX) | |
| idrubaix@nordnet.fr | |
| Common Name | Surgical motor for implantology |
| Classification Name | Dental Handpieces and accessories |
| Trade Name | IMPLANTEO |
| Class | I |
| Product Code | EKX |
| CFR section | 872.4200 |
| Device panel | DENTAL |
2. DEVICE DESCRIPTION
ANTHOGYR has developed a dental unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices.
IMPLANTEO kit includes: Control unit, Peristaltic pump, Motor, Motor, Motor holder, Control pedal, Calibration module, Bag carner
Four adjustable parameters are displayed on a large size screen : Speed which adjustment takes into account the reduction value used, Torque, Pump flow rate and Contra angle reduction ratio
In order to cover all the possible uses of the motor, up to 3 different protocols can be programmed. Each protocol allows for implant fitting in 4 sequences: drilling, reaming, tapping and screwing.
3. INTENDED USE
IMPLANTEO dental unit is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics,
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Image /page/1/Picture/1 description: The image shows the word "anthogyr" in a stylized font. Below the word are three small squares. The first square is white with black speckles, the second square is a medium gray with a circular design, and the third square is solid black.
4. PERFORMANCE DATA
IMPLANTEO conforms to the following voluntary FDA recognized Consensus standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- ISO 11498 (1997) Dental Handpieces: Dental Low Voltage Electrical Motors .
- ISO 13402 (1995) « Surgical and dental hand instruments Determination of . resistance against autoclaving, corrosion and thermal exposure »
- ISO 15223 (2000) « Medical devices Symbols to be used with medical device . labels, labeling and information to be supplied »
- NF EN ISO 7494 (1997) Dental units .
- NF EN ISO 7153-1 (2000) Surgical instruments Metallic materials Part 1 : . stainless steel
- EN 1441 (1997) "Medical devices Risk management" .
5 SUBSTANTIAL EQUIVALENCE
Predicate devices:
K033597 - ATR 5000 Implant system - Advanced Technology Research K030163 -VCT Versatile Control Technology Model AEU -925 - Aseptico
IMPLANTEO is substantially equivalent to these predicate devices in terms of intended use, material, design and function.
Summary preparation date: April 30, 2004
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
SEP 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Geneve R & D Manager ANTHOGYR 164 Rue Des Trois Lacs 74700 Sallanches FRANCE
Re: K041279
Trade/Device Name: IMPLANTEO Implantology Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 3, 2004 Received: August 3, 2004
Dear Mr. Geneve:
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. Geneve
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,
Susan Kummer
O. Shi-Lin, Ph.D.
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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510(k) Premarket Notification IMPLANTEO Implantology Motor
Image /page/4/Picture/1 description: The image shows the word "anthogyr" in a stylized font above three small, square images. The first image on the left appears to be a textured or patterned design. The middle image contains a series of parallel lines or bars, possibly representing a ladder or a similar structure. The image on the right is dark and contains a circular shape with internal details, possibly representing a gear or a mechanical component.
510(k) Number (if known):
Device Name: IMPLANTEO Implantology Motor
Indications for Use: IMPLANTEO motor is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
(Optional Format 1-2-96)
(PER 21 CFR 801.109)
Susan Punne
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ._
Number: Kolia75
2-003
§ 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.