ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.

Device Description

ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is « Impulsion » . ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces".

AI/ML Overview

The provided document describes a Special 510(k) for a modification to Anthogyr Dental Contra-Angles. This type of submission is typically for minor changes to a legally marketed device and often relies on conformance to recognized consensus standards rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard Conformance)	Reported Device Performance (Conformance Statement)
ISO 14971 (2001) - Medical devices - Application of risk management to medical devices	Conforms to ISO 14971 (2001)
ISO 15223 (2000) - Medical devices Symbols to be used with medical device labels, labeling and information to be supplied	Conforms to ISO 15223 (2000)
ISO 13402 (2002) - Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure	Conforms to ISO 13402 (2002)
ISO 7785-2 (1995) - Dental Handpieces Part 2: Straight and geared angle handpieces	Conforms to ISO 7785-2 (1995) and NF EN ISO 7785-2
ISO 3964 (1982) - Dental Handpieces - Coupling dimensions	Conforms to ISO 3964 (1982)
ISO 7153-1 (1999) - Surgical instruments - Metallic materials - Part 1 : stainless steel	Conforms to ISO 7153-1 (1999)
ISO 13485 (1996) - Medical devices Particular requirements for the application of the ISO 9001	Conforms to ISO 13485 (1996)
NF EN ISO 1797-1 (1995) - Dental rotatory instruments - Shanks - Part 1: Shanks made of metal	Conforms to NF EN ISO 1797-1 (1995)
NF EN ISO 17664 (2004) - Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices	Conforms to NF EN ISO 17664 (2004)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not report any specific test set sample size or data provenance for human-involved studies. The performance data section refers to conformance with recognized consensus standards, implying that the device was tested against the requirements of these standards. The nature of these standards (e.g., mechanical testing, material analysis, risk management processes) would dictate the "sample size" and "provenance" in a manufacturing and testing context, but this information is not detailed here.

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 applicable and not provided in the context of this device. The regulatory submission relies on conformance to engineering and material standards, not diagnostic or clinical expert review of a "test set" in the way an AI algorithm might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. No expert adjudication method is described, as the evaluation is based on conformance to established standards.

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 was not conducted and is not relevant to this type of device (dental contra-angles). This is a hardware device, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a dental contra-angle device. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is defined by the requirements and specifications within the referenced international and national standards. For example, for mechanical properties, the ground truth would be the defined acceptable limits and test methods in ISO 7785-2. For material composition, it would be the specifications in ISO 7153-1. These are established engineering and quality standards, not clinical "ground truth" derived from patient data or expert consensus in a diagnostic sense.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML product and does not have a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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MAR - 3 2010

SPECIAL 510(k) - MODIFICATION TO K040674 ANTHOGYR DENTAL CONTRA-ANGLES

anthogyr

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. GENERAL INFORMATION

Submitter	ANTHOGYR (Registration number 8020776)
	2237, avenue André Lasquin
	74700 SALLANCHES FRANCE
	Phone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60
	Web : www.anthogyr.com
Contacts	Sabine BRAYETTE (QULITY INGINEER IN CHARGE OFREGULATORY AFFAIRS)
	sabine.brayette.prod@anthogyr.com
Trade Names	ANTHOGYR « Impulsion » Implantology Contra-angles
Legally marketedpredicate devices	Anthogyr Implantology Contra angles K040674
Classification Name	Dental handpiece and accessories
Class	I
Product Code	EFA
CFR section	872.4200
Intended Use	ANTHOGYR'S fully autoclavable contra-anglesImplantology « Impulsion » are devices intended for a widerange of dental procedures including:Implant surgery such as perforating the bone, tapping andthreading procedures

2. INTENDED USE

ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including:

Implant surgery such as perforating the bone, tapping and threading procedures. >

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SPECIAL 510(k) - MODIFICATION TO K040674 ANTHOGYR DENTAL CONTRA-ANGLES

anthogyr

3. DEVICE DESCRIPTION

4. PERFORMANCE DATA

ANTHOGYR Contra angles & Handpieces conform to the following FDA recognized Consensus standards:

ISO 14971 (2001) *Medical devices - Application of risk management to medical devices" (Recognition List Number: 005 Effective Date: 05/04/2001)
ISO 15223 (2000) « Medical devices Symbols to be used with medical device labels, labeling and information to be supplied » (Recognition List Number: 008 Effective Date: 10/29/2003)
ISO 13402 (2002) « Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure » (recognized Recognition List Number: 001 Effective Date: 02/19/1998)
V ISO 7785-2 (1995) "Dental Handpieces Part 2: Straight and geared angle handpieces" (Recognition List Number: 003 Effective Date: 05/03/1999)
ISO 3964 (1982) "Dental Handpieces - Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
ISO 7153-1 (1999) « Surgical instruments - Metallic materials - Part 1 : stainless steel » (Recognition List Number: 006 Effective Date: 10/01/2001)

In addition, ANTHOGYR Contra angles & Handpieces conform to the following standards:

I ISO 13485 (1996) *Medical devices Particular requirements for the application of the ISO 9001"
NF EN ISO 1797-1 (1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal"

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SPECIAL 510(k) -- MODIFICATION TO K040674 anthogyr dental contra-angles

anthogyr

NF EN ISO 17664 (2004) « Sterilization of medical devices Information to be > provided by the manufacturer for the processing of resterilizable medical devices »

5. SUBSTANTIAL EQUIVALENCE

The ANTHOGYR « Impulsion » Implantology Contra-angles have the same fundamental scientific technology, operating principle and intended use as predicate devices.

December 15, 2009 Summary preparation date:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

MAR - 3 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Sabine Brayette Quality Engineer in Charge of Regulatory Affairs Anthogyr 2237 Avenue André Lasquin Sallanches FRANCE 74700

Re: K093894

Trade/Device Name: Anthogyr Contra Angles and Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: January 20, 2010 Received: February 1, 2010

Dear Ms. Brayette:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Bravette

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I DA 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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SPECIAL 510(k) - MODiFICATION TO K040674 ANTHOGYR DENTAL CONTRA-ANGLES

thogyr

Indications for Use

510(k) Number (if known):

Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES

/ Indications for Use: ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including:

Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.

Prescription Use_ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSher DDS for Dr. K.P. Mulvey
(Division Sign-Off)

Page 1 of 1

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 15/48

Regulation Number and Section

§ 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.