Compothixo is indicated for modeling of composite, occlusal modeling, fissures and removal of excess composite, layer application technique, bulk technique in small cavities, and for direct veneering. Compothixo represents the next generation composite placement and modeling instrument suitable for all classes of restorations. Compothixo technology utilizes the thixotropic properties of composites by only changing viscosity, without altering the chemical or mechanical characteristics of the material.
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.

Device Description

Compothixo is a hand-held, battery-operated, vibration composite modeling instrument. When the device is turned on the unit begins to vibrate at 140 Hz. It functions in the same way as a hand-operated composite modeling instrument, and also has interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW. Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status. The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.

AI/ML Overview

Here's an analysis of the provided text regarding the Compothixo device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on functional characteristics and safety, comparing the Compothixo to a predicate device. Acceptance criteria are implicitly defined by establishing substantial equivalence based on these comparisons.

Acceptance Criteria Category	Specific Criteria	Predicate Device Performance / Reference	Compothixo Performance / Reference
Intended Use Equivalence	Intended Use	Composite modeling by dental professionals (Hu-Friedy Composite Instrument)	Composite modeling by dental professionals (vibration instrument)
Technological Characteristics Equivalence	Tip Shapes	Same as predicate	Same as predicate
	Operation Method	Manual movement of tip across surface with intermittent hand motion (up to 4 Hz)	Movement of tip across surface with integrated vibration element (140 Hz) or hand-operated when off
Biocompatibility	Material Safety	Not explicitly stated for predicate in this document, assumed to be safe.	Passed ISO 10993 testing.
Electromagnetic Compatibility (EMC)	EMC Compliance	Not explicitly stated for predicate in this document, assumed to be compliant.	Passed IEC 60601-1-2 testing at an independent laboratory.
Bench Testing (Performance)	Frequency of Hand Movement	Up to 4 Hz (intermittent)	140 Hz (vibration element)
	Activation Frequency	Not applicable (manual)	140 Hz
	Maximal Radial Amplitude of Modeling Tip	Not explicitly stated for predicate in this document.	Evaluated against predicate, but specific values not provided in summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document states, "Clinical testing has not been conducted on this product." The testing performed was bench testing and biocompatibility testing.
Data Provenance: Not applicable for a clinical test set. Bench testing data provenance is from the manufacturer's own evaluation or independent labs for EMC.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as clinical testing was not performed; therefore, no "ground truth" derived from expert assessment of patient data was established for a test set.

4. Adjudication Method for the Test Set

Not applicable as clinical testing was not performed.

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

Not applicable. This device is a dental hand instrument, not an AI-powered diagnostic tool, and no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical hand tool, not an algorithm or software. The "standalone" performance refers to the device's functional characteristics (vibration frequency, amplitude) as evaluated in bench testing, separate from human use for final substantial equivalence determination.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by adherence to documented international standards (ISO 10993).
For electromagnetic compatibility, the ground truth is established by adherence to documented international standards (IEC 60601-1-2).
For bench testing of performance characteristics (Frequency of hand movement, Activation frequency, Maximal radial amplitude of the modeling tip), the "ground truth" for comparison was the performance characteristics of the predicate device (Hu-Friedy Composite Instrument) or the inherent physical properties of the device itself (e.g., its designed vibration frequency of 140 Hz). This involved direct measurement and comparison.

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as this is a physical medical device, not an AI/machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "sds", which appears to be a dental company. Next to the logo is the number "K11 1465" written in a handwritten style. The logo is black and white and has a stylized font.

JUL 25 2012

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: 10 July 2012

Trade name Compothixo .
Section 5 - 510(k) Summary
. Common name - Composite Modeling Instrument
Classification name Dental Hand Instrument, Class I (21 CFR §872.4565, DZN) ●

Devices for Which Substantial Equivalence is Claimed:

Composite Instruments, Class I Medical Devices, Product Code DZN, Hu-Friedy ●

Summary

Device Description

1717 West Collins Avenve, Orange, CA 92867 800-537-7824 714-516-7400

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interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW.

Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status.

The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.

Intended use of the Device

The Compothixo is a vibration instrument intended for composite modeling by dental professionals.

Technological Characteristics Compared to Predicate

The Compothixo is substantially equivalent to one legally marketed device in the United States. The Compothixo functions in a manner similar to and is intended for the same use as the Hu-Friedy Composite instrument manufactured Hu-Friedy.

Compothixo is similar to the Hu-Friedy Composite Instrument in that the shapes of the Compothixo tips used for the modeling of the composite are the same as used for the composite instrument. Both devices operate via movement of the tip across the surface of the newly placed composited material in the tooth. The frequency of the Compothixo instrument is about 140 Hz and the intermittent frequency of a hand operated composite instrument can reach up to 4 Hz. The Compothixo differs from the composite instrument in that the Compothixo is operated by an integrated vibration element powered by an AAAA alkaline battery in the handle which can be switched on or off according to the clinician's preference.

Non-Clinical Performance Data

Biocompatibility studies have been completed according to ISO 10993, which demonstrate that the material used to produce Compothixo is safe for its intended use. Additionally, Compothixo successfully passed electro-magnetic compliance (IEC 60601-1-2) testing at an independent testing laboratory.

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This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Compothixo to the predicate device, the Hu-Friedy Composite Instrument. The characteristics evaluated include Frequency of hand movement, Activation frequency, and Maximal radial amplitude of the modeling tip.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion .

Based upon the biocompatibility tests and bench testing, the clinical performance of Compothixo is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

KerrHawe SA C/O Ms. Wendy Garman Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K111465

Trade/Device Name: Compothixo Regulation Number: 21 CFR 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: DZN Dated: July 10, 2012 Received: July 11, 2012

Dear Ms. Garman:

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.

JUL 25 2012

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Page 2 - Ms. Garman

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); 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 yours,

Eintwong Dintan

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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Indications for Use

510(k) Number (if known):

Device Name: Compothixo

Indications for Use:

Indications for USE.
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.

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

Over-The-Counter Use (21 CFR 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 Runyon

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111465

Page 1 of 1

Regulation Number and Section

§ 872.4565 Dental hand instrument.

(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.