Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

Device Description

Thor 700 Electric Handpiece System is composed of a system unit, which is connected to a : power supply and a control tube, that system unit drives a dental drive device. The system unit converts pneumatic output from the dental treatment unit to control the torque, speed and directional rotation of the dental drive device. The dental drive device, in turn, provides the control for motorized dental handpieces. The inputs to the system unit are supplied by a dental treatment unit. Inputs can also be controlled by the foot pedal of the treatment unit.

AI/ML Overview

This submission package for the Thor 700 Electric Handpiece System primarily focuses on demonstrating substantial equivalence to a predicate device (Siro Torque L, K031584) through a comparison of technical specifications and non-clinical performance testing. It does not describe an AI/ML-based device, therefore, many of the requested details concerning acceptance criteria and studies for AI performance metrics are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance (Table)

The document evaluates the Thor 700's performance against established standards and safety requirements, rather than against specific clinically relevant accuracy metrics typically associated with AI/ML devices. The "acceptance criteria" here are generally compliance with international standards and direct comparison of specifications to the predicate device.

Acceptance Criteria / Performance Metric	Target (Predicate/Standard)	Thor 700 Reported Performance	Study/Test Conducted
Electrical Safety	IEC 60601-1	Complies	IEC 60601-1 testing
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Complies	IEC 60601-1-2 testing
Software Validation	FDA Guidance "General principle of Software Validation; Final Guidance for Industry and FDA staff", Jan 11, 2002	Successfully validated	Software validation
Performance (Noise)	ISO 11498	Complies	ISO 11498 performance testing
Sterilization Validation (132°C for 15 min, drying 30 min)	ANSI/AAMI ST79:2010	Complies	Sterilization validation (132°C/15min, 30min drying)
Biocompatibility (Erythema & Oedema)	ISO 10993-10 (Response "negligible")	No erythema, no oedema; "negligible" response	ISO 10993-10 testing on rabbits
Intended Use Equivalence	Matches Predicate (Siro Torque L)	Substantially equivalent	Comparison of intended uses
Components Equivalence	Comparable to Predicate	System unit, power supply, control tube, dental drive device	Comparison of components
Principle of Operation Equivalence	Comparable to Predicate	Similar power, cooling, and foot pedal control	Comparison of operating principles
Material Composition Equivalence	Identical to Predicate	Aluminum, Stainless Steel, Plastic	Comparison of materials
Patient Contact	None (Matches Predicate)	No contact with patients	Technical comparison
System Unit Presence	Yes (Matches Predicate)	Yes	Technical comparison
Speed Control	Yes (Matches Predicate)	Yes	Technical comparison
Digital Speed Readout	Yes (Matches Predicate)	Yes	Technical comparison
Installation Capability	Predicate: internal/external	Thor 700: external	Technical comparison
Individually Programmable Settings	2 (Matches Predicate)	2	Technical comparison
Forward/Reverse Switches	Yes (Matches Predicate)	Yes	Technical comparison
Spray Water Pressure	Predicate: 29 psi (2.0 bar)	Thor 700: 36 psi (2.5 bar)	Technical comparison
Spray Air Pressure	Predicate: 39 psi (2.7 bar)	Thor 700: 29 psi (2.0 bar)	Technical comparison
Voltage Input	AC: 100-240V, 50/60 Hz (Matches Predicate)	AC: 100-240V, 50/60 Hz	Technical comparison
Voltage Output	Predicate: DC: 24V DC	Thor 700: DC: 48V DC	Technical comparison
Motor Speed	2000-40000 rpm (Matches Predicate)	2000-40000 rpm	Technical comparison
Motor Diameter	Predicate: 21 mm	Thor 700: 22 mm	Technical comparison
Torque	Predicate: 2.4 N-cm maximum	Thor 700: 3 N-cm maximum	Technical comparison
Weight	Predicate: 100 grams	Thor 700: 62 grams	Technical comparison
Cooling Air Pressure	30 NL/min (Matches Predicate)	30 NL/min	Technical comparison
Coupling Dimensions	According to ISO-3964 (Matches Predicate)	According to ISO-3964	Technical comparison
Hose Connections	According to ISO-9168 (Matches Predicate)	According to ISO-9168	Technical comparison

Details for AI-Specific Questions (Not Applicable for this Device)

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

Not Applicable. This is a hardware device (electric handpiece system) and does not involve an AI/ML component or a "test set" of data in the context of diagnostic or predictive performance. The testing involved
- Electrical safety and EMC testing (IEC standards).
- Software validation (internal process, not a clinical data set).
- Performance testing (ISO 11498 for noise, likely empirical measurements of mechanical properties).
- Sterilization validation (empirical testing in a lab).
- Biocompatibility testing (animal studies - rabbits).

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)

Not Applicable. No ground truth in the context of AI/ML classification or prediction was established. "Ground truth" for this device relates to compliance with engineering standards and physiological safety, typically assessed by qualified engineers and toxicologists/biocompatibility experts with appropriate certifications, not medical specialists for diagnostic accuracy.

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

Not Applicable. No test set requiring expert adjudication for ground truth was used.

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 an electric handpiece system, not an AI-assisted diagnostic or therapeutic tool for human readers. 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 not an algorithm-only device. Software validation was performed, but it pertains to the control and operation of the hardware, not an AI for interpretation or diagnosis.

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

Not Applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by compliance with established international standards (IEC, ISO, ANSI/AAMI) for electrical safety, EMC, mechanical performance (e.g., speed, torque, noise), software functionality, and biocompatibility. The predicate device's specifications also serve as a comparative benchmark.

8. The sample size for the training set

Not Applicable. This device does not use an AI/ML model that requires a training set of data.

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

Not Applicable. No training set was used.

Summary

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K132570

APR 2 9 2014

Image /page/0/Picture/2 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters followed by the word "BIO". The "T" letters are bold and angled, with the first "T" being solid black and the second "T" having a textured appearance. The word "BIO" is outlined, with the letters "B" and "O" having distinct shapes.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 FAX : 886-4-23594196 TEL : 886-4-23595958 E-mail: medical@ttbio.com http://www.ttbio.com

510(K) SUMMARY Electric Handpiece System

1. Date Summary Prepared: March 25,2014
1. Submitter Information
- 510(k) Owner: TTBIO CORP.

2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Jo S.C. Lee/QA Engineer Phone: 886-4-23595958/e-mail: jo@ttbio.com

3. Device Name

Trade Name: Thor 700 Electric Handpiece System Common Name: Dental Handpiece and Accessories Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200, Product Code EBW)

1. Predicate Device: Siro Torque L, (K031584)
1. Device Description:

1. Intended Use:
  Thor 700 Electric Hnadpiece system is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

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Image /page/1/Picture/0 description: The image shows the logo for TT BIO. The logo consists of two stylized, bold, black "T"s followed by the word "BIO" in a thin, outlined font. The "T"s are angled and slightly overlapping, creating a modern and dynamic look. The word "BIO" is positioned to the right of the "T"s, completing the logo.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 E-mail: medical@ttbio.com http://www.ttbio.com

Substantial Equivalency:

Substantial Equivalence Table
Descriptive Information	Device(Thor 700)	Predicate devices (Siro TorqueL; K031584)

Intended for Use	Thor 700 is intended to convertpneumatic output from a dentaltreatment center to electricalenergy for operation ofelectrically-driven dentalhandpieces.	The Siro Torque L is intended toconvert pneumatic output from adental treatment center toelectrical energy for operation ofelectrically-driven dentalhandpieces.
Components	System unit, power supply,control tube and a dental drivedevice (micromotor).	Control unit, power supply, hoseand two alternative electricmicromotors.
Principle of operation	External power was supplied toThor 700 through a powersupply. Cooling water andcooling air are supplied by thedental treatment center and thefoot padel controls the dentaldrive device speed.	External power was supplied toSiro Torque L through a powersupply. Cooling water andcooling air are supplied by thedental treatment center and thefoot padel controls themicromotor speed.
Composition of Materials	Aluminum, Stainless Steel,Plastic	Aluminum, Stainless Steel,Plastic
The patient-contactingportions of the device	No contact with patients	No contact with patients
System unit	Yes	Yes
Speed Control	Yes	Yes
Digital speed readout	Yes	Yes
Installation capability	external	internal/external
Individuallyprogrammable settings	2	2
Forward/reverse switches	Yes	Yes
Spray water pressure	36 psi (2.5bar)	29 psi (2.0 bar)
Spray air pressure	29 psi (2.0bar)	39 psi (2.7 bar)
Power supply
Voltage input	AC : 100 - 240 V AC50/60 Hz	AC : 100-240 V AC50/60 Hz
Voltage output	DC : 48V DC	DC : 24V DC
Dental drive device
Motor speed	2000 ~ 40000 rpm	2000 ~ 40000 rpm
Motor diameter	22 mm	21 mm
torque	3 N-cm maximum	2.4 N-cm maximum
weight	62 grams	100 grams
Substantial Equivalence Table
Descriptive Information	Device(Thor 700)	Predicate devices (SiroTorqueL; K031584)
Technical Specification
Cooling air pressure	30 NL/min	30 NL/min
Spray air pressure	36 psi (2.5bar)	39 psi (2.7bar)
Spray water pressure	29 psi (2.0bar)	29 psi (2.0bar)
Torque	max. 3.0 N-cm	max. 2,4 N-cm
Speed range	2000~40000 rpm	2000~40000 rpm
Coupling dimensions	According to ISO-3964	According to ISO-3964
Hose connections	According to ISO-9168	According to ISO-9168
Noise	According to ISO-11498	According to ISO-11498

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TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 E-mail: medical@ttbio.com http://www.ttbio.com

Thor 700 Electric Handpiece System is substantially equivalence to the Siro Torque L (K031584) on equivalence intended uses and technical characteristics.

1. Discussion of non-clinical data:
  Testing of electromagnetic compatibility and electrical safety has been conducted in accordance with IEC 60601-1-2 and IEC 60601-1. The software has been successfully validated to confirm the performance of Thor 700 Electric handpiece System according to the FDA guidance-" General principle of Software Validation; Final Guidance for Industry and FDA staff", dated January 11, 2002.

The performance testing was conducted according to ISO 11498 and sterilization validation 132℃ for 15 minutes, drying time for 30 minutes was performed in accordance to ANSI/AAMI ST79:2010.

Biocompatibility testing was conducted according to ISO 10993-10 and the results showed that No erythema and no oedema were observed on the skin of the rabbits. The response of the test article was categorized as "negligible".

1. Discussion of Clinical Tests Performed:
  N/A

10. Conclusion:

The above descriptions coincide with the substantial equivalence, Siro Torque L (K031584). They are substantial equivalent to the predicate device in terms of its intended use, operating principles and functions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G60 Silver Spring, MI) 20993-0002

April 29, 2014

TTBIO CORPORATION Shu-Ching Lee Engineer 2F, No.7, 6th Road Industry Park Taichung. Taiwan R.O.C 40755

Re: K132570

Trade/Device Name: Electric Handpiece System, Model Thor 700 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 25. 2014 Received: March 27, 2014

Dear Mr. Lee:

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.

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

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Page 2 - Mr. Lee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Susan Russo, DDS, MA

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T"s followed by the word "BIO". The "T"s are blocky and angled, with a three-dimensional effect. The word "BIO" is written in a simple, sans-serif font.

TTBIO CORP. 2F, NO.7, 6" ROAD INDUSTRY PARK, AICHUNG, TAIWAN, R.O.C. 40755 FAX : 886-4-23594196 886-4-23595958 -mail: medical@ttbio.com http://www.ttbic

Indications for Use

510(K) Number (If Known): Device Name: Electric Handpiece System, Model Thor 700. Indications for Use:

Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

CAUTION: Federal (US)) law restricts the use of this device to licensed professionals

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

4-1

Sheena 2014.04

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.