TRAUS SUS20

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 13, 2020 Saeshin Precision Co., Ltd. Jong Choi Quality Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 42921 Kr Re: K192561 Trade/Device Name: TRAUS SUS20 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: June 18, 2020 Received: June 25, 2020 Dear Jong Choi: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K192561 Device Name TRAUS SUS20 Indications for Use (Describe) TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape resembling a stylized letter 'S' above the word "SAESHIN" in a bold, sans-serif font, also in blue. The geometric shape is made up of several smaller, interconnected diamond-like shapes, creating a three-dimensional effect. # K192561 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: July 10, 2020 #### 1. Applicant / Submission Sponsor Saeshin Precision Co., Ltd. Address: #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 42921 Republic of Korea Fax : +82-53-580-0939 Tel : +82-53-587-2345 #### 2. Submission Correspondent DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com ## 3. Device Identification - Trade/Proprietary Name: TRAUS SUS20 - - -Classification Name: Bone cutting instrument and accessories. - Classification Regulation: 21CFR872.4120 - - Product Code: DZI - - -Device Class: 2 - -Review Panel: Dental #### 4. Predicate Device - K number: K151171 - -Manufacturer: Saeshin Precision Co., Ltd. - Trade Name: TRAUS SUS10 (Reference Device: Compact Piezo LED, K151023) ## 5. Device Description TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in blue block letters. The geometric shape is made up of several smaller blue shapes that are arranged to form a larger cube-like structure. The logo is simple and modern, and the blue color gives it a sense of professionalism and trustworthiness. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to set such as power (output intensity) and boost (vibration frequency). ## 6. Intended use / Indications for Use TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation. ## 7. Substantial Equivalence The subject device, TRAUS SUS20 is derived from the predicate device, TRAUS SUS10. The predicate device. TRAUS SUS10 has two functions as a piezo ultrasonic dental surgery function and a motor based dental surgery function. The subject device, TRAUS SUS20 has only piezo ultrasonic surgery function and it is the same as the predicate device. TRAUS SUS20 is substantially equivalent to the predicate device, TRAUS SUS10 (K151171), in which the principle of operation, intended use, technological characteristics and performance characteristics are same. The differences have been verified and the result shows that it does not raise any new questions of safety and effectiveness. The reference device K151023 is used for substantial equivalence comparison of the LED functionality only. The following comparison table is presented to demonstrate substantial equivalence. | - | Subject Device | Predicate Device | Reference Device | Comparison | |-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | Manufacturer | Saeshin Precision Co.,<br>Ltd. | Saeshin Precision Co.,<br>Ltd. | Mectron Spa | - | | Device Name | TRAUS SUS20 | TRAUS SUS10 | Compact Piezo LED | - | | 510(k) number | - | K151171 | K151023 | - | | Classification<br>Product Code /<br>Regulatory<br>Number | DZI / 872.4120 | DZI / 872.4120 | ELC / 872.4850 | Identical to<br>Predicate<br>Device | | Subsequent<br>Product Code | None | EGS, EBW | Non | - | | Regulatory<br>Class | 2 | 2 | 2 | Identical to<br>Predicate<br>Device | | Indications for<br>Use | TRAUS SUS20, Piezo<br>Surgery Engine Set, is<br>intended for use in<br>dental surgery<br>including: osteotomy,<br>osteoplasty,<br>periodontal surgery<br>and implantation. | TRAUS SUS10, Piezo<br>Surgery and Implant<br>Engine Unit, is intended<br>for use in dental surgery<br>including:<br>osteotomy, osteoplasty,<br>periodontal surgery and<br>implantation (for<br>ultrasonic surgery), and<br>implantology, maxilla-<br>facial surgery and<br>endodontics for<br>treatment of dental hard<br>tissue and mechanical<br>rotating root canal<br>preparation (for dental | The Compact Piezo<br>LED is an ultrasonic<br>scaler intended for<br>use, with the<br>appropriate<br>associated insert tips,<br>in the following<br>dental applications:<br>• Scaling: Procedures<br>for removal of<br>supragingival/<br>subgingival and<br>interdental<br>calculus/plaque<br>deposits:<br>· Periodontology: | Very<br>similar to<br>Predicate<br>Device | | | | implant surgery). | Periodontal therapy<br>and debridement for<br>periodontal diseases,<br>including periodontal<br>pocket irrigation and<br>cleaning;<br>• Endodontics:<br>Treatments for root<br>canal reaming<br>irrigation, revision,<br>filling, gutta-percha<br>condensation and<br>retrograde<br>preparation;<br>• Restorative and<br>Prosthetics:<br>Restorative<br>procedures<br>including cavity<br>preparation,<br>removal of<br>prostheses,<br>amalgam<br>condensation,<br>finishing of crown<br>preparations,<br>inlay/onlay<br>condensation and<br>implants/restorations<br>cleaning. | | | Prescription or<br>OTC | Prescription | Prescription | Prescription | Identical to<br>Predicate<br>Device | | Principle<br>of<br>Operation | Piezoelectric ultrasonic<br>vibrations to perform<br>in dental surgery | Piezoelectric ultrasonic<br>vibrations to perform in<br>dental surgery | Piezoelectric<br>ultrasonic vibrations<br>to perform in dental<br>surgery | Identical to<br>Predicate<br>Device | | Device Design - Control box | | | | | | Model Name | TRAUS BUS20 | TRAUS XUS10 | None | Identical to<br>Predicate<br>Device | | Input Power | AC 100-120V, 50 / 60<br>Hz, 48VA | AC 100-120V, 50 / 60<br>Hz, 48VA | None | Identical to<br>Predicate<br>Device | | Max. Irrigation<br>Volume | Max. 110Q/min ±<br>20% | Max. 90Q/min ± 20% | None | Identical to<br>Predicate<br>Device | | Device Design - Piezo Handpiece | | | | | | Model Name | TRAUS PEZ10XX<br>(Non-optic),<br>TRAUS PEZ10LN<br>(Optic) | TRAUS PEZ10XX<br>(Non-optic) | COMPACT PIEZO<br>LED | - | | Vibration<br>frequency | 27 ± 3KHz | 27 ± 3KHz | 24 kHz to ~36 kHz | Identical to<br>Predicate<br>Device | | Maximum<br>output<br>power of piezo<br>operation | 59 VA | 59VA | 59VA | Identical to<br>Predicate<br>Device | | LED system<br>incorporated<br>inside<br>the<br>handpiece to<br>provide<br>illumination of<br>the<br>operative<br>site | Yes<br>(only for TRAUS<br>PEZ10LN / 2,400 lux) | None | Yes | Identical to<br>Reference<br>Device | | Device Design - Ultrasonic Tip (Not provided) | | | | | | Model Name | FDA listed accessory<br>(Listing number<br>D250061)<br>SP-028i<br>SP-024i<br>SP-016<br>SP-SAW<br>SP-SAW L<br>SP-SAW R<br>SP-320<br>SP-400<br>SP-610<br>SP-020is | FDA listed accessory<br>(Listing number<br>D250061)<br>SP-028i<br>SP-024i<br>SP-016<br>SP-SAW<br>SP-SAW L<br>SP-SAW R<br>SP-320<br>SP-400<br>SP-610<br>SP-100<br>SP-020is | FDA listed accessory<br>OT7<br>OT7S-3<br>OT7S-4<br>OT8R<br>OT9L | Identical to<br>Predicate<br>Device | | Material<br>(in<br>contact<br>with<br>patient) | Trimrite | Trimrite | Trimrite | Identical to<br>Predicate<br>Device | | Device Design - Foot Controller | | | | | | Model Name | TRAUS FUS10 | TRAUS FUS10 | NA | Identical to<br>Predicate<br>Device | | Degree<br>of<br>protection<br>against ingress<br>of water (IEC<br>60529) | IPX8 | IPX8 | NA | Identical to<br>Predicate<br>Device | | Accessories | | | | | | Handpiece<br>Stand | Part No. 2017<br>STANDER | Part No. 2011 STAND | NA | Identical to<br>Predicate<br>Device | | Hanger | Part No. X-CUBE 06 | Part No. X-CUBE 06 | NA | Identical to<br>Predicate<br>Device | | Tube Holder | Part No. FORTE<br>100aEI 05 | Part No. FORTE<br>100aEI 05 | NA | Identical to<br>Predicate<br>Device | | Torque wrench | Part No. TRAUS<br>ATW10 | Part No. TRAUS<br>ATW10 | NA | Identical to<br>Predicate<br>Device | | Tip Holder | Part No. TRAUS<br>ATH10 | Part No. TRAUS<br>ATH10 | NA | Identical to<br>Predicate<br>Device | | Sterilization<br>Case | Part No. TRAUS<br>ATR10 | Part No. TRAUS<br>ATR10 | NA | Identical to<br>Predicate<br>Device | | Power Cord | Part No. BC-02 | Part No. BC-02 | NA | Identical to<br>Predicate<br>Device | | (Optional)<br>Irrigation Tube | * FDA listed<br>accessory. (Listing No:<br>D289551)<br>Part No. DB-001,<br>Part No. DB-003 | * FDA listed accessory.<br>(Listing No: D289551)<br>Part No. DB-001,<br>Part No. DB-003 | NA | Identical to<br>Predicate<br>Device | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape above the company name. The geometric shape is made up of several smaller shapes that are arranged to form a larger, more complex shape. The company name is written in a stylized font. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape resembling a stylized letter 'S' above the word "SAESHIN" in blue, blocky letters. The geometric shape is made up of several smaller cubes or parallelograms arranged to create a three-dimensional effect. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized, sans-serif font, also in blue. The geometric shape appears to be composed of several smaller cubes or parallelograms arranged to form a larger, more complex shape. ## 8. Electrical Safety and Electromagnetic compatibility The Electrical Safety and Electromagnetic Compatibility tests were performed in accordance with the following standards. - IEC 60601-1:2005 + A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance - IEC 80601-2-60:2012, Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dentalequipment - IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests ## 9. Software Validation: TRAUS SUS20 contains MODERATE level of concern software (firmware). The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices. #### 10. Biocompatibility TRAUS SUS20 is supplied with piezo handpiece which can contact with a patient. The handpiece has been evaluated about biocompatible throughout previous FDA clearance (K151171) as the materials and manufacturing process are identical to the company's own predicate device. The ultrasonic tips which also can contact with a patient are FDA listed accessories(Listing number D250061). The biocompatibility test for the tips were performed in accordance with the following FDA recognized standards - -ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized, blue font. The geometric shape is made up of several smaller shapes, creating a three-dimensional effect. - -ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. - -ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. ## 10. Sterilization The piezo handpiece, ultrasonic tip and torque are sterilized by the user prior to use. The sterilization was validated in accordance with the standard ISO 17665-1. #### 11. Nonclinical Performance Test - Bench Test For nonclinical performance testing - Bench test, piezo output frequency, Piezo output power and Irrigation water flow rates were evaluated according to SOP. ## 12. Clinical Testing No clinical study was considered necessary and performed. ## 13. Conclusion Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as Product Code, Regulation number, Classification, Indications for use, Principle of Operation and Design Specification (Maximum output power of piezo operation and Vibration frequency). A piezo handpiece (TRAUS PEZ10XX) and foot controller (TRAUS FUS10) are identical to the predicate device. Although there are some differences Control box - Max. irrigation volume, a handpiece with optic function, ultrasonic tips), the performance test reports are supported to the substantial equivalence of the subject device. The differences of the subject device do not raise different questions of safety and effectiveness. The subject device follows the recommendations of the FDA Guidance Document Dental Handpieces - Premarket Notification [510(k)] Submissions. In this regard, we conclude that the subject device is substantially equivalent to the predicate device.