(123 days)
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces. The dental handpieces of TRAUS SUS10 are supplied with two types: Piezo handpiece and Dental implant motor handpiece incorporating an implant motor and an angle handpiece. 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 select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.
The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "TRAUS SUS10 Piezo Surgery and Implant Engine Unit," which is a dental surgery device.
The document discusses:
- The device's intended use and technological characteristics.
- Comparison to predicate devices to establish substantial equivalence.
- Non-clinical test summaries covering electrical safety, EMC, software validation, biocompatibility, sterilization validation, and mechanical performance testing.
- A explicit statement that "No clinical studies were considered necessary and performed."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as the provided text does not describe such a study or and the device is a piece of surgical equipment, not an AI or software-only device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2015
Saeshin Precision Co., Ltd. Mr. Sae Kwan Choi Quality Manager #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-Gun Daegu. 711-814 Republic of Korea
Re: K151171
Trade/Device Name: TRAUS SUS10 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: II Product Code: DZI, EGS, and EBW Dated: July 30, 2015 Received: August 4, 2015
Dear Mr. 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. 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.
{1}------------------------------------------------
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape above the company name, "SAESHIN," which is written in a bold, sans-serif font. The geometric shape is composed of several smaller blue triangles arranged to form a larger, abstract design.
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 | |
|---|---|---|
| Indications for Use | See PRA Statement below. | |
| 510(k) Number (if known) | ||
| K151171 | ||
| Device Name | ||
| TRAUS SUS10 | ||
| Indications for Use (Describe) | ||
| including: | TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery | |
| osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), andimplantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue andmechanical rotating root canal preparation (for dental implant surgery). | ||
| 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. | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) Staff | ||
| PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | ||
| information unless it displays a currently valid OMB number." |
{3}------------------------------------------------
Image /page/3/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 three parallelograms that are stacked on top of each other.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
August 28, 2015
2. Submitter's Information [21 CFR 807.92(a)(1)]
- . Name of Sponsor: Saeshin Precision Co., Ltd.
- Address: #52,Secheon-ro 1-gil, Dasa-eup, Dalseong-Gun, Daegu, 711-814, Repulic of Korea
- Contact Name: Sae Kwan Choi / Quality Manager
- Telephone No. : +82 53-587-2341 -
- +82 53-580-0999 -Fax No. :
- -Email Address : ksqc@saeshin.com
- Registration Number: . 3007958831
- Name of Manufacturer: . Same as Sponsor
- Address: Same as Sponsor -
3. Trade Name, Common Name, Classification [21 CFR 807.92a]
- . Trade Name: TRAUS SUS10
- . Common Name: Piezo Surgery and Implant Engine Unit
| Classification: | |
|---|---|
| Classification Name: | Bone Cutting Instrument and Accessories |
| Classification Panel: | Dental |
| Classification Regulation: | 21 CFR 872.4120 |
| Product Code: | DZI, EGS, and EBW |
| Device Class: | II |
General Information
TRAUS SUS10
{4}------------------------------------------------
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
| Primary Predicate | ||
|---|---|---|
| • | 510(k) Number: | K121620 |
| • | Applicant: | DMETEC Co., Ltd. |
| • | Common Name: | Ultrasonic Surgery |
| • | Device Name: | SmarThor |
| Reference Predicate | ||
| • | 510(k) Number: | K123695 |
| • | Applicant: | Saeshin Precision Co., Ltd. |
| • | Common Name: | Dental Handpiece and Accessories |
| • | Device Name: | TRAUS SIP10 |
There are no significant differences between TRAUS SUS10 Piezo Surgery and Implant Engine Unit and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in device design, composition of materials, and technical specifications.
5. Description of the Device [21 CFR 807.92(a)(4)]
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device.
TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces.
The dental handpieces of TRAUS SUS10 are supplied with two types:
- . Piezo handpiece
- . Dental implant motor handpiece incorporating an implant motor and an angle handpiece.
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 select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Saeshin. The logo features a blue geometric shape resembling a cube or a stylized letter 'S' above the company name. The company name, "SAESHIN," is written in a modern, sans-serif font, also in blue.
6. Intended Use [21 CFR 807.92(a)(5)]
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including:
osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).
7. Technological Characteristics [21 CFR 807.92(a)(6)]
TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device.
The dental implant motor handpiece has been cleared by FDA (K123695, date – Dec. 18, 2012)
| Proposed Device | Primary PredicateDevice | Reference PredicateDevice | |
|---|---|---|---|
| K Number | K151171 | K121620 | K123695 |
| Model | TRAUS SUS10 | SmarThor | TRAUS SIP10 |
| Manufacturer | Saeshin Precision | DMETEC | Saeshin Precision |
| Intended Use | TRAUS SUS10 PiezoSurgery and ImplantEngine Unit areintended for use indental surgeryincluding:osteotomy,osteoplasty,periodontal surgeryand implantation(for ultrasonicsurgery), andimplantology,maxilla-facialsurgery andendodontics fortreatment of dentalhard tissue andmechanical rotating | The device isintended for use insurgical proceduresincluding osteotomy,osteoplasty,periodontal surgeryand implantation | TRAUS SIP10 isintended for use indental surgery,implantology,maxilla-facialsurgery andendodontics fortreatment of dentalhard tissue andmechanical rotatingroot canalpreparation. |
| root canalpreparation (fordental implantsurgery). | |||
| Design | |||
| Component | Control box, Footcontroller, Piezohandpiece,Implant motor,Angle handpiece | Control unit,Foot Switch,Ultrasonichandpiece,Tip | Control box, Footcontroller,Implant motor,Angle handpiece |
| Handpiece | Piezo handpiece:TRAUS PEZ10XXImplant motor:TRAUS MBP10SX,TRAUS MBP10SLAngle handpiece:TRAUS CRB26LX,TRAUS CRB26XX,TRAUS CRB27LX,TRAUS CRB27XX | Ultrasonic handpiece | Implant motor:TRAUS MBP10SX,TRAUS MBP10SLAngle handpiece:TRAUS CRB26LX,TRAUS CRB26XX,TRAUS CRB27LX,TRAUS CRB27XX |
| Accessory | Motor stand,Hanger,Internal spraynozzle,Tube holder,Tube clamp,Power cord,Motor cap,Irrigation tube,Foot pole,Torque wrench,Tip holder,Sterilization Tray,Instruction manual,Spray nozzle,Spanner | Autoclave tray,Torque wrench,Hanger,Peristaltic pumptubing | Motor stand,Hanger,Internal spraynozzle,Tube holder,Tube clamp,Power cord,Motor cap,Irrigation tube,Foot hanger,Foot hanger jointcap,Y-connector |
| LED LightIntensity | 25,000 Lux at 1 cmdistance | N/A | 25,000 Lux at 1 cmdistance |
| Operation Mode | Ultrasonicmechanical vibrationand Gear-driven | Ultrasonicmechanicalvibration | Gear-driven |
| OperationalDirection | Forward andReverse | Not known | Forward andReverse |
| Reduction Ratio | 1:1, 16:1, 20:1,27:1, 32:1, 64:1 | Not known | 1:1, 16:1, 20:1,27:1, 32:1, 64:1 |
| CouplingDimension | ISO 3964 | Not known | ISO 3964 |
| Chuck Type | Push-button Locking | Not known | Push-button Locking |
| Shank Type | Type 1 (ISO 1797-1) | Not known | Type 1 (ISO 1797-1) |
| Water Port (forsaline irrigation) | Yes | Yes | Yes |
| Hose Connection | Luer lock, dualconnectionOne hose connectedfrom irrigationpump to inlet ofPiezo Handpiece andanother hose fromirrigation pumpconnected to Y-tubeon Angle Handpiece | Luer lock, singleconnectionSingle hoseconnected fromirrigation pump toinlet of ultrasonicsurgical handpiece | Luer lock, singleconnectionSingle hoseconnected fromirrigation pump to Y-tube on AngleHandpiece |
| Composition of Material | |||
| Bur (in contactwith patient) | Not provided. | N/A | Not provided. |
| Head and Nozzle(in contact withpatient andoperator) | Stainless steel | N/A | Stainless steel |
| Chuck (in contactwith patient) | Stainless steel | N/A | Stainless steel |
| Handle (in contactwith operator) | Stainless steel | N/A | Stainless steel |
| Tubing (in contactwith patient andoperator) | Silicon Rubber,Reference No.32.F0244.00, OMNIA | Not known | Silicon Rubber,Reference No.32.F0244.00, OMNIA |
| Technical Specification | |||
| Supply Voltage | AC 100 - 120 V, 50/60 Hz | AC 100 - 240 V, 50/60 Hz | AC 100 - 120 V, 50/60 Hz |
| Sterilization | Autoclave | Autoclave | Autoclave |
| Bur Extraction Force(N) | Not less than 45 N | Not known | Not less than 45 N |
| Max. Torque | 65 N·cm | Not known | 65 N·cm |
| Max. Speed in rpm | 40,000 rpm | Not known | 40,000 rpm |
| Eccentricity | 0.04 mm | Not known | 0.04 mm |
| Output characteristics (Ultrasonic Mechanical Vibration) | |||
| Maximum output power with load | 48 W | 50 W | N/A |
| Vibration frequency | 24 to 30 kHz | 24 to 32 kHz | N/A |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a blue geometric shape above the word "SAESHIN" in a sans-serif font. The geometric shape is made up of several smaller diamond shapes that are arranged to form a larger diamond shape.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for Saeshin. The logo features a blue geometric shape above the company name, "SAESHIN," which is written in a stylized, futuristic font. The geometric shape is composed of several smaller triangles arranged to form a larger, abstract design.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a blue geometric shape above the company name, which is written in a stylized, sans-serif font. The geometric shape appears to be a stylized cube or a collection of interconnected shapes, giving it a modern and technological feel. The company name is written in all capital letters.
Non-Clinical Test Summary:
-
- Electrical Safety, Electromagnetic Compatibility and Performance:
TRAUS SUS10 complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2. Bench testing of the subject devices includes:
- Electrical Safety, Electromagnetic Compatibility and Performance:
-
• Testing to confirm compliance with the safety requirements of standard AAMI ES60601-1
-
· Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2
2) Software Validation:
TRAUS SUS10 contains MODERATE level of concern software. 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, on May 11, 2005.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Saeshin. The logo features a blue geometric shape resembling three interconnected diamonds or pyramids, positioned above the company name "SAESHIN" in a stylized, sans-serif font. The overall design is clean and modern, suggesting a focus on technology or innovation.
3) Biocompatibility:
TRAUS SUS10 is supplied with the dental implant motor handpiece which has patient contact materials and are found to be biocompatible throughout previous FDA clearance (K123695, date - Dec. 18, 2012) as the materials and manufacturing process are identical to the company's own predicate device.
4) Sterilization Validation:
The handpieces of TRAUS SUS10 are not provided for the sterilization but are sterilized by the user prior to use. The sterilization of the handpieces was validated in accordance with the standard ISO 17665-1.
5) Mechanical Performance Testing
The TRAUS SUS10 is in compliance with ISO 14457:2012, Dentistry - Handpieces And Motors, and the following tests:
- Eccentricity
- Extraction Force
- Visual inspection of General Design
- Temperature Rise
- Resistance to Reprocessing
- Working Frequency ●
- Output Intensity Level
- Vibration Frequency Booster Level
- . Torque
- . Speed
- . Irrigation Water Flow Rates
6) Clinical Test Summary:
No clinical studies were considered necessary and performed.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Saeshin. The logo features a blue geometric shape resembling a stylized letter 'S' above the company name, which is written in a modern, sans-serif font. The color scheme is primarily blue, giving the logo a clean and professional appearance.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K121620 and K123695), TRAUS SUS10 Piezo Surgery and Implant Engine Unit in this submission presented the same in terms of:
- Intended Use
- Device design
- Components and materials ●
- Technological characteristics ●
- . Output characteristics
9. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Precision Co., Ltd. concludes that TRAUS SUS10 is substantially equivalent to predicate devices as described herein.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.