(273 days)
No
The summary describes a mechanical device for dental procedures with no mention of AI or ML capabilities, image processing, or data analysis.
Yes
The device is described as being used for the "treatment of dental hard tissue and mechanical rotating root canal preparation", indicating a therapeutic purpose.
No
The device description indicates it is used for treatment (e.g., mechanical rotating root canal preparation, dental surgery) and regulation of instrument speed/direction, not for diagnosing conditions.
No
The device description explicitly states it is an AC-powered device that includes hardware components such as a hand-held motor, contra angle handpiece, and foot controller.
Based on the provided information, the TRAUS SIP20 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in dental surgery, implantology, treatment of dental hard tissue, and mechanical rotating root canal preparation. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a motor, handpiece, and foot controller, all components used for mechanical manipulation within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TRAUS SIP20's function is entirely mechanical and procedural, not diagnostic based on sample analysis.
N/A
Intended Use / Indications for Use
TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.
Product codes (comma separated list FDA assigned to the subject device)
EBW, EGS
Device Description
TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue, root canal, maxilla-facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery, implantology, endodontics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 dental equipment
- 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
The performance tests were conducted as bench test according to ISO 14457: 2017.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 and Human Services logo. To the right of that 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.
February 11, 2021
Saeshin Precision Co., Ltd. % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul. 08375 REPUBLIC OF KOREA
Re: K201292
Trade/Device Name: TRAUS SIP20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EBW, EGS Dated: January 15, 2021 Received: January 26, 2021
Dear DongHa 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. 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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201292
Device Name TRAUS SIP20
Indications for Use (Describe)
TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows 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 triangles that form a larger hexagon. The company name, "SAESHIN", is written in a stylized, sans-serif font in blue.
510(k) Summary (K201292)
This summary of 510(K) - substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 10, 2021
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 Fax: +82-2-856-5904 Tel: +82-70-8965-5554 Email: dhlee@kmcerti.com
3. Device Identification
- -Trade/Proprietary Name: TRAUS SIP20
- -Classification Name: Dental handpiece and accessories
- -Classification Regulation: 21CFR 872.4200
- -Product Code: EBW, EGS
- -Device Class: 1
- -Review Panel: Dental
4. Primary Predicate Device
- -K number: K123695
- -Manufacturer: Saeshin Precision Co., Ltd.
- -Trade Name: TRAUS SIP10
5. Reference Device
- -K number: K182892
- -Manufacturer: Saeshin Precision Co., Ltd.
- -Trade Name: TRAUS Dental Handpieces
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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 a stylized blue font. The geometric shape is made up of several smaller blue shapes, creating a three-dimensional effect. The word "SAESHIN" is written in all capital letters and has a futuristic, angular design.
4. Device Description
TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.
5. Indications for Use
TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanical rotation.
6. Substantial Equivalence
The subject device, TRAUS SIP20 is derived from the primary predicate device, TRAUS SIP10.
Under the comparing substantial equivalence between the primary predicate device, there are the same points such as Product Code. Regulation number. Classification, Indications for use, and Principle of Operation. Besides, Micro motors (TRAUS MBP10SY and TRAUS MBPIOSL), Angle handpieces (TRAUS CRB26XX, TRAUS CRB27LX and TRAUS CRB27XX) and foot controller (TRAUS FUSIO) are identical to the primary predicate devices (TRAUS CRB46LN, TRAUS CRB46LN, TRAUS CRB46NN) for the subject device are identical to the reference device which is FDA cleared components (K182892).
Although there are some differences between the primary predicate device such as control box specification (gear ratio and maximum irrigation volume), nev angle handpieces (TRAUS CRB46NN), the safety and performance test reports are supported to the substantial equivalence. The differences do not raise different questions of safety and effectiveness.
| Descriptive Information | Subject Device | Primary Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Manufacturer | Saeshin Precision Co., Ltd. | Saeshin Precision Co., Ltd. | Saeshin Precision Co., Ltd. | The same |
| Device Name | TRAUS SIP20 | TRAUS SIP10 | TRAUS Dental Handpieces | - |
| 510(k) number | - | K123695 | K182892 | - |
| Classification Product Code / | ||||
| Regulatory Number | EBW, EGS / 872.4200 | EBW, EGS / 872.4200 | EGS / 872.4200 | The same |
| Regulatory Class | 1 | 1 | 1 | The same |
| Indications for Use | TRAUS SIP20 is intended | |||
| for use in dental surgery, | ||||
| implantology, for | ||||
| treatment of dental hard | ||||
| tissue and mechanical | ||||
| rotating root canal | ||||
| preparation. | TRAUS SIP10 is intended | |||
| for use in dental surgery, | ||||
| implantology, maxilla- | ||||
| facial surgery and | ||||
| endodontics for treatment | ||||
| of dental hard tissue and | ||||
| mechanical rotating root | ||||
| canal preparation. | The TRAUS Dental | |||
| Handpieces are indicated | ||||
| for wide range of dental | ||||
| procedures. | ||||
| A. Implant placement, | ||||
| including |
- Preparation of the
osteotomy site - Bone contouring,
osteoplasty
B. Periodontal surgeries - Bone contouring &
alveoplasty around living
teeth - Removal of exostosis
C. Bone grafting - Preparation of the
donor site (for e.g.
symphysis and ascending
rames etc.) - Harvesting autogen
living bone - Sinus elevation &
grafting of alveolar
sockets
D. Removal and
sectioning of teeth and | The same as the primary predicate
device. |
| | | | impacted third molars and
complicated extractions | |
| Prescription or OTC | Prescription | Prescription | Prescription | The same |
| Principle of Operation | Dental handpiece is driven
by electrical micromotor
and internal gearings. The
micromotor and internal
gearings are controlled by
a control box. | Dental handpiece is driven
by electrical micromotor
and internal gearings. The
micromotor and internal
gearings are controlled by
a control box. | Dental Handpiece is gear
driven hand-held dental
handpieces. It can be
driven by torque
adjustable electrical
motors for surgery
treatment. | The same as the primary predicate
device. |
| Components | Control box,
Foot controller,
Micro motor,
Handpieces | Control box,
Foot controller,
Micro motor,
Handpieces | Handpieces | The same as the primary predicate
device. |
| Device Design - Control box | | | | |
| Model Name | TRAUS BIP20 | TRAUS XIP10 | - | - |
| Input Power | AC 100-120V, 50 / 60 Hz,
48VA | AC 100-120V, 50 / 60 Hz,
120W | N/A | Different |
| Gear Ratio | 1:1, 1:2, 1:5, 16:1, 20:1,
32:1 | 1:1, 16:1, 20:1, 27:1, 32:1,
64:1 | N/A | Different |
| LED Optic / Light Intensity | 25,000 lux | 25,000 lux | | The same |
| Max. Irrigation Volume | Max. 90ml/min ± 20% | Max. 75ml/min | | Different |
| Device Design - Foot controller | | | | |
| Model Name | TRAUS FUS10 | TRAUS FUS10 | N/A | Same component as the primary
predicate device |
| Degree of protection against
ingress of water (IEC 60529) | IPX8 | IPX8 | N/A | |
| Device Design - Micro motor | | | | |
| Model Name | TRAUS MBP10SX,
TRAUS MBP10SL | TRAUS MBP10SX,
TRAUS MBP10SL | | |
| Fiber optics | N/A | N/A | | Same components as the primary
predicate device |
| Motor Type | BLDC | BLDC | N/A | |
| RPM | 40,000 rpm | 40,000 rpm | | |
| Fiber optics | Only for TRAUS
MBP10SL | Only for TRAUS
MBP10SL | | |
| Device Design - Angle Handpiece | | | | |
| Model Name | TRAUS CRB26LX,
TRAUS CRB26XX,
TRAUS CRB27LX,
TRAUS CRB27XX,
TRAUS CRB46LN,
TRAUS CRB46NN | TRAUS CRB26LX,
TRAUS CRB26XX,
TRAUS CRB27LX,
TRAUS CRB27XX, | TRAUS CRB46LN
TRAUS CRB46NN | |
| Fiber optics | Only for
TRAUS CRB26LX,
TRAUS CRB27LX, | Only for
TRAUS CRB26LX,
TRAUS CRB27LX | Only for
TRAUS CRB46LN, | Same components as the primary
predicate device or the reference |
| Rear Ratio | 20:1
(TRAUS CRB26LX,
TRAUS CRB26XX)
32:1
(TRAUS CRB27LX,
TRAUS CRB27XX)
20:1
(TRAUS CRB46LN,
TRAUS CRB46NN) | 20:1
(TRAUS CRB26LX,
TRAUS CRB26XX)
32:1
(TRAUS CRB27LX,
TRAUS CRB27XX) | 20:1
(TRAUS CRB46LN,
TRAUS CRB46NN) | device |
| | | | | |
| Speed in rpm | Max. 2,000 rpm
(TRAUS CRB26LX,
TRAUS CRB26XX)
Max. 1,250 rpm
(TRAUS CRB27LX,
TRAUS CRB27XX)
Max. 2,000 rpm
(TRAUS CRB46LN,
TRAUS CRB46NN) | Max. 2,000 rpm
(TRAUS CRB26LX,
TRAUS CRB26XX)
Max. 1,250 rpm
(TRAUS CRB27LX,
TRAUS CRB27XX) | Max. 2,000 rpm
(TRAUS CRB46LN,
TRAUS CRB46NN) | |
| Material (in contact with patient) | SUS 303F
SUS 420F | SUS303F
SUS 420F | SUS303F
SUS 420F | |
| Chuck Design | For Shank Type 1 by ISO 1797 | For Shank Type 1 by ISO 1797-1 | For Shank Type 1 by ISO 1797-1 | |
| Bur Extraction Force | 45 N | 45 N | 45 N | |
| Conformance with standards for shanks | Shank Type: Type 1 by ISO 1797 | Shank Type: Type 1 by ISO 1797-1 | Shank Type: Type 1 by ISO 1797 | |
| Coupling dimensions for micro motor | ISO 3964 | ISO 3964 | ISO 3964 | |
The following comparison table is presented to demonstrate substantial equivalence.
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Image /page/5/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 blue, futuristic-looking font. The geometric shape is made up of several smaller diamond shapes arranged to form the larger S shape.
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Image /page/6/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. The geometric shape is made up of several smaller blue triangles arranged to form a larger, three-dimensional shape.
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Image /page/7/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a geometric shape resembling a stylized letter "S" above the word "SAESHIN" in a stylized font. The geometric shape is made up of several blue diamond shapes, and the word "SAESHIN" is in a blue, sans-serif font.
8
Image /page/8/Picture/0 description: The image features the logo for SAESHIN. The logo consists of a geometric shape above the company name. The geometric shape is a blue hexagon made up of smaller blue triangles. The company name, "SAESHIN", is written in a stylized blue font below the geometric shape.
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Image /page/9/Picture/0 description: The image shows 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 squares and triangles, arranged to form a larger cube-like structure. The company name, "SAESHIN," is written in a stylized, sans-serif font in blue.
7. 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 dental equipment
- 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
8. Software Validation:
TRAUS SIP20 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.
9. Biocompatibility
The handpiece has been completely evaluated and cleared through the previous FDA 510K (K123695 and K182892) as the same materials and the same manufacturing process as the company's own devices. (There have been no design changes in any of these models.)
In comparing the biocompatibility of the device with the primary predicate device and reference device, it is demonstrated that the device has the same type of patient contacting parts, which are classified the same concerning body contact and contact duration.
Based on the above evaluation, the dental handpieces are substantially equivalent to the primary predicate devices in terms of biocompatibility.
10. Sterilization
The sterilization validation of the applied components (Micro motor cap, Angle Handpiece) has been completely evaluated and cleared through the previous FDA 510K (K123695 and K182892) as the same materials and the same manufacturing process as the company's own devices. (There have been no design changes in any of these models (micromotors and handpieces))
11. Nonclinical Performance Test - Bench Test
The performance tests were conducted as bench test according to ISO 14457: 2017.
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Image /page/10/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a geometric shape above the word "SAESHIN" in blue, block letters. The geometric shape is a stylized, three-dimensional hexagon composed of smaller blue triangles, creating a sense of depth and complexity.
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, and Principle of Operation. Besides, Micro motors (TRAUS MBP10SX and TRAUS MBP10SL), Angle handpieces (TRAUS CRB26LX, TRAUS CRB26XX, TRAUS CRB27LX and TRAUS CRB27XX) and foot controller (TRAUS FUS10) are identical to the predicate device. The newly added angle handpieces (TRAUS CRB46LN, TRAUS CRB46NN) for the subject device are identical to the reference device which is FDA cleared components (K182892).
Although there are some differences between the subject device and the predicate device such as control box specification (gear ratio and maximum irrigation volume), new angle handpieces (TRAUS CRB46LN and TRAUS CRB46NN), the safety and performance test reports are supported to substantial equivalence. The differences do not raise different questions of safety and effectiveness.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.