(276 days)
Not Found
No
The description focuses on controlling motor speed and torque based on user-programmable parameters and foot pedal input, with no mention of AI or ML technologies.
No
The device is intended for cutting hard and soft tissues and screwing dental implants, which are surgical procedures, not therapeutic applications.
No
The device is described as a "software based driving engine that controls the speed of a specific dental micromotor" for dental surgery and implantology, specifically to "cut hard and soft tissues in the mouth and screw dental implants." Its function is entirely operational, not diagnostic.
No
The device description explicitly lists multiple hardware components beyond just software, including a main controller unit, charger, foot controller, micro motor, cable, water holder, tube holder, and micro motor holder.
Based on the provided information, the iCTmotor (WL-1) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for dental surgery and implantology, specifically for cutting hard and soft tissues in the mouth and screwing dental implants. This is a surgical procedure performed directly on a patient.
- Device Description: The device controls a dental micromotor and handpiece for mechanical actions within the mouth. It involves physical manipulation of tissues and implants.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health or condition. IVDs are used for diagnostic purposes based on analysis of biological samples.
The iCTmotor (WL-1) is a surgical tool used in vivo (within the living body) for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.
Product codes
EBW
Device Description
iCTmotor (WL-1) is a software based driving engine that controls the speed of a specific dental micromotor. This device is optimized for dental implant procedures and user programmable parameters operate and control a dental handpiece for dental implant surgery. iCTmotor (WL-1) consists of a main controller unit, a charger, a foot controller, micro motor, cable, a water holder, tube holder, and micro motor holder. The main control unit operates the speed and torque of a dental micromotor that drives dental handpiece to cut tissues in the mouth and to screw dental implants. The main control unit is operated via a wireless foot pedal. The holders are used for placement of a water bag, a micro motor and a handpiece. The power cord delivers electric power to the main control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery and implantology
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
Non-clinical tests were conducted.
Electrical Safety: Testing was conducted in accordance with IEC 60601-1:2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility: Testing was conducted in accordance with IEC 60601-1-2:2015 Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
Software: Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Reprocessing: Cleaning and sterilization validation test report subject to "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) are provided.
Biocompatibility: Not considered as the device is not in direct contact with a patient's skin and the user is instructed to wear gloves.
Performance testing was conducted according to ISO 14457:2012 to show that the device meets its design requirements and performs as intended. The specifications were met for:
- Rotating speed of micromotor
- . Torque of micromotor
- Stop of micromotor
- . Rotating direction of micro motor
- Irrigation amount
Clinical testing was not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 4, 2020
Dentium Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 Houston, Texas 77054
Re: K193341
Trade/Device Name: iCTmotor (WL-1) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EBW Dated: September 3, 2020 Received: September 3, 2020
Dear Dave Kim:
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.
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 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 (OS) 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 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
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Indications for Use
510(k) Number (if known) K193341
Device Name iCTmotor (WL-1)
Indications for Use (Describe)
iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.
| 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) |
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3
510(k) Summary K193341
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: September 2, 2020
I. SUBMITTER
| Submitter's Name | Dentium Co., Ltd (ICT Branch) |
|---|---|
| Submitter's Address | 76, Changnyong-daero 256beon-gil, Yeongtong-gu |
| Suwon-si, Gyeonggi-do, Korea (Zip. 16229) | |
| Submitter's Telephone | +82 (70) 7098-4027 |
| Contact person | Sangwoo Lee / RA Manager |
| swlee1@dentium.com | |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | Mtech Group |
| 7707 Fannin St. Ste 200-V111 | |
| Houston, TX 77054 | |
| Telephone | +713-467-2607 |
II. DEVICE
| Trade/proprietary Name | iCTmotor (WL-1) |
|---|---|
| Common Name | Controller, Foot, Handpieces and Cord |
| Regulation Name | Dental Handpieces and Accessories |
| Regulation Number | 21 CFR 872.4200 |
| Product Code | EBW |
| Regulatory Class | Class I |
PRIMARY PREDICATE DEVICE (K140308) III.
| Primary Manufacturer | Kaltenbach & Voigt GmbH |
|---|---|
| Device Name | MASTERsurg / EXPERTsurg |
| Common Name | Controller, Foot, Handpieces and Cord |
| Regulation Name | Dental Handpieces and Accessories |
| Regulation Number | 21 CFR 872.4200 |
| Product Code | EBW, EGS |
| Regulatory Class | Class I |
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IV. DEVICE DESCRIPTION
iCTmotor (WL-1) is a software based driving engine that controls the speed of a specific dental micromotor. This device is optimized for dental implant procedures and user programmable parameters operate and control a dental handpiece for dental implant surgery. iCTmotor (WL-1) consists of a main controller unit, a charger, a foot controller, micro motor, cable, a water holder, tube holder, and micro motor holder. The main control unit operates the speed and torque of a dental micromotor that drives dental handpiece to cut tissues in the mouth and to screw dental implants. The main control unit is operated via a wireless foot pedal. The holders are used for placement of a water bag, a micro motor and a handpiece. The power cord delivers electric power to the main control unit.
V. INDICATIONS FOR USE:
iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.
| Device name | iCTmotor (WL-1) | EXPERTsurg + INTRA LUXS600 LED | Remarks |
|---|---|---|---|
| 510K Number | K193341 | K140308 | |
| Main body image | Image: iCTmotor (WL-1) | Image: EXPERTsurg + INTRA LUXS600 LED | |
| Foot switch image | Image: Foot switch | Image: Wireless type | Wireless |
| type (same) | |||
| Micromotor | Image: Micromotor | Image: Micromotor | Similar |
| Indication for use | iCTmotor (WL-1) is intended | ||
| for use in dental surgery and | |||
| implantology. The main control | |||
| unit is designed to operate a | |||
| specific dental micro motor that | |||
| drives dental handpieces to cut | |||
| hard and soft tissues in the | |||
| mouth and screw dental | |||
| implants. iCTmotor (WL-1) is | |||
| compatible with a handpiece | |||
| equipped with connection | |||
| according to ISO 3964. | Unit: This KaVo product is intended | ||
| for surgery to expose and dissect oral | |||
| tissue structures or endodontic | |||
| treatments (e.g. periodontal gap, | |||
| gingiva, bone, aw, extractions and | |||
| implantations). Motor: The medical | |||
| device is intended to drive / operate | |||
| a dental handpiece / contra-angle | |||
| handpiece equipped with a | |||
| handpiece connection according to | |||
| ISO 3964. This medical device is an | |||
| electrical low-voltage motor for | |||
| dental purposes according to ISO | |||
| 11498 type 2 and classified as a type | |||
| B application part. | Similar | ||
| Compliance to | |||
| Standards | Handpiece in compliance with | ||
| ISO 3964 | Handpiece in compliance with ISO | Same | |
| Dimensions | 278 x 175 x 134 (mm) | 265 x 255 x 100 mm | Similar |
| Electrical | |||
| Specification | 100 – 240 V | 100 – 240 V | Same |
| Main Weight | 3kg | 2.0kg | Similar |
| Foot Weight | 0.7kg | 1.1kg | Similar |
| Motor | 135g | 125g | Similar |
| Max output power | Max 70W | Max 150W | Different |
| Motor Type | Surgical Motor (Collector) | Surgical Motor (Collector) | Same |
| Handpiece | |||
| Connection | INTRAmatic Coupling System | ||
| (ISO 3964) | INTRAmatic Coupling System | ||
| (ISO 3964) | Same | ||
| Electrical | |||
| Specification | |||
| Motor (Voltage) | 36 VDC | 22 V AC | Different |
| Electrical | |||
| Specification | |||
| Motor (20:1 | |||
| Torque) | 70Ncm | 55 Ncm | Different |
| Electrical | |||
| Specification | |||
| Motor (Torque) | 2.3mNm | 5.5Ncm | Different |
| Micro motor LED | |||
| Input Voltage | DC 3.3V | DC 3.0-3.6V | Similar |
| Micro motor LED | |||
| Input | |||
| Current(Max) | 150mA | 150mA | Same |
| Electrical | |||
| Specification | |||
| Motor (Rotation) | Clockwise, Counter Clockwise | Clockwise, Counter Clockwise | Same |
| Electrical | |||
| Specification | |||
| Motor (Speed) | 400- 40,000rpm | 300 - 40,000 rpm | Similar |
| Pump Delivery | |||
| rate | 40-60ml/min | 30-110ml/min | Different |
| Handpiece | |||
| rotational speed | |||
| (20:1 ratio) | 20 ~ 2,000 rpm | 15 ~ 2,000 rpm | Similar |
| Wireless foot | |||
| Emitted power | Max 8.6dBm(e.i.r.p.) | Max 3dBm(e.i.r.p.) | Different |
| Wireless foot | |||
| Frequency bend | 2.405~2.480GHZ | 2.4GHZ | Similar |
| Length of motor | |||
| cable | 2m | 2m | Same |
| Operating mode | 3min ON/10min OFF | 30sec. of operation/9min.pause | Different |
| Handpiece gearing 20:1 | |||
| ratio | 20:1 | Same | |
| Sterilization | Sterilizable | Sterilizable | Same |
| Storage | |||
| Ambient | |||
| temperature | 0°C-+60°C | -20°C-+50°C | Different |
| Operating | |||
| Ambient | |||
| temperature | 10°C-+35°C | 10°C-+35°C | Same |
| Storage | |||
| Relative humidity | Max 90% | 5%-95% | Similar |
| Operating | |||
| Relative humidity | Max 80% | 15%-80% | Similar |
| Atmospheric | |||
| pressure Range | 700hPa-1,060hpa | 700hPa-1,060hpa | Same |
| Foot switch | |||
| control | - Speed key |
- Program key
- Motor | - Direction of motor rotation key
- Speed key
- Program key
- Pump key | Similar |
| Electrical
Specification
Motor (Speed) | Up to 40,000rpm | Up to 40,000 rpm | Same |
| Handpiece
rotational speed | 20 ~ 2,000 rpm | 15 ~ 2,000 rpm | Similar |
| Handpiece gearing | 20:1 | 20:1 | Same |
| Sterilization | Sterilizable | Sterilizable | Same |
VI. PREDICATE COMPARISON
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K193341
The proposed iCTmotor (WL-1) is similar in the indications for use, overall design and function to the EXPERTsurg + INTRA LUXS600 LED (K140308). Both the proposed subject device and the primary predicate device consist of a control unit with a micromotor, connecting cable and a wireless foot pedal.
The subject device does not include a straight or contra angle handpiece. An irrigation tube is not included neither.
ICTmotor(WL-1) motor is compatible with any contra-angle handpiece in compliance with EN ISO 3964:2016 and ICTmotor (WL-1) motor is also compatible with irrigation tubes in compliance with EN ISO 7405
The differences do not render the device NSE because the performance tests demonstrate that the differences in technological characteristics do not raise new safety concerns.
8
VII. SUMMARY OF NON-CLINICAL TESTS
iCTmotor (WL-1) complies with voluntary standards for electrical safety, EMC testing, and use in the dental clinic. The following data were provided to support the substantial equivalence determination:
Electrical Safety:
Testing was conducted in accordance with IEC 60601-1:2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
Electromagnetic Compatibility:
Testing was conducted in accordance with IEC 60601-1-2:2015 Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
Software:
Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)
Reprocessing:
Cleaning and sterilization validation test report subject to "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) are provided.
Biocompatibility:
The subject device is not in direct contact with a patient's skin. The user is instructed to wear gloves while operating the iCTmotor (WL-1). Therefore, biocompatibility test is not considered.
The manufacturer also provided a material/chemical composition and manufacturing based rationale as to how your final finished device is substantially equivalent to the identified primary predicate device:
"The [Stainless Steel: SUS 304] of iCTmotor (K193341) in its final finished form is identical to the [Stainless Steel: SUS 304] of other micro motor manufactured by Maxon motor ag and marketed in the US in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."
" iCTmotor micro motor in its final finished form is identical to other micro motor manufactured by Maxon motor ag and marketed in the US as private labels in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."
9
K193341
Performance testing was conducted cording to ISO 14457:2012 to show that the device meets its design requirements and performs as intended. The specifications were met for:
- Rotating speed of micromotor
- . Torque of micromotor
- Stop of micromotor
- . Rotating direction of micro motor
- Irrigation amount
VIII. SUMMARY OF CLINICAL TESTS
Clinical testing was not required to demonstrate the substantial equivalence of iCTmotor (WL-1) to its predicate device.
CONCLUSIONS IX.
Based on the information above, iCTmotor (WL-1) is substantially equivalent to the predicate device. Based on the performance testing results including the nonclinical tests, the subject device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3))