(193 days)
The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
The provided text is a 510(k) summary for the DMETEC SmarThor Ultrasonic Surgery device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria, performance metrics, and detailed study design as might be done for a novel device or AI/software.
Therefore, the following information is extracted or inferred based on the nature of a 510(k) submission for this type of device (an ultrasonic bone-cutting instrument).
Here's a breakdown of the information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (EMS Piezon Master Surgery). The performance is reported by comparing the specifications of the SmarThor to the predicate device.
| Characteristic / Acceptance Criteria (Implied) | DMETEC (SmarThor) Reported Performance | EMS (Piezon Master Surgery) Predicate Performance |
|---|---|---|
| Indication for Use | The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. | The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry. |
| Supply Voltage | 24V DC | 100-240 V AC |
| Power Consumption (max) | 50W max | 105VA |
| Maximum Output Power with Load | 50W | 25W |
| Frequency Range Available | 24-32 kHz | 24-32 kHz |
| Transformer Input | 100-240 VAC, 50-60Hz | 100/220 VAC/50-60Hz |
| Transformer Output | 24V DC/ 2.7A | 24V AC/ 1.25A |
| Main Components | 1 Unit Body, 1 Hand-piece, 1 Tip | 1 Unit Body, 1 Hand-piece, 5 Tips |
| Tip Material (contact with patient) | Stainless steel | Stainless steel |
| Biocompatibility | Meets ISO 10993-5:2009 (Grade 0 cytotoxicity, 0% sensitization, no oral mucosa irritation/mortality) | (Implied predicate meets standards) |
| Electrical Safety | Meets IEC 60601-1:1988 + A1:1991 + A2:1995 | (Implied predicate meets standards) |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1-2: 2007 | (Implied predicate meets standards) |
| Software Validation | Software validation report shows substantial equivalence and proper performance. | (Implied predicate has validated software) |
| Device Life | 5 years | (Not explicitly stated for predicate in summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. No specific "test set" of cases or patients was used for evaluating performance in the way an AI/software study would. The evaluation is based on non-clinical bench testing and comparison of specifications to a predicate device, as well as biocompatibility testing on biological samples.
- Data Provenance:
- Non-clinical tests (biocompatibility, electrical safety, EMC, software validation): These tests would have been performed by DMETEC CO., LTD. in Korea (country of origin). These are "prospective" tests conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This 510(k) does not involve expert-established ground truths for performance evaluation in the way a diagnostic AI would. The "ground truth" for compliance with standards (e.g., biocompatibility) is defined by the standard itself, and the comparison to the predicate relies on published specifications and post-market experience.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical "test set" requiring adjudication by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This device is a physical instrument, and its 510(k) submission relies on demonstrating substantial equivalence through technical specifications, non-clinical bench testing, and comparison with a predicate device, not through a comparative effectiveness study involving human readers and interpretations.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (ultrasonic surgery instrument), not an AI algorithm. Its performance is inherent in its physical and electrical characteristics.
7. The Type of Ground Truth Used
- For non-clinical tests (biocompatibility, electrical safety, EMC): The ground truth is established by the requirements and methodologies defined in the cited international standards (e.g., ISO 10993-5:2009, IEC 60601-1, IEC 60601-1-2).
- For comparison to the predicate: The ground truth is the published technical specifications and intended use of the legally marketed predicate device (EMS Piezon Master Surgery), as well as its established safety and effectiveness through "post-market experience."
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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KI21620
DEC 1 1 2012 1
510(k) Summary
Owner Information
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Name: DMETEC CO., LTD.
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Address: 402-603 Techno-Park, 193 Yakdae-Dong, Wonmi-Ku, Bucheon City, KOREA
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- Phone Number: 82-32-234-0011
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- FAX Number: 82-32-234-1444
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- Name of Contact Person: Hong-Geun, Lee
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- Date the Summary was Prepared: 05/11/2012
Device Information
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- Common Name: Bone cutting instrument and accessories
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- Trade Name: Ultrasonic Surgery
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- Model Number(s): SmarThor
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- Classification Name: Drill, Bone, Powered
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- Requlation Number: 872.4120
Predicate Device Information
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- 510(k) Number: K072146
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- Trade Name: EMS Piezon Master Surgery
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- Product Code: DZI
Description of the Device
This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
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Specifications of unit:
Model: Supply voltage: Supply frequency: Power input: Device life Output characteristics(Ultrasonic output):
Type of protection against electric shock: Degree of protection against electric shock: Specification of transformer Output characteristics of transformer:
SmarThor DC 24V 50 / 60 Hz 24 VA 5years Maximum output power with load:50W Frequency range available: 24-32kHz. Class 1, with transformer Applied part type BF AC100-250V, 50-60Hz DC 24V
Intended Use
The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
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Product Name: Ultrasonic Surgery
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Model: SmarThor
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| DMETEC(SmarThor) | EMS(Piezon Master Surgery) | |
|---|---|---|
| 510(k) reference | K072146 | |
| Indication for use | The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. | The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry |
| UNIT | ||
| Supply voltage | 24V DC | 100-240 V AC |
| Power consumption(max) | 50W max | 105VA |
| OUTPUT CHARACTERISTICS | ||
| Maximum output power with load | 50W | 25W |
| Frequency range available | 24-32 kHz | 24-32 kHz |
| TRANSFORMER | ||
| Input | 100-240 VAC, 50-60Hz | 100/220 VAC/50-60Hz |
| Output | 24V DC/ 2.7A | 24V AC/ 1.25A |
| MAIN COMPONENT | ||
| 1 Unit Body1 Hand-piece1 Tip | 1 Unit Body1 Hand-piece5 Tips | |
| MATERIAL | ||
| Tip(contact with patient) | Stainless steel | Stainless steel |
:
Summary of Technical Characteristics Compared to the Predicate Device
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Brief Discussion of Nonclinical Tests (if applicable)
For biocompatibility, in vitro cytotoxicity test, skin sensitization test and oral mucosa irritation test were conducted. During the in vitro cytotoxicity test, no evidence of causing cell lysis or toxicity was found and it was evaluated as Grade 0 on the criteria of ISO 10993-5:2009. As for skin sensitization, sensitization scores were zero and the sensitization rates were observed 0% at 24 hours. As for oral mucosa irritation test, no mortality was observed, no changes in body weight were observed, and there were no differences in saline and test group.
For electric safety and electromagnetic compatibility, the device was tested according to IEC 60601-1:1988 + A1:1991 + A2:1995 and IEC 60601-1-2: 2007 and the device was found to meet the requirements of the standards.
Software validation report shows that the device is substantially equivalent and performs as it should.
Brief Discussion of Clinical Tests (if applicable)
Comparison with the predicate indicates they are similar in functions and efficiency, and the post market experience proves that it is substantially equivalent.
Conclusion from Nonclinical and Clinical Tests (if applicable)
Biocompatibility tests, electric safety test and electromagnetic compatibility test show that the device meets the requirements of those standards.
Literatures and post market experience show that the device is substantially equivalent.
Comparison with the predicate device shows that the device has similar specification . and performance.
Thus, we conclude that SmarThor are substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three thick, curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
DMETEC Company, Limited C/O Mr. Daniel Nam General Manager PATS Corporation 4568 West 155 Street, Suite 104 Los Angeles, California 90004
Re: K121620
Trade/Device Name: Ultrasonic Surgery (SmarThor) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 14, 2012 Received: November 23, 2012
Dear Mr. Nam:
We have reviewed vour 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.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K121620
Device Name: Ultrasonic Surgery (SmarThor)
Indications For Use: The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
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)
2012.12.11 Susan Runner DDS, MA -1:3:22:33 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number,
§ 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.