(139 days)
No
The summary describes a piezoelectric ultrasonic surgical device and its intended uses. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of these technologies. The performance studies focus on compliance with electrical safety standards.
Yes.
The device is used for mechanical ultrasound treatment, osteotomy, and osteoplasty techniques in dental surgery, which are therapeutic interventions.
No
The device is described as an ultrasonic surgical unit for treatment (mechanical ultrasound treatment, osteotomy, osteoplasty, periodontal surgery, and implantation), not for diagnosis.
No
The device description explicitly states that the devices are "piezoelectric devices for surgery" and "ultrasonic surgical units," indicating they are hardware devices that utilize ultrasound technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an "ultrasonic surgical unit" used for procedures like "tooth scaling applications," "osteotomy," "osteoplasty," "periodontal surgery," and "implantation." These are all in-vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sonic Surgeon devices are surgical tools used for direct treatment.
N/A
Intended Use / Indications for Use
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.
Product codes
DZI
Device Description
Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L are ultrasonic surgical units intended for mechanical ultrasound treatment in prophylaxis, periodontics. The normal mode is tooth scaling applications, and the Boost Mode of Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L can be used for surgical procedures, including osteotomy, osteoplasty, periodontal surgery and implantation.
The tips can easily be changed during the treatment and must also be cleaned and autoclaved. Materials for Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are as follows:
| Component | Material |
|---|---|
| Enclosure (Generator Unit, Foot | |
| Switch) | PC(Polycarbonate) |
| Hose, and seals | ABS(Acrylonitrile-Butadiene-Styrene Terpolymer) |
| Enclosure (Handpiece) | Silicone |
| Tip | PES(Polyethersulfone) |
| PPSU(Polyphenylsulfone) |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L have been manufactured and tested to meet the safety requirements of several IEC standards. The Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L comply with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2007, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
The performance tests and evidence demonstrate that Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L function in a substantially equivalent manner to the predicate device.
In terms of output power, Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are substantially equivalent to the predicate device UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220). The maximum output power of Sonic Surgeon 800L is 70~90W and that of UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220)' is 90W. In terms of light power, the capacity of the device's LED light is demonstrated in 'Biocompatibility' section and an LED report was attached as evidence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2015
Dong Il Technology Ltd. c/o Mr. Peter Chung Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K150076
Trade/Device Name: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: April 29, 2015 Received: April 30, 2015
Dear Mr. Chung:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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
Indications for Use
510(k) Number (if known) K150076
Device Name
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
Indications for Use (Describe)
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K150076
510(k) Summary[as required by 807.92(c)]
A. Submission Information
-
- Submission: 510(k) Submission
-
- Submission Date: June 1, 2015
-
- Submission Type: Traditional
-
- 510(k) number: K150076
B. Applicant:
-
- Company name: DONG IL TECHNOLOGY LTD.
-
- Address: 28, Namyang-ro, 930(gubaeksamsip)beon-gil, Bugyang-dong, Hwaseong-si, Gyeonggi-do, Republic of Korea
-
- Tel: +82(31)229-5500
-
- Fax: +82(31)357-2610
-
- Homepage: http://www.dit-med.co.kr
-
- Contact person: Peter Chung 412-687-3976
-
- Contact person address: 300, Atwood ST, Pittsburgh, PA, 15213
C. Proprietary and Established Names:
-
- Trade Name: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
-
- Common Name: Bone cutting instrument and accessories
-
- Regulation Name: Sonic surgical instrument and accessories/attachments
-
- Regulation Number: 872.4120
-
- Classification: Class 2
-
- Panel: Dental
-
- Product Code: DZI
-
- Identify contact classification:
Category: External communicating device Contact: Tissue/bone/dentin Contact duration: Limited exposure (A)
D. legally marketed predicate devices:
Primary: Sonic Surgeon 300 (K110881) Reference: UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220)
E. Device Description:
Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L are ultrasonic surgical units intended for mechanical ultrasound treatment in prophylaxis, periodontics. The normal mode is tooth scaling applications, and the Boost Mode of Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L can be used for surgical procedures, including osteotomy, osteoplasty, periodontal surgery and implantation.
The tips can easily be changed during the treatment and must also be cleaned and autoclaved. Materials for Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are as follows:
| Component | Material |
|---|---|
| Enclosure (Generator Unit, Foot | |
| Switch) | PC(Polycarbonate) |
| Hose, and seals | ABS(Acrylonitrile-Butadiene-Styrene Terpolymer) |
| Enclosure (Handpiece) | Silicone |
| Tip | PES(Polyethersulfone) |
| PPSU(Polyphenylsulfone) |
4
F. Intended use
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied to use.
G. Technological Characteristics:
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L have the following features:
- . Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L transform generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it to the tip.
- . The generator of the Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece. This feature makes it possible to perform bone cutting, grinding and drilling action.
Our device is very similar to predicate devices, Sonic Surgeon 300 (K110881), UBS ultrasonic bone surgery and UDD ultrasonic debridement device(K080220), because Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L have the following equivalent characteristics: intended use, sterilization method, material used, electrical input power, frequency, and power output as predicate devices.
| Manufacturer | Model | Insulation
Class | Input Voltage | Input Power
Current or
Power | Frequency | Ultrasonic
Operation
Frequency |
|-------------------------------|-------------------------------------------------------------------------------|---------------------|-----------------------------|------------------------------------|------------|------------------------------------------|
| K150076 | | | | | | |
| DONG IL
TECHNOLOG
Y LTD | Sonic Surgeon
310L, 600L, 800L | Class I,
Type B | AC 100-240 V | AC Max 2A | 50 / 60 Hz | Automatic
scanning,
$26 \pm 3$ KHz |
| K110881 | | | | | | |
| DONG IL
TECHNOLOG
Y LTD | Sonic Surgeon
300 | Class I,
Type B | AC 95-115 V
AC 210-240 V | AC Max 1A | 50 / 60 Hz | Automatic
scanning,
$26 \pm 3$ KHz |
| K080220 | | | | | | |
| ITALIA
MEDICA
S.R.L | UBS ultrasonic
bone surgery and
UDD ultrasonic
debridement
device | Class I,
Type CF | AC 230V±10% | 140 VA | 50 / 60 Hz | $26$ kHz $\pm$
10% |
Summary Comparison table
| Manufacturer | Model | Indications for Use |
|---|---|---|
| K150076 | ||
| DONG IL | ||
| TECHNOLOGY | ||
| LTD | Sonic Surgeon 310L | |
| Sonic Surgeon 600L | ||
| Sonic Surgeon 800L | Sonic Surgeon 310L, Sonic Surgeon 600L, Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use. | |
| K110881 | ||
| DONG IL | ||
| TECHNOLOGY | ||
| LTD | Sonic Surgeon 300 | Ultrasonic Surgical Unit is a piezoelectric device for bone surgery that enables osteotomy and osteoplasty techniques to be applied to in dental use. |
| K080220 | ||
| ITALIA MEDICA | ||
| S.R.L | UBS ultrasonic bone surgery and UDD ultrasonic | |
| debridement | The UBS Ultrasonic Bone Surgery and the UDD Ultrasonic Debridement Device are bone cutting instruments intended for use in oral surgery. |
5
(1) Comparison between proposed Device and predicate Sonic Surgeon 300(K110881)
| Predicate Device | Proposed Device | remark | |||
|---|---|---|---|---|---|
| Model Name | Sonic Surgeon 300 | Sonic Surgeon 310L | Sonic Surgeon 600L | Sonic Surgeon 800L | |
| Features | |||||
| LED Light | X | O | O | O | |
| LCD | LCD Display | Touch LCD | Touch LCD | Touch LCD | |
| Input Voltage | AC 95 - 115V | ||||
| (50/60Hz) | |||||
| AC 210 – 240 V | |||||
| (50/60Hz) | AC100V - | ||||
| AC240V | |||||
| (50/60Hz) | AC100V - AC240V | ||||
| (50/60Hz) | AC100V - AC240V | ||||
| (50/60Hz) | |||||
| Pump Cover | Automatic | Manual | Manual | Manual | |
| Power Supply | Toroidal Transformer | SMPS | SMPS | SMPS | |
| Foot Switch IP class | IPX1 | IPX8 | IPX8 | IPX8 | |
| Operating Frequency | 26 ± 3 kHz | 26 ± 3 kHz | 26 ± 3 kHz | 26 ± 3 kHz | |
| Other features are same as Predicate. | |||||
| Dimensions | |||||
| Hand piece | A type: | ||||
| $Ø$ 20×154.2mm(L) | A type: | ||||
| $Ø$ 20×154.2mm(L) | |||||
| B type(LED): | |||||
| $Ø$ 20×152.7mm(L) | C type(LED): | ||||
| $Ø$ 22.5×155.4mm(L) | C type(LED): | ||||
| $Ø$ 22.5× | |||||
| Generator | H:106mm | ||||
| L:300mm | |||||
| W:284mm | H:106mm | ||||
| L:300mm | |||||
| W:298mm | H:106mm | ||||
| L:300mm | |||||
| W:298mm | H:106m | ||||
| m | |||||
| L:300m | |||||
| Foot Switch | H: 37 mm | ||||
| L: 140 mm | |||||
| W: 240 mm | H: 37 mm | ||||
| L: 140 mm | |||||
| W: 240 mm | H: 37 mm | ||||
| L: 140 mm | |||||
| W: 240 mm | H: 37 mm | ||||
| L: 140 mm | |||||
| W: 240 mm | |||||
| Tip Holder | H: 37.9 mm | ||||
| L: 41 mm | |||||
| W: 58 mm | H: 38 mm | ||||
| L: 41 mm | |||||
| W: 58 mm | H: 38 mm | ||||
| L: 41 mm | |||||
| W: 58 mm | H: 38 mm | ||||
| L: 41 mm | |||||
| W: 58 mm | |||||
| Torque Wrench | $Ø$ 40×31mm(L) | $Ø$ 40×31mm(L) | $Ø$ 40×31mm(L) | $Ø$ 40×31mm(L) | |
| Wire Water Pack | $Ø$ 5×477mm(L) | $Ø$ 5×470mm(L) | $Ø$ 5×470mm(L) | $Ø$ 5×470mm(L) | |
| Storage tray-not for sterilizer use | H: 61 mm | ||||
| L: 180 mm | |||||
| W: 200 mm | H: 61 mm | ||||
| L: 180 mm | |||||
| W: 200 mm | H: 61 mm | ||||
| L: 180 mm | |||||
| W: 200 mm | H: 61 mm | ||||
| L: 180 mm | |||||
| W: 200 mm | |||||
| Wire Hand piece | H: 128 mm | ||||
| L: 66 mm | |||||
| W: 83 mm | H: 128 mm | ||||
| L: 66 mm | |||||
| W: 83 mm | H: 128 mm | ||||
| L: 66 mm | |||||
| W: 83 mm | H: 128 mm | ||||
| L: 66 mm | |||||
| W: 83 mm | |||||
| Tips | Refer to Table 4 | Table.1 | |||
| Refer to Table 5 & Table 6 | |||||
| The material of handpiece enclosure is different from Sonic Surgeon 300. | |||||
| Other materials are same as predicate device. | |||||
| Materials | |||||
| Performance parameters | |||||
| LED Light Control | X | O | O | O | Table.2 |
| Output Power | MAX 40W | 15 ~ 50W | 15 ~ 70W | 15 ~ 90W | Table.3 |
| Irrigation | 10~90 ml/min. | 7~110 ml/min. | 7~110 ml/min. | 7~110 ml/min. | Table.4 |
6
(2) Comparing 'output Power' between proposed Device and predicate model 'UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220)'
| Predicate Device | Proposed Device | remark | |||
|---|---|---|---|---|---|
| Manufacturer | ITALIA MEDICA | ||||
| S.R.L | DONG IL TECHNOLOGY LTD. | ||||
| Model Name | Model Ultrasonic | ||||
| Debridement | Sonic Surgeon | ||||
| 310L | Sonic Surgeon | ||||
| 600L | Sonic Surgeon | ||||
| 800L | |||||
| Performance parameters | |||||
| Output | |||||
| Power | 90 W | 30~50 W | 50~70 W | 70~90 W | Table.3 |
Table.1 Tips (Sonic Surgeon 300/310L/600L/800L)
| No. | Sonic Surgeon 300 / 310L | Sonic Surgeon 600L / 800L | ||
|---|---|---|---|---|
| Name | Size | Name | Size | |
| 1 | DG3-001 | Ø 4.5x28.26mm(L) | BTG-B017 | Ø 5.5x28.5mm(L) |
| 2 | DG3-002 | Ø 4.5×30.51mm(L) | BTG-R018 | Ø 5.5x29.5mm(L) |
| 3 | DM3-003 | Ø 4.5x31.86mm(L) | BTM-D019 | Ø 5.5x31.5mm(L) |
| 4 | DE3-004 | Ø 4.5×28.29mm(L) | BTE-K020 | Ø 5.5x29.0mm(L) |
| 5 | DH6-005 | Ø 4.5x30.75mm(L) | BTH-S021 | Ø 5.5x30.1mm(L) |
| 6 | DD6-016 | Ø 4.5x27.7mm(L) | BTD-F022 | Ø 5.5x27.5mm(L) |
| 7 | DD6-028i | Ø 4.5x28.2mm(L) | BTD-F023 | Ø 5.5x28.5mm(L) |
| 8 | DC6-Saw | Ø 4.5x31.5mm(L) | BTC-I024 | Ø 5.5x31.5mm(L) |
| 9 | DC6-Saw L | Ø 4.5x30.9mm(L) | BTC-I025 | Ø 5.5×31.0mm(L) |
| 10 | DC6-Saw R | Ø 4.5x30.9mm(L) | BTC-I026 | Ø 5.5x31.0mm(L) |
Table.2 LED Brightness
| LED
| level | LED brightness (lux) | Remark | ||
|---|---|---|---|---|
| Sonic Surgeon 310L | Sonic Surgeon 600L | Sonic Surgeon 800L | ||
| 1 | $1,900\pm100$ | $2,000\pm100$ | $2,000\pm100$ | |
| 2 | $2,400\pm100$ | $2,500\pm100$ | $2,500\pm100$ | Distance: |
| 20mm | ||||
| 3 | $2,600\pm100$ | $2,800\pm100$ | $2,800\pm100$ |
7
Table.3 Output Power
| [Unit: W] | ||||||
|---|---|---|---|---|---|---|
| Model Name | Normal Mode | Boost Mode | ||||
| Level1 | Level2 | Level3 | Level1 | Level2 | Level3 | |
| Sonic Surgeon 310L | 15~17 | 17~21 | 21~27 | 30~50 | 30~50 | 30~50 |
| Sonic Surgeon 600L | 15~17 | 17~21 | 21~27 | 50~70 | 50~70 | 50~70 |
| Sonic Surgeon 800L | 15~17 | 17~21 | 21~27 | 70~90 | 70~90 | 70~90 |
Table.4 Water flow
| Pump level | Water flow (ml/min approximately) | Remark | |
|---|---|---|---|
| Sonic Surgeon 300 | Sonic Surgeon 310L/600L/800L | ||
| 1 | 10 | 7 ~ 13 | |
| 2 | 30 | 15 ~ 40 | |
| 3 | 50 | 40 ~ 60 | |
| 4 | 70 | 60 ~ 80 | |
| 5 | 90 | 80 ~ 110 |
Table.5 Materials (Sonic Surgeon 300)
| No | Name | Materials | Company | CAS No. | Grade |
|---|---|---|---|---|---|
| 1 | Enclosure | ||||
| (Generator | |||||
| Unit) | PC(Polycarbonate) | ||||
| ABS(Acrylonitrile- | |||||
| Butadiene-Styrene | |||||
| Terpolymer) | LG Chemical | PC | |||
| (103598-77-2) | |||||
| ABS | |||||
| (9003-56-9) | LUPOY | ||||
| GN5001RF | |||||
| 2 | Hose, and | ||||
| seals | Silicone | Elkem | 7440-21-3 | Synthetic | |
| rubber | |||||
| 3 | Enclosure | ||||
| (Hand Piece) | PES | ||||
| (Polyethersulfone) | BASF | 25608-63-3 | Ultrason | ||
| E2010 | |||||
| 4 | Tips | TrimRite stainless | CARPENTER | - | UNS S42010 |
| 5 | Tip Coating | ZrN | |||
| (Zirconium Nitride) | |||||
| ZrN+Diamond | Chemetall | ||||
| (Zirconium) | |||||
| ProSciTech | 25658-42-8 | ||||
| Diamond | |||||
| (77820-40-3) | CA | ||||
| M24 |
8
| Table.6 Materials (Sonic Surgeon 310L/600L/800L) | |||||
|---|---|---|---|---|---|
| No | Name | Materials | Company | CAS No. | Grade |
| 1 | Enclosure | ||||
| (Generator | |||||
| Unit) | PC(Polycarbonate) | ||||
| ABS(Acrylonitrile- | |||||
| Butadiene-Styrene | |||||
| Terpolymer) | LG Chemical | PC | |||
| (103598-77-2) | |||||
| ABS | |||||
| (9003-56-9) | LUPOY | ||||
| GN5001RF | |||||
| 2 | Hose, and | ||||
| seals | Silicone | Elkem | 7440-21-3 | Synthetic | |
| rubber | |||||
| 3 | Enclosure | ||||
| (Hand Piece) | PPSU | ||||
| (Polyphenylsulfone) | Solvay | Polyphenylsulfone | |||
| (25608-64-4) | |||||
| Titanium dioxide | |||||
| (13463-67-7) | |||||
| Carbon black | |||||
| (1333-86-4) | Duradex | ||||
| D-3000 | |||||
| 4 | Tips | TrimRite stainless | CARPENTER | - | UNS S42010 |
| 5 | Tip Coating | ZrN | |||
| (Zirconium Nitride) | |||||
| ZrN+Diamond | Chemetall | ||||
| (Zirconium) | |||||
| ProSciTech | 25658-42-8 | ||||
| Diamond | |||||
| (77820-40-3) | CA | ||||
| M24 |
H. Performance Information
The Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L have been manufactured and tested to meet the safety requirements of several IEC standards. The Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L comply with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2007, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
l. Conclusion:
The performance tests and evidence demonstrate that Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L function in a substantially equivalent manner to the predicate device.
In terms of output power, Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are substantially equivalent to the predicate device UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220). The maximum output power of Sonic Surgeon 800L is 70~90W and that of UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220)' is 90W. In terms of light power, the capacity of the device's LED light is demonstrated in 'Biocompatibility' section and an LED report was attached as evidence.
Because our proposed device has the same intended use, the same sterilization method, same materials used, same electrical input power, same frequency, and same power output as predicate devices, as well as similarity of product configuration and administration, it can be concluded the Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are substantially equivalent to the identified predicate devices.