(359 days)
Not Found
No
The description focuses on mechanical control of rotational speed, torque, and water injection based on user input, with no mention of AI/ML terms or functions.
No
The device is described as an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling. It is an operative tool for mechanical intervention, not a device used for treating or curing a disease or condition.
No
The device is described as an electrical appliance intended for cutting, shaving, bone & tissue resection, grinding, and drilling in the cranium and spine. Its function involves physical action on anatomical structures rather than gathering and analyzing information for the purpose of diagnosis.
No
The device description explicitly states it is composed of a control box, micro motor, and foot controller, which are hardware components. The performance studies also include electrical safety, EMC, and sterilization, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for cutting, shaving, bone & tissue resection, grinding, and drilling in the cranium and spine. These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a surgical system with a control box, micro motor, and foot controller used for puncturing and cutting bones and tissues through rotation and reciprocating motion. This is consistent with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical for surgical intervention.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures
Product codes
HBC, HBE
Device Description
Traus SSG10 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc.., is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount.
It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpieces and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium and spine
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)
Non-clinical Performance Data:
- (1) Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety, EMC and device-related electrical safety for high frequency were conducted on the Traus SSG10 according to the following consensus standards:
• IEC60601-1:2005/AMD2:2020, Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
· IEC 60601-1:2015+A1:2021. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic - (2) Software Verification and Validation Testing
Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern. IEC 62304 including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. - (3) Performance Testing
We conducted bench testing to assure that the SSG 10 operates safely and within the predefined design specifications. We declare our performance report based on performance criteria such as RPM. - (4) Sterilization
Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices.
Clinical Data: No clinical performance testing was performed.
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.
Not Found
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
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
September 20, 2024
Image /page/0/Picture/1 description: The image shows the logo for 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Saeshin Precision Co., Ltd. % Sanghwa Myung Regulatory Affairs Consultant E & M D-1474, 230, Simin-daero, Dongan-gu Anyang, Gyeonggi-do 14067 South Korea
Re: K233153
Trade/Device Name: Traus SSG10 Surgical System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC Dated: August 16, 2024 Received: August 16, 2024
Dear Sanghwa Myung:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Digitally signed by Adam D. Adam D. Pierce -S Pierce -S Date: 2024.09.20
16:39:32 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233153
Device Name Traus SSG10 Surgical System
Indications for Use (Describe)
Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not in neurosurgical procedures.
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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4
K233153
Submitter: Saeshin Precision Co., Ltd. # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Republic of Korea Telephone: +82 53 587 2345 Fax: +82 53 580 0939 Email: ksqc(@saeshin.com Contact: E&M Regulatory Affair/Sang Hwa Myung
Telephone: +80-70-7807-0550 FAX: +82-31-388-9263 Cellphone: +82-10-4952-6638 E-mail: mshenmc@gmail.com Primary Contact: Terri Myung
Date 510(k) summary: September 16th, 2024
Trade/common Name: Traus SSG10 Surgical System Regulation Name: Electric cranial drill motor Regulation Numbers: 872.4360 Product Code: HBC, HBE Classification: Class II
Description of Device:
Traus SSG10 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc.., is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount.
It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpieces and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.
Indications for Use
Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures
5
Predicate Device:
Manufacturer: Bien-Air Surgery SA 510(k) Number: K173066 Trade/Device Name: OSSEODUO Shaver and Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, HBE
Comparison table is as follows.
| Descriptive
Information | Subject Device | Predicate Device | Comparison
Comment |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | Saeshin Precision Co.,
Ltd. | Bien-Air Surgery SA | - |
| Device Name | TRAUS SSG10
Surgical System | OSSEODUO Shaver
and Drill System | - |
| 510(k) number | K233153 | K173066 | - |
| Classification
Product Code /
Regulatory
Number | HBC
21 CFR 882.4360 | HBC
21 CFR 882.4360 | - |
| Regulatory
Class | Class II | Class II | - |
| Indications for
Use | Traus SSG10 Surgical
System is an electrical
appliance in the form of
an electric console-type
product that connects
with a handpiece to cut,
shave, bone & tissue
resection, grinding, and
drilling. | The OSSEODUO system
is intended for shaping
bones in spine and cranium
surgical operation. Shaver
handpiece is not intended
for use in neurosurgical
procedures. | Substantial
Equivalent |
| Controller | Console with Foot
pedal | Console with Foot pedal | Substantial
Equivalent |
| Speed Indication | Digital | Digital | Substantial
Equivalent |
| Function | Drill, Saw, Shaver | Drill and
Microdebrider(Shaver) | Substantial
Equivalent |
Table 1: Substantial equivalence comparison: Predicate Device
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Image /page/6/Picture/1 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 shapes that are arranged to form a larger cube-like structure. The company name is written in a sans-serif font and is also blue.
| Energy Source | Electrical | Electrical | Substantial
Equivalent |
|---------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------|
| Motor Speed | Max. 40,000rpm | Max 80,000rpm | #1 Different |
| Sterilization | Steam Autoclave
ISO 17665-1:2006 | Steam Autoclave
AAMI TIR12, ISO
17664, ISO17665 | Substantial
Equivalent |
| Irrigation | 1 peristaltic pump
integrated into console
for irrigation | 1 peristaltic pump
integrated into console
for irrigation | Substantial
Equivalent |
Discussion
The predicate device OSSEODUO Shaver and Drill System, has 80,000 Max rpm. In this respect, the performance is different from that of subject device, Traus SSG10 Surgical System, which is Max. 40,000 rpm.
The subject device safety was conducted according to IEC 60601-1 with the above differences. Performance test (Bench test) also was conducted. The testing results show that the difference does not raise any problems in the safety and effectiveness.
Biocompatibility: Materials tested in accordance with 10993-1 are used and materials that have been confirmed to be biologically safe are used.
-
ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Non-clinical Performance Data:
- (1) Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety, EMC and device-related electrical safety for high frequency were conducted on the Traus SSG10 according to the following consensus standards:
7
• IEC60601-1:2005/AMD2:2020, Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
· IEC 60601-1:2015+A1:2021. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
(2) Software Verification and Validation Testing
Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern. IEC 62304 including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.
(3) Performance Testing
We conducted bench testing to assure that the SSG 10 operates safely and within the predefined design specifications. We declare our performance report based on performance criteria such as RPM.
(4) Sterilization
Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices.
Clinical Data: No clinical performance testing was performed.
Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the SSG10 device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the SSG10 device performs comparably to the predicate device that is currently marketed for the same intended use Based on the available information, the subject device and the predicates are similar indication for use. operational principal. performance data. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device.