Traus SSG30 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.

Device Description

Traus SSG30 Surgical System, is available to apply surgical operation by various handpieces incorporating a micro motor and a handpiece. The technological characteristics and operating parameters of OSSEODUO Shaver and Drill System is very similar to the predicate device. With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces. Traus SSG30 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 handpiece 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Traus SSG30 Surgical System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance data, especially concerning AI/ML aspects.

The document explicitly states: "Clinical Data: No clinical performance testing was performed."

Therefore, I cannot fulfill all parts of your request as the information required for a study proving the device meets acceptance criteria, particularly for AI/ML performance, is not present in this regulatory submission. This submission primarily focuses on functional equivalence, electrical safety, software verification, and sterilization validation.

However, I can extract information related to the acceptance criteria that were tested (non-clinical) and the methods described:

Summary of Acceptance Criteria and Device Performance (Based on Non-Clinical Data Provided):

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Validation
Biocompatibility	Biological safety of materials	Materials tested in accordance with ISO 10993-1, -5, -10, -12 are used and confirmed to be biologically safe.
Electrical Safety & EMC	Basic safety and essential performance, electromagnetic compatibility	Testing conducted according to IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2015+A1:2021. Implicitly, the device met these standards for clearance.
Software Performance	Software verification and validation	Software verification and validation testing was conducted. Documentation provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (moderate level of concern). IEC 62304 including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Implicitly, the software performed as intended.
Mechanical Performance	Operating safely within predefined design specifications (e.g., RPM)	Bench testing conducted to assure SSG 30 operates safely and within predefined design specifications. Performance report based on criteria such as RPM. Implicitly, the device met these specifications.
Sterilization	Sterilization validation	Validated in conformance to FDA recognized consensus standard ISO 17665-1:2006 for moist heat sterilization.
Operational Equivalence	Comparison to Predicate Device	Indications for Use: Substantially equivalent. Controller: Console with Foot pedal (Substantial Equivalent). Speed Indication: Digital (Substantial Equivalent). Function: Drill, Saw, Shaver (Substantial Equivalent to Drill and Microdebrider(Shaver)). Energy Source: Electrical (Substantial Equivalent). Motor Speed: Max. 80,000rpm (Substantial Equivalent). Irrigation: 1 peristaltic pump integrated into console (Substantial Equivalent).

Information Not Available / Not Applicable for this Device's Clearance:

As stated previously, this submission is for a Traditional 510(k) of a physical surgical system, not an AI/ML-driven device that requires performance studies related to diagnostic accuracy or human-AI collaboration. Therefore, many of your specific questions are not applicable to the context of this FDA clearance.

Sample sized used for the test set and the data provenance: Not applicable for a traditional surgical system's non-clinical performance tests like electrical safety or mechanical RPM. The "test set" here refers to physical bench tests and software V&V, not a clinical data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and electrical systems is typically defined by engineering specifications and standards, not expert consensus on images or clinical outcomes.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For non-clinical tests, ground truth is based on engineering specifications, physical measurements, and industry standards (e.g., IEC, ISO).
The sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

Conclusion from the Document:

The 510(k) summary concludes: "The non-clinical data support the safety of the device and software and software verification and validation demonstrate that the SSG30 device should perform as intended in the specified use conditions. The clinical data demonstrate that the SSG30 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."

This explicitly indicates that substantial equivalence was primarily demonstrated through non-clinical performance and a comparison of technical specifications to a predicate device, without clinical performance testing.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. The symbol is a stylized representation of human figures, while the text clearly identifies the organization.

September 16, 2024

Saeshin Precision Co., Ltd. % Sanghwa Myung Regulatory Affairs Consultant E&M D-1471, 230, Simin-daero, Dongan-gu Anyang, Gyeonggi-do 14067 Korea, South

Re: K232938

Trade/Device Name: Traus SSG30 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. Digitally signed by Adam D. Pierce -S Pierce - S Date: 2024.09.16
16:36:16 -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) K232938

Device Name Traus SSG30 Surgical System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) SUMMARY / K232938

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: Sanghwa Myung

Date 510(k) summary: September 16, 2024

Trade Name: Traus SSG30 Surgical System Regulation Name: Electric cranial drill motor Regulation Numbers: 872.4360 Product Code: HBC Secondary Product code: Classification: Class II

Description of Device:

With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces.

Traus SSG30 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 handpiece 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.

{5}------------------------------------------------

Indications for Use

Traus SSG30 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection,

giinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical

procedures.

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

Substantial Equivalence:

Comparison table is as follows.

DescriptiveInformation	Subject Device	Predicate Device	ComparisonComment
Manufacturer	Saeshin Precision Co.,Ltd.	Bien-Air Surgery SA	-
Device Name	TRAUS SSG30Surgical System	OSSEODUO Shaverand Drill System	-
510(k) number	K232938	K173066	-
ClassificationProduct Code /RegulatoryNumber	HBC21 CFR 882.4360	HBC21 CFR 882.4360	-
RegulatoryClass	Class II	Class II	-
Indications forUse	Traus SSG30 SurgicalSystem is an electricalappliance intended tocut, shave, bone & tissueresection, grinding, anddrilling in the craniumand spine. Shaverhandpiece is not intendedfor use in neurosurgicalprocedures.	The OSSEODUOsystem is intended forshaping bones in spineand cranium surgicaloperation. Shaverhandpiece is notintended for use inneurosurgicalprocedures.	SubstantialEquivalent
Controller	Console with Footpedal	Console with Foot pedal	SubstantialEquivalent
Speed Indication	Digital	Digital	SubstantialEquivalent
Function	Drill, Saw, Shaver	Drill andMicrodebrider(Shaver)	SubstantialEquivalent

Table 1: Substantial equivalence comparison: Predicate Device

{6}------------------------------------------------

Energy Source	Electrical	Electrical	SubstantialEquivalent
Motor Speed	Max. 80,000rpm	Max 80,000rpm	SubstantialEquivalent
Sterilization	Steam AutoclaveISO 17665-1:2006	Steam AutoclaveAAMI TIR12, ISO17664, ISO17665	SubstantialEquivalent
Irrigation	1 peristaltic pumpintegrated into consolefor irrigation	1 peristaltic pumpintegrated into consolefor irrigation	SubstantialEquivalent

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 SSG30 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.

{7}------------------------------------------------

(3) Performance Testing

We conducted bench testing to assure that the SSG 30 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 software and software verification and validation demonstrate that the SSG30 device should perform as intended in the specified use conditions. The clinical data demonstrate that the SSG30 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.

Regulation Number and Section

§ 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).