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.

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.

AI/ML Overview

The provided text is a Premarket Notification (510(k)) from the FDA for the Traus SSG10 Surgical System. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a detailed study proving acceptance criteria for new or innovative device features.

Therefore, the document does not contain the detailed information requested for acceptance criteria or a study proving those criteria, particularly in the context of an AI/ML medical device. The device in question is an "Electric Cranial Drill Motor," which is a traditional hardware device, not an AI/ML powered one.

Here's a breakdown of why the requested information cannot be extracted from this document:

A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on general features and safety/EMC standards, not specific performance metrics against defined acceptance criteria.
Sample size used for the test set and the data provenance: Not provided. Performance testing mentioned is "bench testing" to assure operation within predefined design specifications, but no details on sample size, data origin, or retrospective/prospective nature are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
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, as this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI/ML device. Performance is assessed against engineering specifications.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Information that can be extracted or inferred from the document regarding "acceptance" in a general sense:

The "acceptance criteria" for devices seeking 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device regarding safety and effectiveness. This is achieved by showing conformance to recognized standards and comparable performance.

Implicit Acceptance Criteria (based on 510(k) process):

Acceptance Criteria Category	Reported Device Performance/Evidence from Document
Intended 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. (Identical to predicate's essential use cases, with one clarification).
Technological Characteristics	Electrical Safety: Conforms to IEC60601-1:2005/AMD2:2020. Electromagnetic Compatibility (EMC): Conforms to IEC 60601-1:2015+A1:2021. Software: Verification and validation testing conducted in accordance with FDA guidance (May 11, 2005) and IEC 62304, commensurate with a "moderate level of concern."Sterilization: Validated to ISO 17665-1:2006. Biocompatibility: Materials tested in accordance with ISO 10993-1, -5, -10, -12, and confirmed biologically safe.Functional Performance: Bench testing confirmed operation within predefined design specifications, including RPM. Max motor speed is 40,000rpm (predicate is 80,000rpm), but testing showed this difference does not raise safety/effectiveness problems.
Performance Data (Non-clinical)
Clinical Data	No clinical performance testing was performed.

Study Proving Device Meets Acceptance Criteria (as described in the document):

The "study" or evidence provided is a collection of non-clinical tests and conformance to standards, rather than a single, formal "study" with specific statistical endpoints to prove new performance claims.

Non-clinical Performance Data:
- (1) Electrical Safety and Electromagnetic Compatibility (EMC): Conducted according to IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2015+A1:2021. This demonstrates adherence to recognized safety standards.
- (2) Software Verification and Validation Testing: Conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304, for a "moderate level of concern." This ensures the software operates as intended and mitigates risks.
- (3) Performance Testing (Bench Test): This testing was performed to "assure that the SSG10 operates safely and within the predefined design specifications." The report references "performance criteria such as RPM." Although the maximum RPM (40,000rpm) is lower than the predicate (80,000rpm), the testing results reportedly showed this difference "does not raise any problems in the safety and effectiveness."
- (4) Sterilization: Validated in conformance to ISO 17665-1:2006.
- Biocompatibility: Materials tested and confirmed safe per ISO 10993 series (1, 5, 10, 12).

Key Takeaway: The document outlines the evidence used to support a substantial equivalence determination, focusing on compliance with established safety and performance standards for a medical device that is not an AI/ML technology. It does not contain the specific AI/ML-related study details requested.

Summary

{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)

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}------------------------------------------------

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:

Indications for Use

{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.

DescriptiveInformation	Subject Device	Predicate Device	ComparisonComment
Manufacturer	Saeshin Precision Co.,Ltd.	Bien-Air Surgery SA	-
Device Name	TRAUS SSG10Surgical System	OSSEODUO Shaverand Drill System	-
510(k) number	K233153	K173066	-
ClassificationProduct Code /RegulatoryNumber	HBC21 CFR 882.4360	HBC21 CFR 882.4360	-
RegulatoryClass	Class II	Class II	-
Indications forUse	Traus SSG10 SurgicalSystem is an electricalappliance in the form ofan electric console-typeproduct that connectswith a handpiece to cut,shave, bone & tissueresection, grinding, anddrilling.	The OSSEODUO systemis intended for shapingbones in spine and craniumsurgical operation. Shaverhandpiece is not intendedfor use in neurosurgicalprocedures.	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}------------------------------------------------

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	SubstantialEquivalent
Motor Speed	Max. 40,000rpm	Max 80,000rpm	#1 Different
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

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.

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).