Surgical Power System

K254174 · Guizhou Zirui Technology Co., Ltd. · HBC · Sep 11, 2026 · Neurology

Device Facts

• Record ID: K254174
• Device Name: Surgical Power System
• Applicant: Guizhou Zirui Technology Co., Ltd.
• Product Code: HBC · Neurology
• Decision Date: Sep 11, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery.

Device Story

Surgical Power System comprises a main control unit, electric drill handpieces, and single-use sterile surgical tools (skull drills, milling cutters, drill burs). Main unit provides electrical power, speed control, and torque to handpieces; peristaltic pump delivers irrigation fluid via sterile tubes to cool tools and flush debris. Foot switch allows hands-free control by surgeons. System used in neurosurgical settings (OR) for bone perforation, cutting, and removal. Output is mechanical rotational power for surgical tools; healthcare providers use this to perform craniotomies and spinal procedures. Benefits include precise bone manipulation and access during neurosurgery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis), and performance testing (thermal, bit-tip strength, rotation, shelf-life).

Technological Characteristics

System components include stainless steel, titanium alloy, DLC-coated stainless steel, and polymer materials. Energy source is electrical. Features include touchscreen control, peristaltic irrigation pumps, and foot switch. Sterilization: Handpieces/attachments are steam-sterilized; surgical tools/tubes are EO-sterilized. Complies with IEC 60601-1 and IEC 60601-1-2. Designed for neurosurgical drilling/cutting.

Indications for Use

Indicated for use by medical professionals in neurosurgery, including craniotomy and spinal surgery, for the operation of removable rotating surgical cutting tools and accessories.

Regulatory Classification

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.

Predicate Devices

• Medtronic Electric Drill Systems (K170312)
• evonos evoDrill Cranial Perforator (K231403)

Reference Devices

• ELAN 4 Tools (K182527)

Submission Summary (Full Text)

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**FDA U.S. FOOD & DRUG**
ADMINISTRATION

September 11, 2026

Guizhou Zirui Technology Co., Ltd.
% Yoyo Chen
Senior Regulatory Affairs Manager
Nanos Medical Shanghai Limited
Rm. 1304, #88 Changning Rd.
Changning District
Shanghai, Shanghai 200042
China

Re: K254174

Trade/Device Name: Surgical Power System
Regulation Number: 21 CFR 882.4360
Regulation Name: Electric Cranial Drill Motor
Regulatory Class: Class II
Product Code: HBC, HBE, HBF
Dated: December 10, 2025
Received: December 23, 2025

Dear Yoyo Chen:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K254174 - Yoyo Chen

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


for Jaime Raben, Ph.D.

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

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254174 | ? |
| Please provide the device trade name(s). | | ? |
| Surgical Power System | | |
| Please provide your Indications for Use below. | | ? |
| The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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## Traditional 510(k) SUMMARY - K254174

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

### 1. Administrative Information

| **Submission Date** | August 12, 2026 |
| --- | --- |
| **Manufacturer information** | Guizhou Zirui Technology Co., Ltd. Address: 2F&3F, Building B, Phase 1,Guizhou Loushanguan High-Tech Industrial Development Zone, Chumi Town, Tongzi County, Zunyi, Guizhou, China, 563200 Contact: Mr. Changfeng Liu TEL: [phone] E-Mail: [e-mail] |
| **Submission Correspondent** | Nanos Medical Shanghai Limited Room 1304, No.88 Changning Road, Changning District, Shanghai, China, 200042 Contact: Ms. Yoyo Chen Senior Regulatory Affairs Manager E-Mail: [e-mail] |

### 2. General Information of Subject Device

| 510(k) Number | K254174 |
| --- | --- |
| Device Common Name: | Surgical Power System |
| Proprietary name of the proposed devices | Surgical Power System, Drill Handpiece, Disposable Sterile Drill Bur, Disposable Sterile Skull Drill, Disposable Sterile Milling Cutter, Disposable Sterile Irrigation Tube, Skull Drill Handpiece Attachment |
| Classification Name: | Motor, Drill, Electric (21 CFR 882.4360) Drills, Burrs, Trephines & Accessories (Simple, Powered) (21 CFR 882.4310) Drills, Burrs, Trephines & Accessories (Compound, Powered) (21 CFR 882. 4305) |
| Regulation Description: | Electric cranial drill motor (21 CFR 882.4360) Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310) Powered compound cranial drills, burrs, trephines, and their accessories (21 CFR 882. 4305) |
| Regulation Medical Specialty: | Neurology |
| Product Code(s): | HBC, HBE, HBF |
| Regulatory Class | Class 2 |
| Type of 510(k) Submission | Traditional 510(k) |

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### 3. Legally Market Predicate Device

Primary Predicate Device

| Device Name: | Medtronic Electric Drill Systems |
| --- | --- |
| 510(k) Number | K170312 |
| Product Code: | HBC, HBE, HRX, HWE, EQJ, ERL, KFK |
| Device Class | Class 2 |
| Manufacturer | Medtronic Powered Surgical Solutions |

Secondary Predicate Device

| Device Name: | evonos evoDrill Cranial Perforator |
| --- | --- |
| 510(k) Number | K231403 |
| Product Code: | HBF |
| Device Class | Class 2 |
| Manufacturer | evonos GmbH & CO. KG |

### 4. Device Description

The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery.

The system comprises the following components:

(1) Main Unit (Model DL-HA)

The Main Unit serves as the central power supply and control platform. It provides precise electrical power, speed control, and torque output to the connected handpieces and surgical tools.

(2) Drill Handpiece (Models HMA and HMB)

The Drill Handpiece is an essential system component that connects to disposable sterile surgical tools. Driven by the power provided by the Main Unit, the handpiece transmits high-speed rotational power to the attached surgical tools.

(3) Surgical Tools (Single use, Sterile)

- Disposable Sterile Skull Drill (Product Family Code: LZ series): Intended for cranium perforation during neurosurgical procedures to establish surgical access.
- Disposable Sterile Milling Cutter (Product Family Code: XDB series): Intended for incision, cutting and removal of skull bone in neurosurgical procedure.
- Disposable Sterile Drill Bur (Product Family Code: ZMT series): Intended for drilling, cutting and removal of hard tissue and bone in neurosurgical procedure.

(4) Accessories

- Skull Drill Handpiece Attachment (Models ZSB1 and ZSB2): A dedicated accessory used to connect the Drill Handpiece to the Disposable Sterile Skull Drill. One end matches the interface of the Drill Handpiece, and the other end securely locks with the connecting shaft of the Skull Drill, forming a complete power transmission link to enable skull perforation.
- Disposable Sterile Irrigation Tube (Models BGD-F and BGF-F): A dedicated accessory that connects the Main Unit's peristaltic pump to compatible handpieces and surgical tools, delivering sterile irrigation fluid (typically normal saline) to the surgical site during the procedure to cool the tools and flush debris.

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- Foot Switch (Model JTD): An accessory used to control the handpiece and peristaltic pump. It allows surgeons to intuitively control the instrument with their foot, freeing both hands for delicate surgical maneuvers.

#### **Intended User and Prescription Use**

The Surgical Power System is a prescription-only device, designed for use by medical professionals familiar with powered surgical instruments and related neurosurgical procedures.

#### **Sterility**

The three families of surgical tools and the Disposable Sterile Irrigation Tubes are supplied sterile and are intended for single use only.

### **5. Intended Use /Indication for Use**

The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery.

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# 6. Substantial Equivalence Comparison

Table 1- Comparison with Primary Predicate Device

| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| 1 | Device Name | Surgical Power System | Integrated Power Console (IPC) System | N/A |
| 2 | Product Code | HBC, HBE, HBF | HBC, HBE, HRX, HWE, EQJ, ERL, KFK | Substantially equivalent. The subject device is substantially equivalent to the predicate device(K170312) for product codes HBC and HBE. |
| 3 | Indications for Use | The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery. | The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, | Substantially equivalent. The indications for use of subject device are covered within the scope of the primary predicate device. |

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| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | | | bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF) | |
| 4 | Prescription or OTC | Prescription | Prescription | Same |
| 5 | Energy Source | Electrical | Electrical | Same |
| 6 | Display | Touchscreen | Touchscreen | Same |
| 7 | Functions | Drill | Drill and Microdebrider | Substantially equivalent. Same with drill function. |
| 8 | General System Components | Electrical Handpieces, Surgical Tools, Accessories | Electrical Handpieces, Surgical Tools, Accessories | Same |
| 9 | Materials of Patient Contacting Components | **Drill Handpiece** • Stainless steel, Titanium alloy **Disposable Sterile Drill Bur:** | **Attachments:** • Stainless Steel, Aluminum, Ceramic, Phenolic, Epoxy, Chrome Coated Brass, | Substantially equivalent. Biocompatibility results demonstrate that the materials used in the device do not present any potential |

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| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | | - Stainless steel, DLC Coating, Synthetic Diamond**Disposable Sterile Milling Cutter:** - Stainless steel, DLC Coating**Disposable Sterile Irrigation Tubes:** - Stainless steel, Polymer | Torlon 4301 **Surgical Dissecting Tools:** - Stainless Steel, Tool Steel, Alloy Steel, Carbide, TDC Coating, Diamond Coating in Nickel Substrate, Titanium Nitride**Surgical Curved Burs:** - Stainless Steel, Tool Steel, Alloy Steel, Carbide, TDC Coating, Diamond Coating in Nickel Substrate, Titanium Nitride Coating; | biocompatibility issues. Therefore, it is concluded that the material differences do not adversely affect the safety and effectiveness of the device. |
| 10 | Irrigation | The main unit integrates two peristaltic pumps and includes Disposable Sterile Irrigation Tubes for targeted fluid delivery. | The console integrates two peristaltic pumps and includes irrigation tubing sets for targeted fluid delivery. | Same |
| 11 | Control mode | The device offers multiple control options for user convenience | The device offers multiple control options for user convenience | Same |
| 12 | Handpieces and motor speed | **Drill Handpieces (Models HMA/HMB)** Drill Handpieces provide power to operate disposable surgical tools. These handpieces are designed to interface with a series of attachments and surgical tools. **Motor Speed:** - Forward mode: 10000 rpm -60000 rpm | **Legend EHS Handpieces** Legend EHS Handpieces provide power to operate disposable surgical dissecting tools. These handpieces are designed to interface with a series of attachments and surgical dissecting tools. **Motor Speed:** | Substantially equivalent. The overall similarities in core design, intended use, and safety profile indicate that this difference does not raise any new safety or effectiveness concerns. |

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| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | | - Reverse mode: 10000 rpm -60000 rpm | - Forward mode: 200 rpm -75000 rpm - Reverse mode: 200 rpm -75000 rpm | |
| 13 | Handpiece Attachments | **Skull Drill Handpiece Attachment (ZSB1/ZSB2)** Skull Drill Handpiece Attachment has a interface to accommodate Skull Drill during craniotomy procedures for cranium perforation. | **Triton Electric High Torque Handpiece Attachment:** (Triton Hudson Chuck Attachment) Triton Hudson Chuck Attachment has a Hudson chuck to drive any device with a Hudson shank, such as cranial perforator device. | Substantially equivalent. The Subject Device shares the same overall intended use as the Predicate Device and is employed in the same types of surgical procedures. It does not introduce any new safety or effectiveness concerns. |
| 14 | Surgical Tools-Tip Geometry | **Disposable Sterile Drill Bur:** - Ball, Match, Shield Ball, Taper**Disposable Sterile Milling Cutter:** - Footed taper | Round/Acorn, Match Head, Ball, Cylinder, Oval, Tapered/Side Cutting, Metal, Cutting, Twist Drill, Hole Maker/Saw, Reverse Tapered | Substantially equivalent. The Subject Device shares identical intended use with the Predicate Device and is indicated for the same surgical procedures. This complete alignment in intended use constitutes the fundamental basis for establishing substantial equivalence. |
| 15 | Surgical Tools-Overall Length | **Disposable Sterile Drill Bur:** - 30-320mm**Disposable Sterile Milling Cutter:** - 15-20mm | **Surgical Dissecting Tools:** - 30-420 mm**Surgical Curved Burs:** - 90-140mm | |
| 16 | Surgical Tools-Head Diameter | **Disposable Sterile Drill Bur:** - 0.6-6mm**Disposable Sterile Milling Cutter:** - 2.4 mm | **Surgical Dissecting Tools:** - 0.5-25 mm**Surgical Curved Burs:** - 1-4mm | |
| 17 | Surgical Tools- | **Disposable Sterile Drill Bur:** | **Surgical Dissecting Tools:** | Substantially equivalent. |

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| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | Output Speed | • Max.100,000 rpm **Disposable Sterile Milling Cutter:** • Max.100,000 rpm | • Max.80,000 rpm | Although the maximum output speed of the Subject Device (100,000 RPM) is higher than that of the Predicate Device (80,000 RPM), this parameter has been confirmed as safe and effective through the legally marketed reference device (K182527 ELAN 4 Tools). Therefore, this difference does not introduce any new safety or effectiveness concerns, and the Subject Device is substantially equivalent to the Predicate Device. |
| 18 | Sterilization | 1) Handpiece and handpiece attachments are supplied non-sterile and required to be manually or automatically cleaned and then steam sterilized prior to each surgical use. 2) Disposable Sterile Drill Bur, Disposable Sterile Milling Cutter, and Disposable Sterile Irrigation Tube are supplied EO sterilized. | 1) Electric Handpieces, and Attachments are supplied non-sterile and required to be manually or automatically cleaned and then steam sterilized prior to each surgical use. 2) Surgical Dissecting Tools and Curved Burs are supplied Gamma Sterilized. | Substantially equivalent. Both methods have been validated and confirmed to be safe and effective. This difference does not alter the safety and performance characteristics of the device, nor does it introduce any new risks. Therefore, the Subject Device is substantially equivalent to the Predicate Device. |
| 19 | Packaging system and shelf life of single use surgical | Disposable Sterile Irrigation Tubes are individually packaged in Tyvek Pouch. Disposable Sterile Drill Bur and Disposable | The Surgical Dissecting Tools are individually packaged in PET-Nylon-EVA Pouch. Sterile Curved Burs are individually packaged | Substantially equivalent. Both packaging systems are designed as final sterile barrier systems (SBS), |

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| Description | | Subject Device (K254174) | Primary Predicate Device (K170312) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | tools | Sterile Milling Cutter are individually packaged in Blister Tray. The validated shelf life of each product is 3 years. | into a Tyvek Envelope and sealed. The validated shelf life is 5 years for the Surgical Dissecting Tools and 4 years for the Curved Burs. | and their design and validation strictly adhere to the international standard ISO 11607. |

Table 2- Comparison with Secondary Predicate Device

| Description | | Subject Device (K254174) | Secondary Predicate Device (K231403) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| 1 | Device Name | Disposable Sterile Skull Drill | evoDrill Cranial Perforator | N/A |
| 2 | Product Code | HBF | HBF | Same |
| 3 | Indications for Use | Disposable Sterile Skull Drill is a sterile, single-use device intended for cranium perforation during neurosurgical procedures to establish surgical access. | The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm. | Substantially equivalent. The Subject Device shares the same intended use and core automatic stopping technology as the Predicate Device for cranial bone thicknesses of at least 3mm. The Predicate Device's clearance for a broader range of bone thicknesses (including ≥1mm) predicates the safety and effectiveness of the Subject Device's more specific indication. The difference does not raise new questions of safety or effectiveness, |

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| Description | | Subject Device (K254174) | Secondary Predicate Device (K231403) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | | | | supporting a determination of substantial equivalence. |
| 4 | Prescription or OTC | Prescription | Prescription | Same |
| 5 | Compatible power source | Electric | Pneumatic or electric | Substantially equivalent. The difference in power source compatibility does not raise new questions regarding safety or effectiveness. The Subject Device operates entirely within the scope of the Predicate Device's cleared intended use and its validated electric mode. |
| 6 | Fittings type | Type A Type B (commonly known as Hudson) | Hudson | Substantially equivalent. The Subject Device retains the same standard Hudson fitting as the Predicate Device. |
| 7 | Bone Thicknesses | Indicated for use on cranial bone with a minimum thickness of at least 3 mm. | This device is designed to perforate both thin cranial bone (1-3 mm) and thicker bone segments (exceeding 3 mm). | Substantially equivalent The Subject Device operates within a subset of the Predicate Device's cleared range. Performance and safety for bone thicknesses ≥3 mm are already established within the existing predicate clearance. |
| 8 | Burr hole diameter (Outer/Inner) and Number | 10/7mm; 12/9mm; 14/11mm. 3 flutes | 14/11mm; 13/9mm; 11/7mm; 9/6mm. 3 or 4 flutes | Substantially equivalent. The differences reflect minor design |

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| Description | | Subject Device (K254174) | Secondary Predicate Device (K231403) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | of Cutting Flutes | | | iterations intended to address specific surgical preferences without altering the core safety or functional profile of the device. |
| 9 | Rotation speed range | 970-1450 rpm | 800-1500rpm | Substantially equivalent. The Subject Device is fundamentally similar to the Predicate Device in terms of structural design and mechanism of action. Furthermore, the rotational speed range of the Subject Device falls within the validated range established for the Predicate Device. |
| 10 | Release Mechanism | The device designed with a built-in clutch mechanism to ensure the device skull drills with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm; | The device designed with a built-in clutch mechanism to ensure: The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm. | Substantially equivalent The Subject Device operates within a subset of the Predicate Device's cleared range. Performance and safety for bone thicknesses ≥3 mm are already established within the existing predicate clearance. |
| 11 | Sterilization | Sterilized by EO (Ethylene Oxide) | Sterilized by Radiation | Substantially equivalent. Sterilization method has been validated and confirmed to be safe and effective. This difference does not alter the safety |

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| Description | | Subject Device (K254174) | Secondary Predicate Device (K231403) | Substantial Equivalence Discussion |
| --- | --- | --- | --- | --- |
| | | | | and performance characteristics of the device, nor does it introduce any new risks. |
| 12 | Packaging system and shelf life | Disposable Sterile Skull Drill is individually packaged in Blister Tray. The validated shelf life of each product is 3 years. | Unknown | Substantially equivalent. The packaging system is designed as final sterile barrier systems (SBS), and the design and validation strictly adhere to the international standard ISO 11607. |
| 13 | Materials of Patient Contacting Components | Stainless steel | Plastic/ stainless steel /Aluminum | Substantially equivalent. Biocompatibility results demonstrate that the materials used in the device do not present any potential biocompatibility issues. Therefore, it is concluded that the material differences do not adversely affect the safety and effectiveness of the device. |

Based on the information summarized above, the proposed devices are substantially equivalent to the currently marketed predicates and reference devices in indications for use, design, principle of operation and device material.

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## 7. Summary of Non-Clinical Test Summary

Non-clinical testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.

| Test Category | Test Summary |
| --- | --- |
| Electrical Safety and EMC | (1) Electrical Safety (IEC 60601-1) (2) Electromagnetic Compatibility (IEC 60601-1-2) |
| Biocompatibility | (1) Cytotoxicity (2) Intracutaneous Reactivity (3) Sensitization (4) Acute Systemic Toxicity (5) Material-mediated Pyrogenicity (6) Bacterial Endotoxins (7) Indirect Hemolysis (8) Chemical Characterization and Toxicological Risk Assessment |
| Performance Test | (1) Thermal performance (2) Bit-tip strength (3) Rotating performance (4) Shelf-life validation |

## 8. Clinical Study Data

The substantial equivalence does not depend on clinical data.

## 9. Conclusion

The Surgical Power System has been shown through comparison to be substantially equivalent to the identified predicate devices.

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