Disposable Sterile Skull Drill (LZ)

{0} 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, 200042 China Re: K254177 Trade/Device Name: Disposable Sterile Skull Drill (LZ) Regulation Number: 21 CFR 882.4305 Regulation Name: Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBF Dated: August 12, 2026 Received: August 12, 2026 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254177 - Yoyo Chen Page 2 (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-assistance/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} K254177 - Yoyo Chen Page 3 Sincerely, YEN-CHIH LIN-S Digitally signed by YEN-CHIH LIN-S Date: 2026.09.11 11:11:23 -04'00' 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K254177 Device Name Disposable Sterile Skull Drill Indications for Use (Describe) Disposable Sterile Skull Drill is a sterile, single-use device intended for cranium perforation during neurosurgical procedures to establish surgical access. Type of Use (Select one or both, as applicable) ☑ 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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K254177, Page 1 of 5 # Traditional 510(k) SUMMARY - K254177 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 19, 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: +86-0851-26628484 E-Mail: sunxiaoxiao@nanosmedical.com | | **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: yoyo_chen@nanosmedical.com | ## 2. General Information of Subject Device | 510(k) Number | K254177 | | --- | --- | | Device Common Name: | Disposable Sterile Skull Drill | | Proprietary name of the proposed devices | Disposable Sterile Skull Drill | | Classification Name: | Drills, Burrs, Trephines & Accessories (Compound, Powered) (21 CFR 882. 4305) | | Regulation Description: | Powered compound cranial drills, burrs, trephines, and their accessories (21 CFR 882. 4305) | | Regulation Medical Specialty: | Neurology | | Product Code(s): | HBF | | Regulatory Class | Class 2 | | Type of 510(k) Submission | Traditional 510(k) | Page 1 of 5 {5} K254177, Page 2 of 5 ### 3. Legally Market 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 Disposable Sterile Skull Drill (Product family code: LZ) is a removable drill and designed to couple with a surgical drive shank which fits a standard Hudson coupler. It is indicated for drilling access holes in the skull of patients with a cranial bone thickness of at least 3 mm, where treatment or diagnosis requires access to a specific zone of the brain. The Disposable Sterile Skull Drill is available in different choices of inner and outer drill diameters to meet diverse surgical needs. The device incorporates a built-in clutch mechanism that stops the trephination process as soon as the skull bone has been pierced. Its three-fluted cutter automatically deploys a 3 mm stop-step, which enables automatic release and cessation of drilling once the cranial bone thickness reaches at least 3 mm. ### 5. Intended Use/Indication for Use Disposable Sterile Skull Drill is a sterile, single-use device intended for cranium perforation during neurosurgical procedures to establish surgical access. Page 2 of 5 {6} K254177, Page 3 of 5 ## 6. Substantial Equivalence Comparison Table 1- Comparison with Predicate Device | Description | | Subject Device (K254177) | 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 $$\geq 1\text{mm}$$) predicates the safety and effectiveness of the Subject Device's more specific indication. The difference does not raise new questions of safety or effectiveness, 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 | Hudson | Hudson | Same | | 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 | Page 3 of 5 {7} K254177, Page 4 of 5 | | | | | thicknesses ≥3 mm are already established within the existing predicate clearance. | | --- | --- | --- | --- | --- | | 8 | Burr hole diameter (Outer/Inner) and Number of Cutting Flutes | 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 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 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 | Unknown | Substantially equivalent. The packaging system is designed as final sterile barrier | Page 4 of 5 {8} K254177, Page 5 of 5 | | | in Blister Tray. The validated shelf life of each product is 3 years. | | systems (SBS), and their 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 device is substantially equivalent the currently marketed predicate in indications for use, design, principle of operation and device material. ## 7. Summary of Non-Clinical Test Summary Bench testing and biocompatibility testing were 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. ## 8. Clinical Study Data The substantial equivalence does not depend on clinical data. ## 9. Conclusion The Disposable Sterile Skull Drill has been shown through comparison to be substantially equivalent to the identified predicate device. Page 5 of 5