LEGACY

K252696 · Phasor Health, LLC · HBG · Nov 21, 2025 · Neurology

Device Facts

• Record ID: K252696
• Device Name: LEGACY
• Applicant: Phasor Health, LLC
• Product Code: HBG · Neurology
• Decision Date: Nov 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

Device Story

Manual, sterile, single-use, disposable cranial drill; used in hospital neurosurgical procedures by licensed medical professionals. Device features plastic housing and stainless steel shaft; utilizes AO quick-connect mechanism for compatibility with standard drill bits (≤ 6.35 mm diameter, ≤ 70 mm length). Operation involves manual clockwise rotation of handle to drive drill bit into cranial bone. Device is MR Unsafe. Benefits include providing a simple, disposable mechanical tool for cranial access without electrical components or batteries. Healthcare providers use the device to create holes in cranial bone; output is the physical drilling action. No clinical data required; performance validated via benchtop mechanical testing and human factors study confirming safe user interaction.

Clinical Evidence

No clinical data performed. Evidence consists of bench testing (mechanical performance, packaging validation, sterility validation) and a human factors study. Human factors study confirmed successful completion of all user tasks (identifying, engaging, operating, disposing) without safety-impacting errors.

Technological Characteristics

Manual hand-crank drill; plastic (ABS) housing and stainless steel shaft. AO quick-connect interface for drill bits. Gamma-sterilized. Standards: ANSI/AAMI/ISO 11137-2, ANSI/AAMI/ISO 11737-1/2, ISO 13004, ASTM D4332, ASTM D4169, ASTM F88/F88M-21, ASTM F2096, ISO 11607-1, ISO 15223-1. No electrical components; MR Unsafe.

Indications for Use

Indicated for adult patients undergoing neurosurgical procedures requiring cranial bone drilling.

Regulatory Classification

Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

Predicate Devices

• Clinical Neuro Systems Interchangeable Bit Cranial Drill (K961113)
• Phasor Drill (K161704)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 21, 2025

Phasor Health, LLC
Ray King
Chief Executive Officer
8944 Kirby Drive
Houston, Texas 77054

Re: K252696
Trade/Device Name: LEGACY
Regulation Number: 21 CFR 882.4300
Regulation Name: Manual Cranial Drills, Burrs, Trephines, and Their Accessories
Regulatory Class: Class II
Product Code: HBG
Dated: October 31, 2025
Received: October 31, 2025

Dear Ray King:

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

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K252696 - Ray King
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 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 QS 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 (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 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 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.

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K252696 - Ray King
Page 3

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

XIAOLIN ZHENG
-S

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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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) K252696 | |
| Device Name LEGACY | |
| Indications for Use (Describe) The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone. | |
| 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 [e-mail] | |
| "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." | |

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K252696, Page 1 of 4

510(k) Summary

Phasor Health, LLC

LEGACY™

A. Device Description

| Category | Comments |
| --- | --- |
| Sponsor | Phasor Health, LLC
Ray King
CEO
8944 Kirby Drive
Houston, TX 77054, U.S.A.
[phone] |
| Correspondent Contact Information | Ray King
8944 Kirby Drive
Houston, TX 77054, U.S.A.
[phone] |
| Device Common Name | Cranial Drill |
| Device Regulation & Name | 21 CFR 882.4300; Manual Cranial Drills, Burrs, Trephines, and Their Accessories |
| Classification & Product Code | Class II, HBG |
| Device Proprietary Name | LEGACY |

Predicate Device(s) Information:

| Predicate Device(s) | (1) Clinical Neuro Systems Interchangeable Bit
Cranial Drill (2) Phasor Drill |
| --- | --- |
| Predicate Device Manufacturer(s) | (1) Clinical Neuro Systems; (2) Phasor Health, LLC; respectively |
| Predicate Device Common Name | (1) Cranial drill; (2) Powered simple cranial drills, burrs, trephines, and their accessories; respectively |
| Predicate Device Premarket Notification # | (1) K961113; (2) K161704; respectively |
| Predicate Device Classification & Name | (1) 21 CFR 882.4300; (2) 21 CFR 882.4310; respectively |
| Predicate Device Classification & Product Code: | Class II for each of (1) HBG & (2) HBE, respectively |

B. Date Summary Prepared: November 20, 2025

C. Description of Device

Phasor LEGACY drill is indicated for drilling of cranial bone by licensed and credentialed medical professionals. The LEGACY drill is manually powered by rotating the handle in a clockwise manner, and is a standalone drill driver without bits or any other items included. It is compatible via an AO quick-connect mechanism with similar AO-interface drill bits, ≤ 6.35 mm diameter and ≤ 70 mm usable length (protruding from the housing). The device is gamma-sterilized and composed of plastic housing with stainless steel shaft.

D. Indications for Use

The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

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K252696, Page 2 of 4

E. Comparison of the Technological Characteristics

| | Application Device (K252696) | Predicate Device (K961113) | Predicate Device (K161704) | Impact on Substantial Equivalence |
| --- | --- | --- | --- | --- |
| Company | Phasor Health, LLC | Clinical Neuro Systems | Biotex, Inc. (now Phasor Health, LLC) | N/A |
| Regulation Number | 21 CFR 882.4300 | 21 CFR 882.4300 | 21 CFR 882.4310 | Same as predicate (K961113) |
| Product Code | HBG (Class II) | HBG (Class II) | HBE (Class II) | Same as predicate (K961113) |
| Intended Use & Indications for Use | The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone. | The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only. | The Phasor™ Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone. | Same overall intended use as the predicate devices for drilling cranial bone |
| Target Population and Use Environment | For adults used in healthcare facilities | For adults used in healthcare facilities | For adults used in healthcare facilities | Same as predicates |
| Anatomical Site | Head | Head | Head or Extremities | Same as predicates |
| Where Used | Hospital | Hospital | Hospital | Same as predicates |
| Energy Used and/or Delivered | Manually operated | Manually operated | Battery (DC current) operated | Same as predicate (K961113) |
| Human Factors | Hand-crank drill mechanism | Hand-crank drill mechanism | Switch (on/off) operation | Same as predicate (K961113) |
| Design | Hand-held | Hand-held | Hand-held | Same as predicates |
| Performance | Rotates at hand-crank speed | Rotates at hand-crank speed | Rotates at set speed (est. 400-800 RPM) | Same as predicate (K961113) |
| Standards Met | ANSI/AAMI/ISO 11137-2:2013/(R)2019 & A1:2022, ANSI/AAMI/ISO 11737-1:2018 & A1:2021, ISO 11737-2, ASTM D4332-22, D4169-22, ASTM F88/F88M-21, ASTM F2096, ISO 15223-1, ISO 11607-1 | Not listed | ISO 10993-17:2002 and ISO 10993-18:2005; ASTM F1980-07 (Reapproved 2011), ASTM D4169-14, ASTM F88/F88M-09, ASTM F2096-11 . | Same standards used as predicate (K161704) except differs in biocompatibility since no patient-contacting components are provided for the subject device |

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K252696, Page 3 of 4

| Materials | Plastic (ABS), Steel | Plastic, Steel | Plastic, Steel, Electrical Flex Cable, Batteries, Copper (for motor) | Similar to predicate (K961113), and same as predicate (K161704) |
| --- | --- | --- | --- | --- |
| Biocompatibility | Not applicable due to no direct patient-contacting part(s) | Tested and passed for patient-contacting parts | Tested and passed for patient-contacting parts | Differs from predicates since no patient-contacting parts provided |
| Compatibility with the Environment and Other Devices | Compatibility with AO quick-connect drill bits (not included) established | Compatibility with chuck-bit mechanism (bit included with device) | N/A, as bit connected to motor already in initial version | Comparable to predicate (K961113) as both devices use mechanical means to retain drill bit and benchtop mechanical testing passed |
| Sterility | Provided sterile | Provided sterile | Provided sterile | Comparable to predicates |
| Electrical Safety | N/A, as no electrical components involved | N/A, as no electrical components involved | Established as compliant to respective standards at approval | Comparable to predicate device (K961113) in that both devices do not have electrical components |
| Mechanical Safety | Established via performance testing for intended use, without impairment of device during function | Established via performance testing for intended use, without impairment of device during function | Established via performance testing for intended use, without impairment of device during function | Comparable to predicate devices |
| Radiation Safety | MR Unsafe | MR Unsafe | MR Unsafe | Same as predicates |
| Technology | | | | |
| Drill Power Source | Manual | Manual | Batteries | Same as predicate (K961113) |
| Sterilization Validation | Sterile (Irradiation) | Sterile (EO Sterilization) | Sterile (Irradiation) | The subject device and predicate devices were validated to recognized standards for sterilization and passed the validation testing |

## F. Summary of Supporting Data

Sterilization validation performed for gamma radiation conforming to ANSI/AAMI/ISO 11137-2:2013/(R)2019 & A1:2022, ANSI/AAMI/ISO 11737-1:2018 & A1:2021, ANSI/AAMI/ISO 11737-2:2019, ISO 13004:2022.

Packaging validation performed conforming to ASTM D4332, ASTM D4169, ASTM F88/F88M-21, ASTM F2096, ISO 11607-1.

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K252696, Page 4 of 4

Symbols in labeling conform to ISO 15223-1.

## G. Discussion of Performance Testing

The Phasor LEGACY™ drill performed adequately to drill holes in a simulated cranial bone material in a comparable manner as would be expected with the predicate device. No clinical testing was needed or performed otherwise.

A human factors study was also performed to evaluate the LEGACY drill. The objective of the human factors study was to evaluate whether users could safely and effectively perform all user tasks associated with identifying, engaging, operating, and disposing of the LEGACY™ drill under expected use conditions. The study demonstrated that all user tasks were completed successfully without errors that would impact safety or effectiveness for the involved intended users, uses, and use environments, supporting substantial equivalence to the predicate device.

## H. Conclusion

Comprehensive testing, including packaging, sterility, and performance evaluations, was conducted on the Phasor LEGACY™ drill, with all results meeting acceptance criteria or adequately justified. The performance and design validation data demonstrate that the Phasor LEGACY™ drill is substantially equivalent to the predicate device in terms of safety and effectiveness.