(30 days)
Not Found
No
The device description focuses on mechanical features (ring mechanism, cutting edges) and material properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are also focused on mechanical and sterilization aspects.
No.
Explanation: The device is a surgical burr designed for cutting bone and hard tissue in surgical procedures; it is an instrument, not a device that itself delivers therapy.
No
This device is a surgical burr designed for shaping and removal of hard tissue and bone, which is a therapeutic function, not a diagnostic one. It is used during surgical procedures to cut tissue, not to identify or assess medical conditions.
No
The device description clearly outlines a physical, sterile, single-use rotary cutting device made from metallic materials with a shank, locking features, burr head, and a safety mechanism involving a moving ring and spring. This is a hardware device, not software.
Based on the provided information, the Surgify Halo is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details a "sterile surgical burr" designed for cutting bone and hard tissues. This is a physical instrument used for mechanical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The Surgify Halo does not perform any such analysis of specimens.
The Surgify Halo is a surgical instrument used in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
Surgify Halo is a sterile surgical burr indciated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.
Product codes
HBE
Device Description
The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.
The Surgify Halo comprises:
- Shank: Transfers rotary motion from the drill motor to the burr head.
- Locking Features: Located at the distal end of the shank, these features securely attach the burr to the high-speed surgical drill.
- Burr Head: Shaped with two cutting edges for cutting of bone and hard tissue.
- Safety Mechanism: A self-centering ring and spring mechanism installed in the burr head. The moving ring, larger than the burr head, can adopt two positions:
- First Position: (Hard Tissue Mode) The ring protrudes, preventing the cutting edges from engaging with the work material.
- Second Position: (Soft Tissue Mode) The ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents and performance standards (21 CFR §882.4310). Performance testing in support of substantial equivalence determination included:
- Functional: Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations. The relevant performance tests for the modified device included durability, chattering, and compatibility with drill systems. All tests fulfilled Design input requirements.
- Sterilization Validation: Sterilization assessment (i.e., bioburden re-validation) per ISO 11137 for sterilization validation was conducted with acceptable results.
- In-process validation: Both in-process cleaning and in-process passivation validation were performed with acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
March 13, 2025
Image /page/0/Picture/1 description: The image contains the logo of 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.
Surgify Medical Oy % Richard Lilly Consultant to Surgify Medical Oy Avania, LLC 3031 Tisch Way, Suite 1010 San Jose, California 95128
Re: K250380
Trade/Device Name: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBE Dated: February 7, 2025 Received: February 11, 2025
Dear Richard Lilly:
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.
1
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 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 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 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-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 medical devices and radiation-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-regulatory
2
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).
Sincerely,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2025.03.13 Pierce -S 13:36:23 -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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
Indications for Use (Describe)
Surgify Halo is a sterile surgical burr indciated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures
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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(K) SUMMARY
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92.
I. Submitter
| Name: | Surgify Medical Oy |
|---|---|
| Address: | Otakaari 5 |
| 02150 Espoo, Finland | |
| Phone: | +358 40 707 3200 |
| Email: | jukka.kreander@surgifymedical.com |
| Contact Person: | Jukka Kreander, CQRO |
| Date Prepared: | March 13, 2025 |
| Device Trade | |
| Name: | Surgify Halo |
| Device Common | |
| or Usual Name: | Burr |
| Regulation Name: | Powered simple cranial drills, burrs, trephines, and their accessories. |
| Regulation | |
| Number: | 21CFR 882.4310 |
| Product Code: | HBE |
| Device Class: | Class II |
| Classification | |
| Panel: | Neurology |
II. Predicate Device
Predicate Name and 510(k) Number: Surgify Halo, K232684.
III. Device Description
The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.
5
The Surgify Halo comprises:
- Shank: Transfers rotary motion from the drill motor to the burr head.
- 트 Locking Features: Located at the distal end of the shank, these features securely attach the burr to the high-speed surgical drill.
- 트 Burr Head: Shaped with two cutting edges for cutting of bone and hard tissue.
- 트 Safety Mechanism: A self-centering ring and spring mechanism installed in the burr head. The moving ring, larger than the burr head, can adopt two positions:
- o First Position: (Hard Tissue Mode) The ring protrudes, preventing the cutting edges from engaging with the work material.
- Second Position: (Soft Tissue Mode) The ring extends beyond the cutting edge, O shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.
IV. Indications for Use
Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.
V. Technological Characteristics
The technological characteristics of the subject Surgify Halo remain the same as the previously cleared device under K232684.
The similarities and differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the subject device to the predicate. Both the subject and predicate devices have the same intended use for shaping and removal of hard tissue and bone in Neurological, Spinal, ENT and general surgical procedures. The proposed modifications of adding new models with compatible attachments and supplier changes are verified to ensure overall performance remains the same as the predicate with acceptable results.
In summary, the subject device has the following technological characteristics which are same as the predicate device:
-
- Intended use/Indications for Use: The intended use/indications for use of the subject device are identical to those of the predicate device i.e. for shaping and removal of hard tissue and bone in Neurological, Spinal, ENT and general surgical procedures.
- Environment of Use: The environment of use remains the same as the predicate, i.e., hospital use. 2.
-
- Technology (Operating Principle): The Surgify Halo Burr operates by transferring rotary motion from a high-speed surgical drill motor through the shank to the burr head. equipped with dual cutting edges, is designed for precise cutting and removal of bone and hard tissue. A selfcentering mechanism comprising a ring and spring ensures that the cutting edges only engage with the target tissue when appropriate, enhancing surgical precision and safety. The burr's position can be adjusted through the ring mechanism, which allows the burr to either prevent contact with the tissue or engage it, depending on the surgical requirements.
- Design Configuration: The Surgify Halo Burr consists of a cylindrical shank with locking features 4. at the distal end that securely attach the burr to the drill handpiece for stability. The burr head
6
contains two precision cutting edges for efficient shaping and removal of bone and hard tissue. An end-attachment feature allows the Surgify Halo to be locked to commonly marketed high-speed surgical drill systems.
- Materials Compatibility: Indirect tissue and bone contacting materials meet biocompatibility న. requirements.
-
- Compatible Interface: The device is compatible with commonly available surgical drill handpieces and attachments, allowing for flexible integration into existing surgical setups.
-
- Sterility: Single-use, Gamma Sterilization
7
VI. Performance Data
Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents and performance standards (21 CFR §882.4310). Performance testing in support of substantial equivalence determination included:
- Functional: Testing (see below) to verify that the device functions as intended, and all ● design and functional specifications are met for all models/system configurations. The relevant performance tests for the modified device included durability, chattering, and compatibility with drill systems.
| Test | Test Method Summary | Results |
|---|---|---|
| Design Verification Tests | Device performance | |
| parameters. |
Durability Chatter • Compatibility with the Drill Systems
The durability of the device if
the device is used at higher
speed (rpm) than
recommended.
Geometrical feature of the
device that influences
compatibility with the high-
speed surgical drills.
Geometrical feature of the
device that influence blister
design e.g., overall length and
shaft diameter | All tests fulfilled Design
input requirements |
- Sterilization Validation: Sterilization assessment (i.e., bioburden re-validation) per ISO ● 11137 for sterilization validation was conducted with acceptable results.
- In-process validation: Both in-process cleaning and in-process passivation validation were ● performed with acceptable results.
VII. Conclusions
The subject Surgify Halo device is as safe and as effective as previously cleared predicate devices (K232684), as demonstrated by performance data and risk assessment. The intended use, technological characteristics and principle of operation are substantially equivalent to the predicate device. Thus, the subject Surgify Halo device is substantially equivalent to the predicate device.