(89 days)
No reference devices were used in this submission.
No
The device description focuses on mechanical components and functions, with no mention of AI/ML terms or data processing.
No.
The device is a surgical burr used for cutting and shaping bone during surgical procedures, which is an operative function, not a therapeutic one aimed at treating a disease or condition.
No
The device is a surgical burr intended for shaping and cutting bone, not for diagnosis.
No
The device description clearly outlines physical components made of metallic materials, including a shank, locking features, a head with cutting edges, and a safety mechanism with a ring and spring. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Surgify Halo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "rotary cutting device" that "cuts bone and other hard tissues." This is a mechanical surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Surgify Halo does not perform any such analysis of biological specimens.
Therefore, the Surgify Halo is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.
Product codes
HBE
Device Description
The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems.
The Surgify Halo comprises:
- A shank, which transfers rotary movement of the drill motor to the head.
- Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill.
- A head that is shaped to have two cutting edges to cut bone and hard tissue.
- A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions:
- In the first position, the ring protrudes to a level higher than cutting edges and a. prevents the cutting edges from cutting into the work material.
- b. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material
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
Adult
Intended User / Care Setting
Not Found
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
Tests were performed on the Surgify Halo, which demonstrated that the device, performs comparably to and is substantially equivalent to the predicate device.
Tests included verification/validation testing to internal functional specifications. In addition, testing confirmed that the Surgify Halo device has an equivalent safety profile to the predicate device.
Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility.
A description of these non-clinical performance tests is included in Table 4:
Design Verification Test:
Test Method Summary: Device performance parameters. Durability Cutter Efficiency Chatter Thermal Noise Metallic Contact. 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.
Results: All tests fulfilled Design input requirements.
Noise Testing:
Test Method Summary: Noise testing with suction and irrigation.
Results: All tests fulfilled Design input requirements.
Design Validation Testing and Summative Usability Testing:
Test Method Summary: Nurses Summative Testing - Series of tests based on hazard-related use scenario, user interface. Surgeons Summative Testing, A series of tests based on hazard-related use scenario, user interface (summative) evaluations to validate that the design meets intended use and user needs and to minimize user errors.
Results: All tests fulfilled Design input requirements.
Performance Testing Animal:
Test Method Summary: Comparisons of the performance of the Surgify Halo burr to conventional diamond and fluted burrs.
Results: The performance of the Surgify Halo burr was comparable to that of the conventional diamond and fluted burrs.
Biocompatibility:
Test Method Summary: Test plan was developed and executed in accordance with ISO 10993-1:2018 and ISO 14971:2007, relevant to the nature of body contact: • Externally communication device • Tissue/bone/dentin • Limited contact duration (A ≤ 24 h).
Results: Acceptable per ISO 10993-01 (2018).
Sterilization and Shelf Life:
Test Method Summary: Testing per VDmax Basic Evaluation, EN/ISO 11137-1/2 (2015).
Results: Gamma irradiation method ensures effective conditions (Sterility Assurance level (SAL)
§ 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
November 29, 2023
Image /page/0/Picture/1 description: The image shows 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 % Sujith Shetty Executive Vice President Maxis Medical LLC 3031 Tisch Wav Suite 1010 San Jose, California 95128
Re: K232684
Trade/Device Name: Surgify Halo 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: August 28, 2023 Received: September 1, 2023
Dear Sujith Shetty:
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.
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).
Sincerely.
Image /page/1/Picture/7 description: The image shows the name Adam D. Pierce -S, which is digitally signed. The date of the signature is 2023.11.29. The time of the signature is 13:48:38 -05'00'.
Adam D. Pierce. Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices
2
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) K232684
Device Name Surgify Halo
Indications for Use (Describe)
Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.
| 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)
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4
510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CRF 807.92.
510 (k) number: K232684
Applicant Information
Surgify Medical Oy
Otakaari 5
02150 Espoo, Finland
Applicant Contact:
Contact Person
Applicant Contact Person:
Jukka Kreander CQO & Co-Founder Surgify Medical Oy Email: jukka.kreander@surgifymedical.com Tel.: +358 40 707 3200
Official Correspondent:
Dr. Sujith Shetty Executive Vice President MAXIS LLC 3031 Tisch Way, Suite 1010 San Jose, CA 95128 USA Email: sjshetty@maxismedical.com Cell: 925-212-0899
Date Prepared: November 29, 2023
5
| Device Information | |
|---|---|
| Trade Name: | Surgify Halo |
| Common Name: | Burr |
| Classification name: | Powered simple cranial drills, burrs, trephines, and their accessories. |
| (21CFR 882.4310) | |
| Regulatory Class: | Class II |
| Product Code: | HBE |
ll Predicate Device
Table 1 Predicate Device
| Name | Manufacturer | 510(k) # |
|---|---|---|
| Adeor HiCut Highspeed Instrument | ADEOR MEDICAL AG | K130755 |
No reference devices were used in this submission.
���� Device Description
The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems.
The Surgify Halo comprises:
- A shank, which transfers rotary movement of the drill motor to the head. 1.
-
- Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill.
- റ്റ് A head that is shaped to have two cutting edges to cut bone and hard tissue.
-
- A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions:
- In the first position, the ring protrudes to a level higher than cutting edges and a. prevents the cutting edges from cutting into the work material.
- b. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material
Device Information
6
Indications for Use
The 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.
Comparison of Technological Characteristics with the Predicate Device: IV
A comparison of the intended use, indication for use, and technological characteristics of the Surgify Halo to the predicate device has been performed. The attributes suggested in the FDA's website guidance for this comparison are provided in Table 2 and Table 3.
A. Intended Use
| | Subject Device
Surgify Halo | Predicate Device
Adeor HiCut
Highspeed
Instrument | Comment |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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. | HiCut™ Highspeed
Instruments are
surgical burs
indicated for
trephination,
incision, cutting,
removal, shaping,
sawing of soft and
hard tissue, bone,
and biomaterials in
Orthopedic Surgery.
Neurological and
Spinal Surgery, ENT
Surgery,
Plastic and
Maxillofacial
Surgery,
Arthroscopy,
Sternotomy and
General Surgery. | Substantially
equivalent
Surgify Halo has
limited
indications
compared to the
predicate device.
The specific
indications are a
subset of
indications
already cleared
for the predicate
device. |
| 21CFR Section | 21 CFR 882.4310 | 21 CFR 882.4310 | The same |
| Product Code | HBE | HBE | The same |
| Target Population | Adult | Adult | The same |
Table 2 Intended Use
7
| | Subject Device
Surgify Halo | Predicate Device
Adeor HiCut
Highspeed
Instrument | Comment |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------|
| Contraindications | The device contains
nickel, and it should
not be used on
patients who are
allergic or
hypersensitive to
medical-grade
stainless steel or
any of its alloying
components. | None known | The same |
B. Technological Characteristics
| | Subject Device
Surgify Halo | Predicate Device
Adeor HiCut
Highspeed Instrument | Comment |
|----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of
operation | Open surgical
procedures | Open surgical
procedures | The same |
| Conditions for
Use | Single use | Single use | The same |
| Sterilization | Supplied sterile,
gamma
irradiated | Supplied sterile,
gamma irradiated | The same |
| Main Materials | Commonly used
medical grade
metals | Commonly used
medical grade metals | The same |
| Packaging
Configuration | A packaging
system
according to the
requirements of
ISO 11607
series of
standards | A packaging system
according to the
requirements of ISO
11607 series of
standards | The same |
| | Subject Device
Surgify Halo | Predicate Device
Adeor HiCut
Highspeed Instrument | Comment |
| Available Style | Straight | Straight | The same |
| Driving motor | Compatible
high-speed
surgical drill
systems | Compatible high-speed
surgical drill systems | The same |
| Head Style
Offering | Round | Multiple head styles
available, including
round, diamond, and
pin | The same
Both devices have
a round head style
available. |
| Diameter/Head
Size | 5.55 mm | 1.0 mm-7.9 mm (round
head style) | The same |
| Length | 85 mm and 140
mm | 5.9 cm, 6.1 cm, 8.2 cm,
11.25 cm, 12.6 cm, 19.0
cm, 26.65 cm | Similar
Predicate lengths
cover and include
lengths of the
Surgify Halo device |
| Max Speed | 37,500 RPM | 75,000 RPM | Similar
There is no
technical limitation
for the predicate,
as the device is
attached to a
compatible high-
speed drill system
where the RPM
can be adjusted up
to 75 000. The
limitation of the
Surgify Halo device
rotational speed is
based on the best
performance of the
Surgify Halo
device. |
Table 3 Technology Characteristics
8
9
V Performance Data:
Tests were performed on the Surgify Halo, which demonstrated that the device, performs comparably to and is substantially equivalent to the predicate device.
Tests included verification/validation testing to internal functional specifications. In addition, testing confirmed that the Surgify Halo device has an equivalent safety profile to the predicate device.
Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility.
A description of these non-clinical performance tests is included in Table 4
| Test | Test Method Summary | Results |
|---|---|---|
| Design Verification Test | Device performance parameters. | |
| Durability Cutter Efficiency Chatter Thermal Noise Metallic Contact 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 | |
| Noise Testing | Noise testing with suction and irrigation | All tests fulfilled Design input requirements |
| Test | Test Method Summary | Results |
| Design Validation | ||
| Testing and | ||
| Summative Usability | ||
| Testing | Nurses Summative Testing- | |
| Series of tests based on hazard- | ||
| related use scenario, user | ||
| interface . | ||
| Surgeons Summative Testing, A | ||
| series of tests based on hazard- | ||
| related use scenario, user | ||
| interface (summative) | ||
| evaluations to validate that the | ||
| design meets intended use and | ||
| user needs and to minimize user | ||
| errors | All tests fulfilled Design | |
| input requirements | ||
| Performance | ||
| Testing Animal | Comparisons of the performance | |
| of the Surgify Halo burr to | ||
| conventional diamond and fluted | ||
| burrs | The performance of the | |
| Surgify Halo burr was | ||
| comparable to that of the | ||
| conventional diamond | ||
| and fluted burrs | ||
| Biocompatibility | Test plan was developed and | |
| executed in accordance with | ||
| ISO 10993-1:2018 and ISO | ||
| 14971:2007, relevant to the | ||
| nature of body contact: | ||
| • Externally communication | ||
| device | ||
| • Tissue/bone/dentin | ||
| • Limited contact duration (A ≤ | ||
| 24 h) | Acceptable per | |
| ISO10993-01 (2018) | ||
| Sterilization and | ||
| Shelf Life | Testing per VDmax Basic | |
| Evaluation, EN/ISO 11137-1/2 | ||
| (2015) | Gamma irradiation | |
| method ensures effective | ||
| conditions (Sterility | ||
| Assurance level (SAL) |