(89 days)
Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.
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 prevents the cutting edges from cutting into the work material. 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
The provided text describes the Surgify Halo, a sterile surgical burr, and its performance evaluation to demonstrate substantial equivalence to a predicate device (Adeor HiCut Highspeed Instrument).
Here's an analysis of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of formal acceptance criteria with specific numerical thresholds. Instead, it states that "All tests fulfilled Design input requirements" and that the "performance of the Surgify Halo burr was comparable to that of the conventional diamond and fluted burrs." This implies that the acceptance criteria were defined by the product's design input requirements and the performance of established devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification | All tests fulfilled Design input requirements (Device performance parameters, Durability Cutter Efficiency, Chatter, Thermal Noise, Metallic Contact, Geometrical features). |
| Noise Testing | All tests fulfilled Design input requirements. |
| Design Validation | All tests fulfilled Design input requirements (Summative Usability Testing for Nurses and Surgeons based on hazard-related use scenarios and user interfaces). |
| Performance Testing | The performance of the Surgify Halo burr was comparable to that of conventional diamond and fluted burrs. |
| Biocompatibility | Acceptable per ISO10993-01 (2018). |
| Sterilization & Shelf Life | Gamma irradiation method ensures effective conditions (Sterility Assurance Level (SAL) < 10-6) to sterilize the product by application of a sterilization dose of 25 kGy. |
| Transportation Validation | All tests fulfilled Design input requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the individual tests. Similarly, there is no information provided regarding the provenance of the data (e.g., country of origin, retrospective or prospective nature). The testing appears to be primarily laboratory-based "Design Verification Test" and "Design Validation Testing." The "Performance Testing Animal" section suggests an animal model was used, but details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "Nurses Summative Testing" and "Surgeons Summative Testing" for Design Validation/Usability. These tests involved a "series of tests based on hazard-related use scenario, user interface." However, the number of nurses and surgeons involved, their specific qualifications, or how their input established a "ground truth" (beyond fulfilling design input requirements for usability) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method. The testing seems to be based on meeting predefined design input requirements and comparative performance, rather than a system requiring expert adjudication of ambiguous cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The Surgify Halo is a physical surgical burr, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The Surgify Halo is a physical surgical burr. Its performance is inherent to the device itself (e.g., cutting efficiency, durability), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation appears to be based on:
- Design Input Requirements: The device was tested against its own design specifications (e.g., durability, cutting efficiency, noise levels, geometrical features).
- Predicate Device Comparability: The performance of the Surgify Halo was compared to that of "conventional diamond and fluted burrs," implying these established devices served as a benchmark for acceptable performance.
- Biocompatibility Standards: Compliance with ISO 10993-1:2018.
- Sterilization Standards: Compliance with EN/ISO 11137-1/2 (2015).
- Usability Feedback: Input from nurses and surgeons during summative testing to ensure the device meets intended use and user needs.
- Animal Performance: Comparison to conventional burrs in an animal model.
8. The sample size for the training set
This section is not applicable. The Surgify Halo is a physical surgical burr, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this device.
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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"
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(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
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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
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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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
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| 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
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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 DeviceSurgify Halo | Predicate DeviceAdeor HiCutHighspeedInstrument | Comment | |
|---|---|---|---|
| Intended Use | Surgify Halo is asterile surgical burrindicated forshaping andremoval of hardtissue and bone inNeurosurgical,Spinal, ENT andgeneral surgicalprocedures. | HiCut™ HighspeedInstruments aresurgical bursindicated fortrephination,incision, cutting,removal, shaping,sawing of soft andhard tissue, bone,and biomaterials inOrthopedic Surgery.Neurological andSpinal Surgery, ENTSurgery,Plastic andMaxillofacialSurgery,Arthroscopy,Sternotomy andGeneral Surgery. | SubstantiallyequivalentSurgify Halo haslimitedindicationscompared to thepredicate device.The specificindications are asubset ofindicationsalready clearedfor the predicatedevice. |
| 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
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| Subject DeviceSurgify Halo | Predicate DeviceAdeor HiCutHighspeedInstrument | Comment | |
|---|---|---|---|
| Contraindications | The device containsnickel, and it shouldnot be used onpatients who areallergic orhypersensitive tomedical-gradestainless steel orany of its alloyingcomponents. | None known | The same |
B. Technological Characteristics
| Subject DeviceSurgify Halo | Predicate DeviceAdeor HiCutHighspeed Instrument | Comment | |
|---|---|---|---|
| Type ofoperation | Open surgicalprocedures | Open surgicalprocedures | The same |
| Conditions forUse | Single use | Single use | The same |
| Sterilization | Supplied sterile,gammairradiated | Supplied sterile,gamma irradiated | The same |
| Main Materials | Commonly usedmedical grademetals | Commonly usedmedical grade metals | The same |
| PackagingConfiguration | A packagingsystemaccording to therequirements ofISO 11607series ofstandards | A packaging systemaccording to therequirements of ISO11607 series ofstandards | The same |
| Subject DeviceSurgify Halo | Predicate DeviceAdeor HiCutHighspeed Instrument | Comment | |
| Available Style | Straight | Straight | The same |
| Driving motor | Compatiblehigh-speedsurgical drillsystems | Compatible high-speedsurgical drill systems | The same |
| Head StyleOffering | Round | Multiple head stylesavailable, includinground, diamond, andpin | The sameBoth devices havea round head styleavailable. |
| Diameter/HeadSize | 5.55 mm | 1.0 mm-7.9 mm (roundhead style) | The same |
| Length | 85 mm and 140mm | 5.9 cm, 6.1 cm, 8.2 cm,11.25 cm, 12.6 cm, 19.0cm, 26.65 cm | SimilarPredicate lengthscover and includelengths of theSurgify Halo device |
| Max Speed | 37,500 RPM | 75,000 RPM | SimilarThere is notechnical limitationfor the predicate,as the device isattached to acompatible high-speed drill systemwhere the RPMcan be adjusted upto 75 000. Thelimitation of theSurgify Halo devicerotational speed isbased on the bestperformance of theSurgify Halodevice. |
Table 3 Technology Characteristics
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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 ValidationTesting andSummative UsabilityTesting | Nurses Summative Testing-Series of tests based on hazard-related use scenario, userinterface . | |
| Surgeons Summative Testing, Aseries of tests based on hazard-related use scenario, userinterface (summative)evaluations to validate that thedesign meets intended use anduser needs and to minimize usererrors | All tests fulfilled Designinput requirements | |
| PerformanceTesting Animal | Comparisons of the performanceof the Surgify Halo burr toconventional diamond and flutedburrs | The performance of theSurgify Halo burr wascomparable to that of theconventional diamondand fluted burrs |
| Biocompatibility | Test plan was developed andexecuted in accordance withISO 10993-1:2018 and ISO14971:2007, relevant to thenature of body contact:• Externally communicationdevice• Tissue/bone/dentin• Limited contact duration (A ≤24 h) | Acceptable perISO10993-01 (2018) |
| Sterilization andShelf Life | Testing per VDmax BasicEvaluation, EN/ISO 11137-1/2(2015) | Gamma irradiationmethod ensures effectiveconditions (SterilityAssurance level (SAL) <10-6) to sterilize theproduct by application ofa sterilization dose of 25kGy. |
| TransportationValidation | Trasportaion testing per thestandard ISTA 3A to confirm thatthe sterile barrier wasmaintained during simulateddistribution | All tests fulfilled Designinput requirements |
Table 4 Non-Clinical Performance Testing
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VI Conclusions:
The Surgify Halo, based on the indications for use, product performance, and technological characteristics provided in this notification, has been shown to be substantially equivalent to the currently marketed predicate device. This 510(k) submission includes information on the Surgify Halo's technological characteristics, performance data, and verification and validation activities that demonstrate that the Surgify Halo is substantially equivalent to the predicate.
§ 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).