Surgify Halo

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {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: team@surgifymedical.com https://surgifymedical.com/ ### 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.<br>(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. - 2. 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. - 4. 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<br>Surgify Halo | Predicate Device<br>Adeor HiCut<br>Highspeed<br>Instrument | Comment | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Surgify Halo is a<br>sterile surgical burr<br>indicated for<br>shaping and<br>removal of hard<br>tissue and bone in<br>Neurosurgical,<br>Spinal, ENT and<br>general surgical<br>procedures. | HiCut™ Highspeed<br>Instruments are<br>surgical burs<br>indicated for<br>trephination,<br>incision, cutting,<br>removal, shaping,<br>sawing of soft and<br>hard tissue, bone,<br>and biomaterials in<br>Orthopedic Surgery.<br>Neurological and<br>Spinal Surgery, ENT<br>Surgery,<br>Plastic and<br>Maxillofacial<br>Surgery,<br>Arthroscopy,<br>Sternotomy and<br>General Surgery. | Substantially<br>equivalent<br>Surgify Halo has<br>limited<br>indications<br>compared to the<br>predicate device.<br>The specific<br>indications are a<br>subset of<br>indications<br>already cleared<br>for the predicate<br>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<br>Surgify Halo | Predicate Device<br>Adeor HiCut<br>Highspeed<br>Instrument | Comment | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------| | Contraindications | The device contains<br>nickel, and it should<br>not be used on<br>patients who are<br>allergic or<br>hypersensitive to<br>medical-grade<br>stainless steel or<br>any of its alloying<br>components. | None known | The same | # B. Technological Characteristics | | Subject Device<br>Surgify Halo | Predicate Device<br>Adeor HiCut<br>Highspeed Instrument | Comment | |----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type of<br>operation | Open surgical<br>procedures | Open surgical<br>procedures | The same | | Conditions for<br>Use | Single use | Single use | The same | | Sterilization | Supplied sterile,<br>gamma<br>irradiated | Supplied sterile,<br>gamma irradiated | The same | | Main Materials | Commonly used<br>medical grade<br>metals | Commonly used<br>medical grade metals | The same | | Packaging<br>Configuration | A packaging<br>system<br>according to the<br>requirements of<br>ISO 11607<br>series of<br>standards | A packaging system<br>according to the<br>requirements of ISO<br>11607 series of<br>standards | The same | | | Subject Device<br>Surgify Halo | Predicate Device<br>Adeor HiCut<br>Highspeed Instrument | Comment | | Available Style | Straight | Straight | The same | | Driving motor | Compatible<br>high-speed<br>surgical drill<br>systems | Compatible high-speed<br>surgical drill systems | The same | | Head Style<br>Offering | Round | Multiple head styles<br>available, including<br>round, diamond, and<br>pin | The same<br>Both devices have<br>a round head style<br>available. | | Diameter/Head<br>Size | 5.55 mm | 1.0 mm-7.9 mm (round<br>head style) | The same | | Length | 85 mm and 140<br>mm | 5.9 cm, 6.1 cm, 8.2 cm,<br>11.25 cm, 12.6 cm, 19.0<br>cm, 26.65 cm | Similar<br>Predicate lengths<br>cover and include<br>lengths of the<br>Surgify Halo device | | Max Speed | 37,500 RPM | 75,000 RPM | Similar<br>There is no<br>technical limitation<br>for the predicate,<br>as the device is<br>attached to a<br>compatible high-<br>speed drill system<br>where the RPM<br>can be adjusted up<br>to 75 000. The<br>limitation of the<br>Surgify Halo device<br>rotational speed is<br>based on the best<br>performance of the<br>Surgify Halo<br>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.<br>Durability Cutter Efficiency Chatter Thermal Noise Metallic Contact The durability of the device if the device is used at higher speed (rpm) than recommended.<br>Geometrical feature of the device that influences compatibility with the high-speed surgical drills.<br>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<br>Testing and<br>Summative Usability<br>Testing | Nurses Summative Testing-<br>Series of tests based on hazard-<br>related use scenario, user<br>interface . | | | | Surgeons Summative Testing, A<br>series of tests based on hazard-<br>related use scenario, user<br>interface (summative)<br>evaluations to validate that the<br>design meets intended use and<br>user needs and to minimize user<br>errors | All tests fulfilled Design<br>input requirements | | Performance<br>Testing Animal | Comparisons of the performance<br>of the Surgify Halo burr to<br>conventional diamond and fluted<br>burrs | The performance of the<br>Surgify Halo burr was<br>comparable to that of the<br>conventional diamond<br>and fluted burrs | | Biocompatibility | Test plan was developed and<br>executed in accordance with<br>ISO 10993-1:2018 and ISO<br>14971:2007, relevant to the<br>nature of body contact:<br>• Externally communication<br>device<br>• Tissue/bone/dentin<br>• Limited contact duration (A ≤<br>24 h) | Acceptable per<br>ISO10993-01 (2018) | | Sterilization and<br>Shelf Life | Testing per VDmax Basic<br>Evaluation, EN/ISO 11137-1/2<br>(2015) | Gamma irradiation<br>method ensures effective<br>conditions (Sterility<br>Assurance level (SAL) <<br>10-6) to sterilize the<br>product by application of<br>a sterilization dose of 25<br>kGy. | | Transportation<br>Validation | Trasportaion testing per the<br>standard ISTA 3A to confirm that<br>the sterile barrier was<br>maintained during simulated<br>distribution | All tests fulfilled Design<br>input requirements | ## Table 4 Non-Clinical Performance Testing {10}------------------------------------------------ {11}------------------------------------------------ #### 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.