hekaDrill

{0}------------------------------------------------ Image /page/0/Picture/0 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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue. March 14, 2024 Zethon Ltd Faith Robertson Senior Quality and Regulatory Officer 2 Halton Brook Business Park Aston Clinton, Buckinghamshire HP22 5WF United Kingdom # Re: K233958 Trade/Device Name: hekaDrill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, HBC, HBB, HBE, HSZ, GEY Dated: November 8, 2023 Received: December 15, 2023 Dear Faith Robertson: 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" (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). {1}------------------------------------------------ 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. 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, Joyce C. Lin -S for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use | Indications for Use | | See PRA Statement below. | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Submission Number (if known) | K233958 | | | | Device Name | hekaDrill | | | | Indications for Use (Describe) | The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures. | | | | Type of Use (Select one or both, as applicable) | <table><tr><td><div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | 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 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." {3}------------------------------------------------ # 510(k) Summary # 22nd February 2024 - I. Company: Zethon Ltd 2 Halton Brook Business Park Weston Road Aston Clinton Buckinghamshire HP22 5WF United Kingdom - Contact: Faith Robertson Senior Quality and Regulatory Officer Telephone Number: (+44) 01296634090 Email: faith.robertson@zethon.com - II. Proprietary Trade Name: hekaDrill - III. Common Name: High Speed System - IV. Classification Name: Drill, Surgical, ENT (Electric or Pneumatic) including Handpiece (21 CFR 874.4250) Motor, Drill, Electric (21 CFR 882.4360) Motor, Drill, Pneumatic (21 CFR 882.4370) Motor, Surgical Instrument, AC-Powered (21 CFR 878.4820) Drills, Burs, Trephines & Accessories (21 CFR 882.4310) - V. Classification: Class II - VI. Product Code: ERL, HBC, HBB, HBE, HSZ, GEY #### VII. Product Description: The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use. ### VIII. Indications for Use: The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures. #### IX. Identification of Legally Marketed Devices (Primary Predicate Device) - Skeeter Ultra-Lite Oto-Tool Drill (Accessory of K041523) ● - X. Identification of Legally Marketed Devices (Secondary Predicate Devices) - Midas Rex MR8 Drill System (K163565) ● - Midas Rex Legend EHS Electric Drill System (K081475) ● - Midas Rex MR7 Pneumatic High Speed System (K090112) ● {4}------------------------------------------------ ### XI. Comparison of the Technological Characteristics The primary predicate (Skeeter Ultra-Lite Oto-Tool Drill system) consists of a dedicated electric handpiece, consoles, footpedals and a range of cutting accessories. The primary predicate device is similar to the system under review in that electric energy is used to supply power to the handpiece which then operates interchangeable cutting tools. Both systems have ENT specific indications for use. In addition, the secondary predicate devices (Midas Rex Drill Systems) are currently available on the market consisting of both pneumatic and electric handpieces, consoles, footpedals, attachments, cutting tools and system accessories. The secondary predicate devices are similar to the system under review in that air or electric energy is used to supply power to the handpiece which then operates interchangeable cutting tools that are supported by interchangeable attachments. Both systems have the same indications for use and both use similar materials. In summary, a full comparison between the predicate devices and the hekaDrill system demonstrated that any of the differences between the devices do not have an impact on safety and effectiveness or its ability to perform its intended use. #### XII. Discussion of the Performance Testing The following testing has been performed on the hekaDrill system in order to demonstrate the functionality of the device. A summary of this testing is as follows: | Test performed | Description of testing | Conclusion | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | General Performance | | | | Performance<br>Validation | Cutting performance was compared to<br>predicate drill system in terms of<br>vibration, noise, control and<br>performance. | Cutting performance was equivalent or<br>better to that of predicate device | | Electrical Performance | | | | Electrical Safety | Electric powered instruments evaluated<br>for electrical safety | Instruments conform to IEC 60601-<br>1:2005 for electrical safety. | | Electromagnetic<br>Compatibility | Electric powered instruments evaluated<br>for electromagnetic compatibility | Instruments conform to IEC 60601-1-<br>2:2014 for electromagnetic<br>compatibility. | | Biocompatibility | | | | Cytotoxicity – L929<br>MEM Elution | There was no biological reactivity<br>(Grade 0) of the cells exposed to the test<br>article extract. | Non-cytotoxic | | Sensitization –<br>Kligman<br>Maximization | The extracts of the test article, elicited<br>no reaction at the challenge (0%<br>sensitization) | Non-sensitizer | | Irritation –<br>Intracutaneous<br>Injection | The test article sites did not show a<br>significantly greater biological reaction<br>than the control article. | Non-irritant | | Systemic Toxicity | The test article did not induce a<br>significantly greater biological reaction<br>than the control extracts. | Non-toxic | | Pyrogenicity | The test article did not induce a<br>Pyrogenic response. | Non-pyrogenic | | Indirect Hemolysis | The test article led to a hemolysis index<br>above the negative control of 0.14%. | Non-hemolytic | ### XIII. Conclusions The hekaDrill system is substantially equivalent to the predicate devices, as shown through comparisons and testing.