The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in Neurologic and general surgical procedures.

Device 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.

AI/ML Overview

The provided text describes a 510(k) submission for the hekaDrill System. It includes details about performance testing, but it does not provide acceptance criteria in a quantitative format or a detailed study section with specific sample sizes, ground truth procedures, or expert involvement as requested.

However, based on the limited information available in the "Discussion of the Performance Testing" table, I can extract and infer some aspects related to acceptance criteria and reported device performance.

Here's an attempt to structure the answer based on the given information, with caveats about missing details:

Acceptance Criteria and Supporting Study for hekaDrill System

The K193630 submission for the hekaDrill System included performance testing to demonstrate the functionality and safety of the device compared to predicate devices. The following table summarizes the reported performance relative to general criteria.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (Inferred from "Conclusion" column in source)	Reported Device Performance
General Performance	Cutting performance (vibration, noise, control) equivalent or superior to predicate.	Cutting performance was equivalent or better to that of predicate device.
Electrical Performance	Adherence to IEC 60601-1:2005 for electrical safety.	Instruments conform to IEC 60601-1:2005 for electrical safety.
Electromagnetic Compatibility	Adherence to IEC 60601-1-2:2014 for electromagnetic compatibility.	Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility.
Biocompatibility	Non-cytotoxic.	Non-cytotoxic (No biological reactivity - Grade 0).
	Non-sensitizer (0% sensitization).	Non-sensitizer (elicited no reaction at challenge).
	Non-irritant.	Non-irritant (Test article sites did not show significantly greater biological reaction than control).
	Non-toxic (systemic).	Non-toxic (Test article did not induce a significantly greater biological reaction than control extracts).
	Non-pyrogenic.	Non-pyrogenic (Test article did not induce a Pyrogenic response).
	Non-hemolytic.	Non-hemolytic (Test article led to a hemolysis index above the negative control of 0.14%).

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes used for any of the performance tests. For instance, for "Cutting performance," it does not state how many devices were tested or how many cutting tasks were performed. For biocompatibility tests, the number of samples or specimens analyzed is not provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab-based performance tests for a new device submission, they would typically be prospective studies conducted in a controlled lab environment by Zethon Ltd (a UK company) or its contracted testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance tests described (cutting performance comparison, electrical safety, EMC, biocompatibility) are primarily objective, quantitative measurements against established standards or predicate device performance, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

This information is not applicable/provided. The tests are objective measurements against standards or predicate performance, not subjective readings requiring adjudication for ground truth.

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 information is not applicable. The device, hekaDrill System, is an electric cranial drill motor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance would not be relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. As stated above, the hekaDrill System is a surgical instrument, not an algorithm.

7. The type of ground truth used:

For the General Performance (Cutting performance), the ground truth was based on a comparison to a predicate drill system (Midas Rex Drill Systems), implying the predicate's performance served as a benchmark for "equivalent or better."
For Electrical Performance and Electromagnetic Compatibility, the ground truth was adherence to international consensus standards (IEC 60601-1:2005 and IEC 60601-1-2:2014, respectively).
For Biocompatibility, the ground truth was established by recognized biocompatibility testing methods (e.g., L929 MEM Elution for cytotoxicity, Kligman Maximization for sensitization, etc.) where specific biological responses or lack thereof (e.g., "Non-cytotoxic," "Non-sensitizer") define compliance.

8. The sample size for the training set:

This information is not applicable/provided. The device is a surgical instrument, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 3, 2021

Zethon Ltd Faith Green Quality and Regulatory Engineer 2 Halton Brook Business Park Aylesbury, Buckinghamshire HP22 5WF United Kingdom

Re: K193630

Trade/Device Name: hekaDrill Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, HBB, HBE, HSZ, GEY

Dear Faith Green:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 9, 2021. Specifically. FDA is updating this SE Letter to remove the ERL product code, since the device was not reviewed for ENT indications, as an administrative correction. Also, the GEY product code was added.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Adam Pierce, OHT5: Office of Neurological and Physical Medicine Devices, adam.pierce@fda.hhs.gov, (240) 402-6128.

Sincerely,

Adam D. Pierce -S 2021.06.03 11:40:47 -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

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Image /page/1/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 USA 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.

April 9, 2021

Zethon Ltd Faith Green Quality and Regulatory Engineer 2 Halton Brook Business Park Aylesbury, HP22 5WF United Kingdom

Re: K193630

Trade/Device Name: hekaDrill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBB, HBE, HSZ, ERL Dated: March 9, 2021 Received: March 12, 2021

Dear Faith Green:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

Adam D. Pierce -S 2021.04.09 15:22:46 -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K193630

Device Name hekaDrill System

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 and bone. The specifically intended for use in neurologic 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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Traditional 510(k) Submission

510(k) Summary

10 March, 2021

I. Company: Zethon Ltd 2 Halton Brook Business Park Weston Road Aston Clinton Buckinghamshire HP22 5WF United Kingdom
- Contact: Faith Green Quality and Regulatory Engineer Telephone Number: (+44) 01296634090 Email: faith.green@zethon.com

II. Proprietary Trade Name: hekaDrill

III. Common Name: High Speed System
IV. Classification Name: 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: HBC, HBB, HBE, HSZ, GEY

VII. Product Description:

VIII. Indications for Use:

IX. Identification of Legally Marketed Devices (Predicate Devices)

· Midas Rex Legend EHS Electric Drill System (K081475)
· Midas Rex MR8 Drill System (K163565)
Midas Rex MR7 Pneumatic High Speed System (K090112) .
Midas Rex Legend System (K020069) .

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X. Comparison of the Technological Characteristics

The Midas Rex Drill Systems that are currently available on the market consist of both pneumatic and electric handpieces, consoles, footpedals, attachments, cutting tools and system accessories. The predicate device is 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. A full comparison of the two devices 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.

XI. 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
PerformanceValidation	Cutting performance was compared topredicate drill system in terms ofvibration, noise, control andperformance.	Cutting performance was equivalent orbetter to that of predicate device
Electrical Performance
Electrical Safety	Electric powered instrumentsevaluated for electrical safety	Instruments conform to IEC 60601-1:2005 for electrical safety.
ElectromagneticCompatibility	Electric powered instrumentsevaluated for electromagneticcompatibility	Instruments conform to IEC 60601-1-2:2014 for electromagneticcompatibility.
Biocompatibility
Cytotoxicity - L929MEM Elution	There was no biological reactivity(Grade 0) of the cells exposed to thetest article extract.	Non-cytotoxic
Sensitization –KligmanMaximization	The extracts of the test article, elicitedno reaction at the challenge (0%sensitization)	Non-sensitizer
Irritation –IntracutaneousInjection	The test article sites did not show asignificantly greater biologicalreaction than the control article.	Non-irritant
Systemic Toxicity	The test article did not induce asignificantly greater biologicalreaction than the control extracts.	Non-toxic
Pyrogenicity	The test article did not induce aPyrogenic response.	Non-pyrogenic
Indirect Hemolysis	The test article led to a hemolysisindex above the negative control of0.14%	Non-hemolytic

XII. Conclusions

The hekaDrill system is substantially equivalent to the predicate devices, as shown through comparisons and testing.

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).