hekaDrill

K193630 · Zethon, Ltd. · HBC · Apr 9, 2021 · Neurology

Device Facts

• Record ID: K193630
• Device Name: hekaDrill
• Applicant: Zethon, Ltd.
• Product Code: HBC · Neurology
• Decision Date: Apr 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

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 and bone. The specifically intended for use in neurologic and general surgical procedures.

Device Story

The hekaDrill System is a surgical power tool platform comprising electric and pneumatic handpieces, a power console, footswitches, attachments, and cutting tools. It is used by surgeons in operating rooms for neurologic and general surgical procedures involving bone and soft tissue. The system transforms electrical or pneumatic energy into mechanical rotation to drive interchangeable cutting tools. The surgeon operates the device via a footswitch to control speed and power, enabling precise tissue removal or incision. The system provides the surgeon with tactile and visual feedback during operation, facilitating controlled bone and tissue manipulation. The device benefits patients by providing a reliable, versatile tool for complex surgical access and resection, reducing the need for multiple specialized instruments.

Clinical Evidence

Bench testing only. Performance validation compared cutting performance (vibration, noise, control) against predicate devices, showing equivalent or superior results. Electrical safety and electromagnetic compatibility testing confirmed conformance to IEC 60601-1:2005 and IEC 60601-1-2:2014. Biocompatibility testing (L929 MEM Elution, Kligman Maximization, Intracutaneous Injection, Systemic Toxicity, Pyrogenicity, and Indirect Hemolysis) confirmed the device is non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, and non-hemolytic.

Technological Characteristics

System includes electric and pneumatic handpieces, power console, footswitches, and attachments. Energy sources: electric and pneumatic. Connectivity: wired connection cables. Sterilization: reusable components (handpieces, attachments, console) are non-sterile; single-use components (cutting tools, irrigation kits) are sterile. Electrical safety: IEC 60601-1:2005. Electromagnetic compatibility: IEC 60601-1-2:2014. Materials passed ISO 10993 biocompatibility testing.

Indications for Use

Indicated for patients undergoing neurologic and general surgical procedures requiring incision, cutting, removal, drilling, or sawing of soft tissue, hard tissue, and bone.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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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, [e-mail], [phone].

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 ([e-mail]) or phone [phone] 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: ([phone] Email: [e-mail]

#### 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:

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 and bone. The system is specifically intended for use in Neurologic and general surgical procedures.

## 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 | | |
| 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<br>evaluated for electrical safety | Instruments conform to IEC 60601-<br>1:2005 for electrical safety. |
| Electromagnetic<br>Compatibility | Electric powered instruments<br>evaluated for electromagnetic<br>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<br>test 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<br>reaction than the control article. | Non-irritant |
| Systemic Toxicity | The test article did not induce a<br>significantly greater biological<br>reaction 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<br>index above the negative control of<br>0.14% | Non-hemolytic |

#### XII. Conclusions

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