(470 days)
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No
The summary describes a traditional surgical drill system with various components and performance testing focused on mechanical and electrical properties, not AI/ML capabilities. There are no mentions of AI, ML, or related concepts like image processing or training/test sets for algorithms.
No
The device is used for surgical procedures involving incision, cutting, removal, drilling, and sawing of tissue and bone, which are direct interventions rather than therapeutic treatments.
No
Explanation: The hekaDrill system is described as a surgical tool for cutting, removal, drilling, and sawing tissue and bone. Its purpose is to perform surgical procedures, not to identify or determine the nature of a disease or condition.
No
The device description explicitly lists multiple hardware components including handpieces, a power console, footswitches, attachments, cables, irrigation kits, and cutting tools. This is not a software-only device.
Based on the provided information, the hekaDrill system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for surgical procedures involving incision, cutting, removal, drilling, and sawing of soft and hard tissue and bone. This describes a surgical tool used directly on a patient, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The components listed (handpieces, console, footswitches, attachments, cutting tools, etc.) are all consistent with surgical equipment used in an operating room.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The hekaDrill system's function is to physically manipulate tissue during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HBC, HBB, HBE, HSZ, GEY
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Validation | Cutting performance was compared to predicate drill system in terms of vibration, noise, control and performance. | Cutting performance was equivalent or better to that of predicate device |
| Electrical Performance | ||
| Electrical Safety | Electric powered instruments evaluated for electrical safety | Instruments conform to IEC 60601-1:2005 for electrical safety. |
| Electromagnetic Compatibility | Electric powered instruments evaluated for electromagnetic compatibility | Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility. |
| Biocompatibility | ||
| Cytotoxicity - L929 MEM Elution | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. | Non-cytotoxic |
| Sensitization – Kligman Maximization | The extracts of the test article, elicited no reaction at the challenge (0% sensitization) | Non-sensitizer |
| Irritation – Intracutaneous Injection | The test article sites did not show a significantly greater biological reaction than the control article. | Non-irritant |
| Systemic Toxicity | The test article did not induce a significantly greater biological reaction than the control extracts. | Non-toxic |
| Pyrogenicity | The test article did not induce a Pyrogenic response. | Non-pyrogenic |
| Indirect Hemolysis | The test article led to a hemolysis index above the negative control of 0.14% | Non-hemolytic |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K081475, K163565, K090112, K020069
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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:
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 | ||
| Validation | Cutting performance was compared to | |
| predicate drill system in terms of | ||
| vibration, noise, control and | ||
| performance. | Cutting performance was equivalent or | |
| better to that of predicate device | ||
| Electrical Performance | ||
| Electrical Safety | Electric powered instruments | |
| evaluated for electrical safety | Instruments conform to IEC 60601- | |
| 1:2005 for electrical safety. | ||
| Electromagnetic | ||
| Compatibility | Electric powered instruments | |
| evaluated for electromagnetic | ||
| compatibility | Instruments conform to IEC 60601-1- | |
| 2:2014 for electromagnetic | ||
| compatibility. | ||
| Biocompatibility | ||
| Cytotoxicity - L929 | ||
| MEM Elution | There was no biological reactivity | |
| (Grade 0) of the cells exposed to the | ||
| test article extract. | Non-cytotoxic | |
| Sensitization – | ||
| Kligman | ||
| Maximization | The extracts of the test article, elicited | |
| no reaction at the challenge (0% | ||
| sensitization) | Non-sensitizer | |
| Irritation – | ||
| Intracutaneous | ||
| Injection | The test article sites did not show a | |
| significantly greater biological | ||
| reaction than the control article. | Non-irritant | |
| Systemic Toxicity | The test article did not induce a | |
| significantly greater biological | ||
| reaction than the control extracts. | Non-toxic | |
| Pyrogenicity | The test article did not induce a | |
| Pyrogenic response. | Non-pyrogenic | |
| Indirect Hemolysis | The test article led to a hemolysis | |
| index above the negative control of | ||
| 0.14% | Non-hemolytic |
XII. Conclusions
The hekaDrill system is substantially equivalent to the predicate devices, as shown through comparisons and testing.