The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.

Device Description

The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.

The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.

The evonos evoDrill cranial perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr holes through the skull of a patient. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "evoDrill Cranial Perforator," a single-use surgical device used for cranium perforation. The document focuses on demonstrating substantial equivalence to predicate devices through various tests, including biocompatibility, sterilization, and cutting performance.

However, the provided document does not contain information related to an AI-based or software-driven medical device study. The device described is a mechanical surgical tool. Therefore, several of the requested information points, such as AI-specific acceptance criteria, multi-reader multi-case studies, ground truth establishment for training sets, etc., are not applicable and cannot be extracted from this document.

The available information pertains to the performance testing of a physical medical device.

Information Extracted from the Provided Document:

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

Based on the "PERFORMANCE TESTING" section:

Test	Condition/Method	Acceptance Criteria (Implied)	Reported Device Performance/Results
Biocompatibility	Evaluated in accordance with ISO 10993 as described in FDA's Biocompatibility Guidance for externally communicating devices in contact with tissue/bone for a limited duration (≤24hr).	Device fulfills the biocompatibility requirements considering contact area and duration.	All biocompatibility testing confirmed that the device fulfills the biocompatibility requirements considering contact area and duration.
Sterilization and	Validation testing in accordance with ISO 11137-1, ISO 11137-2, ISO 11607-1, and ISO 11607-2.	Devices are sterile with a Sterility Assurance Level (SAL) of $10^{-6}$. Shelf-life validation confirms the integrity of the product and packaging for the defined shelf-life.	All tested specimens confirm that devices are sterile and the SAL of $10^{-6}$ is met. Shelf-Life validation confirmed the integrity of the product and packaging of the defined shelf-life, labeled on the device.
Cutting Performance	Evaluated for automatic stop function mechanism, maximum number of uses, drilling time, and device geometry for establishing substantial equivalency to the predicate.	The overall cutting performance, related to the auto-stop function mechanism, drilling time, and surface structure, meets the acceptance criteria (implying performance comparable to predicate and safe operation).	All tested specimens confirmed that the overall cutting performance related to the autostop function mechanism, drilling time and surface structure fulfilled the acceptance criteria.

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

The document states "All tested specimen confirm..." for sterilization and cutting performance, and "All biocompatibility testing confirmed..." for biocompatibility. However, specific numerical sample sizes are not provided for any of these tests.
Data Provenance: Not explicitly stated, but given the manufacturer (evonos GmbH & CO. KG) is based in Germany, the testing was likely conducted in Germany or a location compliant with international standards referenced (ISO). The terms "retrospective or prospective" are not applicable to the type of device and testing described.

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

This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Ground truth, in this context, would refer to objective measurements of device performance (e.g., sterilization levels, mechanical integrity, functional features) rather than expert interpretation of medical images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This concept is not applicable to the acceptance criteria and testing described for this mechanical device. Adjudication methods are typically used in studies involving subjective interpretation, often by multiple readers, which is not the case here.

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:

Not applicable. This device is a mechanical cranial perforator, not an AI-based diagnostic or assistive software. No human reader study, AI assistance, or MRMC study was performed or mentioned.

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

Not applicable. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical properties and design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this mechanical device, the "ground truth" for the performance tests would be based on objective measurements and adherence to engineering and medical device standards (e.g., ISO standards).
- For biocompatibility: Lab results adhering to ISO 10993.
- For sterilization: Lab results showing a validated Sterility Assurance Level ($10^{-6}$) per ISO 11137.
- For cutting performance: Mechanical measurements of auto-stop functionality, drilling time, and resulting burr hole characteristics against defined specifications and implied comparison to predicate device performance. It doesn't involve medical "outcomes data" in the sense of patient follow-up or disease progression, but rather the immediate success of the mechanical function.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not applicable. As above, it's a mechanical device, not an AI model.

Summary

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March 6, 2024

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.

Evonos GmbH & Co. KG Jörg Mans CEO Stockacher Strasse 134 Tuttingen, Baden-Württemberg 78532 Germany

Re: K231403

Trade/Device Name: evoDrill Cranial Perforator Regulation Number: 21 CFR 882.4305 Regulation Name: Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBF Dated: December 8, 2023 Received: December 8, 2023

Dear Jörg Mans:

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).

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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 medical devices and radiation-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).

Pierce -S

Sincerely, Digitally signed by Adam D.

Adam D. Pierce -S Date: 2024.03.06 17:22:17 -05'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231403

Device Name evoDrill Cranial Perforator

Indications for Use (Describe)

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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510(k) Summary

Date Prepared: March 6, 2024

Owner's Name (21 CFR 807.92(a)(1):

Company Name:	evonos GmbH & CO. KG
Company Address:	Stockacher Strasse 134
D-78532 Tuttlingen, Germany

Contact Person:	Jörg Mans
Company Telephone:	+ 49 7461-965774-50
Company Fax:	+ 49 7461-965774-89
Email-Address:	j.mans@evonos.de

Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))

Device Trade Name:	evonos evoDrill Cranial Perforator
Device Common Name:	Disposable Cranial Perforator
Device Classification Name:	Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device Classification:	Class II
Classification Code:	HBF
Regulation Number:	21 CFR 882.4305

Predicate Device Names (21 CFR 807.92(a)(3))

Acra Cut Automatic Cranial Drill (DGR-1 #200-241; DGR-II #200-251) (K892866) (Primary) -
-Codman Disposable Perforators 26-1221 (K933894)

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DEVICE DESCRIPTION

The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.

Item Number	Item Description	InnerDiameter	OuterDiameter	BoneThickness
26-000002	evoDrill Cranial Perforator 9/6/1mm, 3-flutes	6mm	9mm	1-3mm
26-000003	evoDrill Cranial Perforator 9/6/3mm, 3-flutes	6mm	9mm	> 3mm
26-000004	evoDrill Cranial Perforator 11/7/1mm, 3-flutes	7mm	11mm	1-3mm
26-000005	evoDrill Cranial Perforator 11/7/3mm, 3-flutes	7mm	11mm	> 3mm
26-000006	evoDrill Cranial Perforator 13/9/1mm, 3-flutes	9mm	13mm	1-3mm
26-000007	evoDrill Cranial Perforator 13/9/3mm, 3-flutes	9mm	13mm	> 3mm
26-000008	evoDrill Cranial Perforator 14/11/1mm, 3-flutes	11mm	14mm	1-3mm
26-000009	evoDrill single use, Ø14/11mm, 3mm, 3-flutes	11mm	14mm	> 3mm

Item Number	Item Description	InnerDiameter	OuterDiameter	BoneThickness
26-409061	evoDrill Cranial Perforator 9/6/1mm, 4-flutes	6mm	9mm	1-3mm
26-409063	evoDrill Cranial Perforator 9/6/3mm, 4-flutes	6mm	9mm	> 3mm
26-411071	evoDrill Cranial Perforator 11/7/1mm, 4-flutes	7mm	11mm	1-3mm
26-411073	evoDrill Cranial Perforator 11/7/3mm, 4-flutes	7mm	11mm	> 3mm
26-413091	evoDrill Cranial Perforator 13/9/1mm, 4-flutes	9mm	13mm	1-3mm
26-413093	evoDrill Cranial Perforator 13/9/3mm, 4-flutes	9mm	13mm	> 3mm
26-414111	evoDrill Cranial Perforator 14/11/1mm, 4-flutes	11mm	14mm	1-3mm
26-414113	evoDrill Cranial Perforator 14/11/3mm, 4-flutes	11mm	14mm	> 3mm

Table 1: Item Description

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Image /page/6/Picture/2 description: The image shows a medical drill being used on a bone. The drill is labeled "evoDrill Made in Germany 14-11-1". The drill is silver with a blue handle. The bone is tan and brown.

Picture 1: Schematic illustration of the bone perforation

INDICATIONS FOR USE

Device	evoDrill	Codman Cranial Perforator	AcraCut Cranial Perforator
Manufacturer	evonos GmbH & Co. KG	Codman	AcraCut
510(k) Number	K231403	K933894	K892866
	(subject device)	(Predicate Device)	(Predicate Device)
Indications ForUse	The evoDrill Cranial Perforatorsare single-use surgical devicesfor cranium perforation. Theperforators with the 3mm stepautomatically release and stopperforating at cranial bonethickness of at least 3mm. Theperforators with the 1mm stepautomatically release and stopperforating at cranial bonethickness of at least 1mm.	The Codman disposablePerforator is for use inperforating the cranium. Whenproperly used, it is designed toautomatically disengage onceperforation is accomplished andwhen pressure is removed fromthe drill point.	The Acra Cut DGR-I, DGR-II andDGR-0 are designed toautomatically release and stopupon penetration of bone that isat least 3mm thick. The DGR-IIperforator is for use at thin skullareas such as pediatric,temporal and suboccipital areas.Thea are designed toautomatically release and stopupon penetration of bone asthin as 1mm.
Material	Plastic/ stainless steel /Aluminium	Plastic/ stainless steel	Plastic/ stainless steel
Fittings	Hudson	Hudson	Hudson

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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Device	evoDrill	Codman Cranial Perforator	AcraCut Cranial Perforator
Manufacturer	evonos GmbH & Co. KG	Codman	AcraCut
510(k) Number	K231403	K933894	K892866
	(subject device)	(Predicate Device)	(Predicate Device)
Prinicpal ofoperation	similar	similar	similar
CuttingPerformance	similar	similar	similar
Burr holediameter	14/11mm; 13/9mm; 11/7mm;9/6mm	14/11 mm; 11/8mm; 9/6mm	14/11mm; 13/9mm; 11/7mm
Bone Thicknesses	1mm and thicker	3mm and thicker	1mm and thicker
Releasemechanism	Automatic spring-loaded releasemechanism; The inner drill iscoupled with the housing oncean axial force is applied on thefitting and the tip of the drill hasto overcome resistance (bone),so that the resistance is higherthan the spring force of thecouple mechanism. Once theinner drill has pierced the skullbone, the resistance drops sothat the spring pressure ishigher than the resistance andthe inner drill is decoupled	SimilarAutomatic spring-loaded releasemechanism; The inner drill iscoupled with the housing oncean axial force is applied on thefitting and the tip of the drill hasto overcome resistance (bone),so that the resistance is higherthan the spring force of thecouple mechanism. Once theinner drill has pierced the skullbone, the resistance drops sothat the spring pressure ishigher than the resistance andthe inner drill is decoupled	SimilarAutomatic spring-loaded releasemechanism; The inner drill iscoupled with the housing oncean axial force is applied on thefitting and the tip of the drill hasto overcome resistance (bone),so that the resistance is higherthan the spring force of thecouple mechanism. Once theinner drill has pierced the skullbone, the resistance drops sothat the spring pressure ishigher than the resistance andthe inner drill is decoupled
Rotation speed	800 – 1500 rpm	800 – 1200 rpm	800 – 1200 rpm
How supplied	SterileSterilized by Radiation	SterileSterilized by Radiation	SterileSterilized by Radiation
Number ofCutting Flutes	3 / 4	4	4

Table 2: Device Comparison

Based on the information summarized above, the proposed evoDrill Cranial Perforators are similar to the currently marketed predicate and reference devices in indications for use, design, principle of operation and device material. All perforators are supplied in sterilized using radiation and for single use only.

PERFORMANCE TESTING

The following performance data were provided in support of the substantial equivalence determination:

Test	Method	Results
Biocompatibility	The device is classified as an externallycommunicating devices in contact with tissue/bonefor a limited duration (≤24hr). Biocompatibilitytesting was addressed in accordance with ISO 10993as described in FDA's Biocompatibility Guidance.	All biocompatibility testing confirmed thatthe device fulfills the biocompatibilityrequirements considering contact area andduration.
Sterilization andpackaging validationtesting	Sterilization validation testing in accordance with ISO11137-1, ISO 11137-2, ISO 11607-1 and ISO 11607-2.	All tested specimen confirm that devicesare sterile and the SAL of 10-6 is met.Shelf-Life validation confirmed the integrityof the product and packaging of the definedshelf-life, labeled on the device.

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Test	Method	Results
Cutting Performance	The performance of the subject device was evaluated for automatic stop function mechanism, maximum number of uses, drilling time and device geometry for establishing substantial equivalency to the predicate.	All tested specimen confirmed that the overall cutting performance related to the autostop function mechanism, drilling time and surface structure fulfilled the acceptance criteria

Table 3: Performance Testing

CONCLUSION

Based on the similarities of the intended use/indications for use, technological and functional characteristics, and the results of the non-clinical performance testing, the evonos evoDrill Cranial Perforators, are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).