The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Device Description

The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc.

The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the ELAN 4 Electro Motor System, not an AI/ML powered device. As such, information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC) that would typically apply to AI/ML devices is not applicable or present in this document.

The document discusses "performance data" in the context of:

Bench testing: In-house design verification to ensure mechanical and functional requirements, including design specifications, were met.
Biocompatibility: Evaluation according to ISO-10993.
Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and UL 2601-1 standards for safety and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing: Conducted in accordance with FDA guidance for software in medical devices, with the software considered a "moderate" level of concern.

Summary of available information:

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

Test	Test Method Summary	Acceptance Criteria	Reported Performance (Results)
Ensuring the function between two service intervals for the ELAN 4 Electric Drill	Demonstrate functionality, performance characteristics, and the safety of the product based on the intended use within a service interval of one year.	All requirements to be met	Pass: All requirements met
Verification of the reactions times of the ELAN 4 Wireless Foot Control	Demonstrate the reaction time in the time between changing the logic level of the function and change in the button status byte.	All requirements to be met	Pass: All requirements met
Biocompatibility	Evaluation according to International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and FDA Guidance.	Compliance with ISO-10993 standards	Compliant based on material equivalence to predicate devices.
Electrical Safety and EMC (Control Unit, Wireless Foot Control, and Drill)	Testing conducted on the ELAN 4 Electro Motor System.	Compliance with IEC 60601-1, UL 2601-1, and IEC 60601-1-2.	Complies with the specified standards.
Software Verification and Validation Testing (ELAN 4 Software V3.00)	Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Documentation provided as recommended.	Documentation provided, software assessed as "moderate" level of concern.

2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are primarily engineering and regulatory compliance tests, not studies involving datasets for AI/ML performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to established engineering specifications, regulatory standards, and functional requirements for the device.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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August 24, 2021

Aesculap Inc. Kathy Racosky Project Manager I 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K203739

Trade/Device Name: ELAN 4 Electro Motor System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: July 28, 2021 Received: July 28, 2021

Dear Kathy Racosky:

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/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.

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 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).

Sincerely,

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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Indications for Use

510(k) Number (if known) K203739

Device Name ELAN 4 Electro Motor System

Indications for Use (Describe)

The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY (as required by 21 CFR 807.92)

ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments August 24, 2021

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com
TRADE NAME:	ELAN 4 Electro Motor System
COMMON NAME:	Drills, Burrs, Trephines & Accessories (Simple, Powered)
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Powered simple cranial drills, burrs, trephines and their accessories
REGULATION NUMBER:	882.4310
PRODUCT CODE:	HBE

Predicate device Aesculap ELAN 4 Electro Motor System, K152960. Reference device Aesculap Microspeed Uni Motor System, K053526

Indications for Use

The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Device description

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Technological characteristic (compared to Predicate(s))

The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are substantially equivalent to the predicate. ELAN 4 Electro Motor System (K152960) and the reference predicate MicroSpeed Uni Motor System (K053526). The subject device is shown to be substantially equivalent and has the same performance characteristics to the primary predicate device through comparison in design, principles of operation and indications for use. The subject device offers similar components, operating speeds, and power sources as the predicate device. The proposed device has some differences in technological features in comparison to the predicate device. The proposed device has a wireless foot control versus the plug in foot control for the predicate device. The subject device is manufactured from Titanium, PEEK and Stainless Steel whereas the predicate device is made from PEEK and Stainless Steel. Similar to the devices that are subject to this submission, the reference predicate, is manufactured from Titanium. The subject device has a permanently attached motor cable when compared to the plug in motor cable of the predicate device. The device characteristics comparing the ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments to the predicate device are summarized in the substantial equivalence comparison table.

System	ELAN 4 Electro Motor System	PredicateELAN 4 Electro Motor System	Reference DeviceMicrospeed Uni Motor System
K#	K203739	K152960	K053526
Indications for Use:	The Elan 4 Electro motor system is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.	The Elan 4 Electro motor system is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.	Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Control Unit:
Software version	3.00	1.03	N/A
Foot Control:
Type	Wireless	Plugs into control unit	Plugs into control unit
Activates motor of hand-piece	Yes	Yes	Yes
Controls	Speed, rotation and irrigation pump	Speed, rotation and irrigation pump	Speed, rotation and irrigation pump
Hand-piece:
Type	Drill	Various	Various
Integrated motor	Yes	Yes	Yes
Motor cable	Permanent	Separate cable	Separate cable
Controls speed and rotation	Yes	No	No
Attachments	Yes	No	Yes
Motor:
Low speed motor Min/Max	1,000/ 20,000 rpm	1,000/ 20,000 rpm	3,000 rpm / 40,000 rpm

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System	ELAN 4 Electro MotorSystem	PredicateELAN 4 Electro Motor System	Reference DeviceMicrospeed Uni MotorSystem
K#	K203739	K152960	K053526
Low speed	Left and right handrotation	Left and right hand rotation	Left and right hand rotation
Materials:	Titanium, PEEK andStainless Steel	PEEK and Stainless Steel	Titanium

Performance data

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

Bench testing

In house design verification testing was performed to ensure that mechanical and functional requirements including design specifications were met. All tests completed met their preestablished acceptance criteria.

Test	Test Method Summary	Results
Ensuring the functionbetween two serviceintervals for the ELAN 4Electric Drill	Demonstrate functionality,performance characteristicsand the safety of the productbased on the intended usewithin service interval of oneyear.	Pass: All requirements met
Verification of the reactionstimes of the ELAN 4Wireless Foot Control	Demonstrate the reaction timein the time between changing thelogic level of the function and changein the button status byte	Pass: All requirements met

Biocompatibility

A biocompatibility evaluation was conducted according to International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, as appropriate for limited exposure (≤ 24 hours) externally communicating device with contact in the area of tissue/bone/dentin devices.

The materials of the Wireless Foot Control. Drill and Attachments are the same types of materials used in the predicate and reference device. There have been no material changes since the clearance of the ELAN 4 Electro Motor System (K152960) and Microspeed Uni Motor System (K053526).

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Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the ELAN 4 Electro Motor System. The control unit, wireless foot control and drill were tested as part of the ELAN 4 Electro Motor System. The system complies with the IEC 60601-1 and UL 2601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor Injury.

Animal and Clinical Testing

No animal or clinical testing was necessary for determination of substantial equivalence.

Conclusion

Based on the indications for use, design, materials, function, comparison to the predicate device, and performance testing performed, it can be concluded that the ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are substantially equivalent to the predicate, ELAN 4 Electro Motor System (K152960).

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).