The ELAN 4 Air 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 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.

AI/ML Overview

The provided text is a 510(k) summary for the ELAN 4 Air Motor System, a pneumatic cranial drill motor. It does not describe a study involving an AI or algorithm-based device, human readers, or a test set with expert ground truth establishment. Instead, it describes a medical device (a surgical drill) and its performance validation through design verification and biocompatibility testing.

Therefore, I cannot answer your request as the information you've asked for (acceptance criteria for an AI/algorithm, sample size for AI test and training sets, expert consensus for ground truth, MRMC study, etc.) is not contained within the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices (other surgical drills) based on:

Indications for Use: The ELAN 4 Air Motor System is intended for high-speed cutting, sawing, and drilling of bone in various surgical fields.
Technological Characteristics: Comparison of components, power source (pneumatic vs. electric), operating speeds, rotation, materials, and control mechanisms.
Performance Data (Design Verification): Functional testing to ensure the device performs as intended and safely meets specifications over time. These tests are explicitly listed as "Pass: All requirements met."
Biocompatibility: Confirmation that materials used are safe for patient contact.

To reiterate, the provided text does not describe the kind of study you are asking about, which typically pertains to diagnostic or assistive AI software rather than mechanical surgical instruments.

Summary

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November 9, 2018

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Aesculap, Inc. Jessica Stigliano Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K172907

Trade/Device Name: ELAN 4 Air Motor System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: Class II Product Code: HBB Dated: April 2, 2018 Received: April 4, 2018

Dear Jessica Stigliano:

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

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

John Marler -S

For

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172907

Device Name ELAN 4 Air Motor System

Indications for Use (Describe)

The ELAN 4 Air 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)
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☒ Reproduction Use (Part 21 CFR 601 Subpart E)
☐ Same as Type Certification (21 CFR 601 Subpart C)

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 Air Motor System

November 8, 2018

COMPANY:	Aesculap®®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Jessica Stigliano610-984-9063 (phone)610-791-6882 (fax)jessica.stigliano@Aesculapimplants.com
TRADE NAME:	ELAN 4 Air Motor System
COMMON NAME:	Motor, drill, Pneumatic
REGULATION NUMBER:	882.4370 - Pneumatic cranial drill motor
PRODUCT CODE:	HBB
REVIEW PANEL:	Neurology

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the ELAN 4 Air Motor System is substantially equivalent to the primary predicate, ELAN 4 Electro Motor System (K152960), and reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686).

DEVICE DESCRIPTION

The ELAN 4 Air 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 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.

INDICATIONS FOR USE

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

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TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))

The ELAN 4 Air Motor System is substantially equivalent to the primary predicate, ELAN 4 Electro Motor System (K152960), and reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686). The subject device is shown to be substantially equivalent and has the same performance characteristics to its primary predicate device and reference predicate device through comparison in design, principles of operation, intended use, and materials. A comparison table summarizing these characteristics can be found below.

The ELAN 4 Air Motor System offers similar components, attachments, and operating speeds when compared to the primary predicate. The main difference between the ELAN 4 Air Motor System and the ELAN 4 Electro Motor System is the source of power for the motor. The ELAN 4 Electro Motor System is operated by an electric motor, while the ELAN 4 Air Motor System is operated by a pneumatic motor. There is no software involved in the ELAN 4 Air Motor System. Similar to the devices that are subject to this submission, the reference predicate, Aesculap® HiLan Motor System for Neurosurgery (K980686) also uses a pneumatic power source.

System	ELAN 4 Air MotorSystem (subject of thissubmission)	Primary predicate:ELAN 4 Electro MotorSystem (K152960)	Reference predicate:Aesculap® HiLan MotorSystem for Neurosurgery(K980686)
Indications for Use	The ELAN 4 Air MotorSystem is intended forhigh speed cutting,sawing, and drilling ofbone in the fields ofSpine, ENT, Neuro, andMaxillofacial Surgery.	The ELAN 4 Electromotor system is intendedfor high speed cutting,sawing, and drilling ofbone in the fields ofSpine, ENT, Neuro, andMaxillofacial Surgery.	Aesculap's HiLan MotorSystem for Neurosurgery is apneumatic motor systemintended for use in surgicalprocedures to provide power tooperate removable cuttingtools or drill bits on a patient'sskull. It is indicated for use inneurosurgery.
Motor
Power	Pneumatic	Electric	Pneumatic
High speed motorMin/Max	10,000/ 80,000 rpm	10,000/ 80,000 rpm	Max: 90,000 rpm
Low speed motorMin/Max	1,000/ 20,000 rpm	1,000/ 20,000 rpm	Max: 75,000 rpm
Motor rotationHigh speed	Right hand/Clockwise	Left and right handrotation	Left and right hand rotation
Low speed	Left and right handrotation	Left and right handrotation	Left and right hand rotation
Materials	PEEK and StainlessSteel	PEEK and Stainless Steel	Stainless Steel
Features
Control mechanismfor speed	Foot Pedal	Foot Pedal	Foot Pedal

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Ability to connectvarious Handpieces	Yes	Yes	Yes
Footswitchconnections	1	1	1

PERFORMANCE DATA

Design Verification

Test	Test Method Summary	Results
Ensuring the functionbetween two serviceintervals - Motor hosewith manualcontrol	Demonstrate functionality, performance features and thesafety of the product based on the intended use within aservice / Maintenance interval of (one year).	Pass: All requirements met
Ensuring the functionbetween two serviceintervals for perforatormotor	Demonstrate functionality, performance features and thesafety of the product based on the intended use within aservice / Maintenance interval of (one year).	Pass: All requirements met
Ensuring the functionbetween two serviceintervals - ELAN 4 AIRMicros-Sagittal Saw	Demonstrate functionality, performance features safety ofthe product	Pass: All requirements met
Ensuring the functionbetween two serviceintervals - ELAN 4 AIRMicro-ReciprocatingSaw	Demonstrate functionality, performance features safety ofthe product	Pass: All requirements met
Ensuring the functionbetween two serviceintervals - ELAN 4 airhigh speed Handpiece	Demonstrate functionality, performance features and thesafety of the product based on the intended use within aservice / Maintenance interval of (one year).	Pass: All requirements met
Verification of ELAN 4Air Foot Control	Simulation of an application of one year for the detection offunctionality, Performance and safety of the product	Pass: All requirements met

Biocompatibility

The materials in the ELAN 4 Air Motor System are exactly the same materials used in the ELAN 4 Electro Motor System. There have been no materials changes since the clearance of the ELAN 4 Electro Motor System (K152960). The ELAN 4 Air Motor System materials and biocompatibility conform to the following standards;

ISO 10993-1: Evaluation and testing within a risk management process ISO 7153-1: Surgical instruments -- Metallic materials -- Part 1: Stainless steel

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Biocompatibility testing within this submission includes cytotoxicity and hemolysis testing. The biocompatibility test results for cytotoxicity and hemolysis yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.

CONCLUSION

The design verification and biocompatibility information along with a comparison between the technology, materials and intended use for the ELAN 4 Air Motor System and the predicate devices demonstrate that the ELAN 4 Air Motor System is as safe, as effective, and performs as well as the predicate devices. The design verification, biocompatibility information and technological comparison demonstrates that the ELAN 4 Air Motor System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

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