ELAN 4 Air Motor System

K172907 · Aesculap, Inc. · HBB · Nov 9, 2018 · Neurology

Device Facts

• Record ID: K172907
• Device Name: ELAN 4 Air Motor System
• Applicant: Aesculap, Inc.
• Product Code: HBB · Neurology
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The ELAN 4 Air Motor System is a pneumatic surgical tool used for cutting, sawing, and drilling bone. It operates using sterile, pressurized gas (typically nitrogen) to power handpieces equipped with attachments like burrs, saw blades, and drills. The system includes wall adaptors, foot pedals, and various handpieces. A surgeon operates the device in clinical settings (Spine, ENT, Neuro, Maxillofacial surgery) using a foot pedal to control motor speed (up to 80,000 RPM for high speed; 1,000–20,000 RPM for low speed) and rotation direction. The device provides mechanical power to surgical instruments, enabling precise bone dissection. It benefits patients by facilitating surgical access and bone manipulation during procedures.

Clinical Evidence

Bench testing only. Design verification testing confirmed functionality, performance, and safety over a one-year service interval for all handpieces, foot controls, and motor hoses. Biocompatibility testing included cytotoxicity and hemolysis, yielding non-toxic results; other endpoints were addressed via risk assessment per ISO 10993-1.

Technological Characteristics

Pneumatic motor system; power source: pressurized gas (nitrogen). Materials: PEEK and stainless steel (ISO 7153-1). Components: handpieces, foot pedal, wall adaptors. High speed: 10,000–80,000 RPM; Low speed: 1,000–20,000 RPM. Connectivity: none. Sterilization: not specified. No software/algorithm.

Indications for Use

Indicated for high speed cutting, sawing, and drilling of bone in Spine, ENT, Neuro, and Maxillofacial surgical procedures.

Regulatory Classification

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.

Predicate Devices

• ELAN 4 Electro Motor System (K152960)
• Aesculap HiLan Motor System for Neurosurgery (K980686)

Submission Summary (Full Text)

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November 9, 2018

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 and 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.

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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:inline-block;">☒</div> 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.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Jessica Stigliano<br>610-984-9063 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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.

B.

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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 Motor<br>System (subject of this<br>submission) | Primary predicate:<br>ELAN 4 Electro Motor<br>System (K152960) | Reference predicate:<br>Aesculap® HiLan Motor<br>System for Neurosurgery<br>(K980686) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ELAN 4 Air Motor<br>System is intended for<br>high speed cutting,<br>sawing, and drilling of<br>bone in the fields of<br>Spine, ENT, Neuro, and<br>Maxillofacial Surgery. | The ELAN 4 Electro<br>motor system is intended<br>for high speed cutting,<br>sawing, and drilling of<br>bone in the fields of<br>Spine, ENT, Neuro, and<br>Maxillofacial Surgery. | Aesculap's HiLan Motor<br>System for Neurosurgery is a<br>pneumatic motor system<br>intended for use in surgical<br>procedures to provide power to<br>operate removable cutting<br>tools or drill bits on a patient's<br>skull. It is indicated for use in<br>neurosurgery. |
| Motor | | | |
| Power | Pneumatic | Electric | Pneumatic |
| High speed motor<br>Min/Max | 10,000/ 80,000 rpm | 10,000/ 80,000 rpm | Max: 90,000 rpm |
| Low speed motor<br>Min/Max | 1,000/ 20,000 rpm | 1,000/ 20,000 rpm | Max: 75,000 rpm |
| Motor rotation<br>High speed | Right hand/Clockwise | Left and right hand<br>rotation | Left and right hand rotation |
| Low speed | Left and right hand<br>rotation | Left and right hand<br>rotation | Left and right hand rotation |
| Materials | PEEK and Stainless<br>Steel | PEEK and Stainless Steel | Stainless Steel |
| Features | | | |
| Control mechanism<br>for speed | Foot Pedal | Foot Pedal | Foot Pedal |

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| Ability to connect<br>various Handpieces | Yes | Yes | Yes |
|------------------------------------------|-----|-----|-----|
| Footswitch<br>connections | 1 | 1 | 1 |

## PERFORMANCE DATA

#### Design Verification

| Test | Test Method Summary | Results |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Ensuring the function<br>between two service<br>intervals - Motor hose<br>with manual<br>control | Demonstrate functionality, performance features and the<br>safety of the product based on the intended use within a<br>service / Maintenance interval of (one year). | Pass: All requirements met |
| Ensuring the function<br>between two service<br>intervals for perforator<br>motor | Demonstrate functionality, performance features and the<br>safety of the product based on the intended use within a<br>service / Maintenance interval of (one year). | Pass: All requirements met |
| Ensuring the function<br>between two service<br>intervals - ELAN 4 AIR<br>Micros-Sagittal Saw | Demonstrate functionality, performance features safety of<br>the product | Pass: All requirements met |
| Ensuring the function<br>between two service<br>intervals - ELAN 4 AIR<br>Micro-Reciprocating<br>Saw | Demonstrate functionality, performance features safety of<br>the product | Pass: All requirements met |
| Ensuring the function<br>between two service<br>intervals - ELAN 4 air<br>high speed Handpiece | Demonstrate functionality, performance features and the<br>safety of the product based on the intended use within a<br>service / Maintenance interval of (one year). | Pass: All requirements met |
| Verification of ELAN 4<br>Air Foot Control | Simulation of an application of one year for the detection of<br>functionality, 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.