ELAN 4 Electro Motor System Tools

K172709 · Aesculap, Inc. · HBE · Oct 17, 2018 · Neurology

Device Facts

• Record ID: K172709
• Device Name: ELAN 4 Electro Motor System Tools
• Applicant: Aesculap, Inc.
• Product Code: HBE · Neurology
• Decision Date: Oct 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery

Device Story

ELAN 4 Tools are stainless steel cutting accessories (burrs, drills, blades) designed for use with the ELAN 4 Electro Motor System; used for high-speed bone cutting, sawing, and drilling in Spine, ENT, Neuro, and Maxillofacial surgery. Tools feature specific attachment mechanisms for motor compatibility. Operated by surgeons in clinical settings. Device output is mechanical bone resection; clinical benefit is precise bone removal during surgical procedures. Bench testing confirms performance at speeds up to 100,000 rpm for burrs and 20,000 rpm for blades.

Clinical Evidence

Bench testing only. Testing included rotating performance (up to 100,000 rpm), functional tool adaptation/locking, oscillation frequency/fatigue testing for blades, and thermal evaluation of bone temperature during use. Biocompatibility testing (cytotoxicity, hemolysis) per ISO 10993-1 yielded non-toxic results. Sterilization validated per ISO 11137.

Technological Characteristics

Materials: Stainless steel. Principle: Mechanical bone resection via high-speed motor-driven tools. Form factor: Burrs, drills, and sagittal/reciprocating blades. Connectivity: Mechanical attachment to ELAN 4 Electro Motor System. Sterilization: Gamma irradiation. Standards: ISO 10993-1 (biocompatibility), ISO 11137 (sterilization), ISO 11607 (packaging).

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• Anspach Dissection Tools (K113476)

Reference Devices

• Aesculap ELAN 4 Electro Motor System (K152960)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 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.

October 17, 2018

Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K172709

Trade/Device Name: ELAN 4 Tools 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: September 7, 2017 Received: September 8, 2017

Dear Ms. 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

{1}------------------------------------------------

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 (OS) 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,

# Matthew C. Krueger -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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172709

Device Name Aesculap ELAN 4 Tools

#### Indications for Use (Describe)

Aesculap ELAN 4 Tools are 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> <span> <span style="font-size:16px">✔</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### Page 1 of 4

#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

## Aesculap ELAN 4 Tools October 15, 2018

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| TRADE NAME: | ELAN 4 Tools |
| COMMON NAME: | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Powered simple cranial drills, burrs, trephines and their<br>accessories |
| REGULATION NUMBER: | 882.4310 |
| PRODUCT CODE: | HBE |

### SUBSTANTIAL EQUIVALENCE

The ELAN 4 Tools are substantially equivalent to the primary predicate, Anspach Dissection Tools (K113476) and the reference predicate, Aesculap ELAN 4 Electro Motor System (K152960).

#### DEVICE DESCRIPTION

The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.

#### INDICATIONS FOR USE

The ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

{4}------------------------------------------------

#### Page 2 of 4

# TECHNOLOGICAL CHARACTERISTICS (compared to predicate)

The ELAN 4 Tools are substantially equivalent to the predicate, Anspach Dissection Tools (K113476) and the reference predicate ELAN 4 Electro Motor System (K152960). The subject device is shown to be substantially equivalent and has the same performance characteristics to its primary predicate device through comparison in design, principles of operation, intended use, and materials. The subject device has the exact same indications as the reference predicate. A comparison table summarizing these characteristics can be found below.

The ELAN 4 Tools offers similar components when compared to the primary predicate. Anspach Dissection Tools (K113475). The only difference is the subject device is also offered in a blade type design. Bench testing determined that the blade design does not raise new questions of safety and effectiveness. Similar to the devices that are subject to this submission, the reference predicate, ELAN 4 Electro Motor System (K152960) also has the same indications for use.

| | Aesculap Inc.<br>ELAN 4 Tools | Anspach Dissection Tool | Aesculap, Inc.<br>ELAN 4 Electro Motor<br>System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K172709 | K113476 - Primary | K152960 |
| Indications | The ELAN Tools are<br>intended for high speed<br>cutting, sawing, and<br>drilling of bone in the<br>fields of Spine, ENT,<br>Neuro, and Maxillofacial<br>Surgery. | Dissection tools are<br>intended for cutting and<br>shaping bone including<br>spine and cranium. | 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. |
| Regulation number | 882.4310 | 882.4310 | 882.4310 |
| Product Code | HBE | HBE | HBE |
| Regulatory Panel | Neurology | Neurology | Neurology |
| Tools | | | |
| Burrs & drills | | | |
| --Size | 0.6 mm to 9 mm | 0.5 mm to 24.5 mm | N/A |
| --Type | fluted, ball, conical, oval,<br>barrel, acorn, pin, twist,<br>drills, cutters, and discs | fluted, ball, conical, oval,<br>barrel, acorn, pin, twist,<br>drills, cutters, and discs | N/A |
| Blades | Sagittal & reciprocating | N/A | N/A |
| Materials | Stainless Steel | Stainless Steel, diamond | N/A |
| Attachment mechanism | Yes | Yes | N/A |
| Sterile Single Use | Yes | Yes | N/A |
| Sterilization | GAMMA irradiation | unknown | N/A |

# PERFORMANCE DATA

### Biocompatibility Testing

Biocompatibility testing in accordance to ISO 10991-1 and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -1 Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff has been performed to demonstrate that the ELAN 4 Tools are substantially equivalent to other predicate devices.

{5}------------------------------------------------

Page 3 of 4

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

#### Sterilization Validation

Product sterilization is validated in accordance with the ANSI/AAMI/ ISO 11137-1:2006 -Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006 - Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.

Packaging is validated per ISO 11607. Accelerated aging data (5 years) for ELAN 4 Tools has been generated to support this submission. Bacterial Endotoxin testing per Endotoxin ISO 10993-5 met the acceptance criterion.

#### Bench Testing

The following bench testing was performed to demonstrate that the ELAN 4 Tools perform as intended and are substantially equivalent to the predicate devices.

| Test | Test Summary | Results |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Rotating performance test for<br>burrs and disc | Design not suitable, suitable<br>for speeds up to 100,000 rpm | Pass |
| Functional testing of the tool<br>adaptation with small blade | Distal tool adaptation and<br>burr release mechanism,<br>locks during use | Pass |
| Measurement of oscillation<br>frequency and fatigue test<br>(small blade) | Downforce oscillation output<br>frequencies 0 to 20,000 rpm<br>at the distal tool adaptation. | Pass |
| Measurement of oscillation<br>frequency and fatigue test<br>(large blade) | Distal tool adaptation and<br>burr release mechanism,<br>locks during use. Downforce<br>oscillation output frequencies<br>0 to 20,000 rpm at the distal<br>tool adaptation. | Pass |
| Measurement of temperature | With constant pressure and<br>regular irrigation, evaluated<br>bone temperature increase<br>after milling, drilling or<br>cutting | Pass |

{6}------------------------------------------------

#### CONCLUSION:

Page 4 of 4

The biocompatibility and bench testing results along with a comparison between the technology, materials and intended use for the ELAN 4 Tools and the predicate devices demonstrate that the ELAN 4 Tools are as safe, as effective, and perform as well as the predicate devices. The biocompatibility and bench testing results and technological comparison demonstrates that the ELAN 4 Tools are substantially equivalent to the predicate devices.